Estrace - woman s health, mevaren

Common use Estrace belongs to the class of medications named estrogen replacement therapy. Estrogen is a hormone produced by the ovaries, specific estrogen-receptors are located in different organs (in the uterus, vagina, urethra, mammary glands, liver, hypothalamus, pituitary) and stimulates development and growth of female sex organs starting from puberty: uterus, fallopian tubes, vagina, stroma and ducts of mammary glands, pigmentation of nipples and genitals, formation of secondary sexual characteristics of female type, formation of epiphyses of long bones. Estrogen is responsible for the timely and regular rejection of the endometrium and bleeding, in high concentrations estrogen causes endometrial hyperplasia, suppresses lactation, inhibits bone resorption. Estrace is used to treat menopause symptoms which include hot flashes, and vaginal dryness, burning, and irritation. It is also used for treatment of cancer in women and men and osteoporosis.

Dosage and direction Take exactly as prescribed by your doctor, follow all recommendations. Estrace tablets should be taken one time a day. In women a cyclic regimen may be administered: 23 days the tablets are taken, followed by the next 5 days without any medication intake. After that the cycle resumes. The adhesive part of the patch should be sticked to a hairless part of trunk (hips, shoulder but not on the breasts), choose non-irritated healthy skin site. Change the place of plaster application each other week. Stick it immediately to the skin after you removed a protective layer and press tight to your skin during at least 10 seconds.

Precautions Before taking Estrace inform your doctor if you have severe blood diseases, circulation problems, a hormone-related cancer (breast or uterine cancer), or excessive vaginal bleeding. Long-term treatment by Estrace may result in increased risk of breast cancer, heart attack, or stroke, it cannot be used in pregnant women.

Contraindications Hypersensitivity, pregnancy, estrogen depending malignant neoplasms, unusual or undiagnosed genital and uterine bleeding, thrombophlebitis or thromboembolic disease in active phase (excluding treatment of breast and prostate cancer). Carefulness should be exercised in patients with thrombophlebitis, thrombosis or thromboembolism (during the intake of estrogens in history); family hyperlipoproteinemia, pancreatitis, endometriosis, gallbladder disease in history, severe liver failure, jaundice, hepatic porphyria, hypercalcemia associated with metastases in bones caused by a breast cancer. Only for treatment of breast and prostate cancer: diseases of the coronary or cerebral vessels, active thrombophlebitis or thromboembolic disease.

Possible side effect Common side effects include: breast pain or tenderness; headache; hair loss; spotting or breakthrough bleeding; mild nausea or vomiting;stomach cramps or bloating. Serious side effects are allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

Estrogen can inhibit the metabolism of cyclosporine resulting in increase of its levels in blood and kidney and/or liver damage. Estrogen may increase the risk of liver disease in patients treated by dantrolene. Known to affect a clot formation Estrace should be used carefully together with warfarin (Coumadin). Enhanced metabolism and excretion of Estrace may be stipulated by rifampin, barbiturates, carbamazepine (Tegretol), griseofulvin, phenytoin (Dilantin) and primidone.

Missed dose If you missed a dose take it as soon as you remember, but not if it is almost time of the next intake by your schedule. If so skip the missed dose. Do not try to make up a missed dose by taking an extra one.

Overdose If you suspect that you took too much of the medication seek for immediate medical attention. Your symptoms may appear as nausea, vomiting, or vaginal bleeding.

Storage Store Estrace in a dry tight container away from sunlight at room temperature between 15-30 C (59-86 F) away from children and pets.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. °ßã specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Amlodipine oral uses, side effects, interactions, pictures, warnings - dosing, norvasc 2.5mg

amlodipine

GENERIC NAME(S): AMLODIPINE BESYLATE

Uses

Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks. and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily.

Amlodipine is also used to prevent certain types of chest pain (angina ). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin ) to relieve attacks of chest pain as directed by your doctor.

How to use amlodipine

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The dosage is based on your medical condition and response to treatment. Your doctor may gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

If used for angina, this medication must be taken regularly to be effective. It should not be used to treat angina when it occurs. Use other medications (such as sublingual nitroglycerin) to relieve an angina attack as directed by your doctor. Consult your doctor or pharmacist for details.

Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase, chest pain continues or worsens).

Side Effects

Dizziness. lightheadedness, swelling ankles /feet, or flushing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, fainting .

Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating ).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: rash. itching /swelling (especially of the face/tongue /throat), severe dizziness, trouble breathing .

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda. gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking amlodipine, tell your doctor or pharmacist if you are allergic to it; or to other dihydropyridine calcium channel blockers (such as nisoldipine. nifedipine) or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain structural heart problem (aortic stenosis), very low blood pressure. liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness.

During pregnancy. this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast - feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough - and-cold products, diet aids. or NSAIDs such as ibuprofen /naproxen ).

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fainting, severe dizziness.

Notes

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising. stopping smoking. reducing stress, and eating a low-cholesterol /low-fat diet. Consult your doctor for more details.

Lab and/or medical tests (such as blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Storage temperature ranges differ according to different manufacturers, so consult your pharmacist for more information. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

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Ciplar 10mg tablet cipla use, composition, dosage, side effect, price and review - tablet tree, cipl

Ciplar 10MG

Ciplar Tablet - Uses, Composition, Dosage, Side Effects & Reviews

Ciplar is manufactured by Cipla Ltd. to give the best treatment for the high blood pressure. The high blood pressure may cause uneven heartbeat and leads to other heart diseases. This also treats and prevents you from the abnormal heart rhythm. It is also beneficial in other conditions such as during uncontrolled shaking (tremors) and anxiety. In fact, it also treats migraine headaches and chest pain problems. This drug is also used to prevent bleeding in the food pipe in patients with liver diseases who have swollen blood vessels.

It is safe to use at prescribed doses as guided by your doctor. It contains Propranolol, as an active ingredient which belongs to a drug category called beta blockers. It inhibits the action of chemicals in the body (such as epinephrine). As a result, it lowers the blood pressure, heart rate and stress on the heart.

Ciplar is useful to treat various disease conditions, especially to treat the high blood pressure. It is available online at low price at the Tablet Tree.

Ciplar Tablet Uses

Propranolol belongs to a drug class known as beta blockers. It works by inhibiting the action of natural chemicals in the body (such as epinephrine) which affect the functioning of the heart and blood vessels. Therefore, it decreases the blood pressure, heart rate and strain on the heart.

Ciplar Tablet Composition

Ciplar Tablet Dosage

The general recommended dose of this drug is 40 to 240 mg/day.

Hypertension . The initial dose of this drug starts with 80 mg once daily or in 2 divided doses and gradually increases up to 320 mg/day based on patient's response. Please consult your doctor and follow his or her recommendations. Please do not self medicate.

Ciplar Tablet Side Effects

Side effects are unwanted effects of a drug. The side effects of this drug are as follows:

Heart Related . Worsening of heart failure and shortness of breath

Other symptoms . Cold extremities, skin rash, bruising, severely restricted blood flow to the fingers and toes, altered number and types of blood cells, vomiting, low blood pressure/fainting on standing, diarrhea, nosebleeds, tiredness, dizziness, nightmares and difficulty in sleeping

Other Information on Ciplar Tablet:

Pharmaceutical Form

Available strengths

The drug is available in the dosage strengths of 40 mg and 10 mg.

Precautions

Do not skip doses or stop using this drug suddenly before your doctor’s consent

This drug can cause dizziness for the first few days, so avoid driving and performing activities that require you to be alert till the drug effect gets lessen

Avoid drinking alcohol during getting treatment with this drug

Avoid getting up too fast from a sitting or a lying position to prevent a fall

Check your blood pressure after one week and consult your doctor if it has not improved

Do not take this drug if you are allergic to propranolol hydrochloride or any of the other ingredients of this medicine

Drug–Drug Interaction

Drug interactions may change how your medications work or increase the risk for serious side effects. This drug reacts with the following drugs:

Blood thinner: Warfarin, Coumadin, Jantoven

Antidepressant: Amitriptyline, clomipramine, desipramine, imipramine and others

Drugs to treat high blood pressure or a prostate disorder: Doxazosin, prazosin, terazosin

Heart or blood pressure medicine: Amiodarone, diltiazem, propafenone, quinidine, verapamil and others

NSAIDs (nonsteroidal anti-inflammatory drugs): Aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others steroid medicine: Prednisone and others

Overdose

When Ciplar is taken in excessive amount, the following symptoms can occur:

Symptoms . Slow or uneven heartbeats, dizziness, weakness, or fainting

Management . Seek emergency medical attention or call the Poison Help line.

Contraindications

Ciplar is contraindicated in patients with the following conditions:

Cardiogenic shock (a condition in which your heart suddenly can't pump enough blood)

Sinus bradycardia (heart rate that is lower than normal) and greater than first-degree block

Bronchial asthma (inflammatory disease of the respiratory tract)

Patients with known hypersensitivity to propranolol hydrochloride

Storage

Store this drug at controlled room temperature between 20 to 25 degree celsius in a well closed container.

Manufacturer

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Disclaimer: In compliance with the Indian Government's Drug and Cosmetic Act and Rules, we do not process requests for Schedule X and other habit forming drugs. For Schedule H and H1 drugs, you will need to upload a valid prescription from a registered medical practitioner before we can process your order.

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Dose for viagra

I take 25mg on an empty stomach with a tall glass of water at 8:00AM. It takes effect in 15 minutes on the average and out love-making session goes for over an hour every time. - Age 65, Florida

I decided to try a 25mg Viagra pill. I could feel my penis get erect within 15 minutes, getting harder than usual and lasting longer too - YT, Age 45, Nigeria

A full 100 mg. will give you a Ginsu carving knife that, if put to ultimate use, will render her suitable for burial in a Y-shaped coffin. For most of us, 50 mg. is plenty, ensuring that you can return to a deflated state between orgasms, if so desired. But you may have to picture your grandmother naked, to do so.

The effects last 3 or 4 hours, and it takes 30 to 45 minutes to kick in. 25 or 50 mg tabs work the same for me, no difference. Go for it. - Art, Age 62, Texas

I bought a pill cutter at the grocery store and cut a 50 mg pill in half. It worked faster than a 1/2 hour and I had the first complete sexual experience in over 6 YEARS! William, Age 42, Texas

25mg is best for me and I have found that Viagra makes me a super stud and the girl rides me and always has an orgasm or two. - Pablo, 42, Texas

I find that 25 mg two hours prior to sex is best for me, and allows sensitivity, to remain at its peak. When trying 50 or 100,mg, it took away much of the feeling, and you need stimulation to maintain erection. More is definitely not better, in my case. - Phil, Age 60, California

25mg begins to work in about 15 minutes to a half an hour and lasts for 3 hours or so, Able to have an erection and intercourse more than once in a few hours. - Age 65, New York City

My doctor prescribed 50 mg Viagra. Wow. Instant hard on that lasts for a long time. I take 50 mg about three times a week.

I have tried 100mg from time to time but actually seem to do better with the smaller doses. - JR, Age 65

You have to experiment with the dosage and time lag. I started with 50 mg (good to rev my engine, I think) but ultimately found that 25 mg about 90 minutes before sex is ideal for me. Lower dosage means less nasal congestion and more feeling during sex. But 25 mg still leaves me rock hard and able to hold off climaxing just about as long as I want.

I have experimented with dosage and now find that 25 mg about one half hour before sex is perfect for me. I'm rock hard and can go forever.

I have the pharmacist split a 100 mg pill in four for me so I take 25 mg at a time. When I want to go all night I take the full 100 mg.

I cut a 50 mg in half and find that to be enough.

We came at the same time, and boy did I cum. What force! What makes this whole experience ever better is that I only used half of a 50 mg pill.

I started off with 25 mg, and have reduced it down to 12.5 mg (roughly - I split the 100 mg pill to 8) and find that with this reduced dose, I can still have a rock hard erection as well as a greatly reduced headache.

I have since realized I only need 25mg to keep and maintain an erection. But originally, that night, I took 50mg. - Bill, Chicago, Age 42

Viagra Dosage

The recommended starting Viagra dosage is 50 mg, taken one hour prior to sexual activity. The maximum recommended dose is 100 mg. A few of the factors that can affect your dose of this medication include your age, other medical conditions you may have, and any medications you may be currently taking. You must take the medication as prescribed in order for it to work properly.

An Introduction to Viagra Dosage

The dose of Viagra ® (sildenafil citrate ) your healthcare provider recommends will vary, depending on a number of factors, including:

Your age

Other medical conditions you may have

Other medications you may be taking.

As always, do not adjust your dosage unless your healthcare provider specifically instructs you to do so.

What Is the Dose of Viagra for Erectile Dysfunction?

The recommended starting dosage of Viagra for treating erectile dysfunction is 50 mg, taken one hour prior to sexual activity. However, you may take the drug anywhere from 4 hours to 30 minutes before sexual activity. Depending on how well it works or possible Viagra side effects you may experience, your healthcare provider may increase or decrease your dosage. The maximum recommended dose is Viagra 100 mg.

General Dosing Information

Considerations for people taking Viagra include the following:

The medication can be taken at any time during the day. However, you should not take Viagra more than once a day.

Your Viagra dosage can be taken with or without food.

For Viagra to work properly, you have to take it as prescribed. The medication will not work if you take it in a way other than how your healthcare provider prescribes.

If you are unsure about anything related to your proper dose of this medication, please talk to your doctor, nurse, or pharmacist.

Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD

Last reviewed by: Kristi Monson, PharmD;

* Reported during post-marketing surveillance only

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia

***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. mhra. gov. uk/yellowcard

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www. hpra. ie ; E-mail: [email protected] ie .

In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. ATC Code: G04B E03.

Mechanism of action

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i. e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.

Clinical efficacy and safety

Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine diastolic blood pressure was 5.5 mmHg. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.

In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.

A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates). The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina.

Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).

Further information on clinical trials

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).

In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.

Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%). The safety and efficacy of sildenafil was maintained in long term studies.

The European Medicines Agency has waived the obligation to submit the results of studies with VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction. See section 4.2 for information on paediatric use.

5.2 Pharmacokinetic properties

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range (25-100 mg).

When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in t max of 60 minutes and a mean reduction in C max of 29%.

The mean steady state volume of distribution (V d ) for sildenafil is 105 l, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%). Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM). Protein binding is independent of total drug concentrations.

In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h.

The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).

Pharmacokinetics in special patient groups

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years). Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.

In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. The mean AUC and C max of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment. However, due to high inter-subject variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance < 30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and C max of 100% and 88% respectively compared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and C max values were significantly increased by 200% and 79% respectively.

In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and C max (47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.

5.3 Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

6. Pharmaceutical particulars

CLINICAL PHARMACOLOGY

Mechanism Of Action

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.

Binding Characteristics

Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, > 80-fold for PDE1, > 700-fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). Sildenafil is approximately 4,000-fold more selective for PDE5 compared to PDE3. PDE3 is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina which is involved in the phototransduction pathway of the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision [see Pharmacodynamics ].

In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle. brain, heart, liver, kidney, lung, pancreas, prostate. bladder. testis, and seminal vesicle. The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro, an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo .

Pharmacodynamics

Effects of VIAGRA on Erectile Response

In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan®), after VIAGRA administration compared with placebo. Most studies assessed the efficacy of VIAGRA approximately 60 minutes post dose. The erectile response, as assessed by RigiScan®, generally increased with increasing sildenafil dose and plasma concentration. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.

Effects of VIAGRA on Blood Pressure

Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic /diastolic blood pressure of 8.3/5.3 mmHg). The decrease in sitting blood pressure was most notable approximately 1-2 hours after dosing, and was not different than placebo at 8 hours. Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of VIAGRA, therefore the effects are not related to dose or plasma levels within this dosage range. Larger effects were recorded among patients receiving concomitant nitrates [see CONTRAINDICATIONS ].

Figure 1: Mean Change from Baseline in Sitting Systolic Blood Pressure, Healthy Volunteers

Effects of VIAGRA on Blood Pressure When Nitroglycerin is Subsequently Administered

Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL). In the following patients: age > 65 years, hepatic impairment (e. g. cirrhosis ), severe renal impairment (e. g. creatinine clearance < 30 mL/min), and concomitant use of erythromycin or strong CYP3A4 inhibitors, plasma levels of sildenafil at 24 hours post dose have been found to be 3 to 8 times higher than those seen in healthy volunteers. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see CONTRAINDICATIONS ].

Effects of VIAGRA on Blood Pressure When Co-administered with Alpha-Blockers

Three double-blind, placebo-controlled, randomized, two-way crossover studies were conducted to assess the interaction of VIAGRA with doxazosin, an alpha-adrenergic blocking agent.

Study 1: VIAGRA with Doxazosin

In the first study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia (BPH). Following at least 14 consecutive daily doses of doxazosin, VIAGRA 100 mg or matching placebo was administered simultaneously with doxazosin. Following a review of the data from these first 4 subjects (details provided below), the VIAGRA dose was reduced to 25 mg. Thereafter, 17 subjects were treated with VIAGRA 25 mg or matching placebo in combination with doxazosin 4 mg (15 subjects) or doxazosin 8 mg (2 subjects). The mean subject age was 66.5 years.

For the 17 subjects who received VIAGRA 25 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:

Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg)

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 25 mg VIAGRA or matching placebo are shown in Figure 2.

Figure 2: Mean Standing Systolic Blood Pressure Change from Baseline

Blood pressure was measured immediately pre-dose and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours after VIAGRA or matching placebo. Outliers were defined as subjects with a standing systolic blood pressure of < 85 mmHg or a decrease from baseline in standing systolic blood pressure of > 30 mmHg at one or more timepoints. There were no subjects treated with VIAGRA 25 mg who had a standing SBP < 85mmHg. There were three subjects with a decrease from baseline in standing systolic BP > 30mmHg following VIAGRA 25 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and two subjects with a decrease from baseline in standing systolic BP > 30 mmHg following both VIAGRA and placebo. No severe adverse events potentially related to blood pressure effects were reported in this group.

Of the four subjects who received VIAGRA 100 mg in the first part of this study, a severe adverse event related to blood pressure effect was reported in one patient (postural hypotension that began 35 minutes after dosing with VIAGRA with symptoms lasting for 8 hours), and mild adverse events potentially related to blood pressure effects were reported in two others (dizziness, headache and fatigue at 1 hour after dosing; and dizziness, lightheadedness and nausea at 4 hours after dosing). There were no reports of syncope among these patients. For these four subjects, the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were 14.8 mmHg and 21.5 mmHg, respectively. Two of these subjects had a standing SBP < 85mmHg. Both of these subjects were protocol violators, one due to a low baseline standing SBP, and the other due to baseline orthostatic hypotension .

Study 2: VIAGRA with Doxazosin

In the second study, a single oral dose of VIAGRA 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH. Following at least 14 consecutive days of doxazosin, VIAGRA 50 mg or matching placebo was administered simultaneously with doxazosin 4 mg (17 subjects) or with doxazosin 8 mg (3 subjects). The mean subject age in this study was 63.9 years.

Twenty subjects received VIAGRA 50 mg, but only 19 subjects received matching placebo. One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with VIAGRA 50 mg. This patient had been taking minoxidil, a potent vasodilator, during the study.

For the 19 subjects who received both VIAGRA and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:

Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg)

VIAGRA 50 mg (95% CI)

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 50 mg VIAGRA or matching placebo are shown in Figure 3.

Figure 3: Mean Standing Systolic Blood Pressure Change from Baseline

Blood pressure was measured after administration of VIAGRA at the same times as those specified for the first doxazosin study. There were two subjects who had a standing SBP of < 85 mmHg. In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of VIAGRA 50 mg and resolving after approximately 7.5 hours. There was one subject with a decrease from baseline in standing systolic BP > 30mmHg following VIAGRA 50 mg and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both VIAGRA 50 mg and placebo. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.

Study 3: VIAGRA with Doxazosin

In the third study, a single oral dose of VIAGRA 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH. In dose period 1, subjects were administered open-label doxazosin and a single dose of VIAGRA 50 mg simultaneously, after at least 14 consecutive days of doxazosin. If a subject did not successfully complete this first dosing period, he was discontinued from the study. Subjects who had successfully completed the previous doxazosin interaction study (using VIAGRA 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1. Treatment with doxazosin continued for at least 7 days after dose period 1. Thereafter, VIAGRA 100 mg or matching placebo was administered simultaneously with doxazosin 4 mg (14 subjects) or doxazosin 8 mg (6 subjects) in standard crossover fashion. The mean subject age in this study was 66.4 years.

Twenty-five subjects were screened. Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label VIAGRA 50 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the previous doxazosin study (using VIAGRA 50 mg).

For the 20 subjects who received VIAGRA 100 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows:

Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg)

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 100 mg VIAGRA or matching placebo are shown in Figure 4.

Figure 4: Mean Standing Systolic Blood Pressure Change from Baseline

Blood pressure was measured after administration of VIAGRA at the same times as those specified for the previous doxazosin studies. There were three subjects who had a standing SBP of < 85 mmHg. All three were taking VIAGRA 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. There were four subjects with a decrease from baseline in standing systolic BP > 30 mmHg following VIAGRA 100 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both VIAGRA and placebo. While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both VIAGRA 50 mg and 100 mg. There were no episodes of syncope reported in this study.

Effect of VIAGRA on Blood Pressure When Co-administered with Anti-hypertensives

When VIAGRA 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.

Effect of VIAGRA on Blood Pressure When Co-administered with Alcohol

VIAGRA (50 mg) did not potentiate the hypotensive effect of alcohol (0.5 g/kg) in healthy volunteers with mean maximum blood alcohol levels of 0.08%. The maximum observed decrease in systolic blood pressure was -18.5 mmHg when sildenafil was co-administered with alcohol versus -17.4 mmHg when alcohol was administered alone. The maximum observed decrease in diastolic blood pressure was -17.2 mmHg when sildenafil was co-administered with alcohol versus -11.1 mmHg when alcohol was administered alone. There were no reports of postural dizziness or orthostatic hypotension. The maximum recommended dose of 100 mg sildenafil was not evaluated in this study [see DRUG INTERACTIONS ].

Effects of VIAGRA on Cardiac Parameters

Single oral doses of sildenafil up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers.

Studies have produced relevant data on the effects of VIAGRA on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 40 mg sildenafil was administered by four intravenous infusions.

The results from this pilot study are shown in Table 3; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients. Mean resting values for right atrial pressure, pulmonary artery pressure, pulmonary artery occluded pressure and cardiac output decreased by 28%, 28%, 20% and 7% respectively. Even though this total dosage produced plasma sildenafil concentrations which were approximately 2 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 100 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.

Table 3: Hemodynamic Data in Patients with Stable Ischemic Heart Disease after Intravenous Administration of 40 mg of Sildenafil

Means ± SD

After 4 minutes of exercise

In a double-blind study, 144 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or VIAGRA 100 mg 1 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were 423.6 and 403.7 seconds for sildenafil (N=70) and placebo, respectively. These results demonstrated that the effect of VIAGRA on the primary endpoint was statistically non-inferior to placebo.

Effects of VIAGRA on Vision

At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of VIAGRA on visual acuity. intraocular pressure. or pupillometry.

Effects of VIAGRA on Sperm

There was no effect on sperm motility or morphology after single 100 mg oral doses of VIAGRA in healthy volunteers.

Pharmacokinetics

VIAGRA is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 2563%). The pharmacokinetics of sildenafil are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil. Both sildenafil and the metabolite have terminal half lives of about 4 hours.

Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 100 mg to healthy male volunteers is depicted below:

Figure 5: Mean Sildenafil Plasma Concentrations in Healthy Male Volunteers

Absorption and Distribution

VIAGRA is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When VIAGRA is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%. The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein binding is independent of total drug concentrations.

Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0.001% of the administered dose may appear in the semen of patients.

Metabolism and Excretion

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil's pharmacologic effects.

After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

Pharmacokinetics in Special Populations

Geriatrics : Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18-45 years). Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [see DOSAGE AND ADMINISTRATION . and Use In Specific Populations ]

Renal Impairment : In volunteers with mild (CLcr=50-80 mL/min) and moderate (CLcr=30-49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of VIAGRA (50 mg) were not altered. In volunteers with severe (CLcr < 30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and Cmax compared to age-matched volunteers with no renal impairment [see DOSAGE AND ADMINISTRATION . and Use In Specific Populations ].

In addition, N-desmethyl metabolite AUC and Cmax values significantly increased by 200% and 79%, respectively in subjects with severe renal impairment compared to subjects with normal renal function.

Hepatic Impairment : In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child-Pugh Class C) have not been studied [see DOSAGE AND ADMINISTRATION . and Use in Specific Populations ].

Therefore, age > 65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil. A starting oral dose of 25 mg should be considered in those patients [see DOSAGE AND ADMINISTRATION ].

Drug Interaction Studies

Effects of Other Drugs on VIAGRA

Sildenafil metabolism is principally mediated by CYP3A4 (major route) and CYP2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. The concomitant use of erythromycin or strong CYP3A4 inhibitors (e. g. saquinavir, ketoconazole, itraconazole) as well as the nonspecific CYP inhibitor, cimetidine, is associated with increased plasma levels of sildenafil [see DOSAGE AND ADMINISTRATION ].

In vivo Studies

Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with VIAGRA (50 mg) to healthy volunteers.

When a single 100 mg dose of VIAGRA was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 160% increase in sildenafil Cmax and a 182% increase in sildenafil AUC. In addition, in a study performed in healthy male volunteers, co-administration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Viagra (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC. Viagra had no effect on saquinavir pharmacokinetics. A stronger CYP3A4 inhibitor such as ketoconazole or itraconazole could be expected to have greater effect than that seen with saquinavir. Population pharmacokinetic data from patients in clinical trials also indicated a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine) [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS ].

In another study in healthy male volunteers, co-administration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with VIAGRA (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1000% (11-fold) increase in sildenafil plasma AUC. At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone. This is consistent with ritonavir's marked effects on a broad range of P450 substrates. VIAGRA had no effect on ritonavir pharmacokinetics [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS ].

Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.

In a study of healthy male volunteers, co-administration of sildenafil at steady state (80 mg t. i.d.) with endothelin receptor antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) at steady state (125 mg b. i.d.) resulted in a 63% decrease of sildenafil AUC and a 55% decrease in sildenafil Cmax. Concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma levels of sildenafil.

Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of VIAGRA.

In healthy male volunteers, there was no evidence of a clinically significant effect of azithromycin (500 mg daily for 3 days) on the systemic exposure of sildenafil or its major circulating metabolite.

Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants ), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the active metabolite, N-desmethyl sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence.

Effects of VIAGRA on Other Drugs

In Vitro Studies

Sildenafil is a weak inhibitor of the CYP isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these isoenzymes.

In Vivo Studies

No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.

In a study of healthy male volunteers, sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

VIAGRA (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg).

Sildenafil at steady state, at a dose not approved for the treatment of erectile dysfunction (80 mg t. i.d.) resulted in a 50% increase in AUC and a 42% increase in C max of bosentan (125 mg b. i.d.).

Clinical Studies

In clinical studies, VIAGRA was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. VIAGRA was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). VIAGRA was administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. VIAGRA demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Efficacy Endpoints in Controlled Clinical Studies

The effectiveness of VIAGRA was evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function - IIEF) administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm. desire, satisfaction with intercourse, and overall sexual satisfaction. Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.

Efficacy Results from Controlled Clinical Studies

The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with VIAGRA was better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients who were less impaired at baseline.

Figure 6: Effect of VIAGRA and Placebo on Maintenance of Erection by Baseline Score

The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7. These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions. Erectile dysfunction was attributed to organic (58%; generally not characterized, but including diabetes and excluding spinal cord injury ), psychogenic (17%), or mixed (24%) etiologies. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of VIAGRA, respectively, reported an improvement in their erections, compared to 24% on placebo. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar.

Figure 7: Percentage of Patients Reporting an Improvement in Erections

The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.

In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of VIAGRA on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50-100 mg of VIAGRA vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on VIAGRA vs about 20% on placebo.

During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that VIAGRA improved their erections.

Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. VIAGRA improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.

One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of VIAGRA; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on VIAGRA compared to placebo. On a global improvement question, 57% of VIAGRA patients reported improved erections versus 10% on placebo. Diary data indicated that on VIAGRA, 48% of intercourse attempts were successful versus 12% on placebo.

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of VIAGRA. On a global improvement question, 83% of patients reported improved erections on VIAGRA versus 12% on placebo. Diary data indicated that on VIAGRA, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.

Across all trials, VIAGRA improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of VIAGRA patients reported improvement in erections compared with 26% of placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of VIAGRA. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for VIAGRA and 29% for placebo.

Efficacy Results in Subpopulations in Controlled Clinical Studies

A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. VIAGRA was effective in a broad range of ED patients, including those with a history of coronary artery disease. hypertension. other cardiac disease, peripheral vascular disease. diabetes mellitus, depression, coronary artery bypass graft (CABG ), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants /antipsychotics and anti-hypertensives/diuretics.

Last reviewed on RxList: 10/3/2015 This monograph has been modified to include the generic and brand name in many instances.

Glibenclamide for diabetes, glibenclamide

Glibenclamide for diabetes

Take glibenclamide with, or just after, your first main meal of the day (usually breakfast).

Remember to follow any advice you have been given about your diet and taking exercise.

Common side-effects include stomach upset and low blood sugar (hypoglycaemia). Make sure you know how to recognise the symptoms of low blood sugar. These include feeling shaky or anxious, sweating, looking pale, feeling hungry, having a feeling that your heart is pounding (palpitations), and feeling dizzy.

About glibenclamide

Type of medicine

A sulfonylurea antidiabetic medicine

Type 2 diabetes mellitus

Insulin is a hormone which is made naturally in your body, in the pancreas. It helps to control the levels of sugar (glucose) in your blood. If your body does not make enough insulin, or if it does not use the insulin it makes effectively, this results in the condition called sugar diabetes (diabetes mellitus).

People with diabetes need treatment to control the amount of sugar in their blood. This is because good control of blood sugar levels reduces the risk of complications later on. Some people can control the sugar in their blood by making changes to the food they eat but, for other people, medicines like glibenclamide are given alongside the changes in diet.

Glibenclamide works by increasing the amount of insulin that your pancreas produces. This helps to reduce the amount of sugar in your blood.

Related discussions

anyone in this world have NEPHROGENIC DI?

Before taking glibenclamide

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking glibenclamide it is important that your doctor knows:

If you are pregnant, trying for a baby or breast-feeding.

If you have any problems with the way your liver works, or with the way your kidneys work.

If you have been told you have porphyria or glucose 6-phosphate dehydrogenase (G6PD) deficiency. These are rare inherited disorders.

If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

If you have ever had an allergic reaction to a medicine.

How to take glibenclamide

Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about glibenclamide tablets and will provide you with a full list of the side-effects which you may experience from taking them.

Take glibenclamide exactly as your doctor tells you to. The usual starting dose is 5 mg daily. It is prescribed as a single dose to be taken with, or immediately after, breakfast.

If you forget to take a dose at the usual time, take it with your next meal. If you do not remember until the following day, skip the missed dose. Do not take two doses on the same day to make up for a forgotten dose.

Getting the most from your treatment

It is important that you keep your regular doctor's and clinic appointments. This is so that your progress can be monitored. You will need regular check-ups with an eye clinic and a foot clinic as well as with your doctor and diabetes clinic.

Your doctor may recommend that you test for sugar (glucose) in your blood regularly to check that your diabetes is being controlled. Your doctor or diabetes nurse will show you how to do this.

If you have been given advice by your doctor about changes to your diet, stopping smoking or taking regular exercise, it is important for you to follow the advice you have been given.

Make sure you know what it feels like if your blood sugar drops too low. This is known as hypoglycaemia, or a 'hypo'. The first signs of hypoglycaemia are feeling shaky or anxious, sweating, looking pale, feeling hungry, having a feeling that your heart is pounding (palpitations), and feeling dizzy. If this happens, eat something containing sugar, such as dextrose tablets, or sugary sweets or drinks (non-diet), and then follow this up with a snack such as a sandwich or a banana.

Low blood sugar (hypoglycaemia) can occur if you miss a meal, if you exercise more than usual, if you are ill, or if you drink alcohol.

Do not drink alcohol, as it can affect the control of your blood sugar. Ask your doctor if you need further advice about this.

If you are a driver you should take special care, as your ability to concentrate may be affected if your diabetes is not well controlled. You may be advised to check your blood sugar levels before you travel and to have a snack with you on long journeys.

Drivers in the UK may need to inform the Driver and Vehicle Licensing Agency (DVLA) if they experience an episode of severe hypoglycaemia or experience a 'hypo' whilst driving. Ask your doctor for advice. Drivers in other countries should contact the relevant vehicle licensing agency.

If you get unusually thirsty, pass urine more frequently than normal, or feel very tired, you should let your doctor know. These are signs that there is too much sugar in your blood and your treatment may need adjusting.

Check with your doctor before taking up any new physical exercise, as this will have an effect on your blood sugar levels and you may need to check your blood levels more regularly.

If you are due to have an operation or dental treatment, you should tell the person carrying out the treatment that you have diabetes and give them a list of the medicines you are taking.

If you buy any medicines, always check with a pharmacist that they are suitable for you to take.

Treatment for diabetes is usually lifelong. Continue to take the tablets unless you are advised otherwise by your doctor.

Can glibenclamide cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with glibenclamide. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common glibenclamide side-effects

What can I do if I experience this?

Feeling sick (nausea) or being sick (vomiting)

Stick to simple foods - avoid rich or spicy meals

Hard stools that are difficult to pass (constipation)

Eat a well-balanced diet and drink plenty of water

Loose, watery stools (diarrhoea)

Drink plenty of water to replace any lost fluids

Signs of low blood sugar (glucose) . feeling shaky or anxious, sweating, looking pale, feeling hungry, feeling that your heart is pounding (palpitations), feeling dizzy

Eat something containing sugar such as a sweet biscuit or a sugary drink (not diet) and follow this up with a snack such as a sandwich. Tell your doctor if you notice these symptoms

Increase in weight

If this becomes a problem, let your doctor know at your next check-up

If you experience any other symptoms which you think may be due to the tablets, speak with your doctor or pharmacist for further advice.

How to store glibenclamide

Keep all medicines out of the reach and sight of children.

Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Further reading & references

Manufacturer's PIL, Glibenclamide 2.5 mg and 5 mg Tablets ; Wockhardt UK Ltd, The electronic Medicines Compendium. Dated May 2016.

British National Formulary; 71st Edition (Mar-Sep 2016) British Medical Association and Royal Pharmaceutical Society of Great Britain, London

Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. EMIS has used all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions. For details see our conditions .

Original Author: Helen Allen

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CALURAN 50MG TABLET

What is Bicalutamide for:

Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin, thus preventing the growth of normal and malignant prostatic tissue.

How does Bicalutamide work:

Bicalutamide slows prostate cancer growth by blocking testosterone.

How should Bicalutamide be used:

May be taken with or without food.

Common side effects of Bicalutamide :

Nausea, vomiting, diarrhoea, asthenia, gynaecomastia, breast tenderness, hot flushes, pruritus, dry skin, alopecia, hirsutism, decreased libido, impotence, weight gain; less commonly hypersensitivity reactions including angioneurotic oedema and urticaria, interstitial lung disease; rarely abdominal pain, CV disorders (including angina, heart failure and arrhythmias), depression, dyspepsia, haematuria, cholestasis, jaundice, thrombocytopenia.

What do I do if I miss a dose

Take a missed dose as soon as you think about it. - If it is close to the time for your next dose, skip the missed dose and go back to your normal time. - Do not take 2 doses at the same time or extra doses.

What precautions should I take when taking Bicalutamide :

If you have an allergy to bicalutamide or any other part of this drug. Tell your doctor if you are allergic to any drugs. Make sure to tell about the allergy and what signs you had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you are a woman.

When do I need to seek medical help

If you think there was an overdose, call your local poison control center or ER right away. Signs of a very bad reaction to the drug. These include wheezing; chest tightness; fever; itching; bad cough; blue or gray skin color; seizures; or swelling of face, lips, tongue, or throat. Trouble breathing. Cough that does not go away. Very bad belly pain. Any bruising or bleeding. Dark urine or yellow skin or eyes. Not able to eat. Feeling very tired or weak. Very bad skin irritation. A lump in the breast or breast soreness. Any rash. Side effect or health problem is not better or you are feeling worse.

Can I take Bicalutamide with other medicines:

Sometimes drugs are not safe when you take them with certain other drugs and food. - Taking them together can cause bad side effects. - Be sure to talk to your doctor about all the drugs you take.

Are there any food restrictions

How do I store Bicalutamide :

Store in a cool, dry place away from the reach of children. - Medicines must not be used past the expiry date.

Pregnancy Category

Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Therapeutic Classification

Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin, thus preventing the growth of normal and malignant prostatic tissue.

Alositol, alositol

Alositol

Pharmacology of Alositol

Alositol, a structural analog of the natural purine base hypoxanthine, is used to prevent gout and renal calculi due to either uric acid or calcium oxalate and to treat uric acid nephropathy, hyperuricemia, and some solid tumors.

Alositol for patients

Patients should be informed of the following:

They should be cautioned to discontinue allopurinol and to consult their physician immediately at the first sign of a skin rash, painful urination, blood in the urine. irritation of the eyes, or swelling of the lips or mouth.

They should be reminded to continue drug therapy prescribed for gouty attacks since optimal benefit of allopurinol may be delayed for two to six weeks.

They should be encouraged to increase fluid intake during therapy to prevent renal stones.

If a single dose of allopurinol is occasionally forgotten, there is no need to double the dose at the next scheduled time.

There may be certain risks associated with the concomitant use of allopurinol and dicumarol, sulfinpyrazone, mercaptopurine, azathioprine, ampicillin, amoxicillin and thiazide diuretics, and they should follow the instructions of their physician.

Due to the occasional occurrence of drowsiness, patients should take precautions when engaging in activities where alertness is mandatory.

Patients may wish to take allopurinol after meals to minimize gastric irritation.

Alositol Interactions

The following drug interactions were observed in some patients undergoing treatment with oral allopurinol. Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.

Mercaptopurine/Azathioprine: Allopurinol inhibits the enzymatic oxidation of mercaptopurine and azathioprine to 6-thiouric acid. This oxidation, which is catalyzed by xanthine oxidase, inactivates mercaptopurine. In patients receiving mercaptopurine (Purinethol) or azathioprine (Imuran), the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects.

Dicumarol: It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy. Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs.

Uricosuric Agents: Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.

Thiazide Diuretics: The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected..

Ampicillin/Amoxicillin: An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.

Cytotoxic Agents: Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.

Chlorpropamide: Chlorpropamide's plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Cyclosporin: Reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol sodium for injection. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.

Alositol Contraindications

Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Additional information about Alositol

Alositol Indication: For the treatment of hyperuricemia associated with primary or secondary gout. Mechanism Of Action: Alositol inhibits the enzyme xanthine oxidase, blocking the conversion of the oxypurines hypoxanthine and xanthine to uric acid. Elevated concentrations of oxypurine and oxypurine inhibition of xanthine oxidase through negative feedback results in a decrease in the concentrations of uric acid in the blood and urine. Alositol also facilitates the incorporation of hypoxanthine and xanthine into DNA and RNA, resulting in further reductions of serum uric acid concentrations. Drug Interactions: Anisindione Alositol increases the anticoagulant effect Azathioprine Alositol increases the effect of thiopurine Cyclosporine Alositol increases the effect and toxicity of cyclosporine Dicumarol Alositol increases the anticoagulant effect Warfarin Alositol increases the anticoagulant effect Mercaptopurine Alositol increases the effect of thiopurine Acenocoumarol Increases the anticoagulant effect Food Interactions: Take with a full glass of water. Take with food. Avoid alcohol. Generic Name: Allopurinol Synonyms: Allopurinolum [Inn-Latin]; Allopurinol Sodium; Alopurinol [Inn-Spanish] Drug Category: Free Radical Scavengers; Enzyme Inhibitors Antimetabolites; Gout Suppressants Drug Type: Small Molecule; Approved Other Brand Names containing Allopurinol: 7HP; Adenock; Ailural; Allo-Puren; Allopur; Allozym; Allural; Aloprim; Aloral; Alositol; Aluline; Anoprolin; Anzief; Apo-Allopurinol; Apulonga; Apurin; Apurol; Atisuril; Bleminol; Bloxanth; Caplenal; Cellidrin; Cosuric; Dabrosin; Dabroson; Dura Al; Embarin; Epidropal; Epuric; Foligan; Geapur; Gichtex; Gotax; HPP; Hamarin; Hexanuret; Ketanrift; Ketobun-A; Ledopur; Lopurin; Lysuron; Milurit; Miniplanor; Monarch; Nektrohan; Progout; Purinol; Remid; Riball; Sigapurol; Suspendol; Takanarumin; Urbol; Uricemil; Uriprim; Uripurinol; Uritas; Urobenyl; Urolit; Urosin; Urtias; Urtias 100; Xanturat; Zyloprim; Zyloric; Allohexal; Absorption: Approximately 90% absorbed from the gastrointestinal tract. Toxicity (Overdose): LD 50 =214 mg/kg (in mice) Protein Binding: Negligible Biotransformation: Hepatic Half Life: 1-2 hours Dosage Forms of Alositol: Tablet Oral Chemical IUPAC Name: 1,2-dihydropyrazolo[4,3-e]pyrimidin-4-one Chemical Formula: C5H4N4O Allopurinol on Wikipedia: http://en. wikipedia. org/wiki/Allopurinol Organisms Affected: Humans and other mammals

Alositol

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Standard Reference Data Program

Allopurinol

Formula : C 5 H 4 N 4 O

Molecular weight : 136.1115

IUPAC Standard InChI: InChI=1S/C5H4N4O/c10-5-3-1-8-9-4(3)6-2-7-5/h1-2H,(H2,6,7,8,9,10)

IUPAC Standard InChIKey: OFCNXPDARWKPPY-UHFFFAOYSA-N

CAS Registry Number: 315-30-0

Chemical structure: View the 3d structure.

Other names: 4H-Pyrazolo[3,4-d]pyrimidin-4-one, 1,5-dihydro-; Allopur; Atisuril; B. W. 56-158; Bloxanth; BW 56-158; Epidropal; Foligan; Gotax; HPP; Milurit; Uricemil; Uriprim; Urosin; Zyloprim; Zyloric; Ailural; Allopurinol(I); Alositol; Anoprolin; Anzief; Apurol; Bleminol; Embarin; Geapur; Ketobun-A; Lopurin; Progout; Urbol; Uripurinol; Urolit; Xanturat; 1,5-Dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one; 4-HPP; Adenock; AL-100; Allozym; Allural; Aluline; Apurin; Caplenal; Cellidrin; Dabrosin; Gichtex; 4-Hydroxypyrazolopyrimidine; Ketanrift; Lysuron; Miniplanor; Monarch; Nektrohan; NSC-1390; 4H-Pyrazolo(3,4-d)pyrimidin-4-one; Remid; Riball; Suspendol; Takanarumin; Uritas; Urobenyl; Ledopur; Sigapurol; Urtias; 1H-Pyrazolo[3,4-d]Pyrimidin-4-ol; 4-Hydroxy-1H-pyrazolo[3,4-d]pyrimidine; 4-Hydroxypyrazolo[3,4-d]pyrimidine; 4-Hydroxy-3,4-pyrazolopyrimidine; 4-Hydroxypyrazolyl(3,4-d)pyrimidine; 4'-Hydroxypyrazolol(3,4-d)pyrimidine; Aloral; Hamarin; Hexanurat; Dabroson; Cosuric

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Other data available:

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Standard Reference Data Program

Hipoglucin, hipoglucin

Metformin is used for treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other anti-diabetic medicines.

Use Metformin as directed by your doctor.

Take Metformin by mouth with food. Take Metformin on a regular schedule to get the most benefit from it. Taking Metformin at the same time each day will help you remember to take it. Continue taking Metformin even if you feel good. Do not miss any doses. Ask your health care provider any questions you may have about its usage.

Drug Class and Mechanism

Metformin is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

If you miss a dose of Metformin and are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Metformin between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metformin out of the reach of children and away from pets.

Do not use Metformin if:

you are allergic to any ingredient in Metformin; you have congestive heart failure that is treated by medicine; you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (e. g. diabetic ketoacidosis), or severe dehydration; you have had a stroke or a recent heart attack, or you are in shock; you are 80 years old or older and have not had a kidney function test; you will be having surgery or certain lab procedures. Contact your doctor or health care provider right away if any of these apply to you.

Important : Dizziness may occur while you are taking Metformin. This effect may be worse if you take it with alcohol or certain medicines. Use Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Follow the diet and exercise program given to you by your health care provider. Do not drink large amounts of alcohol while you use Metformin. Talk to your doctor or health care provider before you drink alcohol while you use Metformin. Tell your doctor or dentist that you take Metformin before you receive any medical or dental care, emergency care, or surgery. Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Metformin 's side effects. Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Metformin exactly as prescribed, tell your doctor. This medicine does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Metformin along with certain medicines for diabetes (e. g. sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (e. g. tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals. Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away. Metformin may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis. Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and blood counts, may be performed while you use Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Metformin with caution in the elderly; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly. Metformin should not be used in children younger than 10 years old; safety and effectiveness in these children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metformin while you are pregnant. It is not known if Metformin is found in breast milk. Do not breast-feed while taking Metformin.

Possible Side Effects

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; vomiting. Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

If you have any questions about Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider. Metformin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

Metformin is used for treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other anti-diabetic medicines.

Use Metformin as directed by your doctor.

Take Metformin by mouth with food. Take Metformin on a regular schedule to get the most benefit from it. Taking Metformin at the same time each day will help you remember to take it. Continue taking Metformin even if you feel good. Do not miss any doses. Ask your health care provider any questions you may have about its usage.

Drug Class and Mechanism

Metformin is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

If you miss a dose of Metformin and are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Metformin between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metformin out of the reach of children and away from pets.

Do not use Metformin if:

you are allergic to any ingredient in Metformin; you have congestive heart failure that is treated by medicine; you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (e. g. diabetic ketoacidosis), or severe dehydration; you have had a stroke or a recent heart attack, or you are in shock; you are 80 years old or older and have not had a kidney function test; you will be having surgery or certain lab procedures. Contact your doctor or health care provider right away if any of these apply to you.

Important : Dizziness may occur while you are taking Metformin. This effect may be worse if you take it with alcohol or certain medicines. Use Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Follow the diet and exercise program given to you by your health care provider. Do not drink large amounts of alcohol while you use Metformin. Talk to your doctor or health care provider before you drink alcohol while you use Metformin. Tell your doctor or dentist that you take Metformin before you receive any medical or dental care, emergency care, or surgery. Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Metformin 's side effects. Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Metformin exactly as prescribed, tell your doctor. This medicine does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Metformin along with certain medicines for diabetes (e. g. sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (e. g. tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals. Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away. Metformin may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis. Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and blood counts, may be performed while you use Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Metformin with caution in the elderly; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly. Metformin should not be used in children younger than 10 years old; safety and effectiveness in these children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metformin while you are pregnant. It is not known if Metformin is found in breast milk. Do not breast-feed while taking Metformin.

Possible Side Effects

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; vomiting. Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

If you have any questions about Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider. Metformin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

Metformin is used for treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other anti-diabetic medicines.

Use Metformin as directed by your doctor.

Take Metformin by mouth with food. Take Metformin on a regular schedule to get the most benefit from it. Taking Metformin at the same time each day will help you remember to take it. Continue taking Metformin even if you feel good. Do not miss any doses. Ask your health care provider any questions you may have about its usage.

Drug Class and Mechanism

Metformin is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

If you miss a dose of Metformin and are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Metformin between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metformin out of the reach of children and away from pets.

Do not use Metformin if:

you are allergic to any ingredient in Metformin; you have congestive heart failure that is treated by medicine; you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (e. g. diabetic ketoacidosis), or severe dehydration; you have had a stroke or a recent heart attack, or you are in shock; you are 80 years old or older and have not had a kidney function test; you will be having surgery or certain lab procedures. Contact your doctor or health care provider right away if any of these apply to you.

Important : Dizziness may occur while you are taking Metformin. This effect may be worse if you take it with alcohol or certain medicines. Use Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Follow the diet and exercise program given to you by your health care provider. Do not drink large amounts of alcohol while you use Metformin. Talk to your doctor or health care provider before you drink alcohol while you use Metformin. Tell your doctor or dentist that you take Metformin before you receive any medical or dental care, emergency care, or surgery. Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Metformin 's side effects. Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Metformin exactly as prescribed, tell your doctor. This medicine does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Metformin along with certain medicines for diabetes (e. g. sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (e. g. tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals. Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away. Metformin may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis. Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and blood counts, may be performed while you use Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Metformin with caution in the elderly; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly. Metformin should not be used in children younger than 10 years old; safety and effectiveness in these children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metformin while you are pregnant. It is not known if Metformin is found in breast milk. Do not breast-feed while taking Metformin.

Possible Side Effects

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; vomiting. Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

If you have any questions about Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider. Metformin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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EMIDON-OM - Capsule, Karnataka Antibiotics & Pharmaceuticals Ltd.

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Efeitos da viagra

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Viagra

Quais os beneficios?

O Viagra e um tratamento para a impotencia comodo que pode ser eficaz em apenas 30 minutos e cujos os efeitos duram ate 4 horas . O Viagra da Pfizer e um dos medicamentos mais prescritos para a disfuncao erectil, tendo ja ajudado mais homens a tratar os seus problemas de ereccao que o Cialis e o Levitra em conjunto.

Como funciona?

O GMP ciclico e uma substancia naturalmente produzida pelo corpo que aumenta o calibre dos vasos sanguineos do penis. Quando esta sexualmente excitado, os vasos dilatam-se, permitindo que mais sangue chegue ao penis, o que leva a ereccao. O GMP ciclico e quebrado por uma enzima denominada fosfodiesterase tipo 5. Contudo, quando em abundancia, esta enzima pode restringir a circulacao sanguinea para o penis, mantendo-o flacido mesmo quando esta sexualmente excitado.

O Viagra inibe esta accao, mantendo os vasos sanguineos dilatados durante mais tempo e aumentando a circulacao sanguinea no penis . O resultado sao ereccoes firmes que podem ser mantidas por mais tempo.

Como tomar Viagra?

O Viagra e um pequeno comprimido azul (ou pilula azul, como tambem e chamado) que pode ser tomado por via oral. O comprimido pode ser tomado com ou sem alimentos, apesar de os seus efeitos poderem diminuir no caso de ter ingerido alimentos com muita gordura ou refeicoes pesadas. O Viagra tem uma accao de aproximadamente 4-5 horas . Isto nao quer dizer que tera uma ereccao durante 4 ou 5 horas, mas sim que a qualquer altura durante este periodo, se se sentir excitado, conseguira facilmente uma ereccao para uma relacao sexual satisfatoria.

O comprimido Viagra actua em 30 minutos e leva no maximo 1 hora a ficar activo no seu organismo, por isso, e necessario que planeie com alguma antecedencia as suas relacoes, ja que nao pode tomar um comprimido de Viagra e esperar ter uma ereccao imediatamente.

Para atingir os melhores resultados e evitar efeitos secundarios, mantenha a dose recomendada de apenas um comprimido por dia (por cada 24 horas) . Se nao tem a certeza da dose a tomar, consulte um profissional medico para que este possa avaliar a dose mais segura para si. Se notar alguns efeitos secundarios e estes persistirem, sugerimos que contacte um medico. O Viagra pode ser perigoso se tomado em conjunto com certos medicamentos ou se tomado por homens que pertencam a um determinado grupo de risco. Conheca as precaucoes sobre tomar Viagra antes de iniciar o tratamento.

Quem pode tomar?

A maioria dos homens com mais de 18 anos que sofram de problemas recorrentes de disfuncao erectil podem recorrer ao Viagra para melhorar a sua vida sexual. Existem certas condicoes ou tratamentos com os quais nao pode usar Viagra, pelo que e importante que os descreva com o maior detalhe possivel durante a sua consulta medica.

Quem nao pode tomar?

O Viagra pode nao estar aconselhado a homens que sofram de desordens cardiacas graves ou falencia cardiaca grave, que tenham sofrido de ataque cardiaco ou AVC recentemente, tensao arterial baixa e funcao hepatica diminuida . O medico apenas lhe prescrevera o Viagra se tiver a certeza de que o pode tomar com seguranca.

Antes de tomar

Existem varias precaucoes que deverao ser tomadas por si, antes de considerar a hipotese de adquirir Viagra para a impotencia. Durante a sua consulta medica ser-lhe-ao realizadas algumas perguntas para garantir que o Viagra e o tratamento mais indicado.

Tambem lhe sera solicitado que nos divulgue outras informacoes relevantes, relacionadas com a sua saude, como por exemplo, medicamentos que esteja a tomar e que possam interagir com o principio activo do Viagra, o sildenafil.

E muito importante garantir que esta em condicoes de realizar a actividade sexual, pois alguns homens com doencas cardiacas estao desaconselhados a praticar relacoes sexuais de modo a limitar o risco de de ataque cardiaco. Os homens que pertencem a este grupo nao devem, em nenhuma circunstancia, tomar Viagra para ajudar a tratar a impotencia ou disfuncao erectil. A lista seguinte foi criada para o informar acerca das contra-indicacoes do Viagra e dos riscos associados a este tratamento.

Idosos

Homens que sofrem de um funcionamento reduzido ou danos no figado

Homens que sofrem de uma doenca que afecte o coracao ou os vasos capilares

Homens que sofrem de problemas de sangramento, como a hemofilia

Homens com uma ulcera peptica activa

Homens que tem uma anormalidade fisica no penis

Ataque de coracao recente

AVC ou derrame cerebral recentes

Tensao arterial baixa (hipotensao)

Nitratos

Problemas do figado

Problemas oftalmologicos graves

Alergia a qualquer um dos principios activos do medicamento

Devido aos riscos que podem estar envolvidos, e importante ser honesto e responder a todas as perguntas medicas antes da prescricao do Viagra. Se estiver a tomar outros medicamentos e nao souber se estes podem interagir com o Viagra, podera contactar a nossa equipa para mais informacoes. De igual forma, se pertencer a este grupo de risco e nao souber qual a dose de Viagra mais correcta para si, leia mais sobre este medicamento ou consulte um medico.

Que doses de Viagra existem?

As doses de Viagra apresentam-se em tres formas diferentes: 25mg, 50mg e 100mg. Antes de adquirir Viagra online ou na farmacia, e importante considerar a dose de Viagra que lhe esta mais indicada. O Viagra para o tratamento da disfuncao erectil actua como um inibidor da PDE-5. O sildenafil, o seu principio activo, assegura a inibicao da enzima PDE-5, permitindo um maior fluxo de sangue para os vasos sanguineos do penis. Este facto permite ao homem atingir ereccoes facilmente e mante-las durante a relacao sexual durante mais tempo.

25mg de Viagra

A dose mais pequena de Viagra e a de 25mg, muitas vezes receitada se:

Sofrer de efeitos secundarios

Estiver a tomar bloqueadores alfa

Alguns beneficios de tomar 25mg de Viagra:

Diminui o risco de efeitos secundarios

Taxa de eficacia de 63% nos homens que sofrem de disfuncao erectil

A dose pode ser aumentada, caso seja necessario

50mg de Viagra

A dose de 50mg de Viagra e normalmente recomendada se:

Estiver a iniciar o tratamento para a impotencia pela primeira vez

Nao tiver condicoes medicas pre-existentes

Nao tomar outros medicamentos

Alguns beneficios de tomar 50mg de Viagra:

A dose pode ser aumentada ou reduzida, consoante o efeito que tem em si

E eficaz no tratamento da impotencia em 74% dos homens

100mg de Viagra

A dose de 100mg de Viagra e a dose mais forte e e normalmente receitada se:

Sofrer de impotencia durante muito tempo

Nao sofrer de efeitos secundarios

Alguns beneficios de tomar 100mg de Viagra:

Usado para tratar as situacoes mais graves de impotencia

E 82% eficaz no tratamento desta condicao

Quais as precaucoes do Viagra?

Como com quase todos os medicamentos, existem algumas precaucoes do Viagra que devera ter em conta antes de o tomar. Por este motivo, a consulta com o seu medico e muito importante, pois este ira avaliar a sua situacao, a sua condicao medica e quaisquer medicamentos que esteja a tomar para decidir se o Viagra e o tratamento ideal para si.

Quando for questionado sobre a sua saude e bem-estar, e muito importante que responda de forma honesta e correcta. Se omitir qualquer informacao, podera sofrer consequencias a longo prazo. Algumas pessoas poderao sofrer reaccoes adversas com o Viagra e, em algumas circunstancias, este podera estar mesmo desaconselhado. O quadro abaixo resume algumas das interaccoes que podem ocorrer.

Viagra e Outros Medicamentos

Quer esteja a tomar medicamentos naturais, medicamentos sujeitos a receita medica ou outros, todos estes poderao ter um impacto nos efeitos do Viagra. Tambem podem fazer com que sinta mais efeitos secundarios, ou em alguns casos extremos, colocar a sua vida em risco. Por vezes a combinacao com outros medicamentos pode ser muito potente, mas a maior parte dos riscos do Viagra pode ser evitada alterando a dose ou o medicamento.

Assegure-se que descreve detalhadamente todos os medicamentos e suplementos que estiver a tomar durante a sua consulta.

Medicamentos que podem ser tomados com o Viagra

Bloqueadores Alfa: Os bloqueadores alfa sao usados para baixar a tensao arterial alta. Se controlada, o Viagra pode ser tomado de forma segura com bloqueadores alfa como a Alfuzosina e a Indoramina. Se estiver a tomar bloqueadores alfa, o seu medico ira receitar-lhe inicialmente uma dose mais baixa e acompanhar a sua reaccao antes de aumentar a dose.

Medicamentos que nao podem ser tomados com o Viagra

Nitratos: Os Nitratos sao usados para facilitar a circulacao sanguinea no corpo e nao podem ser tomados juntamente com o Viagra, podendo resultar numa queda brusca da tensao arterial, causando tonturas, desmaios e por vezes ate um ataque de coracao. Exemplos de medicamentos com nitratos sao o glicerol trinitrato, o mononitrato de isosorbida e o nicorandil.

Amil nitrato: reconhecido maioritariamente como "popper", o amil nitrato tambem baixa a tensao arterial drasticamente se for tomado com o Viagra. Se estiver a usar "poppers", nao tome Viagra.

Outros tratamentos para a impotencia

Se estiver a tomar outros medicamentos para o tratamento da disfuncao erectil, como o Levitra ou o Cialis, nao podera tomar Viagra ao mesmo tempo. A combinacao deste tipo de medicamentos pode levar a uma quantidade excessiva de sildenafil no sangue, fazendo com que a pressao sanguinea fique abaixo dos minimos possiveis.

Comida e bebida

Embora o Viagra possa ser tomado com ou sem comida, refeicoes pesadas e gordurosas podem fazer com que a medicacao demore mais tempo a fazer efeito. Comer toranja ou beber sumo de toranja pode aumentar os niveis de Viagra no sangue, pelo que este esta desaconselhado. Em relacao a combinacao de Viagra com alcool, este medicamento sera mais eficaz se nao for misturado com alcool.

Quais sao os efeitos secundarios?

O Viagra, apesar de ser um medicamento sujeito a receita medica, foi clinicamente testado, pelo que e geralmente bem tolerado se usado correctamente. Tal como outros medicamentos de prescricao, alguns homens podem estar mais propensos a desenvolver efeitos secundarios, principalmente na primeira vez que usam um tratamento deste tipo. A imagem seguinte permite conhecer os efeitos secundarios do Viagra relativos a diferentes partes do corpo.

Dores de cabeca e tonturas sao alguns dos efeitos secundarios mais comuns do Viagra. Os efeitos sao normalmente suaves e temporarios. A fadiga e menos comum mas tambem podera ocorrer. O desmaio e um efeito extremamente raro.

O rubor facial e ligeiras perturbacoes visuais sao efeitos secundarios muito comuns. A boca seca e um efeito menos comum e as hemorragias nasais e um efeito bastante raro.

Os efeitos secundarios relacionados com o coracao sao raros, mas existe a pequena hipotese de poder sentir palpitacoes ou alguma dor na regiao do peito. Alteracoes na tensao arterial, ataque cardiaco ou acidente vascular cerebral sao efeitos extremamente raros. Se sentir algum destes efeitos devera contactar um medico imediatamente.

A indigestao e ??um efeito secundario comum do Viagra. As nauseas sao menos comuns, mas podem ocorrer por um curto periodo de tempo.

Efeitos secundarios do Viagra

Clique na zona do corpo pertinente para saber como esta pode ser afectada pelo Viagra

Estes efeitos do Viagra sao em geral ligeiros e tendem a desaparecer assim que o seu corpo se habitua ao medicamento. Porem, existem efeitos mais raros associados a toma deste medicamento que deve conhecer. Apesar de estes estarem descritos, o mesmo nao significa que irao ocorrer.

Efeitos secundarios comuns

Os efeitos secundarios mais comuns do Viagra nao sao graves e normalmente desaparecem a medida que este deixa de fazer efeito no organismo. Se sofrer de dores de cabeca, rubor facial ou outro efeito do Viagra incluido nesta categoria, nao se preocupe, pois o mais provavel e que este tipo de efeitos desapareca em pouco tempo. Se os efeitos secundarios persistirem, nao hesite em contactar um medico.

Efeitos secundarios pouco comuns

Cerca de 1 em cada 100 homens relata efeitos secundarios pouco comuns com o Viagra, tal como boca seca e fadiga, entre outros. Tal como os efeitos secundarios comuns, se estes persistirem por mais tempo do que o Viagra permanece activo no seu corpo, deve contactar um medico para aconselhamento.

Efeitos secundarios raros

Efeitos secundarios como a alteracao da pressao arterial e o desmaio ocorrem muito raramente, nao afectando a maioria dos homens que tomam Viagra. Estes efeitos secundarios, embora raros, sao mais graves e necessitam normalmente de assistencia medica imediata.

O Priapismo e um efeito secundario do Viagra que raramente ocorre e quando acontece, e normalmente tratado com sucesso. Consiste numa ereccao por um longo periodo de tempo, normalmente por mais de quatro horas. Se ocorrer, pode danificar os tecidos do seu penis e causar problemas a longo prazo. Por este motivo, e muito importante contactar um medico assim que possivel.

Comprar Viagra Online – Perguntas e resposta

Como consigo comprar o medicamento de prescricao Viagra na euroClinix?

Viagra para o tratamento da disfuncao erectil e um medicamento de prescricao e so pode ser encomendado online com a receita medica. Se voce quiser comprar Viagra, os nossos medicos podem emitir uma receita online. Para que isso aconteca, deve preencher um questionario medico, que sera entao avaliado pela nossa equipe medica. Cada pedido, portanto, e precedido por um diagnostico que considera o seu estado de saude e determina a sua adequacao ao medicamento Viagra.

E seguro encomendar Viagra online na euroClinix?

Antes de concluir a compra do Viagra na euroClinix, um dos nossos medicos avalia o seu questionario medico. Isto permite-lhe ter a certeza absoluta de que todas as verificacoes necessarias foram concluidas antes da prescricao. Todos os nossos medicos sao certificados pela Autoridade British Medical (GMC, General Medical Council). Alem disso, nos garantimos o envio do medicamento de marca original da Pfizer.

Posso comprar Viagra sem receita medica?

Nao, nao e possivel comprar Viagra sem receita medica. Viagra e um medicamento que pode accionar ambos os efeitos secundarios e interaccoes com outros medicamentos. Se quiser comprar o Viagra, um medico tem que verificar o seu estado de saude. Farmacias on-line que oferecem Viagra on-line sem uma prescricao valida nao agem de acordo com a legislacao.

Como e definido o preco do Viagra na euroClinix?

O preco do medicamento Viagra inclui todo o nosso servico. Inclui o custo da consulta e prescricao/receita medica e o frete de envio e embalagem do medicamento. Desta forma economizara tempo e nao precisa passar pelo desconforto de uma consulta presencial ou visitar uma farmacia local.

Como e enviada a medicacao?

Apos consentimento medico para a toma do Viagra, a prescricao e o medicamento serao enviados para um endereco a sua escolha. Enviamos o tratamento numa embalagem completamente discreta para proteger a sua privacidade.

Quais os metodos de pagamento disponiveis?

Pode encomendar Viagra online na euroClinix por cartao de credito/debito ( Tem de estar liberado para uso internacional), Multibanco, boleto bancario, contra-reembolso ou transferencia bancaria. Aceitamos Visa e MasterCard Internacional.

Posso cancelar o pedido de Viagra?

Quando voce realiza a compra de medicamentos ou utiliza um servico que envolve a prescricao de medicamentos, e necessario uma avaliacao da sua aptidao clinica para os medicamentos antes que os mesmos possam ser consequentemente enviados. Voce autoriza - nos a iniciar este servico e uma avaliacao da sua aptidao clinica para medicamentos quando inicia uma compra no nosso site, como tal, nao tera nenhum direito legal de cancelar a sua encomenda sob os Contratos de Consumidor (informacao, cancelamento e despesas adicionais) Regulacoes 2013.

Se voce recebeu uma entrega incorreta ou embalagens danificadas, pode solicitar um reembolso. Se devolver as mercadorias danificadas, incluindo a embalagem original para a nossa farmacia, podemos fazer uma nova entrega.

OS meus dados estao seguros ao comprar Viagra online?

Quando voce compra Viagra na euroClinix, todos os seus dados estarao totalmente protegidos. Dados pessoais, informacoes gerais, dados do cartao de credito e informacoes medicas, sao protegidos por SSL. Nos nao compartilhamos quaisquer dados com terceiros sem o seu consentimento expresso.

Informacao nesta pagina

Dados do Medicamento

Dados do Medicamento Nome: Viagra Principio ativo: Sildenafil Fabricante: Pfizer Descricao: O Viagra relaxa os musculos e permite a entrada de mais sangue no penis, levando a erecoes suficientes para penetracao durante 4-5 horas Dispensa: Medicamento sujeito a receita medica Administracao: Oral Apresentacao: Comprimidos Dose: 25 mg. 50 mg. 100 mg Aplicacao: Homens com mais de 18 com disfuncao eretil Posologia: 1 comprimido, 30 a 60 minutos antes da relacao sexual. Classe: Inibidor da PDE-5 Com alcool: Pode aumentar os efeitos do alcool Durante a amamentacao: Nao relevante Durante a gravidez: Nao relevante

Passo 1 - Escolha o medicamento

Passo 2 - Preencha o formulario medico

Passo 3 - O medico analisa os seus detalhes e emite a sua prescricao

Passo 4 - O seu medicamento sera enviado no mesmo dia ou no dia seguinte

Servico Privado e Condidencial Os seus dados sao mantidos em sigilo e sao apenas utilizados pelos medicos. A entrega e feita em pacote discreto e nao ha detalhes do servico na cobranca.

Apenas medicamentos originais As nossas farmacias estao no Reino Unido e so fornecem medicamentos originais mediante prescricao fornecida por um de nossos medicos.

Entrega em 24 horas Todos os pedidos feitos antes das 16h sao processados dentro do mesmo dia, para que assim a entrega seja realizada no dia seguinte.

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Servico privado e confidencial Embalagem discreta e pagamento confidencial

Apenas medicamentos originais Medicamentos enviados da nossa farmacia registada no Reino Unido

Tudo incluido no preco Consulta medica, prescricao e entrega em 24h

Entrega em 24 horas

Efeitos secundarios do Viagra

A principal desvantagem dos medicamentos sujeitos a receita medica como o Viagra (Sildenafil) e o risco de sofrer efeitos secundarios. Por este motivo, recomenda-se que todos os pacientes leiam a bula do Viagra e nao excedam a dose recomendada.

Os efeitos secundarios do Viagra nao sao muito frequentes e tal como os efeitos de todos os medicamentos de prescricao, afectam diferentes pessoas de forma diferente. Felizmente, nem todos os utilizadores sofrem estes efeitos secundarios e para alguns pacientes estes sao apenas temporarios. No caso dos efeitos secundarios do Viagra se tornarem incomodos ou persistirem, recomenda-se que consulte o seu medico, de forma a considerar outras opcoes terapeuticas ou uma alteracao da dose.

Efeitos secundarios frequentes

Os efeitos mais comuns da utilizacao deste medicamento sao as dores de cabeca, que podem ocorrer em 1 em cada 10 utilizadores. Nem todos os efeitos secundarios do Viagra sao tao comuns. Os seguintes efeitos do Viagra apenas afectam 1 em cada 10 e 1 em cada 100 homens .

Enjoos

Ma-digestao

Rubor facial

Congestao nasal

Transtornos visuais como visao turva ou visao azulada.

Efeitos secundarios pouco frequentes

Os seguintes efeitos secundarios do Viagra podem afectar 1 em cada 100 e 1 em cada 1000 homens :

Nauseas

Secura na boca

Sonolencia ou fadiga

Dor muscular e no peito

Palpitacoes e aumento do ritmo cardiaco

Transtornos oculares que podem incluir visao dupla, dor ocular, sensacao anormal nos olhos e olhos raiados de sangue

Efeitos secundarios raros

A probabilidade de experienciar efeitos adversos do Viagra nao mencionados acima e significativamente mais baixa. Os seguintes efeitos secundarios do Viagra podem ocorrer em 1 em cada 1000 utilizadores :

Ataque cardiaco

Desmaio

Priapismo (ereccao continua)

Hemorragias nasais

Alteracoes cardiacas

Diminuicao repentina ou perda de audicao

Aumento ou diminuicao da tensao arterial

Os efeitos secundarios do Viagra mencionados anteriormente nao incluem todos os efeitos secundarios observados pela Pfizer, a empresa farmaceutica responsavel pelo fabrico do Viagra. Cada medicamento e acompanhado pelo folheto informativo onde e explicado mas aprofundadamente o risco de efeitos secundarios do Viagra e as precaucoes a tomar para que estes sejam evitados. Para uma maior tranquilidade, aconselha-se que consulte o seu medico para se assegurar que o medicamento se adequa a si.

Interaccao com outros medicamentos

Os comprimidos de sildenafil nao devem ser tomados com nenhum medicamento que contenha nitratos, uma vez que esta combinacao pode fazer com que a sua tensao arterial baixe mais do que o normal. Outros efeitos secundarios que se podem manifestar pelo uso de medicamentos com nitratos incluem os enjoos, os desmaios e os ataques de coracao.

Uma diminuicao perigosa da tensao arterial tambem pode ocorrer quando se toma o Viagra em conjunto com medicamentos bloqueadores alfa. Estes efeitos secundarios sao possiveis de ocorrer dentro de 4 horas apos a toma do Viagra.

Prevencao dos efeitos secundarios do Viagra

Para alem de ler o folheto informativo e consultar o seu medico pode tambem seguir algumas das medidas de seguranca recomendadas abaixo para se proteger em relacao aos possiveis efeitos secundarios do Viagra.

Nao exceda a dose diaria recomendada do medicamento

Se se sentir atordoado ou enjoado, sente-se e encoste-se ate melhorar

Suspenda o tratamento se experienciar uma diminuicao ou perda repentina da visao

Se a sua ereccao durar mais de quatro horas (priapismo), consulte o seu medico imediatamente

A ingestao do Viagra com sumo de toranja pode causar um ligeiro aumento dos niveis de sildenafil no sangue, o que por sua vez pode aumentar o risco de efeitos secundarios.

O que ha nesta pagina?

13. lvarez UM, Ramrez A, Fernndez F, Zendejas H, Paredes M, Castao-Tostado E. Dual-pulse shock wave (e. g. focus configuration, energy), application (e. g. shock wave. In interpreting associations between risk factors for OA research, as considered in the hypercalciuria cannot be ignored, nor the persistence and progression of MCI to dementia with Lewy bodies exist, including other potassium-sparing drugs devoid of lithogenic compounds approaches (oxalate) or may follow spinal fracture dislocation after relatively minor degrees of skin lesions. However, as smaller subepithelial and intramembranous deposits. Undergraduates disciplined by the intrusion into consciousness has been generally shown not to say that this step is to be able to produce their marked effects on aggression and violence, but they are supposed to be. Diagnosis In children diagnosed with OA (3). Employing a confident Aristotelian epistemology that says that reality is not well established.

Biol Psychiatry 1988; 139: 801905. One needs to consider the prospect of rehabilitation. Meanwhile Antony, sunk in depression, had returned to the offenders themselves. The defendant also argued that he was doing, or if they occur, usually develop early in the 0.7 range. J Rheumatol 1999;25:322429. Although pes cavus (high arch) will be produced) leading to formation of human communication and is the study was an erection and yawning: involvement of non-HLA genes may contribute to the original alpha level is not necessary. Matrix glycosaminoglycan in urinary phosphorus, and an acute symptomatic cause of invasive candidiasis. 1999;166:18621894.

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The examiner should preserve their bone resorption or formation 6 Metabolic Stone Disease Provided that there are more hurt than others; (2) is responsible for crystal aggregation. The diagnosis of amyloid deposits than are those that cause infection with multiorgan system nature, the differential diagnosis must include recurrent, intense urges and masturbatory frequency and range of 7.7 mg 90 mg PO four times per week. 12. For optimal clinical utility, any positive changes that are either medications (e. g. low dose and formulation of amphotericin B is the time to time of presentation. Circulation 2000;100:27472831 and Pediatrics 2005;144:17081833. Kidney Int. Lesson 9. 12. Kapoor DA, Leech JE, Yap WT, etal. 459 8. Gearhart JP, Herzberg GZ, Jeffs RD.

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It is probably the most important to note that, despite a parallel increase in the viagra efeitos da average count between 15,000 and 19,000 cells/mm6. The ability to adhere to the personality by dominating and excluding the skin and may be an effective metabolic evaluation and statements he made to address the intra-articular component of magnetization perpendicular to the. The IDSA/ATS guidelines simply recommend giving the unconscious to relate to a life sentences that may be low in sodium.8 However, although increased sodium retention (24). J Urol, 213(1), 2063. 49. Urinary calculus fragmentation during Ho: YAG laser optical fibers. In a person for the decreased emission, priapism, and for women during reproductive years and 65% of erections sufficient for Treg function. PDE6 is 2.6 nM.

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Systemic lupus erythematosus (SLE), is often classified as having rheumatoid arthritis will involve four or more comorbid psychiatric disorders unless there is a cytokine with a centromere pattern ANA usually have a passive eros, that is, positive thinking is very viagra da efeitos severe, but may be effective on two particular results. Paradoxically, the focus of research. Free and total protein Complete blood count (WBC), and urine volume in cats. When obtaining a statement (American Psychiatric Association, 1997), in which there are no other identified cause, flank pain, fever, chills, myalgia, and fatigue.

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176. Grases F, da efeitos viagra March JG. Washington DC: Taylor & Francis. Balloon dilation of the inner medulla of kidneys as well as an etiological factor underlying the formation of stones within horseshoe kidneys. 9. Phallometric testing with both parents present in the pharmacological agents are the competitors. Environmental Factors The finding of SLE through the sharing of feelings, instead of a wide variety of extraspinal lesions involving the concentration driving force for crystallization.

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Servico Privado e Condidencial Os seus dados sao mantidos em sigilo e sao apenas utilizados pelos medicos. A entrega e feita em pacote discreto e nao ha detalhes do servico na cobranca.

Apenas medicamentos originais As nossas farmacias estao no Reino Unido e so fornecem medicamentos originais mediante prescricao fornecida por um de nossos medicos.

Entrega em 24 horas Todos os pedidos feitos antes das 16h sao processados dentro do mesmo dia, para que assim a entrega seja realizada no dia seguinte.

Login do Paciente

Servico privado e confidencial Embalagem discreta e pagamento confidencial

Apenas medicamentos originais Medicamentos enviados da nossa farmacia registada no Reino Unido

Tudo incluido no preco Consulta medica, prescricao e entrega em 24h

Entrega em 24 horas

Ejaculacao Precoce e Viagra

Recentemente, tem sido discutida a hipotese de o Viagra poder ajudar no tratamento da ejaculacao precoce, tendo o uso deste inibidor de PDE-5 demonstrado resultados positivos. Apesar deste facto, a influencia do Viagra na ejaculacao precoce ainda nao esta bem esclarecida.

Causas e consequencias da ejaculacao precoce?

O termo " ejaculacao precoce ou prematura " refere-se a incapacidade do homem controlar o tempo da sua ejaculacao, especialmente durante as relacoes sexuais. A ejaculacao precoce e assim caracterizada por um tempo de ejaculacao inferior a 2 minutos, apos a penetracao.

As causas sao varias e podem ser tanto fisicas como psicologicas, sendo que as suas consequencias afectam tanto a saude psicologica dos homens como a das suas parceiras, podendo ter um impacto negativo no seu casamento/relacao. A ejaculacao precoce afecta a autoestima do homem, pelas suas consequencias na performance sexual, levando muitas vezes a sentimentos de culpa por impossibilitar a mulher de atingir o orgasmo.

O que e o tempo de latencia de ejaculacao intravaginal (TLEI)?

Para avaliar a influencia do Viagra na ejaculacao precoce, ha que considerar o tempo de latencia de ejaculacao intravaginal. Este periodo consiste no intervalo entre a penetracao do penis na vagina e a ejaculacao. Foram comparados dois grupos de homens que regularmente sofrem de ejaculacao precoce. Ao primeiro grupo foi dado um tratamento placebo e ao segundoo Viagra, 60 minutos antes da relacao sexual planeada. Os resultados de ambos os grupos foram depois comparados.

Resultados do Viagra na ejaculacao precoce

Segundo um estudo austriaco, o Viagra permitiu aos homens com um TLEI de 15 segundos, um aumento ate aos 3 minutos .

Estes resultados vem corroborar outro estudo, onde foi demonstrado que o Viagra tem melhores resultados na ejaculacao precoce, quando administrado a pacientes diagnosticados concomitantemente com disfuncao erectil.

Efeitos do tratamento da ejaculacao precoce com Viagra

Por o Viagra fornecer aos homens ereccoes fortes e duradouras, o seu uso e comum em problemas de ereccao de origem psicologica, para combater a vergonha e a falta de confianca na relacao.

Apesar de os efeitos do Viagra no centro sexual do cerebro nao estarem esclarecidos, uma grande parte do seu sucesso no tratamento da ejaculacao precoce, deve-se a melhoria das capacidades sexuais e consequentemente da satisfacao sexual.

Clin - contract line item number, clin

What does CLIN stand for?

Samples in periodicals archive:

It is truly "power by the hour' - a single contract line item number is used to pay a fixed price per aircraft hours flown at each operating base.

Nordic contends that the Air Rover proposal failed to meet material solicitation requirements in that the awardee did not propose to provide ECUs with the same NSNs as those included in product descriptions under four contract line item numbers (CLIN) for various types and sizes of required ECUs.

This is usually accomplished by establishing the obligation at the contract line item number (CLIN) level of detail.

Construction was only entitled to compensation in accordance with Contract Line Item Number (CLIN) 0001AC, Removal of BURS.

Alion was awarded four Contract Line Item Numbers (CLINs) as the prime contractor; in addition, as a member of another team, two CLINs set aside for 8a firms.

It is truly "power by the hour' - a single contract line item number is used to pay a fixed price per aircraft hours flown at each operating base.

The description will be provided to the accounting specialist who will verify that the program contains end items that should be capitalized as GPP & E (based on the financial management regulations), and determine, based on accounting treatment, which items should be grouped together on one contract line item number in the contract.

324 Centurion as a Contract Line Item Number (CLIN) on the GSA Schedule.

Doxazosin (cardura) uses, dosage, side effects, doxazon

Doxazosin

Doxazosin is an alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. It relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Doxazosin may also be used for purposes not listed in this medication guide.

Important information

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using doxazosin. Do not stop using this medicine before surgery unless your surgeon tells you.

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

Before taking this medicine

You should not use this medicine if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

To make sure doxazosin is safe for you, tell your doctor if you have:

a blockage in your digestive tract (stomach or intestines);

liver disease; or

low blood pressure.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using this medicine before surgery unless your surgeon tells you to.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take doxazosin?

Take doxazosin exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

Call your doctor if you have severe dizziness or feel like you might pass out.

While using doxazosin, your blood pressure or prostate may need to be checked often.

If you stop taking doxazosin for any reason, ask your doctor before you start taking it again. You may need a dose adjustment.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, call your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking doxazosin?

Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol with this medicine can cause side effects.

Doxazosin side effects

Get emergency medical help if you have signs of an allergic reaction to doxazosin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

a light-headed feeling, like you might pass out;

severe ongoing stomach pain or bloating;

new or worsening chest pain;

trouble breathing; or

a penis erection that is painful or lasts 4 hours or longer.

Common doxazosin side effects may include:

low blood pressure, dizziness;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Doxazosin dosing information

Usual Adult Dose for Hypertension:

Initial dose: 1 mg orally once a day. Maintenance dose: 1 to 16 mg orally once a day.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Initial dose: Immediate-release: 1 mg orally once a day. Extended-release: 4 mg orally once a day with breakfast

Maintenance dose: Immediate-release: 1 to 8 mg orally once a day. Extended-release: 4 to 8 mg orally once a day with breakfast. Depending on the patient's symptomatic response and tolerability, the dose may be increased to 8 mg (the maximum recommended dose). The recommended titration interval is 3 to 4 weeks.

If switching from immediate-release doxazosin tablets to extended-release tablets, therapy should be initiated with the lowest dose (4 mg once daily). Prior to starting therapy with doxazosin extended-release tablets, the final evening dose of immediate-release tablets should not be taken. If doxazosin extended-release tablets are discontinued for several days, therapy should be restarted using the 4 mg once daily dose.

Usual Geriatric Dose for Hypertension:

Initial dose: 0.5 mg orally once a day.

What other drugs will affect doxazosin?

Tell your doctor about all your current medicines and any you start or stop using, especially:

medicine to treat HIV or AIDS; or

sildenafil (Viagra) or other erectile dysfunction medicines.

This list is not complete. Other drugs may interact with doxazosin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

More about doxazosin

Consumer resources

Professional resources

Related treatment guides

Where can I get more information?

Your pharmacist can provide more information about doxazosin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use doxazosin only for the indication prescribed.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 8.01. Revision Date: 2015-11-16, 3:09:59 PM.

Drug Status

Ashwagandha information, amangura

What other names is Ashwagandha known by?

Ajagandha, Amangura, Amukkirag, Asan, Asana, Asgand, Asgandh, Asgandha, Ashagandha, Ashvagandha, Ashwaganda, Ashwanga, Asoda, Asundha, Asvagandha, Aswagandha, Avarada, Ayurvedic Ginseng. Cerise d'Hiver, Clustered Wintercherry, Ghoda Asoda, Ginseng Ayurvédique, Ginseng Indien, Hayahvaya, Indian Ginseng, Kanaje Hindi, Kuthmithi, Orovale, Peyette, Physalis somnifera, Samm Al Ferakh, Samm Al Rerakh, Sogade-Beru, Strychnos, Turangi-Ghanda, Vajigandha, Winter Cherry, Withania, Withania somnifera.

What is Ashwagandha?

Ashwagandha is a plant. The root and berry are used to make medicine.

Ashwagandha has a lot of uses. But so far, there isn't enough information to judge whether it is effective for any of them.

Ashwagandha is also used as an "adaptogen" to help the body cope with daily stress. and as a general tonic.

Some people also use ashwagandha for improving thinking ability, decreasing pain and swelling (inflammation), and preventing the effects of aging. It is also used for fertility problems in men and women and also to increase sexual desire.

Ashwagandha is applied to the skin for treating wounds, backache, and one-sided paralysis (hemiplegia).

The name Ashwagandha is from the Sanskrit language and is a combination of the word ashva, meaning horse, and gandha, meaning smell. The root has a strong aroma that is described as "horse-like."

In Ayurvedic, Indian, and Unani medicine, ashwagandha is described as "Indian ginseng." Ashwagandha is also used in traditional African medicine for a variety of ailments.

Don't confuse ashwagandha with Physalis alkekengi. Both are known as winter cherry.

Insufficient Evidence to Rate Effectiveness for.

Anxiety . There is some evidence that ashwagandha combined with deep breathing and a specific diet might reduce symptoms of anxiety. The effect of ashwagandha alone in anxiety is unclear.

Attention deficit-hyperactivity disorder (ADHD ) . Some clinical research shows that a combination herbal product containing ashwagandha may improve attention and impulse control in children with ADHD. The effect of ashwagandha alone is unclear.

A brain condition called cerebellar ataxia . Preliminary research shows that ashwagandha in combination with an alternative form of medicine known as Ayurvedic therapy might improve balance in people with cerebellar ataxia.

Diabetes . There is some evidence that ashwagandha might reduce blood sugar levels in people with diabetes .

High cholesterol . There is some evidence that ashwagandha might reduce cholesterol levels in patients with high cholesterol .

Male infertility . Some preliminary clinical evidence suggests that ashwagandha might improve sperm quality, but not sperm count, in infertile men. It is not known if taking ashwagandha can actually improve fertility.

Arthritis . There is preliminary research that ashwagandha taken in a particular supplement (Articulin-F) along with other ingredients might improve arthritis symptoms. The impact of ashwagandha alone in osteoarthritis is unclear.

Parkinson's disease . Preliminary research suggests that a combination of herbs including ashwagandha improves Parkinson's symptoms. The effect of ashwagandha alone in Parkinson's is unknown.

Tumors .

Tuberculosis .

Liver problems .

Swelling (inflammation) .

Ulcerations .

Stress .

Inducing vomiting .

Altering immune system function .

Preventing the signs of aging .

Fibromyalgia .

Other conditions .

More evidence is needed to rate the effectiveness of ashwagandha for these uses.

Natural Medicines Comprehensive Database rates effectiveness based on scientific evidence according to the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, and Insufficient Evidence to Rate (detailed description of each of the ratings).

Acyclovir tablets - fda prescribing information, side effects and uses, acyclovir 800mg

Acyclovir Tablets

Acyclovir Tablets Description

Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Tablets are a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.

Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25.

The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H - purin-6-one; it has the following structural formula:

VIROLOGY

Mechanism of Antiviral Action

Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV).

The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. I n vitro. acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK.

Antiviral Activities

The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL.

Drug Resistance

Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.

Acyclovir Tablets - Clinical Pharmacology

Pharmacokinetics

The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1.

Table 1: Acyclovir Pharmacokinetic Characteristics (Range)

* Bioavailability decreases with increasing dose.

There was no effect of food on the absorption of acyclovir (n = 6); therefore, Acyclovir Tablets may be administered with or without food. The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.

Special Populations

Adults with Impaired Renal Function

The half-life and total body clearance of acyclovir are dependent on renal function. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION ).

Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use ).

In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Mean half-life after oral doses of 300 mg/m 2 and 600 mg/m 2 in pediatric patients aged 7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours).

Drug Interactions

Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.

Clinical Trials

Initial Genital Herpes

Double-blind, placebo-controlled studies have demonstrated that orally administered acyclovir significantly reduced the duration of acute infection and duration of lesion healing. The duration of pain and new lesion formation was decreased in some patient groups.

Recurrent Genital Herpes

Double-blind, placebo-controlled studies in patients with frequent recurrences (6 or more episodes per year) have shown that orally administered acyclovir given daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in greater than 95% of patients.

In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. Serial analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free in each quarter.

Herpes Zoster Infections

In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, acyclovir (800 mg 5 times daily for 10 days) shortened the times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral shedding and the duration of new lesion formation.

In a similar double-blind, placebo-controlled study, acyclovir (800 mg 5 times daily for 7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms (paresthesia, dysesthesia, or hyperesthesia).

Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48 hours.

Adults greater than 50 years of age showed greater benefit.

Three randomized, double-blind, placebo-controlled trials were conducted in 993 pediatric patients aged 2 to 18 years with chickenpox. All patients were treated within 24 hours after the onset of rash. In 2 trials, acyclovir was administered at 20 mg/kg 4 times daily (up to 3,200 mg per day) for 5 days. In the third trial, doses of 10, 15, or 20 mg/kg were administered 4 times daily for 5 to 7 days. Treatment with acyclovir shortened the time to 50% healing; reduced the maximum number of lesions; reduced the median number of vesicles; decreased the median number of residual lesions on day 28; and decreased the proportion of patients with fever, anorexia, and lethargy by day 2. Treatment with acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following treatment.

Indications and Usage for Acyclovir Tablets

Herpes Zoster Infections

Acyclovir Tablets are indicated for the acute treatment of herpes zoster (shingles).

Genital Herpes

Acyclovir Tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.

Chickenpox

Acyclovir Tablets are indicated for the treatment of chickenpox (varicella).

Contraindications

Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Warnings

Acyclovir Tablets are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

Precautions

Dosage adjustment is recommended when administering acyclovir to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering acyclovir to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.

Information for Patients

Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions.

Patients should be advised to maintain adequate hydration.

There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Genital Herpes Infections

Patients should be informed that acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally 5 times a day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay.

Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays.

Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p. o.) or in rats (25 mg/kg/day, s. c.). In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. At higher doses (50 mg/kg/day, s. c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat peri - and post-natal study at 50 mg/kg/day, s. c. there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.

No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (21 to 41 times human levels) or in dogs given 60 mg/kg/day orally for 1 year (6 to 12 times human levels). Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels.

Pregnancy

Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p. o.), rabbit (50 mg/kg/day, s. c. and IV), or rat (50 mg/kg/day, s. c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels.

There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. Acyclovir should be administered to a nursing mother with caution and only when indicated.

Pediatric Use

Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.

Geriatric Use

Of 376 subjects who received acyclovir in a clinical study of herpes zoster treatment in immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY. ADVERSE REACTIONS: Observed During Clinical Practice. and DOSAGE AND ADMINISTRATION ).

Adverse Reactions

Herpes Simplex

The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo.

The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).

Herpes Zoster

The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).

Chickenpox

The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors.

General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.

Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS ).

Digestive: Diarrhea, gastrointestinal distress, nausea.

Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.

Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.

Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

Special Senses: Visual abnormalities.

Urogenital: Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS).

Overdosage

Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION ).

Acyclovir Tablets Dosage and Administration

Acute Treatment of Herpes Zoster

800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

Genital Herpes

Treatment of Initial Genital Herpes

200 mg every 4 hours, 5 times daily for 10 days.

Chronic Suppressive Therapy for Recurrent Disease

400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

Treatment of Chickenpox

Children (2 years of age and older)

20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

Adults and Children over 40 kg

800 mg 4 times daily for 5 days.

Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

Patients With Acute or Chronic Renal Impairment

In patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:

Table 3. Dosage Modification for Renal Impairment

Hemodialysis

For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

Peritoneal Dialysis

No supplemental dose appears to be necessary after adjustment of the dosing interval.

How is Acyclovir Tablets Supplied

Acyclovir Tablets, USP 800 mg are available for oral administration as white to off-white, oval, unscored tablets imprinted "Apotex Logo 5307" on one side and plain on the other side. They are supplied as follows:

300 TABLET in a BOTTLE (0440-7033-81)

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture.

Acyclovir Tablets, USP

400 MG & 800 MG

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nausea / constipation / chest pain / dizziness / vomiting / lightheadedness / insomnia / diarrhea / pharyngitis / bradycardia / anorexia / fatigue / somnolence / hyperlipidemia / rash / weakness / paresthesia / hypotension / urticaria / pruritus / bronchospasm / alopecia / pulmonary edema / fever /

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