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Treatment of Acute Malaria Infections Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by Mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of Mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with Mefloquine Hydrochloride Tablets, are at high risk of relapse because Mefloquine Hydrochloride Tablets do not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with Mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e. g. primaquine). Prevention of Malaria Mefloquine Hydrochloride Tablets are indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.

Use of Mefloquine Hydrochloride Tablets is contraindicated in patients with a known hypersensitivity to Mefloquine or related compounds (e. g. quinine and quinidine) or to any of the excipients contained in the formulation. Mefloquine Hydrochloride Tablets should not be prescribed for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders, or with a history of convulsions.

Clinical At the doses used for treatment of acute malaria infections, the symptoms possibly attributable to drug administration cannot be distinguished from those symptoms usually attributable to the disease itself Among subjects who received Mefloquine for prophylaxis of malaria, the most frequently observed adverse experience was vomiting (3%). Dizziness, syncope, extrasystoles and other complaints affecting less than 1% were also reported. Among subjects who received Mefloquine for treatment, the most frequently observed adverse experiences included: dizziness, myalgia, nausea, fever, headache, vomiting, chills, diarrhea, skin rash, abdominal pain, fatigue, loss of appetite, and tinnitus. Those side effects occurring in less than 1% included bradycardia, hair loss, emotional problems, pruritus, asthenia, transient emotional disturbances and telogen effluvium (loss of resting hair). Seizures have also been reported. Two serious adverse reactions were cardiopulmonary arrest in one patient shortly after ingesting a single prophylactic dose of Mefloquine while concomitantly using propranolol, and encephalopathy of unknown etiology during prophylactic Mefloquine administration. The relationship of encephalopathy to drug administration could not be clearly established. Postmarketing Postmarketing surveillance indicates that the same kind of adverse experiences are reported during prophylaxis, as well as acute treatment. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Mefloquine Hydrochloride Tablets exposure. The most frequently reported adverse events are nausea, vomiting, loose stools or diarrhea, abdominal pain, dizziness or vertigo, loss of balance, and neuropsychiatric events such as headache, somnolence, and sleep disorders (insomnia, abnormal dreams). These are usually mild and may decrease despite continued use. In a small number of patients it has been reported that dizziness or vertigo and loss of balance may continue for months after discontinuation of the drug. Occasionally, more severe neuropsychiatric disorders have been reported such as: sensory and motor neuropathies (including paresthesia, tremor and ataxia), convulsions, agitation or restlessness, anxiety, depression, mood swings, panic attacks, memory impairment, confusion, hallucinations, aggression, psychotic or paranoid reactions and encephalopathy. Rare cases of suicidal ideation and suicide have been reported though no relationship to drug administration has been confirmed. Other less frequently reported adverse events include: Cardiovascular Disorders: circulatory disturbances (hypotension, hypertension, flushing, syncope), chest pain, tachycardia or palpitation, bradycardia, irregular heart rate, extrasystoles, A-V block, and other transient cardiac conduction alterations Skin Disorders: rash, exanthema, erythema, urticaria, pruritus, edema, hair loss, erythema multiforme, and Stevens-Johnson syndrome Musculoskeletal Disorders: muscle weakness, muscle cramps, myalgia, and arthralgia Respiratory Disorders: dyspnea, pneumonitis of possible allergic etiology Other Symptoms: visual disturbances, vestibular disorders including tinnitus and hearing impairment, asthenia, malaise, fatigue, fever, hyperhidrosis, chills, dyspepsia and loss of appetite Laboratory The most frequently observed laboratory alterations which could be possibly attributable to drug administration were decreased hematocrit, transient elevation of transaminases, leukopenia and thrombocytopenia. These alterations were observed in patients with acute malaria who received treatment doses of the drug and were attributed to the disease itself. During prophylactic administration of Mefloquine to indigenous populations in malaria-endemic areas, the following occasional alterations in laboratory values were observed: transient elevation of transaminases, leukocytosis or thrombocytopenia. Because of the long half-life of Mefloquine, adverse reactions to Mefloquine Hydrochloride Tablets may occur or persist up to several weeks after discontinuation of the drug.

Drug-drug interactions with Mefloquine Hydrochloride Tablets have not been explored in detail. There is one report of cardiopulmonary arrest, with full recovery, in a patient who was taking a beta blocker (propranolol). The effects of Mefloquine on the compromised cardiovascular system have not been evaluated. The benefits of Mefloquine therapy should be weighed against the possibility of adverse effects in patients with cardiac disease.

In case of life-threatening, serious or overwhelming malaria infections due to P. falciparum, patients should be treated with an intravenous antimalarial drug. Following completion of intravenous treatment, Mefloquine Hydrochloride Tablets may be given to complete the course of therapy. Halofantrine should not be administered with Mefloquine Hydrochloride Tablets or within 15 weeks of the last dose of Mefloquine Hydrochloride Tablets due to the risk of a potentially fatal prolongation of the QTc interval. Ketoconazole should not be administered with Mefloquine Hydrochloride Tablets or within 15 weeks of the last dose of Mefloquine Hydrochloride Tablets due to the risk of a potentially fatal prolongation of the QTc interval. Ketoconazole increases plasma concentrations and elimination half-life of Mefloquine following co-administration. Mefloquine may cause psychiatric symptoms in a number of patients, ranging from anxiety, paranoia, and depression to hallucinations and psychotic behavior. On occasions, these symptoms have been reported to continue long after Mefloquine has been stopped. Rare cases of suicidal ideation and suicide have been reported though no relationship to drug administration has been confirmed. To minimize the chances of these adverse events, Mefloquine should not be taken for prophylaxis in patients with active depression or with a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders. Mefloquine Hydrochloride Tablets should be used with caution in patients with a previous history of depression. During prophylactic use, if psychiatric symptoms such as acute anxiety, depression, restlessness or confusion occur, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued and an alternative medication should be substituted. Concomitant administration of Mefloquine Hydrochloride Tablets and quinine or quinidine may produce electrocardiographic abnormalities. Concomitant administration of Mefloquine Hydrochloride Tablets and quinine or chloroquine may increase the risk of convulsions. Hypersensitivity Reactions Hypersensitivity reactions ranging from mild cutaneous events to anaphylaxis cannot be predicted. In patients with epilepsy, Mefloquine Hydrochloride Tablets may increase the risk of convulsions. The drug should therefore be prescribed only for curative treatment in such patients and only if there are compelling medical reasons for its use. Central and Peripheral Nervous System Effects Caution should be exercised with regard to activities requiring alertness and fine motor coordination such as driving, piloting aircraft, operating machinery, and deep-sea diving, as dizziness or vertigo, a loss of balance, or other disorders of the central or peripheral nervous system have been reported during and following the use of Mefloquine Hydrochloride Tablets. These effects may occur after therapy is discontinued due to the long half-life of the drug. In a small number of patients, dizziness or vertigo and loss of balance have been reported to continue for months after discontinuation of the drug. Mefloquine Hydrochloride Tabletsshould be used with caution in patients with psychiatric disturbances because Mefloquine use has been associated with emotional disturbances. Use in Patients with Hepatic Impairment In patients with impaired liver function the elimination of Mefloquine may be prolonged, leading to higher plasma levels. Long-Term Use This drug has been administered for longer than one year. If the drug is to be administered for a prolonged period, periodic evaluations including liver function tests should be performed. Although retinal abnormalities seen in humans with long-term chloroquine use have not been observed with Mefloquine use, long-term feeding of Mefloquine to rats resulted in dose-related ocular lesions (retinal degeneration, retinal edema and lenticular opacity at 12.5 mg/kg/day and higher). Therefore, periodic ophthalmic examinations are recommended. Cardiac Effects Parenteral studies in animals show that Mefloquine, a myocardial depressant, possesses 20% of the anti-fibrillatory action of quinidine and produces 50% of the increase in the PR interval reported with quinine. The effect of Mefloquine on the compromised cardiovascular system has not been evaluated. However, transitory and clinically silent ECG alterations have been reported during the use of Mefloquine. Alterations included sinus bradycardia, sinus arrhythmia, first degree AV-block, prolongation of the QTc interval and abnormal T waves. The benefits of Mefloquine Hydrochloride Tablets therapy should be weighed against the possibility of adverse effects in patients with cardiac disease. Laboratory Tests Periodic evaluation of hepatic function should be performed during prolonged prophylaxis. Information for Patients Medication Guide: As required by law, a Mefloquine Hydrochloride Tablets Medication Guide is supplied to patients when Mefloquine Hydrochloride Tablets are dispensed. An information wallet card is also supplied to patients when Mefloquine Hydrochloride Tablets are dispensed. Patients should be instructed to read the Medication Guide when Mefloquine is received and to carry the information wallet card with them when they are taking Mefloquine Hydrochloride Tablets. The complete texts of the Medication Guide and information wallet card are reprinted at the end of this document. Patients should be advised: that malaria can be a life-threatening infection in the traveler; that Mefloquine Hydrochloride Tablets are being prescribed to help prevent or treat this serious infection; that in a small percentage of cases, patients are unable to take this medication because of side effects, including dizziness or vertigo and loss of balance, and it may be necessary to change medications. Although side effects of dizziness or vertigo and loss of balance are usually mild and do not cause people to stop taking the medication, in a small number of patients it has been reported that these symptoms may continue for months after discontinuation of the drug; that when used as prophylaxis, the first dose of Mefloquine Hydrochloride Tablets should be taken one week prior to arrival in an endemic area; that if the patients experience psychiatric symptoms such as acute anxiety, depression, restlessness or confusion, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued and an alternative medication should be substituted; that no chemoprophylactic regimen is 100% effective, and protective clothing, insect repellents, and bednets are important components of malaria prophylaxis; to seek medical attention for any febrile illness that occurs after return from a malarious area and to inform their physician that they may have been exposed to malaria. Halofantrine and Other Antimalarials Halofantrine should not be administered with Mefloquine Hydrochloride Tablets or within 15 weeks of the last dose of Mefloquine Hydrochloride Tablets due to the risk of a potentially fatal prolongation of the QTc interval. Concomitant administration of Mefloquine Hydrochloride Tablets and other related antimalarial compounds (e. g. quinine, quinidine and chloroquine) may produce electrocardiographic abnormalities and increase the risk of convulsions. If these drugs are to be used in the initial treatment of severe malaria, Mefloquine Hydrochloride Tablets administration should be delayed at least 12 hours after the last dose. Clinically significant QTc prolongation has not been found with Mefloquine alone. Ketoconazole (Potent Inhibitor of CYP3A4) Co-administration of a single 500 mg oral dose of Mefloquine Hydrochloride Tablets with 400 mg of ketoconazole once daily for 10 days in 8 healthy volunteers resulted in an increase in the mean Cmax and AUC of Mefloquine by 64% and 79%, respectively, and an increase in the mean elimination half-life of Mefloquine from 322 hours to 448 hours. Ketoconazole should not be administered with Mefloquine Hydrochloride Tablets or within 15 weeks of the last dose of Mefloquine Hydrochloride Tablets due to the risk of a potentially fatal prolongation of the QTc interval. Other Drugs that Prolong the QTc Interval Co-administration of other drugs known to alter cardiac conduction (e. g. anti-arrhythmic or beta-adrenergic blocking agents, calcium channel blockers, antihistamines or H1-blocking agents, tricyclic antidepressants and phenothiazines) might also contribute to a prolongation of the QTc interval. There are no data that conclusively establish whether the concomitant administration of Mefloquine and the above listed agents has an effect on cardiac function. Anticonvulsants In patients taking an anticonvulsant (e. g. valproic acid, carbamazepine, phenobarbital or phenytoin), the concomitant use of Mefloquine Hydrochloride Tablets may reduce seizure control by lowering the plasma levels of the anticonvulsant. Therefore, patients concurrently taking antiseizure medication and Mefloquine Hydrochloride Tablets should have the blood level of their antiseizure medication monitored and the dosage adjusted appropriately. Vaccines When Mefloquine Hydrochloride Tablets are taken concurrently with oral live typhoid vaccines, attenuation of immunization cannot be excluded. Vaccinations with attenuated live bacteria should therefore be completed at least 3 days before the first dose of Mefloquine Hydrochloride Tablets. Rifampin (Potent Inducer of CYP3A4) Co-administration of a single 500 mg oral dose of Mefloquine Hydrochloride Tablets and 600 mg of rifampin once daily for 7 days in 7 healthy Thai volunteers resulted in a decrease in the mean Cmax and AUC of Mefloquine by 19% and 68%, respectively, and a decrease in the mean elimination half-life of Mefloquine from 305 hours to 113 hours. Rifampin should be used cautiously in patients taking Mefloquine Hydrochloride Tablets. Inhibitors and Inducers of CYP3A4 Mefloquine does not inhibit or induce the CYP 450 enzyme system. Thus, concomitant administration of Mefloquine Hydrochloride Tablets and substrates of the CYP 450 enzyme system is not expected to result in a drug interaction. However, co-administration of CYP 450 inhibitors or inducers may increase or decrease Mefloquine plasma concentrations, respectively. Substrates and Inhibitors of P-glycoprotein It has been shown in vitro that Mefloquine is a substrate and an inhibitor of P-glycoprotein. Therefore, drug-drug interactions could also occur with drugs that are substrates or are known to modify the expression of this transporter. The clinical relevance of these interactions is not known to date. Other Potential Interactions No other drug interactions are known. Nevertheless, the effects of Mefloquine Hydrochloride Tablets on travelers receiving comedication, particularly diabetics or patients using anticoagulants, should be checked before departure. In clinical trials, the concomitant administration of sulfadoxine and pyrimethamine did not alter the adverse reaction profile of Mefloquine. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of Mefloquine was studied in rats and mice in 2-year feeding studies at doses of up to 30 mg/kg/day. No treatment-related increases in tumors of any type were noted. Mutagenesis The mutagenic potential of Mefloquine was studied in a variety of assay systems including: Ames test, a host-mediated assay in mice, fluctuation tests and a mouse micronucleus assay. Several of these assays were performed with and without prior metabolic activation. In no instance was evidence obtained for the mutagenicity of Mefloquine. Impairment of Fertility Fertility studies in rats at doses of 5, 20, and 50 mg/kg/day of Mefloquine have demonstrated adverse effects on fertility in the male at the high dose of 50 mg/kg/day, and in the female at doses of 20 and 50 mg/kg/day. Histopathological lesions were noted in the epididymides from male rats at doses of 20 and 50 mg/kg/day. Administration of 250 mg/week of Mefloquine (base) in adult males for 22 weeks failed to reveal any deleterious effects on human spermatozoa. Pregnancy Teratogenic Effects Pregnancy Category C Mefloquine has been demonstrated to be teratogenic in rats and mice at a dose of 100 mg/kg/day. In rabbits, a high dose of 160 mg/kg/day was embryotoxic and teratogenic, and a dose of 80 mg/kg/day was teratogenic but not embryotoxic. There are no adequate and well-controlled studies in pregnant women. However, clinical experience with Mefloquine Hydrochloride Tablets has not revealed an embryotoxic or teratogenic effect. Mefloquine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential who are traveling to areas where malaria is endemic should be warned against becoming pregnant. Women of childbearing potential should also be advised to practice contraception during malaria prophylaxis with Mefloquine Hydrochloride Tablets and for up to 3 months thereafter. However, in the case of unplanned pregnancy, malaria chemoprophylaxis with Mefloquine Hydrochloride Tablets is not considered an indication for pregnancy termination. Nursing Mothers Mefloquine is excreted in human milk in small amounts, the activity of which is unknown. Based on a study in a few subjects, low concentrations (3% to 4%) of Mefloquine were excreted in human milk following a dose equivalent to 250 mg of the free base. Because of the potential for serious adverse reactions in nursing infants from Mefloquine, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Use of Mefloquine Hydrochloride Tablets to treat acute, uncomplicated P. falciparum malaria in pediatric patients is supported by evidence from adequate and well-controlled studies of Mefloquine Hydrochloride Tablets in adults with additional data from published open-label and comparative trials using Mefloquine Hydrochloride Tablets to treat malaria caused by P. falciparum in patients younger than 16 years of age. The safety and effectiveness of Mefloquine Hydrochloride Tablets for the treatment of malaria in pediatric patients below the age of 6 months have not been established. In several studies, the administration of Mefloquine Hydrochloride Tablets for the treatment of malaria was associated with early vomiting in pediatric patients. Early vomiting was cited in some reports as a possible cause of treatment failure. If a second dose is not tolerated, the patient should be monitored closely and alternative malaria treatment considered if improvement is not observed within a reasonable period of time. Geriatric Use Clinical studies of Mefloquine Hydrochloride Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Since electrocardiographic abnormalities have been observed in individuals treated with Mefloquine Hydrochloride Tablets and underlying cardiac disease is more prevalent in elderly than in younger patients, the benefits of Mefloquine Hydrochloride Tablets therapy should be weighed against the possibility of adverse cardiac effects in elderly patients.

Buy captopril 25mg

Capoten

What is Capoten? Capoten contains captopril, a substance which belongs to a family of enzyme inhibitors. These substances block the ACE enzyme which is responsible for blood pressure regulation, which lets the blood vessels to relax. The vasodilatory action of the drug lowers the blood pressure, and it also helps to mitigate various harmful consequences of abnormally high blood pressure. The drug is used in hypertension therapy, as well as to help to fight various symptoms of heart attacks and diabetes.

What are the indications for using Capoten? The main indications for Capoten use are the following: hypertension (high blood pressure), congestive heart failure (insufficient heart pump action), myocardial infarction (heart attack), and kidney disease related to diabetes. What is the dosage of Capoten? The medication is available as Capoten oral tablets with 12.5 mg, 25 mg, 50 mg and 100 mg captopril content. The drug is recommended to be taken before a meal, with at least an hour margin. When administered for hypertension and heart failure treatment, a 25 mg tablet is taken twice or thrice a day during one or two weeks. The doctor may increase the dose to 50 mg and higher (twice or thrice a day) if the desirable outcome has not been achieved. 450 mg Capoten is the maximal allowed daily dose. When treating consequences of myocardial infarction, 50 mg Capoten is taken thrice a day. For diabetic nephropathy treatment, the daily dose is 75 mg split in three takes.

What are the contraindications for using Capoten? Allergy and/or hypersensitivity to the drug are the contraindications for its use. Pregnant women should refrain from taking this medication, as well as women who plan to become pregnant soon. Tell the doctor about the drugs you take, as well as about your history of liver or kidney disease.

What are the adverse effects of Capoten ? Some of the side effects of the drug are cough, taste sensation change, dizziness, nausea, and diarrhea. However, if you feel like fainting, are short of breath, experience rapid heartbeat, fever, chest pain or tissue swelling, call your doctor immediately if you believe it might be related to Capoten use.

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Celestamin

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DISCLAIMER: MediGuard is not intended to be a substitute for professional medical advice. MediGuard cannot and does not take into consideration every possible interaction or account for individual responses to medicine. Different individuals may respond to medication in different ways. 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. Always seek the advice of a qualified health provider with any questions you may have before making any changes to your treatment. The use of the MediGuard site and its content is at your own risk. The MediGuard site and the information contained in it is intended for users in the United States and information in other countries may be different.

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Skincare - Exabetin (Brand name: betnovate)

Betnovate helps to reduce the redness, itching, and swelling of skin conditions such as eczema, psoriasis, contact dermatitis, and seborrhea.

Use Betnovate as directed by your doctor.

This medication is usually applied 2 or 3 times daily or according to the instruction. Enough medication should be applied to completely cover the affected area with a thin film. The medication should be gently and thoroughly massaged into the affected area. In certain conditions, the doctor will order the application to be covered with a dressing. Ask your health care provider any questions you may have about how to use Betnovate.

Drug Class and Mechanism

Betnovate is a corticosteroid that is used for the topical treatment of skin irritations.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store Betnovate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Betnovate out of the reach of children and away from pets.

Betnovate should not be taken by anyone who:

is allergic to betamethasone valerate or any of the ingredients of the medication; has chickenpox; has fungal, yeast, or viral skin lesions; has herpes simplex; has tuberculosis of the skin; has vaccinia.

Possible Side Effects

Side effects that you should report to your prescriber or health care professional as soon as possible:

burning or itching of the skin; dark red spots on the skin; infection; lack of healing of the skin condition; painful, red, pus-filled blisters in hair follicles; severe burning and continued itching of the skin; thinning of the skin, with easy bruising, sunburn more likely especially on the face. Other serious side effects can develop if you use Betnovate for a long time, or if you use too much. Contact your prescriber or health care professional if you notice any unusual effects.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): burning, itching, or irritation of the skin; dry skin; increased redness or scaling of the skin.

Betnovate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

Ketoconazole medlineplus drug information, ketokonazol

Ketoconazole

AUDIENCE: Dermatology, Family Practice, Pharmacy, Patient

ISSUE: FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.

FDA approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails. See the full MedWatch Communication at http://www. fda. gov/Drugs/DrugSafety/ucm500597.htm for further information.

BACKGROUND: Ketoconazole in tablet form is indicated to treat serious infections caused by fungi and should be used only when other effective therapy is not available or tolerated. It works by killing the fungus or preventing it from growing. The topical forms of ketoconazole that are applied to the skin or nails have not been associated with liver damage, adrenal problems, or drug interactions.

In a July 2013 Drug Safety Communication, FDA warned that ketoconazole tablets should not be used as a first-line treatment for any fungal infection because it can cause severe liver injury and adrenal gland problems, and advised it can lead to harmful interactions with other medicines. FDA determined that the risks outweigh the benefits for treating skin and nail fungal infections and approved label changes removing this indication from the drug label and limited its labeled indication to treating only serious fungal infections.

RECOMMENDATION: Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription, but are also associated with risks that should be weighed against their benefits.

Patients should discuss with their health care professionals the risks and benefits of available therapies before using any medicine to treat skin and nail fungal infections. Patients taking ketoconazole tablets should seek medical attention right away if they experience any of these signs and symptoms of liver problems, which include loss of appetite, nausea, vomiting, or abdominal discomfort; yellowing of the skin or the whites of the eyes (jaundice); unusual darkening of the urine or lightening of the stools; or pain and discomfort in the right upper abdomen where the liver is located.

IMPORTANT WARNING:

Ketoconazole should only be used to treat fungal infections when other medications are not available or cannot be tolerated.

Ketoconazole may cause liver damage, sometimes serious enough to require liver transplantation or to cause death. Liver damage may occur in people who do not already have liver disease or any other conditions that increase the risk that they will develop liver damage. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease. Do not drink any alcoholic beverages during your treatment with ketoconazole because drinking alcoholic beverages may increase the risk that you will develop liver damage. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness, loss of appetite, weight loss, nausea, vomiting, yellowing of the skin or eyes, dark yellow urine, pale stools, pain in the upper right part of the stomach, fever, or rash.

Ketoconazole can cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Do not take disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), pimozide (Orap), quinidine (Quinidex, Quinaglute), cisapride (Propulsid; no longer available in the US), methadone (Dolophine, Methadose), and ranolazine (Ranexa) while you are taking ketoconazole. If you experience any of the following symptoms, stop taking ketoconazole and call your doctor immediately: fast, pounding, or irregular heartbeat; fainting; dizziness; lightheadedness; or loss of consciousness.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to ketoconazole.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ketoconazole and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www. fda. gov/Drugs/DrugSafety/ucm085729.htm ) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking ketoconazole.

Why is this medication prescribed?

Ketoconazole is used to treat fungal infections when other medications are not available or cannot be tolerated. Ketoconazole should not be used to treat fungal meningitis (infection of the membranes surrounding the brain and spinal cord caused by a fungus) or fungal nail infections. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

How should this medicine be used?

Ketoconazole comes as a tablet to take by mouth. It is usually taken once a day Take ketoconazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ketoconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may increase your dose if your condition does not improve.

You may need to take ketoconazole for 6 months or longer to cure your infection completely. Continue to take ketoconazole until your doctor tells you that you should stop, even if you feel better. Do not stop taking ketoconazole without talking to your doctor. If you stop taking ketoconazole too soon, your infection may come back after a short time.

Other uses for this medicine

High doses of ketoconazole are sometimes used to treat Cushing syndrome (a condition that occurs when there is too much corticosteroid hormone in the body) and advanced prostate cancer (cancer of a male reproductive gland). Ketoconazole has not been shown to be safe or effective for these uses. Talk to your doctor about using ketoconazole for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking ketoconazole,

tell your doctor and pharmacist if you are allergic to ketoconazole or any other medications or any of the ingredients in ketoconazole tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

tell your doctor if you are taking alprazolam (Niravam, Xanax);eplerenone (Inspra); ergot alkaloids such as ergotamine (Ergomar, in Cafergot, in Migergot), dihydroergotamine (D. H.E 45, Migranal), and methylergonovine (Methergine); felodipine (Plendil); irinotecan (Camptosar); lovastatin (Mevacor); lurasidone (Latuda); midazolam (Versed); nisoldipine (Sular); simvastatin (Zocor); tolvaptan (Samsca); and triazolam (Halcion). Your doctor will probably tell you not to take ketoconazole if you are taking one or more of these medications or any of the medications listed in the IMPORTANT WARNING section.

tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aliskiren (Tekturna, in Valturna, in Amturnide); anticoagulants ('blood thinners') such as dabigatran (Pradaxa), rivaroxaban (Xarelto) and warfarin (Coumadin); aprepitant (Emend); aripiprazole (Abilify); atorvastatin (Lipitor); bosentan (Tracleer); budesonide (Uceris); buspirone (BuSpar); carbamazepine (Tegretol); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan); cancer medications such as bortezomib (Velcade); busulfan (Myleran); dasatinib (Sprycel); docetaxel (Taxotere), erlotinib (Tarceva); ixabepilone (Ixempra); lapatinib (Tykerb); nilotinib (Tasigna);paclitaxel (Taxol), trimetrexate (Neutrexin), vincristine (Vincasar), vinblastine, and vinorelbine (Navelbine); ciclesonide (Alvesco); cilostazol (Pletal); cinacalcet (Sensipar); colchicine (Colcrys, in Col-Probenecid); dexamethasone; digoxin (Lanoxin); eletriptan (Relpax); fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis); fesoterodine (Toviaz); fluticasone (Flonase, Flovent); haloperidol (Haldol); HIV medications such as darunavir (Prezista), efavirenz (Sustiva), fosamprenavir (Lexiva),indinavir (Crixivan), maraviroc (Selzentry), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); immunosuppressants such as cyclosporine (Neoral, Sandimmune), everolimus (Afinitor, Zortress),sirolimus (Rapamune), and tacrolimus (Prograf); imatinib (Gleevec); medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); medications for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), and ranitidine (Zantac); medications to treat tuberculosis such as isoniazid (INH, Nydrazid), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane); methylprednisolone (Medrol); nadolol (Corgard); oxycodone (Oxecta, Oxy Contin, in Percocet, others); phenytoin (Dilantin); praziquantel (Biltricide); quetiapine (Seroquel); ramelteon (Rozerem); repaglinide (Prandin, in PrandiMet); risperidone (Risperdal); salmeterol (Serevent, in Advair);saxagliptin (Onglyza); solifenacin (Vesicare); immunosuppressants such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); tamsulosin (Flomax, in Jalyn); telithromycin (Ketek); and tolterodine (Detrol). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ketoconazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

if you are taking an antacid containing aluminum, calcium, or magnesium (Maalox, Mylanta, Tums, others), take it 1 hour before or 2 hours after you take ketoconazole.

tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or adrenal insufficiency (condition in which the adrenal glands do not make enough steroid hormones).

tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ketoconazole, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketoconazole.

you should know that drinking alcoholic beverages (including wine, beer, and medications that contain alcohol such as cough syrup) while taking ketoconazole increases the risk that you will develop liver damage and may cause unpleasant symptoms such as flushing, rash, nausea, headache, and swelling of the hands, feet, ankles, or lower legs if you drink alcohol while you are taking ketoconazole.

What special dietary instructions should I follow?

Ketoconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache

stomach pain

diarrhea

constipation

heartburn

gas

change in ability to taste food

dry mouth

change in tongue color

difficulty falling asleep or staying asleep

nervousness

numbness, burning, or tingling of the hands or feet

muscle pain

hair loss

flushing

chills

sensitivity to light

nosebleeds

breast enlargement in males

decrease in sexual ability

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

rash

hives

itching

swelling of the eyes, face, lips, tongue, hands, feet, ankles, or lower legs

hoarseness

difficulty breathing or swallowing

tiredness or weakness

Ketoconazole may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is taken at high doses. Talk to your doctor about the risks of taking this medication if you are a man and would like to have children.

Ketoconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www. fda. gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

Buy solodyn

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Solodyn ER (Minocycline ER)

Full information about Solodyn ER

General Information on Solodyn ER

Solodyn ER is an extended release tetracycline antibiotic. It is indicated for he treatment of inflammatory lesions caused by moderate to severe acne. The generic name of this drug is Minocycline. This drug is available as Solodyn ER 90mg tablet.

This medication works by slowing the growth of certain bacteria which allows the body’s immune system to kill them. You can only buy Solodyn ER as per a doctor’s prescription.

Side effects of Solodyn ER

You should not buy Solodyn ER online if.

You are taking acitretin, isotretinoin, methoxyflurane, a liver oral typhoid vaccine or penicillin antibiotics

You have hypersensitivity to Minocycline

Before you buy Solodyn ER, inform your doctor if you have any of the following:

Asthma or an autoimmune disorder such as lupus

Liver or kidney problems

History of vision problems

Allergy to medicines, foods or other substances

Some of the common side effects of this drug are:

You should consult your doctor immediately if your experience any of the following side effects:

Persistent heartburn

Severe diarrhea

Swollen skin or glands

Symptoms of pancreatitis

Unusual bruising or bleeding

Pregnant women should avoid Solodyn ER since it harms the fetus. Nursing mothers should avoid this medicine since it gets excreted in breast milk and causes permanent discoloring of the teeth in a nursing baby.

Dosage of Solodyn ER

A patient should follow the directions of using this medicine as provided by a doctor or an information leaflet available with this medicine. The recommended dose is to swallow one tablet of Solodyn ER 90 mg a day with a full glass (240ml) of water. It is better for a patient to take this medicine at the same time each day. Additional monitoring of dose is needed if a patient is taking vitamins/minerals, anticoagulants, birth control ills, ergot derivatives, or urinary alkalinizers.

This medicine may be taken on an empty stomach or with food. However, to reduce risk of esophagus irritation taking this medicine with food is advisable. A patient should continue taking Solodyn ER 90mg if he or she is feeling better. A patient should not take medicine that have magnesium, calcium or zinc, bismuth or urinary alkalinizers should be taken within 2 hour and medicines that have iron within 3 hours of taking Solodyn ER 90mg tablet.

In case of a missed dose, a patient should take it as soon as possible. You can continue with your regular schedule if it is already time for your next dose of this medicine. A patient should not take two doses at once. A patient should not take more than one Solodyn ER 90mg tablet a day. In case of an overdose, a patient should immediately contact a healthcare provider.

Interactions

A patient should consult doctor if taking other prescription, over-the-counter medicines, herbal preparation or dietary supplement since they may interact with Solodyn ER. The medicines that can adversely react with Solodyn ER include aluminum salts, acitretin or isotretinoin, anticoagulant such as warfarin, methotrexate and digoxin. This medicine should be avoided if patient is receiving a live typhoid vaccine.

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IMPORTANT DISCAIMER: All medical content is supplied by a third party company who is independent from this web site. As such, this web site can not guarantee the reliability, accuracy, and /or medical efficacy of the information provided. In all circumstances, you should seek the advice of a health proffesional pertaining to drug, treatment and/or medical condition advice. Note that not all products are shipped by our contracted Canadian pharmacy. This website cantracts with dispensaries around the world that ship products directly to our customers. Some of the jurisdiction include but are not limited to United Kingdom, Europe, Turkey, India, Singapore, Canada, Vanuatu, Mauritius, and USA. The items within your order may be shipped from any one of these jurisdiction depending on the availability and cost of the products at the time you place your order. The products are sourced from these countries as well as others. Please note that the product appearance may vary from actual product received depending on availability.

What is a "Generic" medication/drug?

Generic drugs are medications that have the comparable medicinal ingredients as the original brand name drug, but which are generally cheaper in price. Nearly 1 in 3 drugs dispensed are "generic". They undergo comparative testing to ensure that they are the same as their "brand" counterparts in:

Active Ingredient (e. g. "Pravastatin" is the active ingredient in brand name Pravachol)

Dosage (e. g. 10 mg of the active ingredient)

Safety (e. g. same or similar side effects, drug interactions)

Strength

Quality

Performance (e. g. 10 mg of a "generic" can be substituted for 10 mg of the "brand" and have the same therapeutic result)

Intended use (e. g. both "generic" and "brand" would be prescribed for the same conditions)

What this means is that "generic" medications can be used as a substitute of their brand equivalents with comparable therapeutic results. There are a few exceptions (examples are outlined at the end of this page) and as always you should consult your physician before switching from a brand name medications to a generic or vice versa.

What differences are there between generic and brand?

While generics and brand equivalent drugs contain comparable active ingredients, they may be different in the following ways:

The color, shape and size of the medication come from the fillers that are added to the active ingredients to make the drug. These fillers that are added to the drug have no medical use and do not to change the effectiveness of the final product. A generic drug must contain comparable active ingredients and must be comparable in strength and dosage to the original brand name equivalent. Generic drugs can be more cost effective than purchasing the brand name.

Why do generics cost less than the brand name equivalents?

When a new drug is "invented", the company that discovered it has a patent on it that gives them the exclusive production rights for this medication. Once the patent expires in a country, other companies can bring the product to market under their own name. This patent prevents other companies from copying the drug during that time so they can earn back their Research and Development costs through being the exclusive supplier of the product. After the patent expires however, other companies can develop a "generic" version of the product. These versions generally are offered at much lower prices because the companies do not have the same development costs as the original company who developed the medication.

The main thing to realize here though is that the two products are therapeutically comparable. They may look different, and be called something different, but they are required to be have the same active ingredient.

How are Generic drugs tested to ensure quality and efficacy?

The two most generally accepted methods to prove the safety of a generic version of a drug are to either repeat most of the chemistry, animal and human studies originally done, or to show that the drug performs comparably with the original brand name drug. This second option is called a "comparative bioavailability" study. During this type of study, volunteers are given the original drug, and then separately later the generic drug. The rates at which the drug is delivered to the patient (into their blood stream or otherwise absorbed) are measured to ensure they are the same. Because the same active ingredient is used the major concern is just that it delivers the common chemical(s) at the same rate so that they have the same effect. Please note that the methods that the manufacturers use may vary from country to country.

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Solodyn

Solodyn ® (MINOCYCLINE HCl, USP) EXTENDED RELEASE TABLETS

KEEP OUT OF REACH OF CHILDREN

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Solodyn ® should be used only as indicated.

Solodyn ® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris.

This formulation of minocycline has not been evaluated in the treatment of infections.

Solodyn Description

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S - (4α,4aα,5aα,12aα)] - 4,7 - Bis(dimethylamino) - 1,4,4a,5,5a,6,11,12a - octahydro - 3,10,12,12a - tetrahydroxy - 1,11 - dioxo - 2 - naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:

C 23 H 27 N 3 O 7 •HCl M. W. 493.95

Solodyn ® Tablets for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg, or 135 mg of minocycline. In addition, 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain opadry II gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain opadry II blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain opadry II yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain opadry II green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2. The 135 mg tablets also contain opadry II pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

Solodyn - Clinical Pharmacology

Pharmacokinetics

Solodyn ® Tablets are not bioequivalent to minocycline products. Based on pharmacokinetic studies in healthy adults, Solodyn ® Tablets produce a delayed T max at 3.5–4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25–3 hours). At steady-state (Day 6), the mean AUC(0–24) and C max were 33.32 µg×hr/mL and 2.63 µg/mL for Solodyn ® Tablets and 46.35 µg×hr/mL and 2.92 µg/mL for Minocin ® capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both products.

A single-dose, four-way crossover study demonstrated that all strengths of Solodyn ® Tablets (45 mg, 90 mg, and 135 mg) exhibited dose-proportional pharmacokinetics.

When Solodyn ® Tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions.

Microbiology

Minocycline is bacteriostatic exerting its antimicrobial effect by the inhibition of bacterial protein synthesis. Minocycline is lipid soluble and distributes in to the skin and sebum. Minocycline has been shown to have in vitro activity against Propionibacterium acnes. an organism associated with acne vulgaris, however, the clinical significance of this activity against P. acnes in patients with acne vulgaris is not known.

Clinical Studies

The safety and efficacy of Solodyn ® in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, studies in subjects ≥ 12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%).

In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received Solodyn ® or placebo for a total of 12 weeks, according to the following dose assignments.

Subject's Weight (lbs.)

Subject's Weight (kg)

Solodyn ® did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

Indications and Usage for Solodyn

Solodyn ® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Solodyn ® did not demonstrate any effect on non-inflammatory lesions. Safety of Solodyn ® has not been established beyond 12 weeks of use.

This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Solodyn ® should be used only as indicated.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings

Teratogenic effects

1) MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

Solodyn ® should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child (see PRECAUTIONS: Impairment of Fertility & Pregnancy ).

2) THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT.

3) All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy (see PRECAUTIONS: Pregnancy section).

Gastro-intestinal effects

1. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

2. Hepatotoxicity – Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.

Metabolic effects

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Central nervous system effects

1. Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

2. Pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents has been associated with the use of tetracyclines. Minocycline has been reported to cause or precipitate pseudotumor cerebri, the hallmark of which is papilledema. Clinical manifestations include headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. Although signs and symptoms of pseudotumor cerebri resolve after discontinuation of treatment, the possibility for permanent sequelae such as visual loss that may be permanent or severe exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papilledema while on treatment.

Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Photosensitivity

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

Precautions

General

Safety of Solodyn ® beyond 12 weeks of use has not been established.

As with other antibiotic preparations, use of Solodyn ® may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Bacterial resistance to the tetracyclines may develop in patients using Solodyn, ® therefore the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of Solodyn, ® it should be used only as indicated.

Autoimmune Syndromes

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

Serious Skin/Hypersensitivity Reaction

Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with minocycline use in treatment of acne.

Tissue Hyperpigmentation

Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Information for Patients

(See Patient Package Insert that accompanies this Package Insert for additional information to give patients)

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.

Patients who experience central nervous system symptoms (see WARNINGS ) should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should also be cautioned about seeking medical help for headaches or blurred vision.

Concurrent use of tetracycline may render oral contraceptives less effective (See Drug Interactions ) .

Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class antibiotics, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.

Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy.

Take Solodyn ® exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

Solodyn ® should not be used by pregnant women or women attempting to conceive a child (See Pregnancy. Carcinogenesis and Mutagenesis sections) .

It is recommended that Solodyn ® not be used by men who are attempting to father a child (See Impairment of Fertility section) .

Laboratory Tests

Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

Drug Interactions

1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

4. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

5. In a multi-center study to evaluate the effect of Solodyn ® on low dose oral contraceptives, hormone levels over one menstrual cycle with and without Solodyn ® 1 mg/kg once-daily were measured.

Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis & Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Impairment of Fertility

Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Solodyn ® ). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of Solodyn ® ) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormailities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Solodyn ® should not be used by individuals of either gender who are attempting to conceive a child.

Pregnancy

Pregnancy category D

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of Solodyn ® ). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use Solodyn ® ).

Solodyn ® should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

Nursing Mothers

Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS ).

Pediatric Use

Solodyn ® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established.

Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration (see WARNINGS ).

Geriatric Use

Clinical studies of Solodyn ® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Adverse Reactions

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. However, adverse reaction information from clinical trials provides a basis for identifying the adverse events that appear to be related to drug use.

Adverse events reported in clinical trials for Solodyn ® are described below in Table 2.

Table 2 – Selected Treatment-Emergent Adverse Events in at least 1% of Clinical Trial Subjects

Solodyn ® (1 mg/kg) N = 674 (%)

Adverse reactions not observed in the clinical trials, but that have been reported with minocycline hydrochloride use in a variety of indications include:

Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: thyroid discoloration, abnormal thyroid function.

Oncology: papillary thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Carcinogenesis, Mutagenesis, Impairment of Fertility section ).

Overdosage

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

Solodyn Dosage and Administration

The recommended dosage of Solodyn ® is approximately 1 mg/kg daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

The following table shows tablet strength and body weight to achieve approximately 1 mg/kg.

Table 3: Dosing Table for Solodyn ®

Patient's Weight (lbs.)

Patient's Weight (kg)

Store at 25ºC (77ºF); excursions are permitted to 15º–30ºC (59º–86ºF) [See USP Controlled Room Temperature].

Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.

U. S. Patent 5,908,8381 and Patents Pending

Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256

Manufactured by: Wellspring Pharmaceutical Canada Corp. Oakville, Ontario L6H 1M5 Canada

1 90 mg is also covered by U. S. Patents 7,541,347 and 7,544,373

Patient Information

Solodyn ® (SO-lo-dīn) Extended Release Tablets (minocycline HCl, USP)

Read all patient information that comes with Solodyn ® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of speaking with your doctor about your condition or treatment.

What is Solodyn ®.

Solodyn ® is a tetracycline-class antibiotic medicine that contains minocycline. Solodyn ® is only for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 12 years and older.

Solodyn ® has not been studied for use longer than 12 weeks.

Solodyn ® has not been studied for the treatment of infections.

Who should not take Solodyn ®.

Do not take Solodyn ® if you are allergic to minocycline or any other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this leaflet for a complete list of ingredients in Solodyn. ®

Solodyn ® should not be used by pregnant women, women attempting to conceive a child, or children up to 8 years old because:

Solodyn ® may harm an unborn baby

Solodyn ® may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Solodyn ® should not be used during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.

It is recommended that Solodyn ® not be used by men who are attempting to father a child.

What should I tell my doctor before taking Solodyn ®.

Tell your doctor about all of your medical conditions including if you:

have kidney problems. Your doctor may prescribe a lower dose of medicine for you.

have any vision problems such as blurred vision.

are pregnant or attempting to conceive a child. Solodyn ® may harm your unborn baby. Stop taking Solodyn ® and call your doctor if you become pregnant while taking it.

are breastfeeding. Solodyn ® passes into your milk and may harm your baby. You should decide whether to use Solodyn ® or breastfeed, but not both.

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Solodyn ® and other medicines may interact. Especially tell your doctor if you take:

birth control pills. Solodyn ® may make your birth control pills less effective. You should use a second form of birth control while taking Solodyn. ®

a blood thinner medicine. The dose of your blood thinner may be lowered.

a penicillin antibiotic medicine. Solodyn ® and penicillins should not be used together.

antacids that contain aluminum, calcium, or magnesium or iron-containing products. These can affect how much Solodyn ® passes into your body.

Isotretinoin products.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I take Solodyn ®.

Solodyn ® comes in 5 strengths. Your doctor will prescribe the strength that is best for your body weight. The usual dose of Solodyn ® is 1 tablet each day for 12 weeks.

Take Solodyn ® at the same time each day, with or without food. Taking Solodyn ® with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.

Swallow Solodyn ® Tablets whole. Do not chew, crush, or split the tablets.

If you forget to take Solodyn, ® take it as soon as you remember. Do not take more than one tablet of Solodyn ® in one day.

If you take too much Solodyn ® at a time, call your doctor.

If you do not notice an improvement in your acne after 12 weeks of treatment with Solodyn, ® call your doctor.

What are the possible side effects of Solodyn ®.

Solodyn ® may cause serious side effects.

Stop Solodyn ® and call your doctor if you have:

watery diarrhea

bloody stools

stomach cramps

unusual headaches

blurred vision

fever

rash

joint pain

feeling very tired

Solodyn ® may also cause:

central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate dangerous machines if you have these symptoms.

sun sensitivity (photosensitivity). You may get a worse sunburn with Solodyn. ® Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in sunlight. Stop Solodyn ® and call your doctor at the first sign of redness or sunburn.

darkening of skin, scars, teeth, and gums.

The most common side effects with Solodyn ® include:

headache

nausea

tiredness

dizziness or spinning feeling

diarrhea

stomach area pain

itching

Call your doctor if you have a side effect that bothers you or that does not go away.

These are not all the side effects with Solodyn. ® Ask your doctor or pharmacist for more information.

How should I store Solodyn ®.

Store Solodyn ® at room temperature. Keep Solodyn ® Tablets in the bottle you received from the pharmacy and store away from moisture and light.

Keep Solodyn ® and all medicines out of the reach of children.

General Information about Solodyn ®

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Solodyn ® for a condition for which it was not prescribed. Do not give Solodyn ® to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Solodyn. ® If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about Solodyn ® that is written for health professionals.

What are the Ingredients in Solodyn ® ?

Active Ingredient: minocycline HCl USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg, or 135 mg of minocycline.

Inactive Ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain opadry II gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain opadry II blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain opadry II yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain opadry II green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, FD&C Blue #2. The 135 mg tablets also contain opadry II pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

Solodyn ® is manufactured by Wellspring Pharmaceutical Canada Corp. for Medicis, The Dermatology Company, Scottsdale, AZ, 85256.

PRINCIPAL DISPLAY PANEL - 45 mg Tablet Bottle Label

NDC 99207-460-30 Rx Only

Solodyn ® (MINOCYCLINE HCl, USP) EXTENDED RELEASE TABLETS

Solodyn

Solodyn Product Description

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OnlineCanadianPharmacy. com's large variety of medication is dispensed from a licensed pharmacy where pharmacy technicians look and review your health records to ensure taking Solodyn is right for you. OnlineCanadianPharmacy. com does not sell any controlled substances under any circumstance. OnlineCanadianPharmacy. com offers the best brand name Solodyn and generic Minocycline Er to open up your options. Our medications are up to 70% off ensuring that you are always saving money. If you have any questions about OnlineCanadianPharmacy. com, contact us so we can ensure you have the best online shopping experience without having any problems.

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General Information On Atripla

Atripla is an oral anti-viral medication that is used for treating HIV. It is a fixed-dose combination drug and consists of three drugs – Tenofovir, Emtricitabine and Efavirenz. Atripla was approved for the treatment of HIV in July, 2006. It may be used alone or in combination with other drugs to treat HIV. The drug prevents the reproduction and growth of the HIV virus (human immunodeficiency virus) inside the patient’s body. It does this by restricting the formation of the genetic material of the virus. Do note that Atripla does not cure AIDS.

Side Effects for Atripla

A large number of patients using Atripla (Tenofovir, Emtricitabine and Efavirenz) may not experience any noticeable side effects. However, many patients may encounter adverse reactions like nausea, diarrhea, flatulence, fatigue and drowsiness, liver problems, lack of concentration, insomnia, disturbed sleep and discoloration of the skin. The list of side effects is not complete, and there may be some other adverse effects. In case you suspect that any adverse reaction is due to the drug, make sure that you discuss it with your doctor.

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Precautions

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Atripla Dosage

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Interactions

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While most HIV medications are required to be taken several times a day; Efavirenz can be taken just once daily, thereby eliminating or decreasing the occurrence of mixed dosage errors or even missed doses.

What do we offer?

Emtricitabine medication requires a doctor’s prescription and you can buy it through our online online prescription service. The dosage available for Atripla is 600/ 200/ 300mg; packaged in assorted quantities and at cheap rates.

Side effects / Precautions

When you buy Tenofovir you should know that it should not be taken by patients who are suffering from kidney problems or who have a history of liver problems, lactic acidosis or unusual liver function tests. Atripla should be completely avoided if the patient is taking carbamazepine, St. John's wort, voriconazole, cisapride, or any medication that contains lamivudine. Atripla may cause moderate to excessive dizziness or drowsiness; and therefore abstinence from alcohol is recommended. Certain medications may also interact with Atripla, so discuss with your doctor if you are on any kind of medication; regular or otherwise. Possible or common side effects of Efavirenz may include back pain, diarrhea, dizziness, drowsiness, skin discoloration, vomiting, stomach discomfort, loss of appetite, stuffy nose, headache, joint and muscle ache.

Safe and Secure

Our online online prescription service offers a safe and secure online shopping environment to its customers coupled with unmatched customer service and cheap rates. We offer a lowest price guarantee on all our products so you get to save hundreds of dollars on prescription medication. So order today.

IMPORTANT DISCAIMER: All medical content is suplied by a third party company who is independent from this web site. As such, this web site can not guarantee the reliability, accuracy, and /or medical efficacy of the information provided. In all circumstances, you should seek the advice of a health proffesional pertaining to drug, treatment and/or medical condition advice. Note that not all products are shipped by our contracted Canadian pharmacy. This website cantracts with dispensaries around the world that ship products directly to our customers. Some of the jurisdiction include but are not limited to United Kingdom, Europe, Turkey, India, Singapore, Canada, Vanuatu, Mauritius, and USA. The items within your order may be shipped from any one of these jurisdiction depending on the availability and cost of the products at the time you place your order. The products are sourced from these countries as well as others. Please note that the product appearance may vary from actual product received depending on availability.

What is a "Generic" medication/drug?

Generic drugs are medications that have comparable medicinal ingredients as the original brand name drug, but which are generally cheaper in price. Nearly 1 in 3 drugs dispensed are "generic". They undergo testing to ensure that they are similar to their "brand" counterparts in:

Active Ingredient (e. g. "Pravastatin" is the active ingredient in brand name Pravachol)

Dosage (e. g. 10 mg of the active ingredient)

Safety (e. g. same or similar side effects, drug interactions)

Strength

Quality

Performance (e. g. 10 mg of a "generic" can be substituted for 10 mg of the "brand" and have the same therapeutic result)

Intended use (e. g. both "generic" and "brand" would be prescribed for the same conditions)

What this means is that "generic" medications can be used as a substitute of their brand equivalents with the comparable therapeutic results. There are a few exceptions (examples are outlined at the end of this page) and as always you should consult your physician before switching from a brand name medications to a generic or vice versa.

What differences are there between generic and brand?

While generics and brand equivalent drugs contain the same active ingredients, they may be different in the following ways:

The color, shape and size of the medication come from the fillers that are added to the active ingredients to make the drug. These fillers that are added to the drug have no medical use and do not to change the effectiveness of the final product. A generic drug must contain comparable active ingredients and must have a comparable strength and dosage as the original brand name equivalent. Generic drugs can be more cost effective than purchasing the brand name.

Why do generics cost less than the brand name equivalents?

When a new drug is "invented", the company that discovered it has a patent on it that gives them the exclusive production rights for this medication. Once the patent expires in a country, other companies can bring the product to market under their own name. This patent prevents other companies from copying the drug during that time so they can earn back their Research and Development costs through being the exclusive supplier of the product. After the patent expires however, other companies can develop a "generic" version of the product. These versions generally are offered at much lower prices because the companies do not have the same development costs as the original company who developed the medication.

The main thing to realize here though is that the two products are therapeutically equivalent. They may look different, and be called something different.

How are Generic drugs tested to ensure quality and efficacy?

Generally speaking, the two most generally accepted methods to prove the safety of a generic version of a drug are to either repeat most of the chemistry, animal and human studies originally done, or to show that the drug performs comparably with the original brand name drug. This second option is called a "comparative bioavailability" study. During this type of study, volunteers are given the original drug, and then separately later the generic drug. The rates at which the drug is delivered to the patient (into their blood stream or otherwise absorbed) are measured to ensure they are the same. Because the same active ingredient is used the major concern is just that it delivers the common chemical(s) at the same rate so that they have the same effect. Please note that the methods that the manufacturers use may vary from country to country.

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Anacin - pain relief, flaviston e

Pain Relief - Flaviston e (Brand name: anacin)

Anacin is used for treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Use Anacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Anacin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Anacin.

Take Anacin with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anacin.

Use Anacin exactly as directed on the package, unless instructed differently by your doctor. If you are taking Anacin without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Anacin and you are taking 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.

Ask your health care provider any questions you may have about how to use Anacin.

Store Anacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anacin out of the reach of children and away from pets.

Anacin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Anacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.

Anacin has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Anacin or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Anacin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Anacin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Anacin regularly may be habit-forming.

Anacin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Anacin to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Diabetes patients - Anacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

If Anacin has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Tell your doctor or dentist that you take Anacin before you receive any medical or dental care, emergency care, or surgery.

Do not take Anacin for at least 7 days after any surgery unless directed by your health care provider.

Do not take Anacin for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

Different brands of Anacin may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Do NOT use Anacin if:

you are allergic to any ingredient in Anacin

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Before using Anacin:

Some medical conditions may interact with Anacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency

if you have anxiety, trouble sleeping, or heart problems

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Anacin. Tell your health care provider if you are taking any other medicines.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anacin while you are pregnant. Anacin is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Anacin is found in breast milk. If you are or will be breast-feeding while you use Anacin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Anacin's side effects may include dizziness, heartburn, irritability, nausea, nervousness, rashes, hives, bloody stools, drowsiness, hearing loss, ringing in the ears, and trouble sleeping.

Check with your doctor if any of the listed above most COMMON side effects persist or become bothersome.

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); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Letrozol medlineplus medicinas, loxifan

Letrozol

?Para cuales condiciones o enfermedades se prescribe este medicamento?

El letrozol se usa para tratar el cancer de seno en etapa inicialen mujeres que han experimentado la menopausia (cambio de vida; fin de los periodos menstruales mensuales) y que han recibido otros tratamientos, como radiacion o cirugia para extraer el tumor. Tambien se usa para tratar el cancer de seno en etapa inicial en las mujeres que han experimentado la menopausia y que ya han sido tratadas con un medicamento llamado tamoxifeno (Nolvadex) durante 5 anos. El letrozol tambien se usa en las mujeres que han experimentado la menopausia como primer tratamiento del cancer de seno que se ha propagado dentro del seno o a otras areas del cuerpo, o en mujeres cuyo cancer de seno ha empeorado mientras tomaban tamoxifeno. El letrozol pertenece a una clase de medicamentos llamados inhibidores de la aromatasa no esteroide. Actua disminuyendo la cantidad de estrogeno que produce el cuerpo. Esto puede retardar o detener el crecimiento de algunos tipos de celulas del cancer de seno que necesitan estrogeno para crecer.

?Como se debe usar este medicamento?

La presentacion del letrozol es en una tableta para administrarse por via oral, una vez al dia, con o sin alimentos. Tome letrozol, aproximadamente, a la misma hora todos los dias. Siga atentamente las instrucciones del medicamento recetado, y pidales a su medico o a su farmaceutico que le expliquen cualquier cosa que no entienda. Tome letrozol exactamente segun lo indicado. No aumente ni disminuya la dosis, ni la tome con mas frecuencia que la indicada por su medico.

Es posible que tenga que tomar letrozol durante varios anos o mas. Continue tomando letrozol aunque se sienta bien. No deje de tomar letrozol sin consultar a su medico.

Pidales a su medico o a su farmaceutico una copia de la informacion del fabricante para el paciente.

?Que otro uso se le da a este medicamento?

Carac user reviews for basal cell carcinoma at, carac 1% 10g

User Reviews for Carac

Exondys 51 Exondys 51 (eteplirsen) is a morpholino antisense oligomer for the treatment of Duchenne muscular.

Kyleena Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing.

Yosprala Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor.

Cuvitru Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment.

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Bicor pillows, bicor

Bicor Pillows Offers: Down alternative pillows, Orthopedic pillows and Medical pillows Bicor Pillows Offers: Down alternative pillows, Orthopedic pillows and Medical pillows Bicor Pillows Offers: Down alternative pillows, Orthopedic pillows and Medical pillows Allergy B'Gone Bicor Pillows Offers: Down alternative pillows, Orthopedic pillows and Medical pillows Bicor Pillows Offers: Down alternative pillows, Orthopedic pillows and Medical pillows

Bicor Pillows are sure to give you a peaceful and restful night. Down alternative pillows, Orthopedic pillows and Medical pillows offer superior comfort and Support.

Bicor Pillows

Get your best night’s sleep with a Bicor pillow, each designed for comfort and support to accommodate your own sleep style.

When shopping for Pillows, for to carry in your store, department store, furniture store or any retail location be sure that Bicor Pillows is the Brand of choice for quality, comfort, affordability, style and durability.

About Bicor Pillows

We carry a wide variety of Bedding Pillow options including Feather Pillows, Down Pillows, White Goose Down Pillows and Down Alternative Pillows. We also carry unique Bed Pillow selections such as Hotel Pillows, Orthopedic Pillows, Medical Pillows and Body Pillows.

Quality Craftmanship

At Bicor Pillows. we meet all of those requirements in our elegant, comfortable, resilient and affordable Pillows! For a high quality Bedding Pillow at a reasonable price, look no further than the great selection of Pillows at Bicor Pillows.

Coracten, coracten

Coracten

Important Notice: The Drugs. com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

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Coracten

nicotine transdermal system

Adalat CC, Adalat LA (UK), Adalat P. A. Adalat Retard (UK), Adalat XL, Adipine (UK), Afeditab CR, Angiopine (UK), Apo-Nifed, Calchan (UK), Cardilate MR (UK), Coracten (UK), Fortipine (UK), Gen-Nifedical, Hypolar Retard (UK), Neozipine XL (UK), Nifediac CC, Nifedical XL, Nifedipress MR (UK), Nifopress MR (UK), Novo-Nifedin, Nu-Nifed, Procardia, Procardia XL, Slofedipine (UK), Tensipine (UK), Valni Retard (UK), Valni XL (UK)TasignaAnandron, NilandronNimotopSular, Syscor (UK)AliniaApo-Nitrofurantoin, Furadantin, Novo-Furantoin

Pharmacologic class: Cholinergic

Therapeutic class: Smoking deterrent

Pregnancy risk category C (gum), D (inhalation, nasal, transdermal)

Pregnancy risk category C (gum), D (inhalation, nasal, transdermal)

Pharmacologic class: Calcium channel blocker

Therapeutic class: Antianginal, anti-hypertensive

Pregnancy risk category C

Pharmacologic class: Protein-tyrosine kinase inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D

Pharmacologic class: Antiandrogen

Therapeutic class: Antineoplastic

Pregnancy risk category C

Pharmacologic class: Calcium channel blocker

Therapeutic class: Cerebral vasodilator

Pregnancy risk category C

Pharmacologic class: Antiprotozoal

Therapeutic class: Anti-infective

Pregnancy risk category B

FDA Box Warning

Drug prolongs QT interval and may lead to sudden death. Don't give to patients with hypokalemia, hypomagnesemia, or long-QT syndrome. Correct hypokalemia or hypomagnesemia before starting drug and monitor for these imbalances periodically. Avoid concomitant drugs known to prolong QT interval; also avoid strong CYP3A4 inhibitors. Instruct patient not to eat 2 hours before or 1 hour after taking dose. Obtain ECG to monitor QTc at baseline, 7 days after drug initiation, periodically thereafter, and after dosage adjustments.

Reduce dosage in patients with hepatic impairment.

Action

Supplies nicotine during controlled withdrawal from cigarette smoking. Binds selectively to nicotinic-choliner-gic receptors in central and peripheral nervous systems, autonomic ganglia, adrenal medulla, and neuromuscular junction. At low doses, has a stimulating effect; at high doses, a reward effect.

Availability

Chewing gum: 2 mg, 4 mg

Inhalation: 42 cartridges/system, each containing 10 mg nicotine (delivers 4 mg)

Nasal spray: 10 mg/ml (0.5 mg/spray) in 10-ml bottles (100 doses)

Transdermal patch: 7 mg/day, 11 mg/day, 14 mg/day, 15 mg/day, 21 mg/day, 22 mg/day

⊘ Indications and dosages

➣ Adjunctive therapy (with behavior modification) for nicotine withdrawal Transdermal system -

Adults: 21 mg/day transdermally (Habitrol) for 4 to 8 weeks, then 14 mg/day for 2 to 4 weeks, then 7 mg/day for 2 to 4 weeks, for a total of 8 to 16 weeks; patient must wear system 24 hours/day. Or 21 mg/day transdermally (Nicoderm CQ) for 6 weeks, then 14 mg/day for 2 weeks, then 7 mg/day for 2 weeks, for a total of 10 weeks; patient must wear system 24 hours/day. Or 15 mg/day transdermally (one Nicotrol patch) for 6 weeks; patient must wear system 16 hours/day, removing it at bedtime.

Adults, adolescents, and children weighing less than 45 kg (100 lb) who smoke fewer than 10 cigarettes daily or have underlying cardiovascular disease: 14 mg/day transdermally (Habitrol) for 4 to 8 weeks, then 7 mg/day for 2 to 4 weeks, for a total of 6 to 8 weeks; patient must wear system 24 hours/day. Or 14 mg/day transdermally (Nicoderm CQ) for 6 weeks, then 7 mg/day for 2 weeks, for a total of 8 weeks; patient must wear system 24 hours/day. Nasal spray -

Adults: One spray intranasally in each nostril once or twice per hour, up to five times per hour or 40 times per day, for no longer than 6 months Inhalation -

Adults: For optimal response, at least six cartridges inhaled daily for first 3 to 6 weeks, to a maximum of 16 cartridges daily for up to 12 weeks. Patient self-titrates dosage to required nicotine level (usually 6 to 16 cartridges daily), followed by gradual withdrawal over 6 to 12 weeks.

Adults: Use as needed depending on smoking urge or chewing rate, or use on fixed schedule q 1 to 2 hours. Initial requirement may range from 18 to 48 mg/day, not to exceed 60 mg/day.

Contraindications

• Hypersensitivity to drug or its components or to menthol (inhaler only) • Allergy to adhesive (transdermal forms only)

Precautions

Use cautiously in: • cardiovascular disease, hypertension, bronchospastic disease, diabetes mellitus, pheochromocytoma, peripheral vascular disease, hyperthyroidism, peptic ulcer disease, hepatic disease • immediately after myocardial infarction, severe arrhythmia, or severe or worsening angina (use not recommended) • skin disorders (transdermal form) • dental disorders, esophagitis, pharyngitis, stomatitis (gum form) • females of childbearing age • pregnant or breastfeeding patients. • children under age 18 (safety and efficacy not established).

Administration

• Apply patch when patient awakens and remove patch (as prescribed) at same time each day. • Administer nasal spray regularly during first week, to help patient get used to irritant effects. • With inhalation use, give at least six cartridges daily for first 3 to 6 weeks. • Encourage patient to titrate dosage to level required, followed by gradual withdrawal.

Adverse reactions

CNS: headache, dizziness, drowsiness, poor concentration, nervousness, weakness, paresthesia, insomnia, abnormal dreams

CV: chest pain, hypertension, tachycardia, atrial fibrillation

EENT: sinusitis; pharyngitis (with gum); mouth and throat irritation (with inhaler); nasopharyngeal irritation, rhinitis, sneezing, watering eyes, eye irritation (with nasal spray)

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dry mouth, dyspepsia; increased salivation, sore mouth (with gum)

Musculoskeletal: joint pain, back pain, myalgia; jaw ache (with gum)

Respiratory: increased cough (with nasal spray or inhaler), bronchospasm

Skin: burning at patch site, erythema, pruritus, cutaneous hypersensitivity, rash, sweating (all with transdermal patch)

Other: abnormal taste, increased appetite (with gum), allergy, hiccups

Interactions

Drug-drug. Acetaminophen, adrenergic antagonists (such as prazosin, labetalol), clozapine, furosemide, imipramine, oxazepam, pentazocine, propranolol and other beta-adrenergic blockers, theophylline: increased effects of these drugs

Bupropion: treatment-emergent hypertension

Insulin: decreased insulin requirement

Isoproterenol, phenylephrine: increased requirements for these drugs

Propoxyphene: decreased nicotine metabolism

Drug-food. Caffeine-containing foods and beverages: increased nicotine effects

Drug-behaviors. Cigarette smoking: increased nicotine metabolism and effects

Patient monitoring

• Assess for signs and symptoms of nicotine withdrawal (irritability, drowsiness, fatigue, headache).

Watch for bronchospasm and evidence of nicotine toxicity (nausea, vomiting, diarrhea, increased salivation, headache, dizziness, visual disturbances).

Patient teaching

Caution patient against any type of smoking during therapy. Urge him to immediately report chest tightness or difficulty breathing. • If patient uses gum, advise him to chew one piece whenever nicotine craving occurs. Instruct him to chew it slowly until he feels a tingling sensation, then store it between cheek and gum until tingling disappears. • Instruct patient to apply transdermal patch to clean, dry skin of upper arm or torso when he awakens; to keep it in place when showering, bathing, or swimming; and to remove it at same time each day. • If patient uses nasal spray, instruct him to tilt head back slightly when spraying. Remind him not to sniff, swallow, or inhale through nose. • If patient uses inhalation form, teach him to puff continuously for 20 minutes and to use at least six cartridges daily for first 3 to 6 weeks. • As appropriate, review all significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and behaviors mentioned above.

nifedipine

Adalat CC, Adalat LA (UK). Adalat P. A. Adalat Retard (UK). Adalat XL, Adipine (UK). Afeditab CR, Angiopine (UK). Apo-Nifed, Calchan (UK). Cardilate MR (UK). Coracten (UK). Fortipine (UK). Gen-Nifedical, Hypolar Retard (UK). Neozipine XL (UK). Nifediac CC, Nifedical XL, Nifedipress MR (UK). Nifopress MR (UK). Novo-Nifedin, Nu-Nifed, Procardia, Procardia XL, Slofedipine (UK). Tensipine (UK). Valni Retard (UK). Valni XL (UK)

Pharmacologic class: Calcium channel blocker

Therapeutic class: Antianginal, anti-hypertensive

Pregnancy risk category C

Action

Inhibits calcium transport into myocardial and vascular smooth muscle cells, suppressing contractions. Dilates main coronary arteries and arterioles and inhibits coronary artery spasm, increasing oxygen delivery to heart and decreasing frequency and severity of angina attacks.

Availability

Capsules: 5 mg, 10 mg, 20 mg

Tablets (extended-release): 10 mg, 20 mg, 30 mg, 60 mg, 90 mg

⊘ Indications and dosages

➣ Vasospastic (Prinzmetal's) angina; chronic stable angina

Adults: Initially, 10 mg P. O. (immediate-release) t. i.d. titrated over 7 to 14 days; usual effective range is 10 to 20 mg t. i.d. not to exceed 180 mg/day. Patient may be switched to extended-release at nearest equivalent of immediate-release daily dosage (for instance, 30-mg immediate-release dose may be switched to 90-mg extended-release dose). Total extended-release dosage should not exceed 90 mg/day.

Adults: 30 to 60 mg/day P. O. (extended-release only) titrated over 7 to 14 days to a maximum of 120 mg/day

Off-label uses

• Aortic regurgitation • Heart failure • Migraine • Prevention of labor

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in: • chronic renal insufficiency • hypotension, aortic stenosis, heart failure, significant left ventricular dysfunction (especially when used with beta-adrenergic blockers), peripheral edema • elderly patients • pregnant or breastfeeding patients (safety not established) • children (safety not established).

Administration

• Give immediate-release form with or without food. If GI upset occurs, give with meals, but never with grapefruit or grapefruit juice. • Don't crush or break extended-release tablet. Make sure patient swallows it whole. Give on empty stomach, and not with grapefruit or grapefruit juice. • Know that Procardia XL and Adalat CC are not equivalent because of their pharmacokinetic differences. • Be aware that only extended-release tablets are used to treat hypertension.

Adverse reactions

CNS: headache, dizziness, fatigue, asthenia, paresthesia, vertigo

CV: peripheral edema, chest pain, hypotension

EENT: epistaxis, rhinitis

GI: nausea, constipation

GU: urinary frequency, erectile dysfunction

Musculoskeletal: leg cramps

Skin: flushing, rash

Interactions

Drug-drug. Beta-adrenergic blockers: increased risk of heart failure, severe hypotension, or angina exacerbation

Cimetidine: increased nifedipine blood level

Coumarin anticoagulants: increased prothrombin time

Digoxin: increased risk of digoxin toxicity

Quinidine: decreased quinidine blood level

Drug-diagnostic tests. Antinuclear antibody, direct Coombs' test false-positive results

Drug-food. Grapefruit, grapefruit juice: increased nifedipine blood level and effects

Drug-herbs. Ephedra (ma huang), yohimbine: antagonism of nifedipine effect

Ginkgo, ginseng: increased nifedipine blood level

St. John's wort: decreased nifedipine blood level

Drug-behaviors. Alcohol use: additive hypotension

Patient monitoring

• Monitor vital signs and cardiovascular status. Stay alert for chest pain and edema. • Watch for rash.

Patient teaching

• Tell patient he may take immediate-release form with or without meals. If GI upset occurs, tell him to take it with meals, but never with grapefruit or grapefruit juice. • Caution patient not to crush or break extended-release tablets. Tell him to swallow them whole. Advise him to take on empty stomach, and not with grapefruit or grapefruit juice. • Inform patient that angina attacks may occur 30 minutes after a dose. Explain that these attacks are usually temporary and don't mean that drug should be withdrawn.

Tell patient to report rash immediately. • Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, balance, and alertness. • Instruct patient to consult prescriber before taking herbs or over-the-counter drugs (especially cold remedies). • As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

nilotinib

Pharmacologic class: Protein-tyrosine kinase inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA BOXED WARNING

Drug prolongs QT interval and may lead to sudden death. Don't give to patients with hypokalemia, hypomagnesemia, or long-QT syndrome. Correct hypokalemia or hypomagnesemia before starting drug and monitor for these imbalances periodically. Avoid concomitant drugs known to prolong QT interval; also avoid strong CYP3A4 inhibitors. Instruct patient not to eat 2 hours before or 1 hour after taking dose. Obtain ECG to monitor QTc at baseline, 7 days after drug initiation, periodically thereafter, and after dosage adjustments.

Reduce dosage in patients with hepatic impairment.

Action

Inhibits proliferation of murine leukemic cell lines mediated by BCR-ABL kinase and human cell lines derived from patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)

Availability

Capsules: 200 mg

⊘ Indications and dosages

➣ Chronic-phase or accelerated-phase Ph+ CML in patients resistant or intolerant to previous imatinib therapy

Adults: 400 mg P. O. q 12 hours

➣ Newly diagnosed Philadelphia chromosome positive CML Adults: 300 mg P. O. q 12 hours

Dosage adjustment

• QTc longer than 480 msec • Hematologic toxicity • Moderate or severe non-hematologic toxicity • Concomitant use of CYP3A4 inducers • Hepatic impairment

Off-label uses

• Ph+ acute lymphoblastic leukemia (ALL) • Systemic mastocytosis with c-kit receptor activation • Hypereosinophilic syndrome

Contraindications

• Hypokalemia • Hypomagnesemia • Long-QT syndrome

Precautions

Use cautiously in: • hepatic impairment • rare hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption (use not recommended) • myelosuppression • electrolyte abnormalities • history of pancreatitis • pregnant or breastfeeding patients • children (safety and efficacy not established).

Administration

Correct hypophosphatemia and hypokalemia before starting drug. • Don't give with food. Know that patient shouldn't consume food for at least 2 hours before or 1 hour after dose. • Administer capsule whole with water. • Be aware that drug may be given in combination with hematopoietic growth factors, if indicated.

Adverse reactions

CNS: headache, fatigue, asthenia, insomnia, dizziness, paresthesia, vertigo, intracranial hemorrhage

CV: palpitations, hypertension, flushing, QT interval prolongation and sudden death

EENT: dysphonia, nasopharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, abdominal discomfort, dyspepsia, flatulence, anorexia

Hematologic: anemia, neutropenia, thrombocytopenia, leukopenia, pan-cytopenia, febrile neutropenia

Metabolic: electrolyte abnormalities

Musculoskeletal: arthralgia, myalgia, extremity pain, bone pain, muscle spasms, back pain, chest pain

Respiratory: cough, dyspnea, exertional dyspnea, pneumonia

Skin: rash, pruritus, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin

Other: fever, peripheral edema, night sweats, weight changes

Interactions

Drug-drug. Drugs eliminated by CYP2B6, CYP2C8, or CYP2C9: decreased blood levels of these drugs

Drugs eliminated by CYP3A4 (such as warfarin), CYP2C8, CYP2C9, CYP2D6, or UGT1A1: increased blood levels of these drugs

Drugs that inhibit P-glycoprotein

ABCB1: increased nilotinib blood level

Midazolam: increased midazolam exposure

P-glycoprotein substrates: increased blood levels of these drugs

Strong CYP3A4 inducers (such as carba-mazepine, dexamethasone, phenytoin, rifabutin, rifampin, rifapentin, phenobarbital): decreased nilotinib blood level

Strong CYP3A4 inhibitors (such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole): increased nilotinib blood level

Drug-diagnostic tests. Albumin, calcium, magnesium, neutrophils, phosphorus, platelets, sodium, white blood cells: decreased levels

ALP, ALT, AST, bilirubin, blood glucose, creatinine, serum amylase, serum lipase: increased levels

Potassium: increased or decreased level

Drug-food. Grapefruit products: increased nilotinib blood level

High-fat meal: increased nilotinib onset

Drug-herbs. St. John's wort: decreased nilotinib blood level

Patient monitoring

Closely monitor for prolonged QT interval if patient has hepatic impairment or is receiving strong CYP3A4 inhibitors. • Obtain complete blood count every 2 weeks for first 2 months of therapy and monthly thereafter, or as indicated. • Periodically monitor electrolyte and lipase levels and liver function tests.

Patient teaching

• Tell patient not to take drug with food and not to consume food for at least 2 hours before or 1 hour after dose. • Advise patient to take capsules whole with water.

Instruct patient to avoid grapefruit products and St. John's wort. • Tell lactose-intolerant patient that drug contains lactose.

Instruct patient to immediately notify prescriber if symptoms of QTc prolongation (faintness or irregular heartbeat) occur.

Urge patient to immediately report signs or symptoms of liver damage, such as nausea, fatigue, anorexia, yellowing of skin or eyes, dark urine, light-colored stools, itching, or abdominal tenderness. • Advise female patient that drug may harm fetus. Caution her to avoid pregnancy. • Advise breastfeeding patient to seek guidance to help her decide whether to discontinue breastfeeding or discontinue drug. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, food, and herbs mentioned above.

nilutamide

Pharmacologic class: Antiandrogen

Therapeutic class: Antineoplastic

Pregnancy risk category C

FDA BOXED WARNING

Drug may cause interstitial pneumonitis. Though rare, interstitial changes have led to hospitalization and death postmarketing. Most cases occurred within first 3 months of therapy and reversed after drug was stopped. Obtain routine chest X-ray before starting treatment, and be prepared to obtain baseline pulmonary function tests if ordered. Instruct patient to report new or worsening shortness of breath; this symptom warrants immediate drug withdrawal pending evaluation.

Action

Inhibits testosterone uptake in target tissue, preventing normal androgenic response and arresting tumor growth in androgen-sensitive tissue

Availability

Tablets: 50 mg, 150 mg

⊘ Indications and dosages

➣ Metastatic prostate cancer (used with surgical castration)

Adults: 300 mg/day P. O. for 30 days, starting on day of or day after surgery; then 150 mg/day P. O.

Contraindications

• Hypersensitivity to drug or its components • Severe hepatic or respiratory insufficiency

Precautions

Use cautiously in: • renal impairment.

Administration

• Give with or without food. • Start therapy on same day as or day after surgical castration.

Adverse reactions

CNS: dizziness, depression, hyperes-thesia, insomnia

CV: hypertension, peripheral edema, heart failure

EENT: abnormal vision, impaired dark and light adaptation, chromatopsia

GI: nausea, vomiting, constipation, dyspepsia, anorexia

GU: hematuria, nocturia, urinary tract infection, gynecomastia, testicular atrophy, decreased libido, erectile dysfunction

Hematologic: anemia, aplastic anemia

Respiratory: dyspnea, upper respiratory infection, interstitial pneumonia

Other: flulike symptoms, pain, fever, hot flushes, alcohol intolerance

Interactions

Drug-drug. Phenytoin, theophylline, vitamin K: increased risk of toxicity from these drugs

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels

Drug-behaviors. Alcohol use: disulfiram-like reaction

Patient monitoring

• Check for signs and symptoms of hepatitis. Monitor liver function tests. • Monitor CBC. • Assess fluid intake and output and weight. Watch for signs and symptoms of heart failure. • Monitor respiratory status, including chest X-rays.

Patient teaching

• Advise patient he may take with or without food. • Tell patient therapy will start on day of or day after surgical castration. • Caution patient not to stop taking drug without consulting prescriber. • Instruct patient to weigh himself daily and report sudden increases.

Advise patient to report new onset or worsening of dyspnea as well as signs and symptoms of hepatotoxicity, such as nausea, vomiting, abdominal pain, unusual tiredness, or yellowing of skin or eyes. • Advise patient to avoid alcohol during therapy, because serious adverse reactions may occur. • Tell patient drug may impair his adaptation to darkness and light, which may cause difficulty driving at night or through tunnels. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, test, and behaviors mentioned above.

nimodipine

Pharmacologic class: Calcium channel blocker

Therapeutic class: Cerebral vasodilator

Pregnancy risk category C

FDA BOXED WARNING

Don't give by I. V. or other parenteral route. Deaths and serious or life-threatening adverse events have occurred when capsule contents have been injected parenterally.

Action

Inhibits calcium transport into vascular smooth muscle cells, suppressing contractions; also dilates coronary and cerebral arteries

Availability

⊘ Indications and dosages

➣ Subarachnoid hemorrhage

Adults: 60 mg P. O. q 4 hours for 21 days. Therapy should start within 96 hours of subarachnoid hemorrhage.

Dosage adjustment

• Hepatic impairment

Contraindications

Precautions

Use cautiously in: • hepatic impairment, hypotension • elderly patients • pregnant or breastfeeding patients (safety not established) • children (safety not established).

Administration

• Give at least 1 hour before or 2 hours after meals. Don't let patient consume grapefruit or grapefruit juice within 1 hour before or 2 hours after dose. • If patient can't swallow capsule, puncture it with sterile needle and empty contents into syringe. Administer through nasogastric tube, then flush with normal saline solution (30 ml).

Adverse reactions

CNS: headache, depression

CV: hypotension, peripheral edema, ECG abnormalities, bradycardia, tachycardia

GI: nausea, diarrhea, abdominal discomfort

Musculoskeletal: muscle cramps

Skin: acne, flushing, rash

Interactions

Drug-drug. Other calcium channel

blockers: enhanced cardiovascular effects

Drug-diagnostic tests. Liver function

tests: abnormal results

Drug-food. Any food: decreased drug blood level and effects

Grapefruit juice, grapefruit juice: increased drug blood level and effects

Drug-herbs. Ephedra (ma huang) ,

yohimbine: antagonism of nimodipine effects

St. John's wort: decreased drug blood level

Drug-behaviors. Alcohol use: increased hypotension

Patient monitoring

• Monitor weight and fluid intake and output. Stay alert for fluid retention. • Assess neurologic status and mood, watching for signs of depression. • Check vital signs and ECG.

Patient teaching

• Tell patient to complete full course of therapy (21 days). • Advise patient to take on an empty stomach 1 hour before or 2 hours after a meal. Instruct him to not to consume grapefruit or grapefruit juice within 1 hour before or 2 hours after taking drug. • Tell patient to report irregular heartbeat, shortness of breath, rash, or swollen hands or feet. • Instruct patient to minimize GI upset by eating small, frequent meals. • Advise patient to weigh himself daily and report sudden weight gain. • As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

nisoldipine

Sular, Syscor (UK)

Pharmacologic class: Calcium channel blocker

herapeutic class: Antihypertensive

Pregnancy risk category C

Action

Suppresses calcium transport into vascular smooth muscle cells. This suppression inhibits vasoconstriction and dilates coronary arteries, improving myocardial oxygen uptake.

Availability

Tablets (extended-release): 8.5 mg, 17 mg, 22.5 mg, 34 mg

⊘ Indications and dosages

Adults: Initially, 17 mg P. O. daily; may increase by 8.5 mg per week or longer intervals to attain adequate blood pressure control. Usual maintenance dosage is 17 to 34 mg daily.

Contraindications

• Hypersensitivity to drug or dihydropyridine calcium channel blockers

Precautions

Use cautiously in: • heart failure and left ventricular dysfunction, hepatic impairment, renal disease, coronary artery disease, hypotension • concurrent phenytoin use • elderly patients • pregnant or breastfeeding patients • children (safety not established).

Administration

• Give with meals, but not with high-fat meals, grapefruit, or grapefruit juice. • Don't crush or break extended-release tablets. Make sure patient swallows them whole. • Know that drug may be given alone or with other antihypertensives.

Adverse reactions

CNS: headache, dizziness

CV: peripheral edema, chest pain, vasodilation, hypotension, palpitations

EENT: pharyngitis, sinusitis

Interactions

Drug-drug. Cimetidine: increased nisoldipine blood level

Phenytoin, other CYP3A4 inducers: decreased nisoldipine blood level and efficacy

Drug-food. Grapefruit juice: significantly increased drug blood level and effects

High-fat meal: decreased drug blood level

Drug-herbs. Ephedra (ma huang), yohimbine: antagonism of nimodipine effects

St. John's wort: decreased nimodipine blood level

Drug-behaviors. Alcohol use: increased hypotensive effects

Patient monitoring

• Check vital signs and ECG. • Monitor fluid intake and output. Watch for peripheral edema.

Patient teaching

• Tell patient to swallow extended-release tablets whole and not to crush or break them. • Advise patient to take with food, but not high-fat food. Recommend small, frequent meals. • Instruct patient to avoid high-fat meals, alcohol, grapefruit, and grapefruit juice. • Tell patient to immediately report irregular heart beat, shortness of breath, swelling, pronounced dizziness, rash, or chest pain. • As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, foods, herbs, and behaviors mentioned above.

nitazoxanide

Pharmacologic class: Antiprotozoal

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Impedes pyruvate:ferredoxin oxidoreductase enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism

Availability

Oral suspension: 100 mg/5 ml

⊘ Indications and dosages

➣ Diarrhea caused by Giardia lamblia or Cryptosporidium parvum

Adults and children ages 12 and older: 500 mg (tablet or 25 ml suspension) P. O. every 12 hours with food for 3 days

Children ages 4 to 11 . 200 mg (10 ml suspension) P. O. every 12 hours with food for 3 days

Children ages 1 to 3: 100 mg (5 ml suspension) P. O. every 12 hours with food for 3 days

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in: • renal, hepatic, or biliary disease or dysfunction; immunodeficiency (including human immunodeficiency virus); diabetes mellitus (suspension) • concurrent use of warfarin or other highly plasma protein-bound drugs • elderly patients • pregnant or breastfeeding patients • children younger than age 11 (tablets) or age 1 (suspension).

Administration

• Give with food. • Because a single tablet contains more nitazoxanide than recommended for pediatric dosing, don't give tablets to children younger than age 11. • Keep suspension container tightly closed and shake well before each use. Suspension may be stored for 7 days; after that, discard unused portion.

Adverse reactions

GI: nausea, vomiting, diarrhea, abdominal pain

Interactions

Drug-drug. Warfarin and other highly plasma protein-bound drugs with narrow therapeutic index: competition for binding sites, resulting in increased nitazoxanide blood level and efficacy

Patient monitoring

• Monitor renal and liver function tests frequently in patients with renal, hepatic, or biliary dysfunction. • Monitor blood glucose levels in diabetic patients taking oral suspension.

Patient teaching

• Instruct patient to take drug with food. • Inform diabetic patient that oral suspension contains sucrose. • As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.

nitrofurantoin

Apo-Nitrofurantoin, Furadantin, Novo-Furantoin

Coracten

Albendol 10ml; suspension, micro labs ltd, albendol

ALBENDOL 10ml - Suspension, Micro Labs Ltd.

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