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Glimepiride

Glimepiride Tablet, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1 ) ].

Important Limitations of Use

Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Glimepiride Dosage and Administration

Recommended Dosing

Glimepiride should be administered with breakfast or the first main meal of the day.

The recommended starting dose of Glimepiride is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e. g. the elderly or patients with renal impairment) should be started on 1 mg once daily [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.5. 8.6 ) ].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.5. 8.6 ) ].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to Glimepiride from longer half-life sulfonylureas (e. g. chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

When colesevelam is coadministered with Glimepiride, maximum plasma concentration and total exposure to Glimepiride is reduced. Therefore, Glimepiride should be administered at least 4 hours prior to colesevelam.

Dosage Forms and Strengths

Glimepiride is formulated as tablets of:

1 mg (Scored white to off-white, round engraved with "CTI 115" on the scored side)

2 mg (Scored white to off-white, round engraved with "CTI 116" on the scored side)

4 mg (Scored white to off-white, round engraved with "CTI 117" on the scored side)

Contraindications

Glimepiride is contraindicated in patients with a history of a hypersensitivity reaction to:

Glimepiride or any of the product's ingredients [ see Warnings and Precautions ( 5.2 ) ].

Sulfonamide derivatives: Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to Glimepiride. Do not use Glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives.

Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e. g. anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 ) ].

Warnings and Precautions

Hypoglycemia

All sulfonylureas, including Glimepiride, can cause severe hypoglycemia [see Adverse Reactions ( 6.1 ) ]. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. These impairments may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death.

Patients must be educated to recognize and manage hypoglycemia. Use caution when initiating and increasing Glimepiride doses in patients who may be predisposed to hypoglycemia (e. g. the elderly, patients with renal impairment, patients on other anti - diabetic medications). Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic impairment are particularly susceptible to the hypoglycemic action of glucose-lowering medications. Hypoglycemia is also more likely to occur when caloric intake is deficient, after severe or prolonged exercise, or when alcohol is ingested.

Early warning symptoms of hypoglycemia may be different or less pronounced in patients with autonomic neuropathy, the elderly, and in patients who are taking beta-adrenergic blocking medications or other sympatholytic agents. These situations may result in severe hypoglycemia before the patient is aware of the hypoglycemia.

Hypersensitivity Reactions

There have been postmarketing reports of hypersensitivity reactions in patients treated with Glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson Syndrome. If a hypersensitivity reaction is suspected, promptly discontinue Glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.

Hemolytic Anemia

Sulfonylureas can cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Because Glimepiride is a sulfonylurea, use caution in patients with G6PD deficiency and consider the use of a non-sulfonylurea alternative.

There are also postmarketing reports of hemolytic anemia in patients receiving Glimepiride who did not have known G6PD deficiency [see Adverse Reactions ( 6.2 ) ].

Increased Risk of Cardiovascular Mortality with Sulfonylureas

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term, prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups.

UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2-1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of Glimepiride and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glimepiride or any other anti-diabetic drug.

Adverse Reactions

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

Hypoglycemia [see Warnings and Precautions ( 5.1 ) ]

Hemolytic anemia [see Warnings and Precautions ( 5.3 ) ]

In clinical trials, the most common adverse reactions with Glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Approximately 2,800 patients with type 2 diabetes have been treated with Glimepiride in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Glimepiride for at least 1 year.

Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebo-controlled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months. Terms that are reported represent those that occurred at an incidence of ≥5% among Glimepiride - treated patients and more commonly than in patients who received placebo.

Table 1. Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months: Adverse Events (Excluding Hypoglycemia) Occurring in ≥5% of Glimepiride - treated Patients and at a Greater Incidence than with Placebo*

*Glimepiride doses ranged from 1-16 mg administered daily

†Insufficient information to determine whether any of the accidental injury events were associated with hypoglycemia

In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Glimepiride 1 mg, 4 mg, 8 mg or placebo. Patients randomized to Glimepiride 4 mg or 8 mg underwent forced-titration from an initial dose of 1 mg to these final doses, as tolerated [see Clinical Studies ( 14.1 )]. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Glimepiride 1 mg, 17% for Glimepiride 4 mg, 16% for Glimepiride 8 mg and 0% for placebo. All of these events were self-treated.

In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Glimepiride or placebo daily. The dose of Glimepiride was titrated to a target fasting plasma glucose of 90-150 mg/dL. Final daily doses of Glimepiride were 1, 2, 3, 4, 6 or 8 mg [see Clinical Studies ( 14.1 )]. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Glimepiride vs. placebo was 19.7% vs. 3.2%. All of these events were self-treated.

Weight gain: Glimepiride, like all sulfonylureas, can cause weight gain [see Clinical Studies ( 14.1 ) ].

Allergic Reactions: In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Glimepiride - treated patients. These may resolve despite continued treatment with Glimepiride. There are postmarketing reports of more serious allergic reactions (e. g. dyspnea, hypotension, shock) [see Warnings and Precautions ( 5.2 ) ].

Laboratory Tests: Elevated Serum Alanine Aminotransferase (ALT): In 11 pooled placebo-controlled trials of Glimepiride, 1.9% of Glimepiride - treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Glimepiride. Because these reactions 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 drug exposure.

Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.2 ) ]

Hemolytic anemia in patients with and without G6PD deficiency [see Warnings and Precautions ( 5.3 ) ]

Impairment of liver function (e. g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.

Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis

Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia

Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura

Hepatic porphyria reactions and disulfiram-like reactions

Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone

Drug Interactions

Drugs Affecting Glucose Metabolism

A number of medications affect glucose metabolism and may require Glimepiride dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.

The following are examples of medications that may increase the glucose-lowering effect of sulfonylureas including Glimepiride, increasing the susceptibility to and/or intensity of hypoglycemia: oral anti-diabetic medications, pramlintide acetate, insulin, angiotensin converting enzyme (ACE) inhibitors, H2 receptor antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids and androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, and those drugs that are highly protein-bound, such as fluoxetine, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid and monoamine oxidase inhibitors. When these medications are administered to a patient receiving Glimepiride, monitor the patient closely for hypoglycemia. When these medications are withdrawn from a patient receiving Glimepiride, monitor the patient closely for worsening glycemic control.

The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including Glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e. g. olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e. g. epinephrine, albuterol, terbutaline), and isoniazid. When these medications are administered to a patient receiving Glimepiride, monitor the patient closely for worsening glycemic control. When these medications are withdrawn from a patient receiving Glimepiride, monitor the patient closely for hypoglycemia.

Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of Glimepiride's glucose-lowering effect.

Both acute and chronic alcohol intake may potentiate or weaken the glucose-lowering action of Glimepiride in an unpredictable fashion.

The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.

Miconazole

A potential interaction between oral miconazole and sulfonylureas leading to severe hypoglycemia has been reported. Whether this interaction also occurs with other dosage forms of miconazole is not known.

Cytochrome P450 2C9 Interactions

There may be an interaction between Glimepiride and inhibitors (e. g. fluconazole) and inducers (e. g. rifampin) of cytochrome P450 2C9. Fluconazole may inhibit the metabolism of Glimepiride, causing increased plasma concentrations of Glimepiride which may lead to hypoglycemia. Rifampin may induce the metabolism of Glimepiride, causing decreased plasma concentrations of Glimepiride which may lead to worsening glycemic control.

Concomitant Administration of Colesevelam

Colesevelam can reduce the maximum plasma concentration and total exposure of Glimepiride when the two are coadministered. However, absorption is not reduced when Glimepiride is administered 4 hours prior to colesevelam. Therefore, Glimepiride should be administered at least 4 hours prior to colesevelam.

8. USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Glimepiride in pregnant women. In animal studies there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at Glimepiride doses 50 times (rats) and 0.1 times (rabbits) the maximum recommended human dose (based on body surface area). This fetotoxicity, observed only at doses inducing maternal hypoglycemia, is believed to be directly related to the pharmacologic (hypoglycemic) action of Glimepiride and has been similarly noted

with other sulfonylureas. Glimepiride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because data suggest that abnormal blood glucose during pregnancy is associated with a higher incidence of congenital abnormalities, diabetes treatment during pregnancy should maintain blood glucose as close to normal as possible.

Nonteratogenic Effects: Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery.

Nursing Mothers

It is not known whether Glimepiride is excreted in human milk. During pre - and post-natal studies in rats, significant concentrations of Glimepiride were present in breast milk and the serum of the pups. Offspring of rats exposed to high levels of Glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. These skeletal deformations were determined to be the result of nursing from mothers exposed to Glimepiride. Based on these animal data and the potential for hypoglycemia in a nursing infant, a decision should be made whether to discontinue nursing or discontinue Glimepiride, taking into account the importance of Glimepiride to the mother.

Pediatric Use

The pharmacokinetics, efficacy and safety of Glimepiride have been evaluated in pediatric patients with type 2 diabetes as described below. Glimepiride is not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.

The pharmacokinetics of a 1 mg single dose of Glimepiride was evaluated in 30 patients with type 2 diabetes (male = 7; female = 23) between ages 10 and 17 years. The mean (± SD) AUC (0-last) (339±203 ng•hr/mL), Cmax (102±48 ng/mL) and t1/2 (3.1±1.7 hours) for Glimepiride were comparable to historical data from adults (AUC ( 0-last ) 315±96 ng•hr/mL, Cmax 103±34 ng/mL and t1/2 5.3±4.1 hours).

The safety and efficacy of Glimepiride in pediatric patients was evaluated in a single-blind, 24-week trial that randomized 272 patients (8-17 years of age) with type 2 diabetes to Glimepiride (n=135) or metformin (n=137). Both treatment-naïve patients (those treated with only diet and exercise for at least 2 weeks prior to randomization) and previously treated patients (those previously treated or currently treated with other oral antidiabetic medications for at least 3 months) were eligible to participate. Patients who were receiving oral antidiabetic agents at the time of study entry discontinued these medications before randomization without a washout period. Glimepiride was initiated at 1 mg, and then titrated up to 2, 4 or 8 mg (mean last dose 4 mg) through Week 12, targeting a self-monitored fasting fingerstick blood glucose < 126 mg/dL. Metformin was initiated at 500 mg twice daily and titrated at Week 12 up to 1000 mg twice daily (mean last dose 1365 mg).

After 24 weeks, the overall mean treatment difference in HbA 1c between Glimepiride and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).

Based on these results, the trial did not meet its primary objective of showing a similar reduction in HbA 1c with Glimepiride compared to metformin.

Table 2. Change from Baseline in HbA 1C and Body Weight in Pediatric Patients Taking Glimepiride or Metformin

* Intent-to-treat population using last-observation-carried-forward for missing data (Glimepiride, n=127; metformin, n=126)

The profile of adverse reactions in pediatric patients treated with Glimepiride was similar to that observed in adults [see Adverse Reactions ( 6 )].

Hypoglycemic events documented by blood glucose values <36 mg/dL were observed in 4% of pediatric patients treated with Glimepiride and in 1% of pediatric patients treated with metformin. One patient in each treatment group experienced a severe hypoglycemic episode (severity was determined by the investigator based on observed signs and symptoms).

Geriatric Use

In clinical trials of Glimepiride, 1053 of 3491 patients (30%) were >65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

There were no significant differences in Glimepiride pharmacokinetics between patients with type 2 diabetes ≤65 years (n=49) and those >65 years (n=42) [see Clinical Pharmacology ( 12.3 ) ].

Glimepiride is substantially excreted by the kidney. Elderly patients are more likely to have renal impairment. In addition, hypoglycemia may be difficult to recognize in the elderly [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ]. Use caution when initiating Glimepiride and increasing the dose of Glimepiride in this patient population.

Renal Impairment

To minimize the risk of hypoglycemia, the recommended starting dose of Glimepiride is 1 mg daily for all patients with type 2 diabetes and renal impairment [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ].

A multiple-dose titration study was conducted in 16 patients with type 2 diabetes and renal impairment using doses ranging from 1 mg to 8 mg daily for 3 months. Baseline creatinine clearance ranged from 10-60 mL/min. The pharmacokinetics of Glimepiride were evaluated in the multiple-dose titration study and the results were consistent with those observed in patients enrolled in a single-dose study. In both studies, the relative total clearance of Glimepiride increased when kidney function was impaired. Both studies also demonstrated that the elimination of the two major metabolites was reduced in patients with renal impairment [see Clinical Pharmacology ( 12.3 ) ].

Overdosage

An overdosage of Glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery [see Warnings and Precautions ( 5.1 ) ].

Glimepiride Description

Glimepiride Tablets USP is an oral sulfonylurea that contains the active ingredient Glimepiride. Chemically, Glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24 H 34 N 4 O 5 S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

Glimepiride tablets contain the active ingredient Glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, and sodium starch glycolate.

Glimepiride - Clinical Pharmacology

Mechanism of Action

Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

Pharmacodynamics

In healthy subjects, the time to reach maximal effect (minimum blood glucose concentrations) was approximately 2-3 hours after single oral doses of Glimepiride. The effects of Glimepiride on HbA 1c. fasting plasma glucose, and post-prandial glucose have been assessed in clinical trials [ see Clinical Studies ( 14 ) ].

Pharmacokinetics

Absorption. Studies with single oral doses of Glimepiride in healthy subjects and with multiple oral doses in patients with type 2 diabetes showed peak drug concentrations (C max ) 2 to 3 hours post-dose. When Glimepiride was given with meals, the mean C max and AUC (area under the curve) were decreased by 8% and 9%, respectively.

Glimepiride does not accumulate in serum following multiple dosing. The pharmacokinetics of Glimepiride does not differ between healthy subjects and patients with type 2 diabetes. Clearance of Glimepiride after oral administration does not change over the 1 mg to 8 mg dose range, indicating linear pharmacokinetics.

In healthy subjects, the intra - and inter-individual variabilities of Glimepiride pharmacokinetic parameters were 15-23% and 24-29%, respectively.

Distribution. After intravenous dosing in healthy subjects, the volume of distribution (Vd) was 8.8 L (113 mL/kg), and the total body clearance (CL) was 47.8 mL/min. Protein binding was greater than 99.5%.

Metabolism. Glimepiride is completely metabolized by oxidative biotransformation after either an intravenous or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2). Cytochrome P450 2C9 is involved in the biotransformation of Glimepiride to M1. M1 is further metabolized to M2 by one or several cytosolic enzymes. M2 is inactive. In animals, M1 possesses about one-third of the pharmacological activity of Glimepiride, but it is unclear whether M1 results in clinically meaningful effects on blood glucose in humans.

Excretion. When 14 C-Glimepiride was given orally to 3 healthy male subjects, approximately 60% of the total radioactivity was recovered in the urine in 7 days. M1 and M2 accounted for 80-90% of the radioactivity recovered in the urine. The ratio of M1 to M2 in the urine was approximately 3:2 in two subjects and 4:1 in one subject. Approximately 40% of the total radioactivity was recovered in feces. M1 and M2 accounted for approximately 70% (ratio of M1 to M2 was 1:3) of the radioactivity recovered in feces. No parent drug was recovered from urine or feces. After intravenous dosing in patients, no significant biliary excretion of Glimepiride or its M1 metabolite was observed.

Geriatric Patients. A comparison of Glimepiride pharmacokinetics in patients with type 2 diabetes ≤65 years and those >65 years was evaluated in a multiple-dose study using Glimepiride 6 mg daily. There were no significant differences in Glimepiride pharmacokinetics between the two age groups. The mean AUC at steady state for the older patients was approximately 13% lower than that for the younger patients; the mean weight-adjusted clearance for the older patients was approximately 11% higher than that for the younger patients.

Gender. There were no differences between males and females in the pharmacokinetics of Glimepiride when adjustment was made for differences in body weight.

Race. No studies have been conducted to assess the effects of race on Glimepiride pharmacokinetics but in placebo-controlled trials of Glimepiride in patients with type 2 diabetes, the reduction in HbA 1C was comparable in Caucasians (n = 536), blacks (n = 63), and Hispanics (n = 63).

Renal Impairment. In a single-dose, open-label study Glimepiride 3 mg was administered to patients with mild, moderate and severe renal impairment as estimated by creatinine clearance (CLcr): Group I consisted of 5 patients with mild renal impairment (CLcr > 50 mL/min), Group II consisted of 3 patients with moderate renal impairment (CLcr = 20-50 mL/min) and Group III consisted of 7 patients with severe renal impairment (CLcr < 20 mL/min). Although, Glimepiride serum concentrations decreased with decreasing renal function, Group III had a 2.3-fold higher mean AUC for M1 and an 8.6-fold higher mean AUC for M2 compared to corresponding mean AUCs in Group I. The apparent terminal half-life (T 1/2 ) for Glimepiride did not change, while the half-lives for M1 and M2 increased as renal function decreased. Mean urinary excretion of M1 plus M2 as a percentage of dose decreased from 44.4% for Group I to 21.9% for Group II and 9.3% for Group III.

Hepatic Impairment. It is unknown whether there is an effect of hepatic impairment on Glimepiride pharmacokinetics because the pharmacokinetics of Glimepiride has not been adequately evaluated in patients with hepatic impairment.

Obese Patients. The pharmacokinetics of Glimepiride and its metabolites were measured in a single-dose study involving 28 patients with type 2 diabetes who either had normal body weight or were morbidly obese. While the t max. clearance, and volume of distribution of Glimepiride in the morbidly obese patients were similar to those in the normal weight group, the morbidly obese had lower C max and AUC than those of normal body weight. The mean C max. AUC 0-24. AUC 0-∞ values of Glimepiride in normal vs. morbidly obese patients were 547 ± 218 ng/mL vs. 410 ± 124 ng/mL, 3210 ± 1030 hours·ng/mL vs. 2820 ± 1110 hours·ng/mL and 4000 ± 1320 hours·ng/mL vs. 3280 ± 1360 hours·ng/mL, respectively.

Aspirin. In a randomized, double-blind, two-period, crossover study, healthy subjects were given either placebo or aspirin 1 gram three times daily for a total treatment period of 5 days. On Day 4 of each study period, a single 1 mg dose of Glimepiride was administered. The Glimepiride doses were separated by a 14-day washout period. Co-administration of aspirin and Glimepiride resulted in a 34% decrease in the mean Glimepiride AUC and a 4% decrease in the mean Glimepiride C max .

Colesevelam. Concomitant administration of colesevelam and Glimepiride resulted in reductions in Glimepiride AUC 0-∞ and C max of 18% and 8%, respectively. When Glimepiride was administered 4 hours prior to colesevelam, there was no significant change in Glimepiride AUC 0-∞ or Cmax, -6% and 3%, respectively [see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7.4 )].

Cimetidine and Ranitidine. In a randomized, open-label, 3-way crossover study, healthy subjects received either a single 4 mg dose of Glimepiride alone, Glimepiride with ranitidine (150 mg twice daily for 4 days; Glimepiride was administered on Day 3), or Glimepiride with cimetidine (800 mg daily for 4 days; Glimepiride was administered on Day 3). Coadministration of cimetidine or ranitidine with a single 4 mg oral dose of Glimepiride did not significantly alter the absorption and disposition of Glimepiride.

Propranolol. In a randomized, double-blind, two-period, crossover study, healthy subjects were given either placebo or propranolol 40 mg three times daily for a total treatment period of 5 days. On Day 4 or each study period, a single 2 mg dose of Glimepiride was administered. The Glimepiride doses were separated by a 14-day washout period. Concomitant administration of propranolol and Glimepiride significantly increased Glimepiride C max. AUC, and T 1/2 by 23%, 22%, and 15%, respectively, and decreased Glimepiride CL/f by 18%. The recovery of M1 and M2 from urine was not changed.

Warfarin. In an open-label, two-way, crossover study, healthy subjects received 4 mg of Glimepiride tablets daily for 10 days. Single 25 mg doses of warfarin were administered 6 days before starting Glimepiride and on Day 4 of Glimepiride administration. The concomitant administration of Glimepiride did not alter the pharmacokinetics of R - and S-warfarin enantiomers. No changes were observed in warfarin plasma protein binding. Glimepiride resulted in a statistically significant decrease in the pharmacodynamic response to warfarin. The reductions in mean area under the prothrombin time (PT) curve and maximum PT values during Glimepiride treatment were 3.3% and 9.9%, respectively, and are unlikely to be clinically relevant.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. In mice, administration of Glimepiride for 24 months resulted in an increase in benign pancreatic adenoma formation that was dose-related and was thought to be the result of chronic pancreatic stimulation. No adenoma formation in mice was observed at a dose of 320 ppm in complete feed, or 46-54 mg/kg body weight/day. This is about 35 times the maximum human recommended dose of 8 mg once daily based on surface area. Glimepiride was non-mutagenic in a battery of in vitro and in vivo mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, and mouse micronucleus test).

There was no effect of Glimepiride on male mouse fertility in animals exposed up to 2500 mg/kg body weight (>1,700 times the maximum recommended human dose based on surface area). Glimepiride had no effect on the fertility of male and female rats administered up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area).

Clinical Studies

Monotherapy

A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Glimepiride monotherapy. Patients discontinued their sulfonylurea therapy then entered a 3-week placebo washout period followed by randomization into 1 of 4 treatment groups: placebo (n=74), Glimepiride 1 mg (n=78), Glimepiride 4 mg (n=76) and Glimepiride 8 mg (n=76). All patients randomized to

Glimepiride started 1 mg daily. Patients randomized to Glimepiride 4 mg or 8 mg had

blinded, forced titration of the Glimepiride dose at weekly intervals, first to 4 mg and then to

8 mg, as long as the dose was tolerated, until the randomized dose was reached. Patients randomized to the 4 mg dose reached the assigned dose at Week 2. Patients randomized to

the 8 mg dose reached the assigned dose at Week 3. Once the randomized dose level was reached, patients were to be maintained at that dose until Week 14. Approximately 66% of

the placebo-treated patients completed the trial compared to 81% of patients treated with Glimepiride 1 mg and 92% of patients treated with Glimepiride 4 mg or 8 mg. Compared to placebo, treatment with Glimepiride 1 mg, 4 mg and 8 mg daily provided statistically significant improvements in HbA 1C compared to placebo ( Table 3).

Table 3. 14-week Monotherapy Trial Comparing Glimepiride to Placebo in Patients Previously Treated With Sulfonylurea Therapy a

a Intent-to-treat population using last observation on study

A total of 249 patients who were treatment-naïve or who had received limited treatment with antidiabetic therapy in the past were randomized to receive 22 weeks of treatment with either Glimepiride (n=123) or placebo (n=126) in a multicenter, randomized, double-blind, placebo-controlled, dose-titration trial. The starting dose of Glimepiride was 1 mg daily and was titrated upward or downward at 2-week intervals to a goal FPG of 90-150 mg/dL. Blood glucose levels for both FPG and PPG were analyzed in the laboratory. Following 10 weeks of dose adjustment, patients were maintained at their optimal dose (1, 2, 3, 4, 6 or 8 mg) for the remaining 12 weeks of the trial. Treatment with Glimepiride provided statistically significant improvements in HbA 1C and FPG compared to placebo ( Table 4).

Table 4. 22-Week Monotherapy Trial Comparing Glimepiride to Placebo in Patients Who Were Treatment-Naïve or Who Had No Recent Treatment with Antidiabetic Therapy a

a Intent to treat population using last observation on study



Download Glimepiride - fda prescribing information, side effects and uses, co glimepiride

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MINIPRESS XL 5MG TABLET

This medication is an alpha-blocker, prescribed for benign prostatic hyperplasia (BPH). It works by relaxing the blood vessels.

How does Prazosin work:

Prazosin lowers blood pressure by calming the arteries and lowering the pressure in them. It calms muscles of the prostate, making signs better.

How should Prazosin be used:

It comes as a capsule to take by mouth, with or without food. The recommended initial dose is 1 mg, two or three times a day. It may be increased if needed.

Common side effects of Prazosin :

Feeling dizzy. Rise slowly over a few minutes when sitting or lying down. Be careful climbing. Feeling tired or weak. Headache. Upset stomach or throwing up. Many small meals, good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. Change in sex ability. This most often goes back to normal.

What do I do if I miss a dose

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

What precautions should I take when taking Prazosin :

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

When do I need to seek medical help

If you think there was an overdose, call your local poison control center or ER right away. Signs of a very bad reaction to the drug. These include wheezing; chest tightness; fever; itching; bad cough; blue or gray skin color; seizures; or swelling of face, lips, tongue, or throat. Very bad dizziness or passing out. Very bad headache. Any rash. Side effect or health problem is not better or you are feeling worse.

Can I take Prazosin with other medicines:

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

Are there any food restrictions

How do I store Prazosin :

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

Pregnancy Category

Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Therapeutic Classification

This medication is an alpha-blocker, prescribed for benign prostatic hyperplasia (BPH). It works by relaxing the blood vessels.

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Brief Info About Medicine

All Information published below is from public sources and cannot be used as expert's opinion. We request you to consult your doctor for more information

1 Why Is it Used ?

PRAZOSIN :

Adult: PO HTN Initial: 500 mcg 2-3 times/day for 3-7 days, increase to 1 mg 2-3 times/day for the next 3-7 days if tolerated. May further increase if needed. Max: 20 mg/day. Heart failure Initial: 500 mcg 2-4 times/day, increase gradually when needed. Maintenance: 4-20 mg/day. Benign prostatic hyperplasia; Raynaud's syndrome Initial: 500 mcg twice daily. Maintenance: =2 mg twice daily.

2 What are the Side Effects ?

PRAZOSIN :

Postural hypotension, syncope, palpitations, lack of energy, nausea, oedema, chest pain, dyspnoea, constipation, diarrhoea, vomiting, depression, nervousness, sleep disturbances, headache, lassitude, drowsiness, loss of consciousness, dizziness, vertigo, hallucinations, paraesthesia, nasal congestion, epistaxis, dry mouth, urinary frequency and incontinence, pruritus, rash. Potentially Fatal: Rarely, hypotension may be life-threatening.

3 What Precautions should be taken ?

PRAZOSIN :

Angina pectoris. Ability to drive or operate machinery may be impaired. Phaeochromocytoma, abrupt withdrawal, impaired renal and liver function. child st dose hypotension is increased in patients receiving ?-blockers or calcium-channel blockers.

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Buy Medicines Online. Cash on Delivery in more than 3100+ pincodes across India.

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MINIPRESS XL 7.5MG

Brief Info About Medicine

All Information published below is from public sources and cannot be used as expert's opinion. We request you to consult your doctor for more information

1 Why Is it Used ?

PRAZOSIN :

Adult: PO HTN Initial: 500 mcg 2-3 times/day for 3-7 days, increase to 1 mg 2-3 times/day for the next 3-7 days if tolerated. May further increase if needed. Max: 20 mg/day. Heart failure Initial: 500 mcg 2-4 times/day, increase gradually when needed. Maintenance: 4-20 mg/day. Benign prostatic hyperplasia; Raynaud's syndrome Initial: 500 mcg twice daily. Maintenance: =2 mg twice daily.

2 What are the Side Effects ?

PRAZOSIN :

Postural hypotension, syncope, palpitations, lack of energy, nausea, oedema, chest pain, dyspnoea, constipation, diarrhoea, vomiting, depression, nervousness, sleep disturbances, headache, lassitude, drowsiness, loss of consciousness, dizziness, vertigo, hallucinations, paraesthesia, nasal congestion, epistaxis, dry mouth, urinary frequency and incontinence, pruritus, rash. Potentially Fatal: Rarely, hypotension may be life-threatening.

3 What Precautions should be taken ?

PRAZOSIN :

Angina pectoris. Ability to drive or operate machinery may be impaired. Phaeochromocytoma, abrupt withdrawal, impaired renal and liver function. child st dose hypotension is increased in patients receiving ?-blockers or calcium-channel blockers.

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Vytorin is used for treating high cholesterol along with a cholesterol-lowering diet. Vytorin is a combination of 2 medicines. Ezetimibe works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or "statin." It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone.

Use Vytorin as directed by your doctor.

Take Vytorin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.

Taking Vytorin at the same time each day will help you remember to take it.

If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours after taking Vytorin. Check with your doctor if you have questions.

For best results, Vytorin should be used along with exercise, a low-cholesterol/low-fat diet, and a weight-loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.

Eating grapefruit or drinking grapefruit juice may increase the amount of Vytorin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Vytorin.

Most people with high cholesterol do not feel sick. Continue to take Vytorin even if you feel well. Do not miss any doses.

If you miss a dose of Vytorin, 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 Vytorin.

Store Vytorin 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 Vytorin out of the reach of children and away from pets.

Active Ingredients: Ezetimibe, Simvastatin.

Do NOT use Vytorin if:

you are allergic to any ingredient in Vytorin

you have liver problems or ongoing abnormal liver function test results

you are taking another medicine that contains simvastatin or ezetimibe

you are taking an HIV protease inhibitor (eg, nelfinavir, lopinavir, ritonavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, clarithromycin, erythromycin, troleandomycin), mibefradil, or nefazodone

you are pregnant or breast-feeding.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Vytorin. 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 are a woman of childbearing age

if you have kidney problems, muscle problems, or a family history of muscle problems; low blood pressure; uncontrolled seizures; or serious metabolic, endocrine, or electrolyte problems

if you are scheduled for major surgery, have recently had a major trauma, or have a severe infection or history of alcohol abuse

if you have had an organ transplant and are taking medicine to suppress a rejection reaction.

Some medicines may interact with Vytorin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amiodarone, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, itraconazole, ketoconazole), cyclosporine, danazol, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate), fluconazole, gemfibrozil, HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressives (eg, tacrolimus), mibefradil, nefazodone, niacin, nicotinic acid, streptogramins, telithromycin, verapamil, or voriconazole because side effects, such as muscle pain, may occur

Bosentan, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vytorin's effectiveness

Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Vytorin.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vytorin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Vytorin may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Vytorin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.

It may take several weeks for Vytorin to work.

Proper dental care is important while you are taking Vytorin. Brush and floss your teeth and visit the dentist regularly.

Vytorin may harm your liver. Your risk may be greater if you drink alcohol while you are using Vytorin. Talk to your doctor before you take Vytorin or other fever reducers if you drink more than 3 drinks with alcohol per day.

Vytorin may cause injury to your muscles, especially when taken at higher doses or when taken with certain other medicines. Contact your doctor right away if you experience muscle pain, tenderness, or weakness, especially with a fever.

Some patients taking Vytorin have reported poor memory or trouble sleeping. If you experience these effects, check with your doctor.

Lab tests, including blood cholesterol levels, liver function tests, or muscle tests, may be performed while you use Vytorin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Vytorin should be used with extreme caution in children younger 10 years; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: Do not use Vytorin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Vytorin is found in breast milk. Do not breastfeed while taking Vytorin.

All medicines may cause side effects, but many people have no, or minor, side effects.

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

Diarrhea; flu-like symptoms; headache; pain in the arms or legs; tiredness; upper respiratory tract infection.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; change in the amount of urine; chest pain; dark urine; depression; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; numbness, tingling, burning, or weakness in the arms, hands, feet, or legs; pale stools; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

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.

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Alesse - woman s health, unofem

Alesse is used to prevent ovulation as a contraception medication. The drug changes condition of cervical mucus and uterine lining and hampers movement of sperm cells to the uterus and attachment of a fertilized egg to the uterus.

Dosage and direction

Follow all recommendations of your health care advisor. Take the first on the first day of your menses or on the first Sunday after your period started. If you use Alesse for the firs time you may need additional birth control means. There are 28-day birth control packs with seven 'reminder' pills for the regular cycle. While you are using 'reminder' pills the period usually begins. Breakthrough bleeding is possible, if it becomes heavy and continues, inform your doctor. Take each pill each day about the same time. When your pill pack is over start a new one. In case of needed medical tests or surgery, it is possible that you may need to stop using Alesse for a short period of time.

Precautions Additional birth control methods (condoms or a spermicide) may be needed when you start to use Alesse. Intake of hormones may increase the risk of blood clotting, heart attack, stroke, especially in the patients over 35 y. o. or smokers. Inform your doctor if you have problems with heart, blood pressure, congestive heart failure, angina, high cholesterol, depression in history, seizures or epilepsy, diabetes, gallbladder disease, varicose veins, tuberculosis, uterine fibroid tumors, a history of fibrocystic breast disease, nodules, lumps.

Contraindications This medication cannot be used in pregnant women or those just after delivery, in patients with a stroke or blood clot in history, circulation problems, vaginal bleeding, hormone-related cancer, liver disease or liver cancer, circulation problems, abnormal vaginal bleeding, migraine headaches, a heart valve disorder, severe high blood pressure, jaundice caused by birth control pills in history.

Side effects Besides allergic symptoms (hives, skin rash, facial swelling, difficulty breathing) this medication may be a reason of sudden numbness or weakness, pain behind the eyes, problems with vision, headache, confusion, speech, or balance, a change in the pattern or severity of migraine headaches, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, swelling of the extremities, depression, loss of appetite, nausea, stomach pain, dark urine, jaundice.

There are drugs which can interact with Alesse. Inform your doctor about all prescribed and over-the counter medications, herbal products and food supplements you use and especially about theophylline (Respbid, Theo-Dur), acetaminophen (Tylenol) or ascorbic acid (vitamin C), prednisolone (Orapred), St. John's wort, seizure medications, cyclosporine (Gengraf, Neoral, Sandimmune), a barbiturate sedatives, HIV or AIDS medications, and antibiotics.

Missed dose If you missed a pill risk of becoming pregnant increases. If you forgot to take one 'active' pill, take two pills as soon as you remember then return to your schedule. If you miss two 'active' pills in a row in first or second week of treatment, take two pills a day for two days in a row. Then return to your schedule. Use birth control test during seven days if such a 'mistake' occurred. If you miss two 'active' pills in a row during third week, or if you miss three pills in a row during any of the first three weeks, you need to start a new pack of pills as if you are a First Day starter. If you did not take three 'active' pills in a row during any of the first three weeks, start a new pack on the same day as if you are a First Day starter. If you skipped intake of two or more pills, you may not have a monthlies during this month. If you miss a period for two months in a row you might be pregnant. If you miss any reminder pills, throw the missed pills away and return to your schedule.

Overdose The most expected overdose symptoms of this medication are vomiting, nausea, and vaginal bleeding.

Storage Store at room temperature between 20-25 C (68-77 F). Store away from moisture, heat, and sunlight. It is not recommended to store in a bathroom and places available for children.

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

Alesse is used to prevent ovulation as a contraception medication. The drug changes condition of cervical mucus and uterine lining and hampers movement of sperm cells to the uterus and attachment of a fertilized egg to the uterus.

Dosage and direction

Follow all recommendations of your health care advisor. Take the first on the first day of your menses or on the first Sunday after your period started. If you use Alesse for the firs time you may need additional birth control means. There are 28-day birth control packs with seven 'reminder' pills for the regular cycle. While you are using 'reminder' pills the period usually begins. Breakthrough bleeding is possible, if it becomes heavy and continues, inform your doctor. Take each pill each day about the same time. When your pill pack is over start a new one. In case of needed medical tests or surgery, it is possible that you may need to stop using Alesse for a short period of time.

Precautions Additional birth control methods (condoms or a spermicide) may be needed when you start to use Alesse. Intake of hormones may increase the risk of blood clotting, heart attack, stroke, especially in the patients over 35 y. o. or smokers. Inform your doctor if you have problems with heart, blood pressure, congestive heart failure, angina, high cholesterol, depression in history, seizures or epilepsy, diabetes, gallbladder disease, varicose veins, tuberculosis, uterine fibroid tumors, a history of fibrocystic breast disease, nodules, lumps.

Contraindications This medication cannot be used in pregnant women or those just after delivery, in patients with a stroke or blood clot in history, circulation problems, vaginal bleeding, hormone-related cancer, liver disease or liver cancer, circulation problems, abnormal vaginal bleeding, migraine headaches, a heart valve disorder, severe high blood pressure, jaundice caused by birth control pills in history.

Side effects Besides allergic symptoms (hives, skin rash, facial swelling, difficulty breathing) this medication may be a reason of sudden numbness or weakness, pain behind the eyes, problems with vision, headache, confusion, speech, or balance, a change in the pattern or severity of migraine headaches, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, swelling of the extremities, depression, loss of appetite, nausea, stomach pain, dark urine, jaundice.

There are drugs which can interact with Alesse. Inform your doctor about all prescribed and over-the counter medications, herbal products and food supplements you use and especially about theophylline (Respbid, Theo-Dur), acetaminophen (Tylenol) or ascorbic acid (vitamin C), prednisolone (Orapred), St. John's wort, seizure medications, cyclosporine (Gengraf, Neoral, Sandimmune), a barbiturate sedatives, HIV or AIDS medications, and antibiotics.

Missed dose If you missed a pill risk of becoming pregnant increases. If you forgot to take one 'active' pill, take two pills as soon as you remember then return to your schedule. If you miss two 'active' pills in a row in first or second week of treatment, take two pills a day for two days in a row. Then return to your schedule. Use birth control test during seven days if such a 'mistake' occurred. If you miss two 'active' pills in a row during third week, or if you miss three pills in a row during any of the first three weeks, you need to start a new pack of pills as if you are a First Day starter. If you did not take three 'active' pills in a row during any of the first three weeks, start a new pack on the same day as if you are a First Day starter. If you skipped intake of two or more pills, you may not have a monthlies during this month. If you miss a period for two months in a row you might be pregnant. If you miss any reminder pills, throw the missed pills away and return to your schedule.

Overdose The most expected overdose symptoms of this medication are vomiting, nausea, and vaginal bleeding.

Storage Store at room temperature between 20-25 C (68-77 F). Store away from moisture, heat, and sunlight. It is not recommended to store in a bathroom and places available for children.

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



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Interactions, usage, facts, and information on postadoxine, postadoxine

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Postadoxine

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Share your story! Tell us how MediGuard has helped you or someone you love. Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Taking multiple medications puts you at risk for possible drug-drug interactions Monitor the medical treatment of you and your loved ones.

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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Legend - definition of legend by the free dictionary, legend

legend

legend

legend

a myth or traditional story, handed down from one generation to another. the legend of St George. legende ????????? легенда lenda legenda die Sage legende; sagn ?????? leyenda legend ?????? legenda legende ???? ??? ???, ?????? ??????? ???????, ???? legenda legenda hikayat ?jo?saga leggenda ?? ??, ?? legenda legenda legenda legende legende. sagn legenda ?????????? lenda legenda легенда legenda legenda legenda legend, folksaga ????? efsane. destan ??,?? легенда ?????? ??? ?? ??? ?????? huy?n tho?i ??,??

1. mentioned etc in legend. legendary heroes. legendaries ????????? ?????? легендарен lendario legendarni Sagen-. legendarisk ???????? legendario legendaarne ?????? ?? legendaarinen legendaire ??????? ???????, ?????? legendaran mesebeli legendaris ?jo?sagna - leggendario ????? ???? legendinis legendars; teiksmains legenda legendarisch legendarisk. legende - legendarny ????????????? lendario legendar легендарный legendarny legendaren legendarni legendarisk ??????? efsanevi ???? легендарний ????? ??? ?? ?????? ?? ????? thu?c huy?n tho?i ????

2. very famous because very great, good etc . His generosity is legendary. legendaries ????????? ????? легендарен lendario legendarni sagenhaft legendarisk ????????. ?????????? legendario legendaarne ????? tarunomainen legendaire ???? ???????? cuven legendas termashur ?jo?sogulegur leggendario ???????? ??? placiai zinomas legendars terkenal legendarisch legendarisk legendarny ????? lendario legendar легендарный legendarny legendaren cuven legendarisk ????????? cok unlu, meshur ??? легендарний ??? ?????? n?i ti?ng ???

legend

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Upon the last lid's polished field-- Legend now both fair and true A gallant knight bears on his shield, "Amy" in letters gold and blue.

Nevertheless, that legend has stuck in my mind, and sunflower-bordered roads always seem to me the roads to freedom.

The whole of that wilderness, in which the latter incidents of the legend occurred, is nearly a wilderness still, though the red man has entirely deserted this part of the state.

As one method of throwing it off, I have put an incident of the Pyncheon family history, with which I happen to be acquainted, into the form of a legend. and mean to publish it in a magazine.

The vulgar, who, in those dreary old times, were always contributing a grotesque horror to what interested their imaginations, had a story about the scarlet letter which we might readily work up into a terrific legend .

But there was everything, for our apprehension, in the lucky fact that no discomfortable legend. no perturbation of scullions, had ever, within anyone's memory attached to the kind old place.

George might have been only a large seal, or sea-horse; bearing all this in mind, it will not appear altogether incompatible with the sacred legend and the ancientest draughts of the scene, to hold this so-called dragon no other than the great Leviathan himself.

His father, and his father's father before him, and as many ancestors back as legend could go, had lived in that part of Lithuania known as Brelovicz, the Imperial Forest.

Whoever visits some estates there, and witnesses the good-humored indulgence of some masters and mistresses, and the affectionate loyalty of some slaves, might be tempted to dream the oft-fabled poetic legend of a patriarchal institution, and all that; but over and above the scene there broods a portentous shadow--the shadow of law.

I floated down its historic stream in something more than imagination, under bridges built by the Romans, and repaired by later heroes, past cities and castles whose very names were music to my ears, and each of which was the subject of a legend .

There was no record or legend of any prisoner with those initials, and many fruitless guesses were made what the name could have been.

He went to India with his capital, and there, according to a wild legend in our family, he was once seen riding on an elephant, in company with a Baboon; but I think it must have been a Baboo - or a Begum.



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Entry-level dslr, nikron

Digital SLR Camera Bodies & Kits

A hobby that grows with your passion

Beautiful memories are all around just waiting to be captured. With a Nikon DSLR you have a fast, responsive camera that lets you capture all the details and action as they unfold. Say goodbye to missed shots or poor quality photos – capture and cherish all the moments with the image quality your photos deserve. As your passion grows, know that you can easily accessorize and customize your system with one of many accessories such as brilliant NIKKOR lenses and versatile Speedlights. With a system that is as easy-to-use, versatile and powerful as one of these Nikon DSLRs, you’ll find yourself taking it with you for all the moments that matter. Welcome to the world of photography.

Beautiful memories are all around just waiting to be captured. With a Nikon DSLR you have a fast, responsive camera that lets you capture all the details and action as they unfold. Say goodbye to missed shots or poor quality photos – capture and cherish all the moments with the image quality your photos deserve. As your passion grows, know that you can easily accessorize and customize your system with one of many accessories such as brilliant NIKKOR lenses and versatile Speedlights. With a system that is as easy-to-use, versatile and powerful as one of these Nikon DSLRs, you’ll find yourself taking it with you for all the moments that matter. Welcome to the world of photography.



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Amoxil 500 amoxil 500 pill - amoxil 500 mg, amoxil 500mg

AMOXIL 500 AMOXIL 500 (Amoxil 500 mg)

Pill imprint AMOXIL 500 AMOXIL 500 has been identified as Amoxil 500 mg .

Amoxil is used in the treatment of dental abscess; urinary tract infection; chlamydia infection; bacterial infection; skin or soft tissue infection (and more ), and belongs to the drug class aminopenicillins. There is no proven risk in humans during pregnancy. Amoxil 500 mg is not a controlled substance under the Controlled Substance Act (CSA).

Images for AMOXIL 500 AMOXIL 500

Amoxil Generic Name: amoxicillin Imprint: AMOXIL 500 AMOXIL 500 Strength: 500 mg Color: Blue & Pink Shape: Capsule-shape Availability: Prescription only

Drug Class: Aminopenicillins Pregnancy Category: B - No proven risk in humans CSA Schedule: Not a controlled drug Manufacturer: GlaxoSmithKline National Drug Code (NDC): 00029-6007

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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 2016 Drugs. com, National Library of Medicine, Truven Health Analytics and Cerner Multum, Inc. All Rights Reserved.

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Albezon vakantiekampen waarden in albezon, albezon

Het doel van ons verblijf is samen te leven als groep jongeren en begeleiders - sober, geweldloos, bewust. Dit trachten we te bereiken door ter plaatse waardevol te leven. We engageren ons om gedurende ons verblijf de volgende waarden samen te beleven.

Eerbied

voor elkaars mening, verleden, eigenheid

voor de streek en de plaatselijke gewoonten voor de permanenten voor de mensen in de omgeving

Respect voor de natuur

de waterbron zuiver houden milieuvriendelijke produkten gebruiken geen verspilling van hout, etensresten. zuiverheid bewaren door enkel te roken op de binnenkoer

Gezonde en eerlijke voeding

we eten vleesarm we doen onze aankopen ook bij wereldwinkel, natuurwinkel en de groentenboer in de buurt

Respect voor de 'stilte'

door het ontbreken van elk elektronisch geluid (dus geen radio ofwalkman meenemen) beleven we de stilte of het geluid van de natuur en elkaar

Leven in gemeenschap

delen van verantwoordelijkheden, zodat iedereen aan zijn trekken komt (dagonthaal, werken, maaltijden, avondactiviteit. ) delen van jouw mening met anderen

Oog hebben voor plezier en gezelligheid

speciale momenten in de bloemetjes zetten. wie is jarig. er is altijd wel een reden om te feesten

De dag onthalen en sluiten

de dag samen beginnen en afsluiten

Geweldloosheid

conflicten oplossen zonder anderen te kwetsen

Bewust en sober leven

stilstaan bij de belangrijkste zaken die ons omringen, genieten van het eenvoudige: in eten, spelen en levensomstandigheden, gelukkig zijn zonder overbodige luxe

Gastvrijheid

voor eenieder die langskomt, voor iedereen die op bezoek komt: een goeiedag, een kopje koffie, een glas zuiver bronwater, een babbeltje met de permanenten

Creativiteit, scheppende arbeid

geen bezigheidstherapie maar plezant, afwisselend werk. opbouwen van de boerderij voor de permanenten, voor jongeren in 'onthaal', voor vakantieverblijven. werken voor het eigen levensonderhoud: maaltijden, afwassen, groepsbevorderend werk, verwarming. (via het werk kunnen goede contacten worden gelegd) we ontdekken het creatieve, het scheppende, solidaire van arbeid, plezier om met de handen te werken

Democratisch leven

we bepalen dagelijks in samenspraak met de hele groep het programma van de dag wie wil eens een activiteit voorbereiden? we streven naar gezamenlijke oplossingen bij meningsverschillen

Albezon Vakantiekampen kan je bereiken via [email protected] be 0491/15 23 78 Het rekeningnummer van de vakantiekampen is: BE67 8906 3432 7487 Albezon Vakantiekampen is een vrijwilligersorganisatie die onderdeel is van vzw aPart

Het adres van de site in Zuid-Frankrijk is: Albezon Route de Pied de Borne 48 800 Villefort Frankrijk

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Bell duovox cassotto accordion, duovox

BELL Tone Chamber Accordion with built-in microphones and electronic organ sounds

Bell accordions have been among the most respected instruments for decades. There are many reasons for this well deserved high reputation. Originally, Aldo Mencaccini made Bell accordions in New York. When the manufacturing was moved to Italy he has collaborated with some of the best companies like Scandalli, Sonola, and recently Borsini. This particular accordion has been serviced at the Accordion Gallery and is ready for decades of trouble free performance. It features a double tone chamber made of a solid mahogany, professional quality reeds with genuine leather reed valves, and excellent mechanics throughout. The fine acoustic instrument is complemented by factory installed crystalline microphones and Duovox solid-state electronics. The Duovox Tone Generator is included. It has been tested and works fine. It will have to be shipped separately.

The accordion can be played as an acoustic accordion without any of the electronics. You can play it amplified using a standard 1/4" jack audio cable and any amplifier with the corresponding 1/4" input. There are separate volume controls for treble and bass conveniently installed on the grill. Finally, if you like the orchestral sounds you can connect the accordion to the included tone generator and enjoy a solid powerful bass sound as well as various synthesized electronic sounds for the keyboard side.

Made in Italy

Professional quality hand-finished reeds

3 sets of treble reeds - LM 1 M 2

Double Tone Chamber (Cassotto) - LM 1

Musette tuning

4 sets of bass reeds

41 keys, 19.25" long professional walnut keyboard with excellent response and action

3 rocker-action treble switches allow access to 7 reed combinations: Bassoon (L), Bandoneon (LM 1 ), Violin (M 1 M 2 ), Master (LM 1 M 2 ). Clarinet (M 1 ), Flute (M 2 ), Sax (LM 1 ). and Closed (used to play only the electronic sounds). The switches highlighted in blue correspond to musette (tremolo) sounds. The other switches are dry/concert tuned.

120 bass

4 bass registers including acoustic mute for playing only electronic bass

Excellent compression

Bellows protector

Very good straps and case

25-26 lb

Factory installed crystalline microphones with 1/4" pick-up and separate Treble and Bass volume controls

Original Duovox electronics package

Tone Generator with leather cover

User friendly grill controller with access to different electronic sounds and effects

Power chord and data cable permanently attached to the Tone Generator and stored in a special compartment inside the generator (see the pictures below)

The accordion is ready to play. It can be used as a fine acoustic instrument without any electronics. If you like to use the electronics sounds all you need is an amplifier/speaker.

Call us at 973-770-6877 with any questions, for a phone demo, or to schedule your visit to the Accordion Gallery where you can try the accordion yourself.

The accordion has mahogany body and a single piece mahogany tone chamber. I have removed the chambered reed blocks to show better the interior. The wax and the reed leathers throughout are in excellent condition.

The electric contacts in the bass machine are designed in a clever way and don't interfere with the smooth mechanical operation.

It is very easy to connect the accordion to the tone generator as shown in he picture below. All you need is an amplifier and you are ready to enjoy the full orchestral capabilities of the instrument.

The built-in microphones can be accessed from a 1/4" pick-up mounted at the bottom of the grill. The microphones can be used without the organ part by connecting the accordion directly to an amplified. When using the tone generator the microphones can be connected to the input section of the front panel.

The front panel of the Tone Generator (see the picture above) consists of 3 sections (left to right): 1) Inputs 1 and 2 (for example for the accordion microphones and a vocal microphone) with tone and volume controls 2) Volume pedal input and a switch to control the operation: fixed volume, volume pedal active, and separate volumes 3) Output section - high level, low level, and bass

Compartment for storing the cables (above) and with the cover closed (below)



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