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Glimepiride (Amaryl)

Trade Name : AMARYL

Sanofi-Aventis U.S. LLC

TABLET

Strength 1 mg/1

GLIMEPIRIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glimepiride (Amaryl) which is also known as AMARYL and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 1 mg/1 per ml. Read more

Glimepiride (Amaryl) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus .
  • Limitations of Use
  • AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
  • AMARYL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ().
  • Limitations of Use
  • Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ().
  • AMARYL should be administered with breakfast or the first main meal of the day.
  • The recommended starting dose of AMARYL 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 n
  • 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 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia .
  • The maximum recommended dose is 8 mg once daily.
  • Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 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, AMARYL should be administered at least 4 hours prior to colesevelam.
  • Recommended starting dose is 1 or 2 mg once daily. Increase in 1 or 2 mg increments no more frequently than every 1u20132 weeks based on glycemic response. Maximum recommended dose is 8 mg once daily. ()
  • Administer with breakfast or first meal of the day. ()
  • Use 1 mg starting dose and titrate slowly in patients at increased risk for hypoglycemia (e.g., elderly, patients with renal impairment). ()
  • AMARYL is formulated as tablets of:
  • Tablets (scored): 1 mg, 2 mg, 4 mg ()
  • AMARYL is contraindicated in patients with a history of a hypersensitivity reaction to:
  • Hypersensitivity to glimepiride or any of the product's ingredients ()
  • Hypersensitivity to sulfonamide derivatives ()
  • No data
  • Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications ().
  • Hypersensitivity Reactions: Postmarketing reports include anaphylaxis, angioedema and Stevens-Johnson Syndrome. If a reaction is suspected, promptly discontinue AMARYL, assess for other potential causes for the reaction, and institute alternative treatment for diabetes. ()
  • Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. ()
  • Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives. ()
  • Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with AMARYL or any other anti-diabetic drug ().
  • The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
  • Common adverse reactions in clinical trials (u22655% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness ().
  • No data
  • Certain medications may affect glucose metabolism, requiring AMARYL dose adjustment and close monitoring of blood glucose. ()
  • Miconazole: Severe hypoglycemia can occur when AMARYL and oral miconazole are used concomitantly. ()
  • Cytochrome P450 2C9 interactions: Inhibitors and inducers of cytochrome P450 2C9 may affect glycemic control by altering glimepiride plasma concentrations. ()
  • Colesevelam: Coadministration may reduce glimepiride absorption. AMARYL should be administered at least 4 hours prior to colesevelam. (, )
  • No data
  • Pediatric Patients: Not recommended because of adverse effects on body weight and hypoglycemia. ()
  • Geriatric or Renally Impaired Patients: At risk for hypoglycemia with AMARYL. Use caution in dose selection and titration, and monitor closely. (, )
  • An overdosage of AMARYL, 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 .
  • AMARYL 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 (CHNOS) 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:
  • AMARYL tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose (hydrous), sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, AMARYL 1 mg tablets contain Ferric Oxide Red, AMARYL 2 mg tablets contain Ferric Oxide Yellow and FD&C Blue #2 Aluminum Lake, and AMARYL 4 mg tablets contain FD&C Blue #2 Aluminum Lake.
  • No data
  • 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 46u201354 mg/kg body weight/day. This is at least 28 times the maximum human recommended dose of 8 mg once daily based on surface area.
  • Glimepiride was non-mutagenic in a battery of and 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 (>1,500 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).
  • 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 AMARYL 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), AMARYL 1 mg (n=78), AMARYL 4 mg (n=76), and AMARYL 8 mg (n=76). All patients randomized to AMARYL started 1 mg daily. Patients randomized to AMARYL 4 mg or 8 mg had blinded, forced titration of the AMARYL 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 AMARYL 1 mg, 4 mg, and 8 mg daily provided statistically significant improvements in HbA1c compared to placebo (Table 3).
  • A total of 249 patients who were treatment-naive or who had received limited treatment with antidiabetic therapy in the past were randomized to receive 22 weeks of treatment with either AMARYL (n=123) or placebo (n=126) in a multicenter, randomized, double-blind, placebo-controlled, dose-titration trial. The starting dose of AMARYL was 1 mg daily and was titrated upward or downward at 2-week intervals to a goal FPG of 90u2013150 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 AMARYL provided statistically significant improvements in HbA1c and FPG compared to placebo (Table 4).
  • AMARYL tablets are available in the following strengths and package sizes:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 20u00b0Cu201325u00b0C (68u00b0Fu201377u00b0F) (see USP Controlled Room Temperature).
  • Dispense in well-closed containers with safety closures.
  • No data
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • Revised December 2018
  • u00a9 2018 sanofi-aventis U.S. LLC
  • NDC 0039-0221-10
  • Amaryln glimepiride tablets
  • 1mg
  • ONCE A DAY
  • 100 Tablets
  • SANOFI
  • NDC 0039-0222-10
  • Amaryln glimepiride tablets
  • 2mg
  • ONCE A DAY
  • 100 Tablets
  • SANOFI
  • NDC 0039-0223-10
  • Amaryln glimepiride tablets
  • 4mg
  • ONCE A DAY
  • 100 Tablets
  • SANOFI

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