Glimepiride
Generic Name: glimepiride
Brand Names:
Glimepiride
11 DESCRIPTION Glimepiride tablets, USP are 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 USP is a white or almost white powder and is practically insoluble in water.
Overview
11 DESCRIPTION Glimepiride tablets, USP are 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 USP is a white or almost white powder and is practically insoluble in water.
Uses
1 INDICATIONS AND USAGE Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)] . Limitations of Use Glimepiride tablets 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 is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) . Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Recommended starting dose is 1 mg or 2 mg once daily. Increase in 1 mg or 2 mg increments no more frequently than every 1 to 2 weeks based on glycemic response. Maximum recommended dose is 8 mg once daily. (2.1) Administer with breakfast or first meal of the day. (2.1) Use 1 mg starting dose and titrate slowly in patients at increased risk for hypoglycemia (e.g., elderly, patients with renal impairment). (2.1) 2.1 Recommended Dosing Glimepiride tablets should be administered with breakfast or the first main meal of the day. The recommended starting dose of glimepiride tablets is 1 mg or 2 mg once daily.
Side Effects
6 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) ] Common adverse reactions in clinical trials (≥5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1(844) 874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Certain medications may affect glucose metabolism, requiring glimepiride dose adjustment and close monitoring of blood glucose. (7.1) Miconazole: Severe hypoglycemia can occur when glimepiride and oral miconazole are used concomitantly. (7.2) Cytochrome P450 2C9 interactions: Inhibitors and inducers of cytochrome P450 2C9 may affect glycemic control by altering glimepiride plasma concentrations. (7.3) Colesevelam: Coadministration may reduce glimepiride absorption. Glimepiride should be administered at least 4 hours prior to colesevelam. (2.1, 7.4) 7.1 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.
Warnings
5 WARNINGS AND PRECAUTIONS 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. (5.1) Hypersensitivity Reactions: Postmarketing reports include anaphylaxis, angioedema and Stevens-Johnson syndrome. If a reaction is suspected, promptly discontinue glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes. (5.2) Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. (5.3) Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives. 4 CONTRAINDICATIONS Glimepiride tablets are 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 tablets.
Pregnancy
8.1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glimepiride should be discontinued at least two weeks before expected delivery (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Glimepiride tablets, USP are available in the following strengths and package sizes: Glimepiride Tablets USP, 2 mg are light green to green colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “32” on either side of the bisect on one face and plain on the other face.
Frequently Asked Questions
What is Glimepiride used for?▼
1 INDICATIONS AND USAGE Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)] . Limitations of Use Glimepiride tablets 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 is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) . Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
What are the side effects of Glimepiride?▼
6 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) ] Common adverse reactions in clinical trials (≥5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1(844) 874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Glimepiride during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glimepiride should be discontinued at least two weeks before expected delivery (see Clinical Considerations) .
What are the important warnings for Glimepiride?▼
5 WARNINGS AND PRECAUTIONS 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. (5.1) Hypersensitivity Reactions: Postmarketing reports include anaphylaxis, angioedema and Stevens-Johnson syndrome. If a reaction is suspected, promptly discontinue glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes. (5.2) Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. (5.3) Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives. 4 CONTRAINDICATIONS Glimepiride tablets are 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 tablets.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.