Overview
11 DESCRIPTION Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP 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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 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. 12.2 Pharmacodynamics In healthy subjects, the time to reach maximal effect (minimum blood glucose concentrations) was approximately 2 to 3 hours after single oral doses of glimepiride tablets. The effects of glimepiride on HbA 1c , fasting plasma glucose, and postprandial glucose have been assessed in clinical trials [see Clinical Studies (14) ]. 12.
Indications
- 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 tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ).
Common Doses
- 2 mg
- 8 mg
- 1 mg
Dosage
2 DOSAGE AND ADMINISTRATION Recommended starting dose is 1 or 2 mg once daily. Increase in 1 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.
Contraindications
- 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. Do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives. Hypersensitivity to glimepiride or any of the product’s ingredients ( 4 ) Hypersensitivity to sulfonamide derivatives ( 4 )
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) ] In clinical trials, the most common adverse reactions with glimepiride were hypoglycemia, dizziness, asthenia, headache, and nausea. 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 Dr. Reddy’s Laboratories, Inc.
Interactions
- 7 DRUG INTERACTIONS Certain medications may affect glucose metabolism, requiring glimepiride tablets 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.