Label: GLIMEPIRIDE tablet
- NDC Code(s): 67046-1114-3
- Packager: Coupler LLC
- This is a repackaged label.
- Source NDC Code(s): 68001-585
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 13, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEGlimepiride 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSGlimepiride is formulated as tablets of: 1 mg (Light pink colored, flat capsule shaped uncoated tablets having breakline on both faces and GM and 1 on engraved on either side of breakline on one ...
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4 CONTRAINDICATIONSGlimepiride 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 ...
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONSThe 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 ...
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7 DRUG INTERACTIONS7.1 Drugs Affecting Glucose Metabolism - A number of medications affect glucose metabolism and may require glimepiride dose adjustment and particularly close monitoring for hypoglycemia or ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEAn 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 ...
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11 DESCRIPTIONGlimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIES14.1 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGGlimepiride Tablets USP are available in the following strengths and package sizes: 1 mg (Light pink colored, flat capsule shaped uncoated tablets having break line on both faces and GM and ...
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17 PATIENT COUNSELING INFORMATIONHypoglycemia - Explain the symptoms and treatment of hypoglycemia as well as conditions that predispose to hypoglycemia. Inform patients that their ability to concentrate and react may be impaired ...
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