Label: GLIMEPIRIDE tablet

  • 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 INFORMATION
    These highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets ...
  • Table of Contents
    Table of Contents
  • 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Glimepiride 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 ...
  • 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 WARNINGS AND PRECAUTIONS
    5.1 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 ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 10 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 ...
  • 11 DESCRIPTION
    Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as ...
  • 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    14.1 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Glimepiride 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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Hypoglycemia - 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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