国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)
Unit Dose Services
GLIMEPIRIDE
GLIMEPIRIDE 4 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
GLIMEPIRIDE- GLIMEPIRIDE TABLET UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLIMEPIRIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIMEPIRIDE. GLIMEPIRIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1.1). Important Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.1). 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). DOSAGE FORMS AND STRENGTHS Tablets (scored): 1 mg, 2 mg, 4 mg (3) (3) CONTRAINDICATIONS Hypersensitivity to glimepiride or any of the product’s ingredients (4) Hypersensitivity to sulfonamide derivatives (4) 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. Promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate 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 (5.4). Macrovascular Outc 完全なドキュメントを読む