מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)
Preferred Pharmaceuticals Inc.
GLIMEPIRIDE
GLIMEPIRIDE 4 mg
ORAL
PRESCRIPTION DRUG
Glimepiride tablets USP 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) ]. Glimepiride tablets USP 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 contraindicated in patients with a history of a hypersensitivity reaction to: 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. Reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ]. Pregnancy Category C There are no adequate and well-controlled studies of
GLIMEPIRIDE Tablets USP are available in the following strengths and package sizes: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Dispense in well-closed containers with safety closures.
Abbreviated New Drug Application
GLIMEPIRIDE- GLIMEPIRIDE TABLET PREFERRED PHARMACEUTICALS INC. ---------- 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 USP INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Glimepiride is 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: • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Tablets (scored): 1 mg, 2 mg, 4 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS 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 BIONPHARMA INC., AT 1-888-235-BION OR 1-888-235- 2466 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.1). 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). Hypersensitivity to glimepiride or any of the product’s ingredients (4) Hypersensitivity to sulfonamide derivatives (4) 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 קרא את המסמך השלם