מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)
Citron Pharma LLC
GLIMEPIRIDE
GLIMEPIRIDE 1 mg
ORAL
PRESCRIPTION DRUG
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)]. 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 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 tablets. Do not use glimepiride tablets 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
Glimepiride tablets, USP are available in the following strengths and package sizes: Glimepiride Tablets USP, 1 mg are pink colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “X” and “76” on either side of the bisect on one face and plain on the other face. Bottles of 100 NDC 57237-151-01 Bottles of 500 NDC 57237-151-05 Glimepiride Tablets USP, 2 mg are light green to green colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “32” on either side of the bisect on one face and plain on the other face. Bottles of 100 NDC 57237-152-01 Bottles of 500 NDC 57237-152-05 Glimepiride Tablets USP, 4 mg are light blue to blue colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “34” on either side of the bisect on one face and plain on the other face. Bottles of 100 NDC 57237-153-01 Bottles of 500 NDC 57237-153-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.
Abbreviated New Drug Application
GLIMEPIRIDE - GLIMEPIRIDE TABLET CITRON PHARMA LLC ---------- 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 FOR ORAL USE 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: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.1). DOSAGE AND ADMINISTRATION Recommended starting dose is 1 mg or 2 mg once daily. Increase in 1 mg 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, and 4 mg (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). Macr קרא את המסמך השלם