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)
NCS HealthCare of KY, Inc dba Vangard Labs
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 aulfonamide 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 R
Glimepiride tablets, USP are available in the following strengths and package sizes: Glimepiride tablets USP, 1 mg are peach, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “320” separating “3” and “20” with bisect line scoring on the other side and are supplied in Blistercards of 30 NDC 0615-7523-39 Glimepiride tablets USP, 2 mg are green, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “321” separating “3” and “21” with bisect line scoring on the other side and are supplied in Blistercards of 30 NDC 0615-6576-39 Glimepiride tablets USP, 4 mg are blue, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “322” separating “3” and “22” with bisect line scoring on the other side and are supplied in Blistercards of 30 NDC 0615-6575-39 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 NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLIMEPIRIDE INFORMATION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIMEPIRIDE. GLIMEPIRIDE TABLETS USP INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glyemic control in adults with type 2 diabetes mellitus (1.1). (1) Important Limitations of Use: (1) • Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.2). (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). (2) • Administer with breakfast or first meal of the day (2.1). (2) • Use 1 mg starting dose and titrate slowly in patients at increased risk for hypoglycemia (e.g., elderly patients with renal impairment) (2.1). (2) 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) (4) • Hypersensitivity to sulfonamide derivatives (4) (4) WARNINGS AND PRECAUTIONS • Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g.,elderly, renally inpaired) and when used with other anti-diabetic medications (5.1). (5) • Hypersensitivity Reactions: Postmarketing reports inlude 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). (5) • Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative (5.3). (5) • Potential Increased Risk of Cardiovascular Mortality wit 完全なドキュメントを読む