GLIMEPIRIDE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)

可用日期:

Teva Pharmaceuticals USA, Inc.

INN（国际名称）:

GLIMEPIRIDE

组成:

GLIMEPIRIDE 1 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 Use 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. 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 associated risks for major birth defects

產品總結:

Glimepiride Tablets USP are available as: 1 mg - mottled pink, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “54” on the other. Available in bottles of 100 (NDC 0093-7254-01). 2 mg - mottled green, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “55” on the other. Available in bottles of 100 (NDC 0093-7255-01). 4 mg - mottled light blue, round tablet, bisected on both sides. One side of the tablet is debossed with “9” on one side of score and “3” on the other. The other side of the tablet is debossed with “72” on one side of score and “56” on the other. Available in bottles of 100 (NDC 0093-7256-01) and 250 (NDC 0093-7256-52). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

授权状态:

Abbreviated New Drug Application

产品特点

GLIMEPIRIDE- GLIMEPIRIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
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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, 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)
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis.
(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)
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.
If a reaction is suspected, promptly discontinue glimepiride, assess
for other potential causes for the reaction, and
institute 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)