GLIMEPIRIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

GLIMEPIRIDE

Composition:

GLIMEPIRIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Do not use glimepiride 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, miscarria

Product summary:

Glimepiride tablets USP, are available in the following strengths and package sizes:   Glimepiride tablets USP, 1 mg are peach, oval, flat beveled edged, uncoated tablets debossed “RDY” on one side and “320” separating “3” and “20” with bisect line scoring on the other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-320-30 Bottles of 100                                     NDC 55111-320-01 Bottles of 500                                     NDC 55111-320-05 Unit dose package of 100 (10 x 10)   NDC 55111-320-78  Glimepiride tablets USP, 2 mg are green, oval, flat beveled edged, uncoated tablets debossed “RDY” on one side and “321” separating “3” and “21” with bisect line scoring on the other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-321-30 Bottles of 100                                     NDC 55111-321-01 Bottles of 500                                     NDC 55111-321-05 Unit dose package of 100 (10 x 10)   NDC 55111-321-78  Glimepiride tablets USP, 4 mg are blue, oval, flat beveled edged, uncoated tablets debossed “RDY” on one side and “322” separating “3” and “22” with bisect line scoring on the other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-322-30 Bottles of 100                                     NDC 55111-322-01 Bottles of 500                                     NDC 55111-322-05 Unit dose package of 100 (10 x 10)   NDC 55111-322-78  Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIMEPIRIDE- GLIMEPIRIDE TABLET
DR. REDDY'S LABORATORIES LIMITED
----------
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) (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