GLIMEPIRIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

GLIMEPIRIDE

Composition:

GLIMEPIRIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 1.1 Important Limitations of Use 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 tablet is 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. 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 P

Product summary:

Glimepiride tablets, USP are available in the following strengths and package sizes: 1 mg tablets (pink coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 1’ on one side and break line on the other) in bottles of 100 (NDC 16729-001-01), 500 (NDC 16729-001-16) and 1,000 (NDC 16729-001-17) 2 mg tablets (green coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 2’ on one side and break line on the other) in bottles of 100 (NDC 16729-002-01), 500 (NDC 16729-002-16) and 1,000 (NDC 16729-002-17) 4 mg tablets (blue coloured, oval shaped, biconvex, uncoated tablets debossed with ‘AHI 4’ on one side and break line on the other) in bottles of 100 (NDC 16729-003-01), 500 (NDC 16729-003-16) and 1,000 (NDC 16729-003-17) Store at 25°C (77°F); excursions permitted to 20 to 25°C (68 to 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
REDPHARM DRUG, INC.
----------
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 USP 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 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. 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).
Ma