GLIMEPIRIDE- glimepiride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

GLIMEPIRIDE

Composition:

GLIMEPIRIDE 4 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) ]. 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 Tablets are contraindicated in patients with a history of a hypersensitivity reaction to: 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 Precautions (5.2) and Adverse Reactions (6.2) ]. Pregnancy Category C There are no adequate and well-controlled studies of

Product summary:

GLIMEPIRIDE Tablets USP are available in the following strengths and package sizes: 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
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIMEPIRIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GLIMEPIRIDE.
GLIMEPIRIDE TABLETS USP
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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets (scored): 1 mg, 2 mg, 4 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Common adverse reactions in clinical trials (≥5% and more common
than with placebo) include hypoglycemia, headache,
nausea, and dizziness (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIONPHARMA INC., AT
1-888-235-BION OR 1-888-235-
2466 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(1.1).
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).
Hypersensitivity to glimepiride or any of the product’s ingredients
(4)
Hypersensitivity to sulfonamide derivatives (4)
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