GLIMEPIRIDE - glimepiride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Citron Pharma LLC

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)]. 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. 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

Product summary:

Glimepiride tablets, USP are available in the following strengths and package sizes: Glimepiride Tablets USP, 1 mg are pink colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “X” and “76” on either side of the bisect on one face and plain on the other face.                      Bottles of 100                       NDC 57237-151-01                      Bottles of 500                       NDC 57237-151-05 Glimepiride Tablets USP, 2 mg are light green to green colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “32” on either side of the bisect on one face and plain on the other face.                        Bottles of 100                       NDC 57237-152-01                        Bottles of 500                       NDC 57237-152-05                       Glimepiride Tablets USP, 4 mg are light blue to blue colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “34” on either side of the bisect on one face and plain on the other face.                       Bottles of 100                        NDC 57237-153-01                        Bottles of 500                        NDC 57237-153-05                Store at 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
CITRON PHARMA LLC
----------
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 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 mg or 2 mg once daily. Increase in 1 mg
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, and 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).
Macr