AMARYL- glimepiride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sanofi-Aventis U.S. LLC

INN (International Name):

glimepiride

Composition:

glimepiride 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMARYL is 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 AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. AMARYL 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 AMARYL. Do not use AMARYL 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 AMARYL use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (in

Product summary:

AMARYL tablets are available in the following strengths and package sizes: Store at 25°C (77°F); excursions permitted to 20°C–25°C (68°F–77°F) (see USP Controlled Room Temperature). Dispense in well-closed containers with safety closures.

Authorization status:

New Drug Application

Summary of Product characteristics

AMARYL- GLIMEPIRIDE TABLET
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMARYL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMARYL.
AMARYL (GLIMEPIRIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
AMARYL is 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 1–2 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
AMARYL, 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)
Macrovascular Outcomes: No clinical studies establ