GLIMEPIRIDE- glimepiride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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: Available data from a small number of published studies and postmarketing experience with glimepiride tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glimepiride tablets should be discontinued at least two weeks before expected delivery (see Clinical Considerations). Poorly controlled diabetes in pregnancy is also

Product summary:

Glimepiride Tablets, USP are available containing 1 mg, 2 mg or 4 mg of glimepiride, USP. The 1 mg tablets are white to off-white, oval, scored tablets debossed with G to the left of the score and 11 to the right of the score on one side of the tablet and MYLAN on the other side. They are available as follows: NDC 0378-4011-01 bottles of 100 tablets The 2 mg tablets are light yellow, oval, scored tablets debossed with G to the left of the score and 12 to the right of the score on one side of the tablet and MYLAN on the other side. They are available as follows: NDC 0378-4012-01 bottles of 100 tablets The 4 mg tablets are peach, oval, scored tablets debossed with G to the left of the score and 13 to the right of the score on one side of the tablet and MYLAN on the other side. They are available as follows: NDC 0378-4013-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIMEPIRIDE- GLIMEPIRIDE TABLET
MYLAN PHARMACEUTICALS INC.
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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:
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DOSAGE AND ADMINISTRATION
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•
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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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•
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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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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).
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)
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. If a reaction is suspected, promptly discontinue glimepiride
tablets,