GLIMEPIRIDE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Lake Erie Medical DBA Quality Care Products LLC

INN (Alþjóðlegt nafn):

GLIMEPIRIDE

Samsetning:

GLIMEPIRIDE 4 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

GLIMEPIRIDE- GLIMEPIRIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 (1.1).
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 TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; 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 synd