GLIMEPIRIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Solco Healthcare U.S., LLC

INN (Internationale Bezeichnung):

GLIMEPIRIDE

Zusammensetzung:

GLIMEPIRIDE 1 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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) ]. Limitations of Use 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 is 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. Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride 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 plac

Produktbesonderheiten:

Glimepiride tablets USP 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 child-resistant closures.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GLIMEPIRIDE- GLIMEPIRIDE TABLET
SOLCO HEALTHCARE U.S., LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIMEPIRIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIMEPIRIDE TABLETS
USP.
GLIMEPIRIDE TABLETS USP, 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).
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 SOLCO HEALTHCARE US,
LLC AT 1-866-257-2597 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 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. If a reaction is suspected, promptly discontinue
glimepiride, as