REPAGLINIDE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)

Disponibbli minn:

Breckenridge Pharmaceutical, Inc.

INN (Isem Internazzjonali):

REPAGLINIDE

Kompożizzjoni:

REPAGLINIDE 0.5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Repaglinide Tablets, USP (repaglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide Tablets, USP (repaglinide) should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide Tablets is contraindicated in patients with: - Concomitant use of gemfibrozil [see Drug Interactions (7.1)] - Known hypersensitivity to repaglinide or any inactive ingredients Risk Summary Limited available data from case reports and case series with Repaglinide Tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ). Teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily

Sommarju tal-prodott:

Repaglinide Tablets, USP (repaglinide) are supplied as round tablets and colored to indicate strength, available in 0.5 mg (white), 1 mg (light yellow) and 2 mg (light red) strengths. Tablets are engraved with "B853" for 0.5 mg, "B854" for 1 mg, and "B855" for 2 mg tablets on the face of the tablet and blank on the back of the tablet. Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with child resistant closure.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

REPAGLINIDE- REPAGLINIDE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REPAGLINIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REPAGLINIDE TABLETS.
REPAGLINIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Repaglinide Tablets is a glinide indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type
2 diabetes mellitus (1)
Limitation of Use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
(1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg, 1 mg, 2 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
• Hypoglycemia: Repaglinide Tablets may cause hypoglycemia. Skip the
scheduled dose of Repaglinide Tablets if a meal is
skipped to reduce the risk of hypoglycemia. Reduce the dose of
Repaglinide Tablets if hypoglycemia occurs. (5.1)
• Serious Cardiovascular Adverse Reactions with Concomitant
NPH-insulin: Repaglinide Tablets is not indicated for use in
combination with NPH-insulin. (5.2)
• Macrovascular outcomes: There have been no clinical studies
establishing conclusive evidence of macrovascular risk
reduction with Repaglinide Tablets. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (5% or greater incidence) among
patients treated with Repaglinide Tablets were:
hypoglycemia, upper respiratory infection, headache, sinusitis,
arthralgia, nausea, diarrhea, and back pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRECKENRIDGE
PHARMACEUTICAL, INC. AT 1-800-367-3395
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Clopidogrel: Avoid concomitant use; if used concomitantly initiate at
0.5 mg before each meal and limit total daily dose
to 4 mg (7)
Cyclosporine: Limit daily dose of Repaglinide Tablets to 6 mg and
increase frequency of glucose monitoring when co-
administered (7)
CYP2C8 and CYP3A4 Inhibitors and Drugs