REPAGLINIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

REPAGLINIDE

Composition:

REPAGLINIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide tablets are contraindicated in patients with: 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 clinical dose, based on body surface area. No adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactatio

Product summary:

Repaglinide tablets, USP, 1 mg are available in the following form: Yellow, round, biconvex tablets, debossed with “745” on one side and ‘C’ on the other side. Bottles of 100                         NDC 57664-745-88 Bottles of 500                         NDC 57664-745-13 Bottles of 1000                       NDC 57664-745-18 Repaglinide tablets, USP, 2 mg are available in the following form: Pink, round, biconvex tablets, debossed with “747” on one side and ‘C’ on the other side. Bottles of 100                         NDC 57664-747-88 Bottles of 500                         NDC 57664-747-13 Bottles of 1000                       NDC 57664-747-18 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with safety closures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

REPAGLINIDE- REPAGLINIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, 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 are 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: 1 mg, 2 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-406-
7984 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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The recommended starting dose is 0.5 mg orally before each meal if HbA
is less than 8%; and 1 or 2 mg orally
before each meal if HbA is 8% or greater. (2.1)
1c
1c
The recommended dose range is 0.5 mg to 4 mg before meals, with a
maximum daily dose of 16 mg. (2.1)
The patient’s dose should be doubled up to 4 mg with each meal until
satisfactory glycemic control is achieved. At
least one week should elapse to assess response after each dose
adjustment. (2.1)
Instruct patients to skip the dose of repaglinide tablets if a meal is
skipped. In patients who experience hypoglycemia,
the dose of repaglinide tablets should be reduced. (2.1; 5.1)
Instruct patients to take repaglinide tablets within 30 minutes before
meals. (2.1)
In patients with severe renal impairment (CrCl = 20 – 40 mL/min),
recommended starting dose is 0.5 m