REPAGLINIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

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: - Concomitant use of gemfibrozil [see Drug Interactions (7.1)] - Known hypersensitivity to repaglinide or any inactive ingredients Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It is unknown whether repaglinide tablets can cause fetal harm when administered to a pregnant woman. Repaglinide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Repaglinide was not teratogenic in rats or rabbits at doses 40 times (rats) and approximately 0.8 times (rabbit) clinical exposure (on a mg/m 2 basis) throughout pregnancy. Offspring of rat dams expos

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. Unit dose packages of 30 (5 x 6) NDC 68084-954-25 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. Unit dose packages of 30 (5 x 6) NDC 68084-967-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

REPAGLINIDE- REPAGLINIDE TABLET
AMERICAN HEALTH PACKAGING
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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
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
2/2017
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
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)
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 mg orally before
each meal. (2.2)
Dose modifications are required when used concomitantly with some
medications. (2.3, 7)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg (3)
CONTRAINDICATIONS
Concomitant use with gemfibrozil (4)
Known hypersensitivity to repaglinide or any inactive ingredients (4)
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 hypog