REPAGLINIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

REPAGLINIDE

Composition:

REPAGLINIDE 0.5 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)] - Known hypersensitivity to repaglinide or any inactive ingredients Risk Summary Limited available data from case reports and case series with repaglinide 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 surfac

Product summary:

Repaglinide Tablets USP, 0.5 mg are white to off white, round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘10’ on other side.         Bottles of 100               NDC 65862-670-01         Bottles of 500               NDC 65862-670-05         Bottles of 1,000            NDC 65862-670-99 Repaglinide Tablets USP, 1 mg are yellow colored, round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘11’ on other side.         Bottles of 100               NDC 65862-671-01         Bottles of 500               NDC 65862-671-05         Bottles of 1,000            NDC 65862-671-99 Repaglinide Tablets USP, 2 mg are peach colored, mottled round, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘12’ on other side.         Bottles of 100               NDC 65862-672-01         Bottles of 500               NDC 65862-672-05         Bottles of 1,000            NDC 65862-672-99 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
AUROBINDO PHARMA LIMITED
----------
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
The recommended starting dose is 0.5 mg orally before each meal if
HbA1c is less than 8%; and 1 or 2
mg orally before each meal if HbA1c 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 to 40 mL/min),
recommended starting dose is 0.5
mg orally before each meal. (2.2)
Dose modifications are required when used concominantly with some
medications. (2.3, 7)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg, 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 may cause hypoglycemia. Skip the scheduled
dose of repaglinide if a meal
is skipped to reduce the risk of hypoglycemia. Reduce the dose of
repaglinide if hypoglycemia occurs.
(5.1)
Serious Cardiovascular Adverse Reactions with Conco