PRANDIN- repaglinide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novo Nordisk

INN (International Name):

REPAGLINIDE

Composition:

REPAGLINIDE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. PRANDIN 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 PRANDIN 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 lactation at approximately 4 times the maximum daily clinical

Product summary:

PRANDIN (repaglinide) tablets are supplied as biconvex tablets available in 0.5 mg (white), 1 mg (yellow) and 2 mg (peach) strengths. 0.5 mg tablets (white) Bottles of 100 NDC 00169-0081-81 Bottles of 500 NDC 00169-0081-82 1 mg tablets (yellow) Bottles of 100 NDC 00169-0082-81 Bottles of 500 NDC 00169-0082-82 2 mg tablets (peach) Bottles of 100 NDC 00169-0084-81 Bottles of 500 NDC 00169-0084-82 All strengths of Prandin are not being marketed. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly close. Dispense in tight containers with safety closures.

Authorization status:

New Drug Application

Summary of Product characteristics

PRANDIN- REPAGLINIDE TABLET
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRANDIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRANDIN.
PRANDIN (REPAGLINIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
PRANDIN 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
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 PRANDIN if a meal is skipped. In
patients who experience hypoglycemia, the dose
of PRANDIN should be reduced. ( 2.1; 5.1)
Instruct patients to take PRANDIN 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 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: PRANDIN may cause hypoglycemia. Skip the scheduled dose
of PRANDIN if a meal is skipped to
reduce the risk of hypoglycemia.
Reduce the dose of PRANDIN if hypoglycemia occurs. ( 5.1)
Serious Cardiovascular Adverse Reactions with Concomitant NPH-insulin:
PRANDIN is not indicated for use in
combination with NPH-ins