REPAGLINIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

REPAGLINIDE

Composition:

REPAGLINIDE 0.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

REPAGLINIDE- REPAGLINIDE TABLET
MYLAN INSTITUTIONAL 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
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 mg 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 mL/min 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 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 o