REPAGLINIDE- repaglinide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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: 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/m2 basis) throughout pregnancy. Offspring of rat dams exposed to repaglinide at 15 times clinical exposure on a mg/m2 basis during days 17 to 22 of gestation and during lactation developed nonteratogenic skeletal deformities consisting of shor

Product summary:

Repaglinide Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of repaglinide, USP. The 0.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and R21 on the other side. They are available as follows: NDC 0378-3121-01 bottles of 100 tablets NDC 0378-3121-05 bottles of 500 tablets The 1 mg tablets are light blue, round, unscored tablets debossed with M on one side of the tablet and R22 on the other side. They are available as follows: NDC 0378-3122-01 bottles of 100 tablets The 2 mg tablets are light green, round, unscored tablets debossed with M on one side of the tablet and R23 on the other side. They are available as follows: NDC 0378-3123-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

REPAGLINIDE- REPAGLINIDE TABLET
MYLAN PHARMACEUTICALS 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
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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: 0.5 mg, 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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Dosage and Administration (2.3) 2/2017
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)
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 impa