REPAGLINIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Golden State Medical Supply, Inc.

INN (Internationale Bezeichnung):

REPAGLINIDE

Zusammensetzung:

REPAGLINIDE 0.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Repaglinide Tablets, USP (repaglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide Tablets, USP (repaglinide) should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide Tablets 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 Repaglinide Tablets 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

Produktbesonderheiten:

Repaglinide Tablets, USP (repaglinide) are supplied as round tablets and colored to indicate strength, available in 0.5 mg (white), 1 mg (light yellow) and 2 mg (light red) strengths. Tablets are engraved with "B853" for 0.5 mg, "B854" for 1 mg, and "B855" for 2 mg tablets on the face of the tablet and blank on the back of the tablet. Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with child resistant closure.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

REPAGLINIDE- REPAGLINIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
REPAGLINIDE TABLETS.
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 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 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 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 of
Repaglinide Tablets if hypoglycemia occu