REPAGLINIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Sandoz Inc

DCI (Denominação Comum Internacional):

REPAGLINIDE

Composição:

REPAGLINIDE 0.5 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

REPAGLINIDE- REPAGLINIDE TABLET
SANDOZ 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
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 were:
hypoglycemia, upper respiratory infection, headache, sinusitis,
arthralgia, nausea, diarrhea, and back pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Repaglinide 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:
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 if a meal is
skipped. In patients who experience hypoglycemia, the
dose of repaglinide should be reduced. (2.1; 5.1)
Instruct patients to take repaglinide 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