PRAVASTATIN SODIUM tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

Disponibil de la:

McKesson Contract Packaging

INN (nume internaţional):

PRAVASTATIN SODIUM

Compoziție:

PRAVASTATIN SODIUM 40 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRAVASTATIN SODIUM
TABLETS USP.
PRAVASTATIN SODIUM TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin Sodium Tablets USP are an HMG-CoA reductase inhibitor
(statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of MI, revascularization, and cardiovascular mortality
in hypercholesterolemic patients without clinically
evident CHD. (1.1)
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase
HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. (1.2)
Reduce elevated serum TG levels in patients with hypertriglyceridemia.
(1.2)
Treat patients with primary dysbetalipoproteinemia who are not
responding to diet. (1.2)
Treat children and adolescent patients ages 8 years and older with
heterozygous familial hypercholesterolemia after
failing an adequate trial of diet therapy. (1.2)
Limitations of use:
Pravastatin Sodium Tablets USP have not been studied in _Fredrickson_
Types I and V dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
Adults: the recommended starting dose is 40 mg once daily. Use 80 mg
dose only for patients not reaching LDL-C goal
with 40 mg. (2.2)
Significant renal impairment: the recommended starting dose is 10 mg
once daily. (2.2)
Children (ages 8 to 13 years, inclusive): the recommended starting
dose is 20 mg once daily. (2.3)
Adolescents (ages 14 to 18 years): the recommended starting dose is 40
mg once daily. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg and 40 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4.1, 6.2, 11)
Active liver disease or unexplained, persistent elevations of serum
transaminases. (4.2, 5.2)
Women who are pregnant or may become pregnant. (4.3, 8.1)
Nursing mothers. (4.4, 8.3)
WARNINGS