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:

Blenheim Pharmacal, Inc.

INN (nume internaţional):

PRAVASTATIN SODIUM

Compoziție:

PRAVASTATIN SODIUM 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets USP are indicated to: - reduce the risk of myocardial infarction (MI). - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. Pravastatin sodium tablets USP are indicated: - as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein chol

Rezumat produs:

Pravastatin sodium tablets USP are supplied as: 10 mg tablets: Yellow colored, circular shaped tablets having flat surface, with “G5” debossed on one surface and “10” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-195-90) and bottles of 500 (NDC 68462-195-05). Bottles contain a desiccant canister. 20 mg tablets: Yellow rounded-rectangular tablets having biconvex surface, with “G5” debossed on one surface and “20” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-196-90) and bottles of 500 (NDC 68462-196-05). Bottles contain a desiccant canister. 40 mg tablets: Green rounded-rectangular tablets having biconvex surface, with “G5” debossed on one surface and “40” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-197-90) and bottles of 500 (NDC 68462-197-05). Bottles contain a desiccant canister. 80 mg tablets: Yellow oval tablets having biconvex surface, with “G5” debossed on one surface and “80” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-198-90) and bottles of 500 (NDC 68462-198-05). Bottles contain a desiccant canister. Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
BLENHEIM PHARMACAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRAVASTATIN SODIUM
TABLETS.
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: 10 mg, 20 mg, 40 mg, 80 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