PRAVASTATIN SODIUM tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

International Laboratories, LLC

INN (Kansainvälinen yleisnimi):

PRAVASTATIN SODIUM

Koostumus:

PRAVASTATIN SODIUM 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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. In patients with clinically evident CHD, pravastatin sodium tablets are indicated to: - reduce the risk of total mortality by reducing coronary death. - reduce the risk of MI. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk

Tuoteyhteenveto:

Pravastatin sodium tablets USP  are supplied as: 10 mg tablets:  Pink, unscored, round tablet, debossed “TEVA” on one side and “771” on the other side in adherence packages of 30 tablets (NDC 54458-927-12); bottles of 30 tablets (NDC 54458-927-16). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
INTERNATIONAL LABORATORIES, LLC
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Patients with Renal Impairment (2.3) 7/2016
Contraindications
Pregnancy (4.3), Lactation (4.4)
7/2016
INDICATIONS AND USAGE
Pravastatin sodium tablets 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 the risk of total mortality by reducing coronary death, MI,
revascularization, stroke/TIA, and the progression of
coronary atherosclerosis in patients with 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 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
pravastatin 10 mg once daily. (2.3)
• Children (ages 8 to 13 years, inclusive): the recommended starting
dose is 20 mg once daily. (2.4)
• Adolescents (ages 14 to 18 years): the recommended starting dose