PRAVASTATIN SODIUM- pravastatin sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Pravastatin sodium tablets USP are supplied as:  10 mg tablets: White to off-white, capsule-shaped tablet with “PV10 ” on one side and “>” on the other side. They are supplied as follow: NDC 16252-526-90-Bottles of 90  20 mg tablets: White to off-white, capsule-shaped tablet with “PV20 ” on one side and “>” on the other side. They are supplied as follow: NDC 16252-527-90-Bottles of 90 NDC 16252-527-50-Bottles of 500 NDC 16252-527-10-Bottles of 1000  40 mg tablets: White to off-white, capsule-shaped tablet with “>” on one side and “PV40 ” on the other side. They are supplied as follow: NDC 16252-528-90-Bottles of 90 NDC 16252-528-50-Bottles of 500  80 mg tablets: White to off-white, capsule-shaped tablet with “>” on one side and “PV80 ” on the other. They are supplied as follow: NDC 16252-529-90-Bottles of 90 NDC 16252-529-35-Bottles of 350 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
BRYANT RANCH PREPACK
----------
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
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin sodium tablets USP are HMG-CoA reductase inhibitors
(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, 8.3)
WARNINGS AND PRECAUTIONS
Ske