País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Llegiu el document complet