Country: United States
Language: English
Source: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
Hisun Pharmaceuiticals USA, Inc
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. In patients with clinically evident CHD, pravastatin sodium tablets USP 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
Pravastatin Sodium Tablets USP are supplied as: 20 mg tablets : Mottled light yellow colored, rounded, rectangular-shaped, biconvex tablets, engraved with “HU” on one side and “20” on the other side and are supplied in bottles of 90 and 1000. Bottle of 90 NDC 42658-105-04 Bottle of 1000 NDC 42658-105-08 40 mg tablets : Mottled light yellow colored, rounded, rectangular-shaped, biconvex tablets, engraved with “HU” on one side and “40” on the other side and are supplied in bottles of 90 and 1000. Bottle of 90 NDC 42658-106-04 Bottle of 1000 NDC 42658-106-08 80 mg tablets : Mottled light yellow colored, oval-shaped, biconvex tablets, engraved with “HU” on one side and “80” on the other side and are supplied in bottles of 90 and 1000 Bottle of 90 NDC 42658-107-04 Bottle of 1000 NDC 42658-107-08 Store at 20° to 25°C (68° to 77°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.
Abbreviated New Drug Application
PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET HISUN PHARMACEUITICALS USA, INC ---------- 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 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 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 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 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 Read the complete document