Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
Sandoz Inc
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM 10 mg
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 are indicated to: Pravastatin sodium tablets are indicated: Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). Hypersensitivity to any component of this medication. Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.2) ] . Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy shoul
Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: light brown, mottled, round tablets, debossed with HLP 10 on one side and plain on the other side. 20 mg tablets: light brown, mottled, round tablets, debossed with HLP 20 on one side and plain on the other side. 40 mg tablets: light brown, mottled, round tablets, debossed with HLP 40 on one side and plain on the other side. 80 mg tablets: light brown, mottled, oval, debossed with HLP 80 on one side, unscored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET SANDOZ INC REFERENCE LABEL SET ID: D47B7E25-1DD3-41DC-886D-98F6EFC0C0BA ---------- 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 INDICATIONS AND USAGE Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • • • • • • Limitations of use: • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • Patients with Renal Impairment (2.3) 7/2016 Contraindications Pregnancy (4.3), Lactation (4.4) 7/2016 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) Pravastatin sodium tablets have not been studied in _Fredrickson_ Types I and V dyslipidemias. (1.3) 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) Childre Citiți documentul complet