Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
NCS HealthCare of KY, LLC dba Vangard Labs
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM 20 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: - 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
Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: Yellow colored, circular shaped, flat faced tablets, with “G5” debossed on one side and “10” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8158-39). 20 mg tablets: Yellow rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8029-39) and in blistercards of 15 (NDC 0615-8029-05). 40 mg tablets: Green rounded-rectangular, biconvex tablets with “G5” debossed on one sideand “40” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8030-39) and in blistercards of 15 (NDC 0615-8030-05). 80 mg tablets: Yellow oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. Store at 20o C to 25o C (68o F to 77o 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 NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS ---------- 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 Warnings and Precautions Immune-Mediated Necrotizing Myopathy (5.2) 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 patient 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 is 40 mg once daily. (2.4) DOSAGE FORMS AND STRENGTHS Tablets: 10 m Прочетете целия документ