देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
Northwind Pharmaceuticals, LLC
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM 40 mg
ORAL
PRESCRIPTION DRUG
Pravastatin sodium tablets are indicated: - To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). - To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. - As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. - As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). - As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. - Primary dysbetalipoproteinemia. - Hypertriglyceridemia. - Acute liver failure or decompensated cirrhosis [see Warning
Pravastatin sodium tablets, USP are supplied as: 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side in bottles of 30 (NDC 51655-073-52). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET NORTHWIND PHARMACEUTICALS, LLC ---------- 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 Contraindications, Pregnancy and Lactation Removed ( 4) 05/2022 Warnings and Precautions, Immune-Mediated Necrotizing Myopathy Updated ( 5.2) 05/2022 INDICATIONS AND USAGE Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated ( 1): To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. DOSAGE AND ADMINISTRATION Take orally once daily at any time of the day, with or without food ( 2.1). For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment ( 2.1). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary ( 2.1). Adults: recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. ( 2.2) Pediatric Patients ( 2.3): aged 8 to 13 years, the rec पूरा दस्तावेज़ पढ़ें