Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
Rising Health, LLC
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM 10 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 Warnings and Precautions (5.3) ]. - Hypersensitivity to a
Pravastatin sodium tablets, USP are supplied as: Pravastatin Sodium Tablets USP, 10 mg are yellow, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with ‘Y’ on one side and ‘37’ on the other side. Bottles of 90 NDC 57237-164-90 Bottles of 500 NDC 57237-164-05 Bottles of 1,000 NDC 57237-164-99 Pravastatin Sodium Tablets USP, 20 mg are white to off-white, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with ‘T’ on one side and ‘36’ on the other side. Bottles of 90 NDC 57237-165-90 Bottles of 500 NDC 57237-165-05 Bottles of 1,000 NDC 57237-165-99 Pravastatin Sodium Tablets USP, 40 mg are yellow, rectangular shaped with rounded edges, biconvex, uncoated tablets debossed with ‘Y’ on one side and ‘39’ on the other side. Bottles of 90 NDC 57237-166-90 Bottles of 500 NDC 57237-166-05 Bottles of 1,000 NDC 57237-166-99 Pravastatin Sodium Tablets USP, 80 mg are yellow, oval shaped biconvex, uncoated tablets, debossed with ‘Y’ on one side and ‘38’ on the other side. Bottles of 90 NDC 57237-167-90 Bottles of 500 NDC 57237-167-05 Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
Abbreviated New Drug Application
PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET RISING HEALTH, 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 LDLC-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 recommended dosage is 2 Đọc toàn bộ tài liệu