(c) 2024 PillSync.com

Pravastatin Sodium 80 MG Oral Tablet

1 INDICATIONS AND USAGE Pravastatin sodium tablet, USP is 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 tablet, USP has not been studied in Fredrickson Types I and V dyslipidemias. ( 1.3 ) 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. 1.1 Prevention of Cardiovascular Disease In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablet, USP is 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 tablet is 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 of stroke and stroke/transient ischemic attack (TIA). slow the progression of coronary atherosclerosis. 1.2 Hyperlipidemia Pravastatin sodium tablet is indicated: as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia ( Fredrickson Types IIa and IIb). 1 as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV). for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet. as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present: a. LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the patient. 1.3 Limitations of Use Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Zydus Pharmaceuticals (USA) Inc.


4 years ago OVAL WHITE ZC43 Pravastatin Sodium 80 MG Oral Tablet

OVAL WHITE ZC43

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

PRAVASTATIN SODIUM Tablets USP, 10 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC46' on one side and plain on the other side and are supplied as follows: NDC 68382-070-16 in bottles of 90 tablets NDC 68382-070-05 in bottles of 500 tablets

PRAVASTATIN SODIUM Tablets USP, 20 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC45' on one side and plain on the other side and are supplied as follows: NDC 68382-071-16 in bottles of 90 tablets NDC 68382-071-05 in bottles of 500 tablets NDC 68382-071-10 in bottles of 1000 tablets

PRAVASTATIN SODIUM Tablets USP, 40 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC44' on one side and plain on the other side and are supplied as follows: NDC 68382-072-16 in bottles of 90 tablets NDC 68382-072-05 in bottles of 500 tablets

PRAVASTATIN SODIUM Tablets USP, 80 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC43' on one side and plain on the other side and are supplied as follows: NDC 68382-073-16 in bottles of 90 tablets NDC 68382-073-05 in bottles of 500 tablets 16.2 Storage Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.


More pills like OVAL ZC43

Related Pills

Pravastatin Sodium 10 MG Oral Tablet

Zydus Pharmaceuticals (USA) Inc.

Pravastatin Sodium 20 MG Oral Tablet

Zydus Pharmaceuticals (USA) Inc.

Pravastatin Sodium 40 MG Oral Tablet

Zydus Pharmaceuticals (USA) Inc.












DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site