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Freebase Commons Common /common

  • Pravastatin sodium (Teva Pharmaceuticals USA), manufactured drug form of Pravastatin sodium, 80mg/tablet pravastatin sodium tablet, NDC 0093-7270

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • 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 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 have not been studied in Fredrickson Types I and V dyslipidemias. (1.3)
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  • 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 10 mg once daily. (2.2) Children (ages 8 to 13 years, inclusive): the recommended starting dose is 20 mg once daily. (2.3) Adolescents (ages 14 to 18 years): the recommended starting dose is 40 mg once daily. (2.3)
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  • Tablets: 80 mg. (3)
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  • Hypersensitivity to any component of this medication. (4.1, 6.2, 11) Active liver disease or unexplained, persistent elevations of serum transaminases. (4.2, 5.2) Women who are pregnant or may become pregnant. (4.3, 8.1) Nursing mothers. (4.4, 8.3)
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  • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to report promptly any symptoms of myopathy. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected. (5.1) Liver enzyme abnormalities and monitoring: persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment. (5.2)
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  • In short-term clinical trials, the most commonly reported adverse reactions (≥ 2% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or drug.safety@tevausa.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Fibrates: use with fibrate products may increase the risk of adverse skeletal muscle effects. (2.4, 5.1) Cyclosporine: combination increases exposure. Limit pravastatin to 20 mg once daily. (2.5, 7.1) Clarithromycin: combination increases exposure. Limit pravastatin to 40 mg once daily. (2.6, 7.2)
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  • 34089-3

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