PRAVACHOL SUMMARY
PRAVACHOL®
(pravastatin sodium) Tablets
PRAVACHOL® (pravastatin sodium) is one of a new class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
Therapy with PRAVACHOL (pravastatin sodium) should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.
PRIMARY PREVENTION OF CORONARY EVENTS
In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVACHOL is indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of undergoing myocardial revascularization procedures
- Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS
In patients with clinically evident coronary heart disease, PRAVACHOL is indicated to:
- Reduce the risk of total mortality by reducing coronary death
- Reduce the risk of myocardial infarction
- 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.
HYPERLIPIDEMIA
PRAVACHOL (pravastatin sodium) is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). 8
PRAVACHOL is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV).
PRAVACHOL is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
PRAVACHOL is indicated as an adjunct to diet and life-style modification for treatment of HeFH in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present.
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LDL-C remains >/=190 mg/dL or
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LDL-C remains >/=160 mg/dL and;
- there is a positive family history of premature cardiovascular disease or
- two or more other CVD risk factors are present in the patient.
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate.
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