Pravastatin indications and usage

Pravastatin
PRAVACHOL ® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Pravastatin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications and Usage

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.

Prevention of Cardiovascular Disease

In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), PRAVACHOL (pravastatin sodium) 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, PRAVACHOL 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.

Hyperlipidemia

PRAVACHOL 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:

1.LDL-C remains ≥190 mg/dL or 2.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.

Limitations of Use

PRAVACHOL has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).