PRAVACHOL PRAVASTATIN SODIUM

Get an overview of PRAVACHOL (pravastatin sodium tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in PRAVACHOL can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as PRAVACHOL.

Drug Basics

Brand Name: PRAVACHOL

Generic Name: PRAVASTATIN SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Packager: E.R. Squibb & Sons, L.L.C.

Data Current As Of: 2021-02-11

Warnings and Precautions:

Immuned-Mediated Necrotizing Myopathy (5.2)                                                                    08/2020

Indications & 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.

PRAVACHOL 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:

PRAVACHOL has not been studied in Fredrickson Types I and V dyslipidemias. (1.3)

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:
    • 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.

limitations of use

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

Patient Counseling Information

Muscle Pain

Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing PRAVACHOL [see Warnings and Precautions (5.1) ].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of PRAVACHOL, and thereafter when clinically indicated. All patients treated with PRAVACHOL should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.3) ].

Embryofetal Toxicity

Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.3), Use in Specific Populations (8.1, 8.3) ].

Lactation

Advise women not to breastfeed during treatment with PRAVACHOL [see Contraindications (4.4), Use in Specific Populations (8.2) ].


Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA

Product of Japan

Revised August 2020

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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