INDICATIONS & USAGE SECTION

Highlight: 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)

1 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.

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).

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CONTRAINDICATIONS SECTION

Highlight: * Hypersensitivity to any component of this medication. ( 4.1, 6.2, 11)

• Active liver disease or unexplained, persistent elevations of serum transaminases. ( 4.2, 5.3)
• Pregnancy ( 4.3, 8.1, 8.3)
• Lactation ( 4.4, 8.2)

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Hypersensitivity to any component of this medication.

4.2 Liver

Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions ( 5.3) ].

4.3 Pregnancy

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. PRAVASTATIN SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations ( 8.1, 8.3) ].

4.4 Lactation

Pravastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require pravastatin sodium treatment should not breastfeed their infants [ see Use in Specific Populations ( 8.2) ].

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INFORMATION FOR PATIENTS SECTION

17 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 pravastatin sodium [see Warnings and Precautions ( 5.1) ].

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium, and thereafter when clinically indicated. All patients treated with pravastatin sodium 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 pravastatin sodium [see Contraindications ( 4.4), Use in Specific Populations ( 8.2) ] .

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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 43063-443-30 in bottles of 30 tablets

NDC 43063-443-90 in bottles of 90 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.

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