Pravastatin

Pravastatin sodium tablets are indicated: • To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). • To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient is chemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. • As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.

Pravastatin is a reversible inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.

• Take orally once daily at any time of the day, with or without food. • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary. • Adults: recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. • Pediatric Patients: o aged 8 to 13 years, the recommended dosage is 20 mg once daily. o aged 14 to 18 years, the recommended starting dosage is 40 mg once daily. • Severe renal impairment: recommended starting dosage is pravastatin sodium 10 mg once daily. Recommended maximum pravastatin sodium tablets dosage is 40 mg once daily.

• Acute liver failure or decompensated cirrhosis. • Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets. • Hypersensitivity to pravastatin or any excipient in pravastatin sodium tablets. • Acute liver failure or decompensated cirrhosis

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher pravastatin dosage. Discontinue pravastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pravastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing pravastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. • Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue pravastatin if IMNM is suspected.

The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis • Immune-Mediated Necrotizing Myopathy • Hepatic Dysfunction • Increases in HbA1c and Fasting Serum Glucose Levels In short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.

• See full prescribing information for details regarding concomitant use of pravastatin sodium tablets with other drugs that increase the risk of myopathy and rhabdomyolysis. • Bile Acid Sequestrants: in patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or at least 4 hours after the bile acid sequestrant

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep tightly closed (protect from moisture). Protect from light. Protect from light.