Pravastatin Sodium

Pravastatin sodium tablets is 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 ischemic 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 sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): · 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 ischemic 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.

· Acute liver failure or decompensated cirrhosis [ see Warnings and Precautions (5.3) ]. · Hypersensitivity to any pravastatin or any excipients in Pravastatin sodium tablets. · Hypersensitivity to pravastatin or any excipient in Pravastatin sodium tablets ( 4 ) · Acute liver failure or decompensated cirrhosis ( 4 , 5.3 )

· Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Pravastatin sodium tablets dosage. Discontinue Pravastatin sodium tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Pravastatin sodium tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.