Pregnancy Risk Category X
How supplied
Tablets: 10 mg, 20 mg, 40 mg
Action
Inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase, which is an early (and rate-limiting) step in the synthetic pathway of cholesterol.
Indications & dosage
Adjunct to diet to reduce low-density lipoprotein, total cholesterol, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb); primary prevention of coronary events in hypercholesterolemic patients without clinical evidence of heart disease--
Adults: initially, 10 or 20 mg P.O. h.s. Dosage adjusted q 4 weeks based on patient tolerance and response; maximum daily dose is 40 mg.
Elderly: initially, 10 mg P.O. h.s. Most patients respond to daily dose of 20 mg or less.
Reduction of risk of acute coronary events or slowing progression of coronary atherosclerosis in hypercholesterolemic patients with clinical evidence of coronary artery disease, including prior MI; reduction of risk of undergoing myocardial revascularization procedure; reduction of risk of recurrent MI, stroke, or transient ischemic attacks in post-MI patients with normal cholesterol levels--
Adults: initially, 10 or 20 mg P.O. h.s. Dosage adjusted q 4 weeks based on patient tolerance and response; maximum daily dose is 40 mg.
Elderly: initially, 10 mg P.O. h.s. Most patients respond to daily dose of 20 mg or less.
Adjust-a-dose: Patients taking immunosuppressants should be initiated at 10 mg P.O. daily. Maximum dose is 20 mg P.O. daily.
Adverse reactions
CNS: headache, dizziness, fatigue.
CV: chest pain.
EENT: rhinitis.
GI: vomiting, diarrhea, heartburn, abdominal pain, constipation, flatulence, nausea.
GU: renal failure secondary to myoglobinuria, urinary abnormality.
Hepatic: increased serum ALT, AST, CK, alkaline phosphatase, and bilirubin levels.
Metabolic: abnormal thyroid function tests.
Musculoskeletal: myositis, myopathy, localized muscle pain, myalgia.
Respiratory: cough, influenza, common cold.
Skin: rash.
Other: flulike symptoms, rhabdomyolysis.
Interactions
Drug-drug. Cholestyramine, colestipol: concomitant administration decreases plasma levels of pravastatin. Administer pravastatin 1 hour before or 4 hours after these drugs.
Drugs that decrease levels or activity of endogenous steroids (such as cimetidine, ketoconazole, spironolactone): may increase risk of developing endocrine dysfunction. No intervention appears needed; take complete drug history in patients who develop endocrine dysfunction.
Erythromycin, fibric acid derivatives (such as clofibrate, gemfibrozil), immunosuppressants (such as cyclosporine), high doses (1 g or more daily) of niacin (nicotinic acid): may increase the risk of rhabdomyolysis. Monitor patient closely if concomitant use cannot be avoided.
Gemfibrozil: decreases protein-binding and urinary clearance of pravastatin. Avoid concomitant use.
Hepatotoxic drugs: increased risk of hepatotoxicity. Avoid concomitant use.
Drug-lifestyle. Alcohol use: increased risk of hepatotoxicity. Avoid concomitant use.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug and in those with active liver disease or conditions that cause unexplained, persistent elevations of serum transaminase levels; also contraindicated in pregnant and breast-feeding women and in women of childbearing age unless there is no risk of pregnancy.
Nursing considerations
Patient teaching
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING