Pregnancy Risk Category X
How supplied
Tablets: 5 mg, 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 for reduction of low-density lipoprotein (LDL) and total cholesterol levels in patients with primary hypercholesterolemia (types IIa and IIb) and mixed dyslipidemia and in patients with coronary heart disease and hypercholesterolemia to reduce the risk of coronary death, nonfatal MI, stroke, transient ischemic attack, and undergoing myocardial revascularization procedures--
Adults: initially, 20 mg P.O. daily in the evening. Dosage adjusted q 4 weeks based on patient tolerance and response; maximum daily dose is 80 mg.
Elderly: initially, 5 mg P.O. daily in the evening. Maximum daily dose is 20 mg.
Reduction of total cholesterol and LDL in patients with homozygous familial hypercholesterolemia--
Adults: 40 mg daily in the evening or 80 mg daily given in three divided doses of 20 mg, 20 mg, and 40 mg in the evening.
Adverse reactions
CNS: headache, asthenia.
GI: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea, vomiting.
Hepatic: elevated liver enzyme levels.
Respiratory: upper respiratory tract infection.
Interactions
Drug-drug. Antifungals, clarithromycin, erythromycin, fibric acid derivatives (such as clofibrate, gemfibrozil), immunosuppressants (such as cyclosporine), nefazodone, high doses (1 g or more daily) of niacin (nicotinic acid): may increase risk of rhabdomyolysis. Monitor patient closely if concomitant use cannot be avoided. Limit daily dose of simvastatin to 10 mg if the patient must take cyclosporine.
Digoxin: simvastatin may slightly elevate digoxin levels. Closely monitor plasma digoxin levels at initiation of simvastatin therapy.
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.
Hepatotoxic drugs: increased risk of hepatotoxicity. Avoid concomitant use.
Warfarin: anticoagulant effect may be slightly enhanced. Monitor INR at start of therapy and during dosage adjustments.
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