Simvastatin

A to Z Drug Facts

 Actions Increases rate at which body removes cholesterol from blood and reduces production of cholesterol by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis.

 Indications Adjunct to diet for reducing elevated total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia (types IIa and IIb) when response to diet and other nonpharmacologic measures alone are inadequate; to reduce the risk of stroke or transient ischemic attack.

Lower elevated cholesterol levels in patients with heterozygous familial hypercholesterolemia, familial combined hyperlipidemia, diabetic dyslipidemia in noninsulin-dependent diabetic patients, hyperlipidemia secondary to nephrotic syndrome, and homozygous familial hypercholesterolemia in patients who have defective, rather than absent, LDL receptors.

 Contraindications Active liver disease or unexplained persistent elevations of liver function values; pregnancy; lactation.

 Route/Dosage

ADULTS: PO 5 to 40 mg/day in evening.

 Interactions

Azole antifungal agents (eg, ketoconazole), cyclosporine, macrolide antibiotics (eg, erythromycin), gemfibrozil, grapefruit juice, niacin, verapamil: Severe myopathy or rhabdomyolysis may occur.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; asthenia; paresthesia; peripheral neuropathy. EENT: Dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis); progression of cataracts. GI: Nausea; vomiting; diarrhea; abdominal pain; constipation; flatulence; dyspepsia; pancreatitis. HEPATIC: Hepatitis; jaundice; fatty change in liver; cirrhosis; fulminant hepatic necrosis; hepatoma; increased serum transaminases. RESPIRATORY: Upper respiratory tract infection. OTHER: Myopathy; rhabdomyolysis; fatigue. Apparent hypersensitivity syndrome has been reported rarely that has included 1 or more of the following features: anaphylaxis; angioedema; lupus erythematous-like syndrome; polymyalgia rheumatica; vasculitis; purpura; thrombocytopenia; leukopenia; hemolytic anemia; positive antinuclear antibody; erythrocyte sedimentation rate increase; arthritis; arthralgia; urticaria; asthenia; photosensitivity; fever; chills; flushing; malaise; dyspnea; toxic epidermal necrolysis; erythema multiforme, including Stevens-Johnson syndrome.

 Precautions

Pregnancy: Category X. Use a reliable form of birth control. LACTATION: Undetermined. CHILDREN: Use in children not recommended. Liver dysfunction: Use drug with caution in patients who consume substantial quantities of alcohol or who have history of liver disease. Marked, persistent increases in serum transaminases have occurred. Renal impairment: High doses may result in severe renal insufficiency. Skeletal muscle effects: Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has occurred in this class of drugs. Consider myopathy in any patient with diffuse myalgias, muscle tenderness, or weakness, or marked CPK elevation.

 Administration/Storage

• Adjust dosage as indicated, usually at 4-wk intervals.
• Administer at bedtime for best results. Hepatic cholesterol production highest during night.
• Store at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Maintain patient on standard cholesterol diet for at least 3 to 6 mo.
• Determine baseline serum cholesterol and triglyceride levels and monitor at 4- to 6-wk intervals and again at 3 mo.
• Determine baseline LFT values and monitor q 6 wk for first 3 mo, q 8 wk for remainder of first year, then q 6 mo thereafter.
• In patients with renal impairment, monitor for possible severe renal insufficiency.
• Periodic CPK determinations may be necessary.
• Notify the health care provider if cholesterol levels are unchanged or if there is significant rise in triglyceride levels.

 Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Advise patient to control weight and to adhere to prescribed dietary regimen.
• Tell patient to notify health care provider or pharmacist if taking, will be taking, or stopping any prescription or OTC medication.
• Advise patient that exercise and diet that reduces intake of cholesterol and saturated fats are helpful.
• Instruct patient to report the following symptoms to health care provider: any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise; yellowing of skin or eyes.
• Tell patient to avoid alcoholic beverages.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts