Class: HMG-CoA Reductase Inhibitor
Dosage Forms. Tablet: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
Common FDA Label Indication, Dosing, and Titration.
1. Hypercholesterolemia, primary or mixed, familial hypercholesterolemia (heterozygous): Children (boys and postmenarchal girls age 10-17 y), 10 mg po daily, may titrate to 20 mg po daily; Adults, 20-40 mg po daily, may titrate to 80 mg po daily
2. Diabetes mellitus Type II, disorder of cardiovascular system, or multiple risk factors for coronary heart disease: 40 mg po daily, may titrate to 80 mg po daily
3. Familial hypercholesterolemia (homozygous): 40 mg po daily
1. Acute coronary syndrome: 10-80 mg po daily
MOA. HMG-CoA reductase inhibitors competitively inhibit conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol synthesis. A compensatory increase in LDL receptors, which bind and remove circulating LDL-cholesterol, results. Production of LDL-cholesterol also can decrease because of decreased production of VLDL-cholesterol or increased VLDL removal by LDL receptors.
Drug Characteristics: Simvastatin
Medication Safety Issues: Simvastatin
Drug Interactions: Simvastatin
Adverse Reactions: Simvastatin
Efficacy Monitoring Parameters. Reduction in total cholesterol, LDL-cholesterol, and triglycerides levels; increase in HDL-cholesterol levels.
Toxicity Monitoring Parameters. Signs/symptoms of rhabdomyolysis (myalgias, dark urine, arthralgias, fatigue) or hepatotoxicity; monitor LFT, SCr, and BUN at baseline, 12 wk after initiation of therapy or after dose increases, and periodically thereafter when indicated; serum creatine kinase should be measured in patients experiencing muscle pain and in those receiving other drugs associated with myopathy.
Key Patient Counseling Points. Contact prescriber immediately if pregnancy occurs. Do not drink alcohol. There are multiple significant drug-drug interactions with simvastatin. Consult a healthcare professional prior to starting any new medications, including over-the-counter and herbal drugs. Simvastatin does not take the place of lifestyle changes (diet, exercise) to lower cholesterol levels.
Clinical Pearls. Lipid level assessment should be done prior to initiation of therapy and periodically during treatment. May increase risk of diabetes.