• Adjunctive management of primary hypercholesterolemia and mixed dyslipidemias.
• Secondary prevention of myocardial infarction, coronary revascularization, stroke, and cardiovascular mortality in patients with clinically evident coronary heart disease.

Contraindicated in:

• Hypersensitivity
• Concurrent use of strong CYP3A4 inhibitors (protease inhibitors, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing products), gemfibrozil, cyclosporine or danazol (↑ risk of myopathy/rhabdomyolysis)
• Active liver disease or unexplained persistant elevations in AST/ALT
• OB: Lactation: Pregnancy or lactation.

Use Cautiously in:

• History of liver disease
• Alcoholism
• Renal impairment
• Concurrent use of amiodarone, amlodipine, diltiazem, dronedarone, verapamil, lomitapide, or ranolazine (↑ risk of myopathy/rhabdomyolysis)
• Chinese patients receiving 1 g/day of niacin (↑ risk of myopathy; do not use simvastatin 80 mg/day in these patients)
• OB: Women of childbearing age
• Pedi: Children <10 yr (safety not established).

CNS: amnesia, confusion, dizziness, headache, insomnia, memory loss, weakness.

GI: abdominal cramps, constipation, diarrhea, flatus, heartburn, altered taste, drug-induced hepatitis, dyspepsia, ↑ liver enzymes, nausea, pancreatitis.

GU: erectile dysfunction.

Derm: rashes, pruritus.

Endo: hyperglycemia.

MS: RHABDOMYOLYSIS, arthralgia, immune-mediated necrotizing myopathy, myopathy (↑ risk with 80 mg dose).
Misc: hypersensitivity reactions.

Drug-Drug:

• Risk of myopathy and rhabdomyolysis are significantly ↑ with concurrent use of cyclosporine, gemfibrozil, danazol, erythromycin, clarithromycin, protease inhibitors, nefazodone, ketoconazole, itraconazole, voriconazole, posaconazole, or cobicistat-containing products; concurrent use contraindicated.
• Cholesterol-lowering effect may be ↑ with bile acid sequestrants (cholestyramine,colestipol).
• Bioavailability may be ↓ by bile acid sequestrants.
• Risk of myopathy is ↑ by concurrent use of amiodarone, amlodipine, diltiazem, dronedarone, verapamil, ranolazine, lomitapide or niacin,
• May slightly ↑ serum digoxin levels.
• May ↑ risk of bleeding with warfarin.

Drug-Food:

• Risk of myopathy and rhabdomyolysis are significantly ↑ with concurrent use of grapefruit juice;.

(Generic available)

• Oral suspension: 20 mg/5 mL; 40 mg/5 mL;
• Tablets: 5 mg; 10 mg; 20 mg; 40 mg; 80 mg;
  • Cost: Generic—
    - 5 mg; price/quantity: $45.97/90
    - 10 mg; price/quantity: $49.97/90
    - 20 mg; price/quantity: $73.97/90
    - 40 mg; price/quantity: $75.97/90
    - 80 mg; price/quantity: $89.97/90.
• In combination with: ezetimibe (Vytorin). See Appendix [not included in this PDA edition].

The 80 mg dose should be restricted to patients who have been taking this dose for 12 mo without evidence of muscle toxicity

• PO (Adults): 5–40 mg once daily in the evening; if LDL goal cannot be achieved with 40 mg/day dose, add another lipid-lowering therapy (do not ↑ simvastatin dose to 80 mg/day). Concurrent verapamil, diltiazem, or dronedarone therapy — Dose should not exceed 10 mg/day. Concurrent amiodarone, amlodipine or ranolazine therapy — Dose should not exceed 20 mg/day; Concurrent lomitapide therapy — ↓dose by 50% (dose should not exceed 20 mg/day or 40 mg/day for patients who previously received 80 mg/day chronically [for 12 mo] without evidence of myopathy).
• PO (Children 10–17 yr): 10 mg/day initially, may be ↑ at 4 wk intervals up to 40 mg/day. Concurrent amiodarone, amlodipine or ranolazine therapy — Dose should not exceed 20 mg/day Concurrent verapamil or diltiazem therapy — Dose should not exceed 10 mg/day.

FloLipid, Zocor

• Inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which is responsible for catalyzing an early step in the synthesis of cholesterol.

• Lowering of total and LDL cholesterol and triglycerides. Slightly increases HDL cholesterol.
• Slows the progression of coronary atherosclerosis with resultant decrease in coronary heart disease-related events.

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: hmg coa reductase inhibitors (statin)

Absorption: 85% absorbed, but rapidly metabolized.

Distribution: Unknown.

Protein Binding: 95%.

Metabolism/Excretion: Extensively metabolized by the liver, most during first pass; excreted in bile and feces; 13% excreted unchanged by the kidneys.

Half-life: Unknown.

(cholesterol-lowering effect)

†After discontinuation.

• Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Advise patient to avoid drinking more than 1 qt of grapefruit juice/day during therapy. Medication helps control but does not cure elevated serum cholesterol levels.
• Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
• Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
• Advise patient to wear sunscreen and protective clothing to prevent photosensitivity reactions (rare).
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient to notify health care professional of medication regimen before treatment or surgery.
• Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected, or if breastfeeding.
• Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

SIM-va-sta-tin