Zocor precautions

List of contraindications
General Concomitant use of drugs Nursing Mothers Pediatric Use Cyclosporine, Gemfibrozil, other fibrates or lipid-lowering doses Amiodarone or Verapamil Myopathy Liver test

General
Simvastatin may cause elevation of CK and transaminase levels. This should be considered in the differential diagnosis of chest pain in a patient on therapy with simvastatin. Return to top

Concomitant use of drugs
Use of simvastatin concomitantly with itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided. If treatment with itraconazole, ketoconazole, erythromycin, or clarithromycin is unavoidable, therapy with simvastatin should be suspended during the course of treatment. Concomitant use with other medicines labeled as having a potent inhibitory effect on CYP3A4 at therapeutic doses should be avoided unless the benefits of combined therapy outweigh the increased risk.Return to top

Nursing Mothers
It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. Return to top

Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Because pediatric patients are not likely to benefit from cholesterol lowering for at least a decade and because experience with this drug is limited (no studies in subjects below the age of 20 years), treatment of pediatric patients with simvastatin is not recommended at this time. Return to top

Cyclosporine, Gemfibrozil, other fibrates or lipid-lowering doses
The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporine, gemfibrozil, other fibrates or lipid-lowering doses (≥1 g/day) of niacin. The combined use of simvastatin with fibrates or niacin should be avoided unless the benefit of further alteration in lipid levels is likely to outweigh the increased risk of this drug combination. Addition of these drugs to simvastatin typically provides little additional reduction in LDL-C, but further reductions of TG and further increases in HDL-C may be obtained. Return to top

Amiodarone or Verapamil
The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone or verapamil. The combined use of simvastatin at doses higher than 20 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy. Return to top

Myopathy
All patients starting therapy with simvastatin, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. The presence of these symptoms, and/or a CK level >10 times the ULN indicates myopathy. In most cases, when patients were promptly discontinued from treatment, muscle symptoms and CK increases resolved. Periodic CK determinations may be considered in patients starting therapy with simvastatin or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy. Return to top

Liver test
It is recommended that liver function tests be performed before the initiation of treatment, and periodically thereafter (e.g., semiannually) for the first year of treatment or until one year after the last elevation in dose. Patients titrated to the 80-mg dose should receive an additional test at 3 months. Return to top