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Cholesterol

INDICATIONS AND USAGE

SIMLO is a combination of simvastatin, an HMG-Co-A reductase inhibitor, and extended-release niacin (Niaspan), nicotinic acid. SIMLO is indicated to:

• Reduce elevated total-C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate. (1.1)

• Reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate. (1.1)

Limitations of use:

No incremental benefit of SIMLO on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established. (1.1)

CONTRAINDICATIONS

• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4, 5.2)

• Active peptic ulcer disease (4)

• Arterial bleeding (4)

• Women who are pregnant or may become pregnant (4, 8.1)

• Nursing mothers (4, 8.3)

• Known hypersensitivity to product components (4, 6.1)

WARNINGS AND PRECAUTIONS

• Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses, advanced age (>/= 65), hypothyroidism, renal impairment, and concomitant use of cyclosporine, danazol, gemfibrozil, amiodarone, and verapamil and potent CYP3A4 inhibitors. (5.1)

• Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment. (5.2)

• Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. If switching from other niacin preparations, initiate with lowest SIMLO dose; niacin extended-release can be converted at equivalent doses. (5.2)

• Niacin extended-release can increase serum glucose levels. Glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use. (5.3)

  
  

  DOSAGE AND ADMINISTRATION
  The simvastatin dose range is 5 to 80 mg daily, administered in one dose at night.
  
  If needed, dose adjustment should be made at intervals of not less than 4 weeks, with a maximum daily dose of 80 mg daily in the evening.
  
  Patients at high risk of developing CHD or with existing coronary heart disease: The usual initial dosificiación Zocor is 40 mg per day administered in a single evening dose in patients with coronary heart disease or at high risk of coronary heart disease (eg , patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or coronary heart disease) with or without hyperlipidemia.
  
  Treatment with ZOCOR can be started simultaneously on a diet and exercise program.
  
  Patients with hyperlipidemia (which are not within the risk categories above): Before starting treatment with ZOCOR the patient should be placed under a standard diet to lower cholesterol, and should continue on this diet during treatment.
  
  The usual starting dose is 20 mg daily, administered in one dose at night. Patients who require a greater reduction in LDL cholesterol (more than 45%) can be initiated with 40 mg per day administered in one dose at night. In patients with mild to moderate hypercholesterolemia, treatment can be initiated with simvastatin 10 mg daily. The dosage adjustments, if needed, should be made as indicated above.
  
  Patients with homozygous familial hypercholesterolemia: Based on the results of controlled clinical studies, the recommended dose for patients with homozygous familial hypercholesterolemia is 40 mg daily in the evening or 80 mg daily in three divided doses of 20, 20 and 40 mg night. In these patients, ZOCOR should be used as an adjunct to other lipid-lowering treatments (eg LDL apheresis) or if such treatments are unavailable.
  
  Concomitant therapy: ZOCOR is effective alone or in combination with bile acid sequestrants.
  
  In patients receiving simvastatin while cyclosporine, gemfibrozil and other fibrates (except fenofibrate or niacin cholesterol-lowering doses (≥ 1 g / day), the dose of simvastatin should not exceed 10 mg daily. In patients while taking amiodarone or verapamil ZOCOR, the dfosis of ZOCOR should not exceed 20 mg daily. (See WARNINGS, Myopathy / Rhabdomyolysis and Interactions other genre).

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