Active ingredient(s) and Contents

• Effective components

  • Simvastatin 20.00 mg

• Other

  • Lactose Hydrate, Corn starch, Butylhydroxyanisole, Opadry (03F42101), Magnesium Stearate, Microcrystalline Cellulose, Hydroxypropyl cellulose

Dosage and administration

• The patient prior to and while taking this drug should be placed on a standard cholesterol-lowering diet.
  • 1. Reduce risks for the following cardiovascular diseases
    
    Adult patients with high risk of coronary artery diseases caused by medical history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular disease
    
    The recommended starting dose of Simvastatin 40 mg daily.
  • 2. Hyperlipidemia
    
    • 1) Reduce the risk of hypercholesterolemia patients with coronary artery diseases and hyperlipemia
      
      The usual starting dose is 20 mg daily given as a single dose in the evening. In patients with mild to moderate hypercholesterolemia the starting dose of this drug is 10 mg.
      
      The dose range is 5 to 40 mg/day given orally as a single dose in the evening.
      
      The dose is appropriately adjusted according to the initial LDL-cholesterol level before the start of administration, the target value of the treatment, and the patient's response to the drug. The cholesterol level is measured four weeks after the start of treatment and thereafter, the dose is adjusted. If the cholesterol level falls below the target level, reduce it.
      
      Due to the increased risk of myopathy including rhabdomyolysis, especially during the first year of treatment, administer 80 mg of this drug only in patients who have taken 80 mg for 12 months or longer without evidence of muscle toxicity (see 1. Warnings in Warnings and precautions).
    • 2) Please refer to the following for the recommended dose in patients who are co-administered this drug and fibrate drugs (except gemfibrozil and fenofibrate), amiodarone, verapamil, diltiazem, and amlodipine and in specific patient groups (i.e., homozygous familial hypercholesterolemia patients, older patients, patients with renal impairment).
      • (1) Administration in homozygous familial hypercholesterolemia patients
        
        In patients with homozygous familial hypercholesterolemia as a result of controlled clinical trials, 40 mg of this drug is administered each evening. This drug is administered in combination with other lipid-lowering treatments (e.g., LDL apheresis), or if other lipid-lowering treatments are not possible.
      • (2) In the elderly, even with a daily dose of 20 mg of this drug, the effect of maximizing cholesterol reduction can be obtained.
      • (3) Administration in patients receiving verapamil or diltiazem or dronedarone
        
        When co-administered with Verapamil or Diltiazem or Dronedarone, the dose of this drug should not exceed 10 mg daily.
      • (4) Administration in patients taking amiodarone or amlodipine or ranolazine
        
        The dose of this drug should not exceed 20 mg daily in the case of co-administration of amiodarone or amlodipine or ranolazine. (see 6. Drug interactions in Warnings and precautions)
      • (5) Co-administration with other lipid-lowering agents
        
        This drug is effective when administered for monotherapy or in combination with a bile acid sequestrant. When this drug is co-administered with a fibrate drug (except gemfibrozil (see 2. Contraindications in Warnings and precautions) and fenofibrate), the dose of this drug should not exceed 10 mg daily (see 6. Drug interactions in Warnings and precautions). Drug interactions in Warnings and precautions)
      • (6) Patients with renal impairment
        
        No dose adjustment is necessary in patients with mild to moderate renal impairment as the excretion of this drug occurs via kidney. In patients with severe renal impairment, the starting dose is 5 mg/day with careful monitoring.
        
        3. Pediatric patients (10 to 17 years of age) with heterozygous familial hypercholesterolemia
        
        The recommended starting dose is 10 mg once daily in the evening. The recommended dosing range is 10~40 mg/day and the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of four weeks or more.

Storage and handling

• 
  Airtight container, keep at room temperature (1~30°C)