ZOCOR TABLET 20 mg

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**DOSAGE AND ADMINISTRATION** The dosage range for ZOCOR is 5–80 mg/day, given as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of ZOCOR should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. Patients unable to achieve their LDL-C goal utilizing the 40-mg dose of ZOCOR should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering (see PRECAUTIONS, _Myopathy/Rhabdomyolysis_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD Patients with coronary heart disease can be treated with a starting dose of 20 mg/day given as a single dose in the evening. Patients at high risk for a CHD event due to existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease have been shown to benefit from 40 mg/day and can be started at this dose. PATIENTS WITH HYPERLIPIDEMIA (WHO ARE NOT IN THE RISK CATEGORIES ABOVE) The patient should be placed on a standard cholesterol-lowering diet before receiving ZOCOR and should continue on this diet during treatment with ZOCOR. The usual starting dose is 10 mg/day given as a single dose in the evening. Patients who require a reduction in LDL-C (more than 45%) may be started at 40 mg/day given as a single dose in the evening. Adjustments of dosage, if required, should be made as specified above. PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Based on the results of a controlled clinical study, the recommended dosage for patients with homozygous familial hypercholesterolemia is ZOCOR 40 mg/day in the evening. The 80-mg dose is only recommended when the benefits are expected to outweigh the potential risks (see above; CONTRAINDICATIONS; PRECAUTIONS, _Myopathy/Rhabdomyolysis_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). ZOCOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. In patients taking lomitapide concomitantly with ZOCOR, the dose of ZOCOR should not exceed 40 mg/day (see PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). CONCOMITANT THERAPY ZOCOR is effective alone or in combination with bile acid sequestrants. In patients taking ZOCOR concomitantly with fibrates other than gemfibrozil (see CONTRAINDICATIONS) or fenofibrate, the dose of ZOCOR should not exceed 10 mg/day. In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with ZOCOR, the dose of ZOCOR should not exceed 20 mg/day. In patients taking amlodipine concomitantly with ZOCOR, the dose of ZOCOR should not exceed 40 mg/day (see PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). DOSAGE IN RENAL INSUFFICIENCY Because ZOCOR does not undergo significant renal excretion, modification of dosage should not be necessary in patients with moderate renal insufficiency. In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.