Zocor/Zocor HP Dosage/Direction for Use

RECOMMENDED DOSE: The dosage range for SIMVASTATIN (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. The 80-mg dose is only recommended in patients at high risk for cardiovascular complications who have not achieved treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see Myopathy/Rhabdomyolysis under Precautions).
PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD: The usual starting dose of SIMVASTATIN (ZOCOR) is 40 mg/day given as a single dose in the evening in patients at high risk of CHD (with or without hyperlipidemia), i.e., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD. Drug therapy can be initiated simultaneously with diet and exercise.
PATIENTS WITH HYPERLIPIDEMIA (WHO ARE NOT IN THE PREVIOUSLY MENTIONED RISK CATEGORIES): The patient should be placed on a standard cholesterol-lowering diet before receiving SIMVASTATIN (ZOCOR) and should continue on this diet during treatment with SIMVASTATIN (ZOCOR).
The usual starting dose is 20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg/day given as a single dose in the evening. Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 10 mg of SIMVASTATIN (ZOCOR). Adjustments of dosage, if required, should be made as specified previously.
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA: Based on the results of a controlled clinical study, the recommended dosage for patients with homozygous familial hypercholesterolemia is SIMVASTATIN (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 Contraindications and Myopathy/Rhabdomyolysis under Precautions). SIMVASTATIN (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 SIMVASTATIN (ZOCOR), the dose of SIMVASTATIN (ZOCOR) should not exceed 40 mg/day (see Myopathy/Rhabdomyolysis under Precautions and Interactions).
CONCOMITANT THERAPY: SIMVASTATIN (ZOCOR) is effective alone or in combination with bile acid sequestrants.
In patients taking SIMVASTATIN (ZOCOR) concomitantly with fibrates, other than gemfibrozil (see Contraindications) or fenofibrate, the dose of SIMVASTATIN (ZOCOR) should not exceed 10 mg/day. In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with SIMVASTATIN (ZOCOR), the dose of SIMVASTATIN (ZOCOR) should not exceed 20 mg/day. In patients taking amlodipine concomitantly with SIMVASTATIN (ZOCOR), the dose of SIMVASTATIN (ZOCOR) should not exceed 40 mg/day. (See Myopathy/Rhabdomyolysis under Precautions and Interactions.)
DOSAGE IN RENAL INSUFFICIENCY: Because SIMVASTATIN (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 (see Pharmacology: Pharmacokinetics under Actions).
DOSAGE IN PEDIATRIC PATIENTS (10-17 YEARS OF AGE) WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA: The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy.
MODE OF ADMINISTRATION: SIMVASTATIN (ZOCOR) is available for oral administration as tablets.