ZOCOR TABLET 20 MG [SIN08893P]

Product Info

ZOCOR TABLET 20 MG

[SIN08893P]

INDICATIONS

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate.

PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, ZOCOR is indicated to:

• Reduce the risk of total mortality by reducing CHD deaths;

• Reduce the risk of non-fatal myocardial infarction and stroke;

• Reduce the need for coronary and non-coronary revascularization procedures.

In hypercholesterolemic patients with coronary heart disease, ZOCOR slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

PATIENTS WITH HYPERLIPIDEMIA

• ZOCOR is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, TG, and apolipoprotein B (apo B), and to increase HDL-C in patients with primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type lla), or combined (mixed) hyperlipidemia (Fredrickson type llb), when response to diet and other nonpharmacological measures is inadequate. ZOCOR, therefore, lowers LDL-C/HDL-C and total-C/HDL-C ratios.

• ZOCOR is also indicated as an adjunct to diet and other non-dietary measures for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) to reduce elevated total-C, LDL-C and apo B.

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 or ticagrelor 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.

CONTRAINDICATIONS

• Hypersensitivity to any component of this preparation.

• Active liver disease or unexplained persistent elevations of serum transaminases.

• Pregnancy and nursing (see also PRECAUTIONS, PREGNANCY and NURSING MOTHERS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and drugs containing cobicistat) (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 administration of gemfibrozil, cyclosporine, or danazol (see PRECAUTIONS, Myopathy/Rhabdomyolysis and DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).