* Indications: | ||
– Primary Hypercholesterolemia: | ||
& ZOCOZET is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density | ||
& lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), && non-high-density lipoprotein cholesterol | ||
& (non-HDL-C), && to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial && | ||
& non-familial) hypercholesterolemia or mixed hyperlipidemia. | ||
– Homozygous Familial Hypercholesterolemia (HoFH): ZOCOZET is indicated for the reduction of elevated total-C levels in patients | ||
& with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). | ||
* Dosage && Administration: | ||
– The patient should be placed on a standard cholesterol-lowering diet before receiving ZOCOZET && should continue on this diet | ||
& treatment with ZOCOZET. | ||
– The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, && the patient’s response. | ||
– ZOCOZET should be taken as a single daily dose in the evening, with or without food. | ||
– Use in the Elderly: No dosage adjustment is required for elderly patients. | ||
– Use in Pediatric Patients: Treatment with ZOCOZET is not recommended. | ||
– Use in Hepatic Impairment: No dosage adjustment is required in patients with hepatic insufficiency. | ||
& Treatment with ZOCOZET is not recommended in patients with moderate or severe liver dysfunction. | ||
– Use in Renal Impairment: No dosage adjustment is required in patients with moderate to severe renal insufficiency with ZOCOZET 10/10. | ||
– Coadministration with other medicines: The safety and effectiveness of ezetimibe administered with fibrates have not been | ||
& established. Theredore, the combination of ZOCOZET and fibrates should be avoided. | ||
& There is an increased risk of myopathy when simvastatin is used concomitantly with fibrates (especially gemfibrozil). | ||
& Therefore, although not recommended, if ZOCOZET is used in combination with gemfibrozil, the dose should not | ||
& exceed 10/10 mg daily. | ||
* Contraindications: | ||
– Hypersensitivity to the active substances or to any of the excipients. | ||
– Active liver disease or unexplained persistent elevations of serum transaminases. | ||
– Pregnancy and nursing. | ||
* Precautions: | ||
& Myopathy / Rhabdomylosis: | ||
– Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy, Rhabdomylosis | ||
& mainfested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper limit | ||
& of normal (ULN). | ||
– The risk of myopathy / rhabdomylosis is increased by concomitant use of ZOCOZET with the following: | ||
& Potent inhibitors of CYP3A4, e.g., itraconazole, ketoconazole, erythromycin, c
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