VALCORE TABLET 10MG/20MG [SIN15931P]

Product Info

VALCORE TABLET 10MG/20MG

[SIN15931P]

III. INDICATIONS
Primary Hypercholesterolemia
VALCORE TABLET 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), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)
VALCORE TABLET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

V. DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving Ezetimibe-Simvastatin Tablet and should continue on this diet during treatment with Ezetimibe-Simvastatin Tablet. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’ s response. Ezetimibe-Simvastatin Tablet should be taken as a single daily dose in the evening, with or without food.
The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is 10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After initiation or titration of Ezetimibe-Simvastatin Tablet, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10/80-mg dose of Ezetimibe-Simvastatin Tablet should be restricted to patients who have been taking Ezetimibe-Simvastatin Tablet 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (See VII. PRECAUTIONS, Myopathy/Rhabdomyolysis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage for patients with homozygous familial hypercholesterolemia is Ezetimibe-Simvastatin Tablet 10/40 mg/day or 10/80 mg/day in the evening. The 10/80 mg dose is only recommended when the benefits are expected to outweigh the potential risks (see above, VI. CONTRAINDICATIONS and VII. PRECAUTIONS, Myopathy/Rhabdomyolysis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Ezetimibe-Simvastatin Tablet 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 Ezetimibe-Simvastatin Tablet, the dose of Ezetimibe-Simvastatin Tablet should not exceed 10/40 mg/day (see VI. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with Renal Impairment
In patients with mild renal insufficiency (estimated GFR ≥ 60 ml/min/1.73 m²) no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of Ezetimibe-Simvastatin Tablet is 10/20 mg once a day in the evening. In such patients, the use of higher doses should be closely monitored. (See VII. PRECAUTIONS, IVb-5. Characteristics in Patients (Special Populations) and IVc. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Use in the Elderly
No dosage adjustment is required for elderly patients (see IVb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Pediatric Patients
Treatment with Ezetimibe-Simvastatin Tablet is not recommended.

Use in Hepatic Impairment
No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 or 6). Treatment with Ezetimibe-Simvastatin Tablet is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score > 9) liver dysfunction. (See VII. PRECAUTIONS and IVb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Co-administration with other medicines
Dosing of Ezetimibe-Simvastatin Tablet should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.
In patients taking amiodarone, verapamil or diltiazem, or products containing elbasvir or grazoprevir concomitantly with Ezetimibe-Simvastatin Tablet, the dose of Ezetimibe-Simvastatin Tablet should not exceed 10/20 mg/day (see VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
In patients taking amlodipine concomitantly with Ezetimibe-Simvastatin Tablet, the dose of Ezetimibe-Simvastatin Tablet should not exceed 10/40 mg/day (see VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The safety and effectiveness of Ezetimibe-Simvastatin Tablet administered with fibrates have not been studied. Therefore, the combination of Ezetimibe-Simvastatin Tablet and fibrates should be avoided (see VI. CONTRAINDICATIONS, VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

VI. 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 (see VIII. PREGNANCY and IX. 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, erythromycin, boceprevir, telaprevir, clarithromycin, telithromycin, nefazodone, and drugs containing cobicistat) (see VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. 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 VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).