- Approval Id
- d16a98de4677da7a
- Drug Name
- VALCORE TABLET 10MG/20MG
- Product Name
- VALCORE TABLET 10MG/20MG
- Approval Number
- SIN15931P
- Approval Date
- 2020-04-17
- Registrant
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Licence Holder
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>V. DOSAGE AND ADMINISTRATION</strong><br>
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.<br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Dosage in Patients with Homozygous Familial Hypercholesterolemia</em></strong><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Patients with Renal Impairment</strong></em><br>
In patients with mild renal insufficiency (estimated GFR ≥ 60 ml/min/1.73 m<sup>2</sup>) no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m<sup>2</sup>, 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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</p>
<p><em><strong>Use in the Elderly</strong></em><br>
No dosage adjustment is required for elderly patients (see IVb-5. Characteristics in Patients [Special Populations] – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em><strong>Use in Pediatric Patients</strong></em><br>
Treatment with Ezetimibe-Simvastatin Tablet is not recommended.</p>
<p><em><strong>Use in Hepatic Impairment</strong></em><br>
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] – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</p>
<p><em><strong>Co-administration with other medicines</strong></em><br>
Dosing of Ezetimibe-Simvastatin Tablet should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.<br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>III. INDICATIONS</strong><br>
<strong><em>Primary Hypercholesterolemia</em></strong><br>
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.</p>
<p><strong><em>Homozygous Familial Hypercholesterolemia (HoFH)</em></strong><br>
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.</p>
- Contraindications
- <p><strong>VI. CONTRAINDICATIONS</strong></p>
<ul>
<li>Hypersensitivity to the active substances or to any of the excipients.</li>
<li>Active liver disease or unexplained persistent elevations of serum transaminases.</li>
<li>Pregnancy and nursing (see VIII. PREGNANCY and IX. NURSING MOTHERS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Concomitant administration of gemfibrozil, cyclosporine, or danazol (see VII. PRECAUTIONS, Myopathy/Rhabdomyolysis and XI. DRUG INTERACTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- C10BA02
- Atc Item Name
- simvastatin and ezetimibe
- Pharma Manufacturer Name
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/teva-pharmaceutical-investments-singapore-pte-ltd
