- Approval Id
- e5b435fae2c07752
- Drug Name
- EZETIMIBE-SIMVASTATIN SANDOZ TABLET 10/10MG
- Product Name
- EZETIMIBE-SIMVASTATIN SANDOZ TABLET 10/10MG
- Approval Number
- SIN16228P
- Approval Date
- 2021-06-08
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **4.2. Posology and method of administration**
The patient should be placed on a standard cholesterol-lowering diet before receiving ezetimibe/simvastatin and should continue on this diet during treatment with ezetimibe/simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. Ezetimibe/simvastatin 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, 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 should be restricted to patients who have been taking ezetimibe/simvastatin 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity (See Section 4.4 – _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 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, Sections 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Ezetimibe/simvastatin 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, the dose of ezetimibe/simvastatin should not exceed 10/40mg/day (See Sections 4.4 and 4.5 – _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 is 10/20 mg once a day in the evening. In such patients, the use of higher doses should be closely monitored (See Sections 4.4, 5.1 and 5.2 – _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 Section 5.2 – _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 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 is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction (See Sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Coadministration with other medicines**
Dosing of ezetimibe/simvastatin should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.
In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with ezetimibe/simvastatin, the dose of ezetimibe/simvastatin should not exceed 10/20 mg/day (See Sections 4.4 and 4.5 – _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, the dose of ezetimibe/simvastatin should not exceed 10/40 mg/day (See Sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The safety and effectiveness of ezetimibe/simvastatin administered with fibrates have not been studied. Therefore, the combination of ezetimibe/simvastatin and fibrates should be avoided (See Sections 4.3, 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- ORAL
- Indication Info
- **4.1. Therapeutic indications**
**Primary Hypercholesterolemia**
EZETIMIBE-SIMVASTATIN SANDOZ 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)**
EZETIMIBE-SIMVASTATIN SANDOZ 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.
- Contraindications
- **4.3. 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 Section 4.6 – _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 Sections 4.4 and 4.5 – _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 Sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
- Atc Code
- C10BA02
- Atc Item Name
- simvastatin and ezetimibe
- Pharma Manufacturer Name
- SANDOZ SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sandoz-singapore-pte-ltd
