- Approval Id
- 518eec8f450e5099
- Drug Name
- EZETROL TABLET 10 MG
- Product Name
- EZETROL TABLET 10 MG
- Approval Number
- SIN12375P
- Approval Date
- 2003-08-01
- Registrant
- ORGANON SINGAPORE PTE. LTD.
- Licence Holder
- ORGANON SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>IV. DOSAGE AND ADMINISTRATION</strong></p>
<p>The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with EZETROL.</p>
<p>The recommended dose of EZETROL is 10 mg once daily, used alone, with a statin, or with fenofibrate. EZETROL can be administered at any time of the day, with or without food.</p>
<p><strong><em>Patients with Renal Impairment</em></strong><br>
Monotherapy<br>
In patients with renal impairment, no dosage adjustment of EZETROL is necessary (see IIIb-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>Combination Therapy with Simvastatin<br>
In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m<sup>2</sup>), no dosage adjustment of EZETROL or simvastatin 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 EZETROL is 10 mg and the dose of simvastatin is 20 mg once a day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored (see VI. PRECAUTIONS, IIIb-5. Characteristics in Patients [Special Populations] and IIIc. CLINICAL STUDIES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong><em>Use in the Elderly</em></strong><br>
No dosage adjustment is required for elderly patients (see IIIb-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><strong><em>Use in Pediatric Patients</em></strong><br>
Children and adolescents ≥10 years: No dosage adjustment is required (see IIIb-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>).<br>
Children <10 years: Treatment with EZETROL is not recommended.</p>
<p><strong><em>Use in Hepatic Impairment</em></strong><br>
No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6).</p>
<p>Treatment with ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction (see VI. PRECAUTIONS and IIIb-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><strong><em>Co-administration with bile acid sequestrants</em></strong><br>
Dosing of EZETROL should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>II. INDICATIONS</strong></p>
<p><strong><em>Primary Hypercholesterolemia</em></strong><br>
EZETROL, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.</p>
<p>EZETROL, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.</p>
<p><strong><em>Homozygous Familial Hypercholesterolemia (HoFH)</em></strong><br>
EZETROL, administered with atorvastatin or simvastatin, 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>
<p><strong><em>Homozygous Sitosterolemia (Phytosterolemia)</em></strong><br>
EZETROL is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.</p>
- Contraindications
- <p><strong>V. CONTRAINDICATIONS</strong></p>
<p>Hypersensitivity to any component of this medication.</p>
<p>When EZETROL is to be administered with a statin or with fenofibrate, please refer to the Package Insert for that particular medication.</p>
<p>The combination of EZETROL with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.</p>
<p>All statins and fenofibrate are contraindicated in pregnant and nursing women. When EZETROL is administered with a statin or with fenofibrate in a woman with childbearing potential, refer to the product labeling for that medication.</p>
- Atc Code
- C10AX09
- Atc Item Name
- ezetimibe
- Pharma Manufacturer Name
- ORGANON SINGAPORE PTE. LTD.
