- Approval Id
- a9f2ce460edc0e8e
- Drug Name
- EZZICAD TABLETS 10MG
- Product Name
- EZZICAD TABLETS 10MG
- Approval Number
- SIN16429P
- Approval Date
- 2022-02-18
- Registrant
- GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
- Licence Holder
- GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>Posology and method of administration</strong><br>
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe.</p>
<p>The recommended dose of ezetimibe is 10 mg once daily, used alone, with a statin, or with fenofibrate. Ezetimibe can be administered at any time of the day, with or without food.</p>
<p><strong><em>Patients with Renal Impairment</em></strong><br>
<em>Monotherapy</em><br>
In patients with renal impairment, no dosage adjustment of ezetimibe is necessary.</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 ezetimibe 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 ezetimibe 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.</p>
<p><em><strong>Use in the Elderly</strong></em><br>
No dosage adjustment is required for elderly patients.</p>
<p><em><strong>Use in Pediatric Patients</strong></em><br>
Children and adolescents ≥10 years: No dosage adjustment is required.<br>
Children <10 years: Treatment with ezetimibe 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 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.</p>
<p><em><strong>Co-administration with bile acid sequestrants</strong></em><br>
Dosing of ezetimibe 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>Indications</strong><br>
<em><strong>Primary Hypercholesterolemia</strong></em><br>
Ezetimibe, 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>Ezetimibe, 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><em><strong>Homozygous Familial Hypercholesterolemia (HoFH)</strong></em><br>
Ezetimibe, 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><em><strong>Homozygous Sitosterolemia (Phytosterolemia)</strong></em><br>
Ezetimibe 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>Contraindications</strong><br>
Hypersensitivity to any component of this medication.</p>
<p>When ezetimibe 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 ezetimibe 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 ezetimibe 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
- GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
