Regulatory Information
GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**Posology and method of administration** The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. The recommended dose of Ezetimibe is 10 mg tablet once daily, used alone, with a statin, or with fenofibrate. Ezetimibe can be administered at any time of the day, with or without food. **_Patients with Renal Impairment_** **Monotherapy** In patients with renal impairment, no dosage adjustment of Ezetimibe is necessary. _**Combination Therapy with Simvastatin**_ In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m2), 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 m2, 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. _**Use in the Elderly**_ No dosage adjustment is required for elderly patients. _**Use in Pediatric Patients**_ Children and adolescents ≥10 years: No dosage adjustment is required. Children <10 years: Treatment with Ezetimibe is not recommended. _**Use in Hepatic Impairment**_ No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction. **Co-administration with bile acid sequestrants** Dosing of Ezetimibe should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
ORAL
Medical Information
Under **Clinical particulars** _**Primary Hypercholesterolaemia**_ 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. 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. _**Homozygous Familial Hypercholesterolaemia (HoFH)**_ 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 (eg. LDL apheresis) or if such treatments are unavailable. _**Homozygous Sitosterolaemia (phytosterolaemia)**_ Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.
**Contraindications** Hypersensitivity to any component of this medication. When Ezetimibe is to be administered with a statin or with fenofibrate, please refer to the SPC for that particular medicinal product. The combination of Ezetimibe with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. 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.
C10AX09
ezetimibe
Manufacturer Information
GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
Glenmark Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
Ezzicad Tablet_PI.pdf
Approved: February 18, 2022