EZETROL TABLET 10 mg

TABLET

**IV. DOSAGE AND ADMINISTRATION** The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with EZETROL. 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. **_Patients with Renal Impairment_** Monotherapy In patients with renal impairment, no dosage adjustment of EZETROL is necessary (see IIIb-5. Characteristics in Patients \[Special Populations\] – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Combination Therapy with Simvastatin In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m2), 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 m2, 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 – _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 IIIb-5. Characteristics in Patients \[Special Populations\] – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Use in Pediatric Patients_** Children and adolescents ≥10 years: No dosage adjustment is required (see IIIb-5. Characteristics in Patients \[Special Populations\] – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children <10 years: Treatment with EZETROL 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 (see VI. PRECAUTIONS and IIIb-5. Characteristics in Patients \[Special Populations\] – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Co-administration with bile acid sequestrants_** Dosing of EZETROL should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.