Ezetrol

Ezetrol Dosage/Direction for Use

ezetimibe

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with EZETROL.
Use in Patients with Primary Hypercholesterolemia: 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.
Use in Patients with Coronary Heart Disease: Combination Therapy with a Statin: For incremental cardiovascular event reduction in patients with coronary heart disease, EZETROL 10 mg may be administered with a statin with proven cardiovascular benefit.
Use in Patients with Renal Impairment/Chronic Kidney Disease: Monotherapy: In patients with renal impairment, no dosage adjustment of EZETROL is necessary (see Pharmacology: Pharmacokinetics: Characteristics in Patients (Special Populations) under Actions).
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 PRECAUTIONS and Pharmacology: Pharmacokinetics: Characteristics in Patients (Special Populations) under Actions.)
Use in the Elderly: No dosage adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics: Characteristics in Patients (Special Populations) under Actions).
Use in Pediatric Patients: Children and adolescents ≥ 6 years: No dosage adjustment is required (see Pharmacology: Pharmacokinetics: Characteristics in Patients (Special Populations) under Actions).
Children < 6 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 PRECAUTIONS and Pharmacology: Pharmacokinetics: Characteristics in Patients (Special Populations) under Actions.)
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.
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