Ezetrol 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.
EZETROL may be administered with a statin (in patients with primary hypercholesterolemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of EZETROL may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
If EZETROL 10 mg tablets are used in combination with a statin therapy, the dosage instructions for that particular statin should be consulted.
When initiating lipid lowering treatment, which includes EZETROL 10 mg Tablets and a statin in combination, the indicated usual initial dose of that particular statin should be used or the already established higher statin dose should be continued.
If the statin dose is to be increased for the first time or further, the dosage instructions of that particular statin should be followed (such as dose increase only after at least 4 weeks of regular use of the combination without any change).
The stepwise increase of the statin dose in combination treatment results in a relatively small additional decrease of LDL-C, but increases the risk of dose-related adverse events of the statin. This has to be considered for the risk-benefit-assessment when the statin dose is considered.
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 the Elderly: No dosage adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics: Characteristics in Patients [Special Populations] under ACTIONS). However, greater sensitivity of some older individuals cannot be ruled out.
Use in Pediatric Patients: Children and adolescents ≥10 years: No dosage adjustment is required (see Pharmacology: Pharmacokinetics: Characteristics in Patients [Special Populations] under ACTIONS.
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 EZETROL 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).
Use in Renal Impairment: No dosage adjustment is required for renally impaired patients (see 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.