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 or with a statin. Ezetrol can be administered at any time of the day, with or without food.
Ezetrol may be administered with an HMG-CoA reductase inhibitor for incremental effect. For convenience, the daily dose of Ezetrol may be taken at the same time as the HMG-CoA reductase inhibitor, according to the dosing recommendations for the HMG-CoA reductase inhibitor.
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 (eg, dose increase only after 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.
If Ezetimibe is used in combination with bile acid sequestrants, dosing of ezetimibe should occur either ≥2 hrs before or ≥4 hrs after administration of bile acid sequestrants.
Children and Adolescents ≥10 years: No dosage adjustment is required (see Special Populations under Actions).
Children <10 years: Treatment with Ezetrol is not recommended.
Elderly: No dosage adjustment is required for elderly patients (see Special Populations under Actions). However, greater sensitivity of the same older individuals cannot be ruled out.
Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5-6). Treatment with Ezetrol is not recommended in patients with moderate (Child Pugh score 7-9) or severe (Child Pugh score >9) liver dysfunction. (See Special Populations under Actions and Precautions).
Renal Impairment: No dosage adjustment is required for renally impaired patients (see Special Populations under Actions).
Co-administration with bile acid sequestrants: Dosing of Ezetrol should occur either ≥2 hrs before or ≥4 hrs after administration of a bile acid sequestrant.