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Posology: The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe TEVA.
Route of administration is oral. The recommended dose is one Ezetimibe TEVA 10 mg tablet daily. Ezetimibe TEVA can be administered at any time of the day, with or without food.
When Ezetimibe TEVA is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.
Use in Patients with Coronary Heart Disease and ACS Event History: For incremental cardiovascular event reduction in patients with coronary heart disease and ACS event history, Ezetimibe TEVA 10 mg may be administered with a statin with proven cardiovascular benefit.
Co-administration with bile acid sequestrants: Dosing of Ezetimibe TEVA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
Older people: No dosage adjustment is required for elderly patients (see PHARMACOLOGY: Pharmacokinetics under Actions).
Paediatric population: Initiation of treatment must be performed under review of a specialist.
Children and adolescents ≥6: The safety and efficacy of ezetimibe in children aged 6 to 17 years has not been established. Current available data are described in Precautions, Adverse Reactions, PHARMACOLOGY: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
When Ezetimibe TEVA is administered with a statin, the dosage instructions for the statin, in children should be consulted.
Children <6 years: The safety and efficacy of Ezetimibe in children aged <6 years has not been established. No data are available.
Patients with hepatic impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Ezetimibe TEVA 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 under Actions.)
Patients with renal impairment: No dosage adjustment is required for renally impaired patients (see PHARMACOLOGY: Pharmacokinetics under Actions).
