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Zettrol

Zettrol Dosage/Direction for Use

ezetimibe

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
Dosage/Direction for Use
Posology: The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe.
Route of administration is oral. The recommended dose is one Ezetimibe 10 mg tablet daily. Ezetimibe can be administered at any time of the day, with or without food.
When Ezetimibe 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 10 mg may be administered with a statin with proven cardiovascular benefit.
Coadministration with bile acid sequestrants: Dosing of Ezetimibe should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
Elderly: 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 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.
Hepatic impairment: No dosage adjustment is required in patients with mild hepatic impairment (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 under Actions).
Renal impairment: No dosage adjustment is required for renally impaired patients (see Pharmacology: Pharmacokinetics under Actions).
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