Source: Medicines Authority (MT) Revision Year: 2022 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Ezoleta, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone.
Ezoleta monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated.
Ezoleta is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.
Ezoleta co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).
Ezoleta is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia.
The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezoleta.
The recommended dose is one Ezoleta 10 mg tablet daily. Ezoleta can be administered at any time of the day, with or without food.
When Ezoleta 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.
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.
Dosing of Ezoleta should occur either at least 2 hours before or not less than 4 hours after administration of a bile acid sequestrant.
No dosage adjustment is required for elderly patients (see section 5.2).
Initiation of treatment must be performed under review of a specialist.
The safety and efficacy of ezetimibe in children aged 6 to 17 years has not been established. Current available data are described in sections 4.4, 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
When Ezoleta is administered with a statin, the dosage instructions for the statin in children should be consulted.
The safety and efficacy of ezetimibe in children aged <6 years has not been established. No data are available.
No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Ezoleta is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score more than 9) liver dysfunction. (See sections 4.4 and 5.2.)
No dosage adjustment is required for renally impaired patients (see section 5.2).
Route of administration is oral.
In clinical studies, administration of ezetimibe, 50 mg/day, to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days, was generally well tolerated. In animals, no toxicity was observed after single oral doses of 5,000 mg/kg of ezetimibe in rats and mice and 3,000 mg/kg in dogs.
A few cases of overdose with ezetimibe have been reported. Most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
5 years.
Store in the original package in order to protect from moisture.
Blister (OPA/Alu/PVC//Alu): 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets, in a box.
Blister (perforated unit dose blisters, OPA/Alu/PVC//Alu): 14 × 1, 28 × 1, 30 × 1, 50 × 1, 56 × 1, 60 × 1, 90 × 1, 98 × 1, 100 × 1 tablet, in a box.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
