Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
ATOZET 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), either previously treated with a statin or not.
ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate.
ATOZET is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive adjunctive treatments (e.g. low-density lipoprotein [LDL] apheresis).
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ATOZET.
The dose range of ATOZET is 10/10 mg/day through 10/80 mg/day. The typical dose is 10/10 mg once a day. The patient’s low-density lipoprotein cholesterol (LDL-C) level, coronary heart disease risk status, and response to current cholesterol-lowering therapy should be considered when starting therapy or adjusting the dose.
The dose of ATOZET should be individualised based on the known efficacy of the various dose strengths of ATOZET (see section 5.1, Table 4) and the response to the current cholesterol-lowering therapy. Adjustment of dose should be made at intervals of 4 weeks or more.
The dose of ATOZET in patients with homozygous FH is 10/10 to 10/80 mg daily. ATOZET may be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
Dosing of ATOZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
In patients taking hepatitis C antiviral agents elbasvir/grazoprevir concomitantly with ATOZET, the dose of ATOZET should not exceed 10/20 mg/day (see sections 4.4 and 4.5).
No dose adjustment is required for older patients (see section 5.2).
The safety and efficacy of ATOZET in children has not been established (see section 5.2). No data are available.
ATOZET should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2). ATOZET is contraindicated in patients with active liver disease (see section 4.3).
No dose adjustment is required for renally impaired patients (see section 5.2).
ATOZET is for oral administration. ATOZET can be administered as a single dose at any time of the day, with or without food.
In the event of an overdose, symptomatic and supportive measures should be employed. Liver function tests should be performed and serum CPK levels should be monitored.
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 hyperlipidaemia for up to 56 days, was generally well tolerated. A few cases of overdose have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. 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.
Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
2 years.
Store in the original package in order to protect from oxygen.
ATOZET 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg:
Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-purged aluminium/aluminium (oPA-AlPVC cavity with Al lidding) blisters.
Packs of 30 × 1 and 45 × 1 film-coated tablets in unit dose nitrogen-purged aluminium/aluminium (oPA-Al-PVC cavity with Al lidding) blisters.
Not all pack sizes may be marketed.
No special requirements.
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