sology and method of administration
Posology
Hypercholesterolaemia and/or Coronary Heart Disease (with ACS History)
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 3) and the response to the current cholesterol-lowering therapy. Adjustment of dose should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolaemia
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.
Coadministration with bile acid sequestrants
Dosing of ATOZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
Older people
No dose adjustment is required for older patients (see section 5.2).
Paediatric population
The safety and efficacy of ATOZET in children has not been established (see section 5.2). No data are available.
Patients with hepatic impairment
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).
Patients with renal impairment
No dose adjustment is required for renally impaired patients (see section 5.2).
Method of administration
ATOZET is for oral administration. ATOZET can be administered as a single dose at any time of the day, with or without food.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Therapy with ATOZET is contraindicated during pregnancy and breast-feeding, and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).
ATOZET is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases exceeding 3 times the upper limit of normal (ULN).
4.4 Special warnings and precautions for use
Myopathy/Rhabdomyolosis
In post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin concomitantly with ezetimibe. However, rhabdomyolysis has been reported very rarely with ezetimibe monotherapy and very rarely with the addition of ezetimibe to other agents known to be associated with increased risk of rhabdomyolysis.
ATOZET contains atorvastatin. Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated creatine phosphokinase (CPK) levels (>10 times ULN), myoglobinaemia and myoglobinuria, which may lead to renal failure.
Before the treatment
ATOZET should be prescribed with caution in patient |
