Atozet Dosage/Direction for Use

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 Pharmacology: Pharmacodynamics: Clinical Studies under Actions, Table 1) 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.
Geriatric patients: No dose adjustment is required for older patients [see Pharmacology: Pharmacokinetics under Actions].
Paediatric population: The safety and efficacy of ATOZET in children has not been established [see Pharmacology: Pharmacokinetics under Actions]. No data are available.
Patients with hepatic impairment: ATOZET should be used with caution in patients with hepatic impairment [see Precautions and Pharmacology: Pharmacokinetics under Actions]. ATOZET is contraindicated in patients with active liver disease [see Contraindications].
Patients with renal impairment: No dose adjustment is required for renally impaired patients [see Pharmacology: Pharmacokinetics under Actions].
Cyclosporine, Clarithromycin, Itraconazole, or Certain HIV/HCV Antiviral Agents: In patients taking cyclosporine or the HIV protease inhibitors tipranavir plus ritonavir or the hepatitis C protease inhibitor telaprevir, therapy with ATOZET should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing ATOZET and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, the hepatitis C antiviral agents boceprevir, elbasvir, grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with ATOZET should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the HIV protease inhibitor nelfinavir therapy with ATOZET should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. [See Myopathy/Rhabdomyolysis under Precautions.]
Other Concomitant Lipid-Lowering Therapy: The combination of ATOZET and fibrates is not recommended.
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.