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Recommended Dose: General: Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients, and to treat underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with atorvastatin. The dosage range is 10 to 80mg once daily. Doses may be given any time of the day, with or without food. Starting and maintenance dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly.
Primary hypercholesterolemia and combined (mixed) hyperlipidemia: The majority of patients are controlled with 10mg atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.
Homozygous familial hypercholesterolaemia: Most patients responded to 80mg of atorvastatin with greater than 15% reduction in LDL-C (18%-45%).
Heterozygous familial hypercholesterolaemia in pediatric patients (10-17 years of age): The recommended starting dose of atorvastatin is 10mg/day; the usual dose range is 10 to 20mg orally once daily. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals or 4 weeks or more.
Severe Dyslipidemias in Pediatric Patients: For patients aged 10 years and above, the recommended starting dose is 10 mg atorvastatin once daily. The dose may be increased to 80 mg daily, according to the response and tolerability. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.
Use in patients with hepatic insufficiency: See Contraindications and Precautions.
Use in patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or on the LDL-C reduction with atorvastatin. Thus, no adjustment of the dose is required.
Use in the elderly: No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population.
Dosage in patients taking cyclosporine, clarithromycin, itraconazole, or certain protease inhibitors: In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin should be limited to 20mg, 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 or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin should be limited to 40mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed.
Use in children (homozygous familial hypercholesterolaemia): Treatment experience in a pediatric population is limited to doses of atorvastatin up to 80mg/day for one year in patients with homozygous FH.
Route of Administration: For oral administration only. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
