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 the underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with atorvastatin. The dosage range is 10 mg to 80 mg 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 10 mg atorvastatin once daily. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia: In a compassionate-use study of patients with homozygous familial hypercholesterolemia, most patients responded to 80 mg atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy (see Indications/Uses and Pharmacology: Pharmacodynamics under Actions). Adjustments should be made at intervals of 4 weeks or more.
Experience in pediatric patients younger than 10 years of age is derived from open-label studies (see Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics: Special Populations under Actions).
Use in Patients with Hepatic Insufficiency: See Contraindications and Precautions.
Use in Patients with Renal Insufficiency: Renal disease has no influence on plasma concentrations or on LDL-C reduction with atorvastatin. Thus, no dose adjustment is required (see Precautions).
Use in the Elderly: No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Use in Combination with Other Medicinal Compounds: In cases where co-administration of atorvastatin with cyclosporine, telaprevir, the combination tipranavir/ritonavir, or glecaprevir/pibrentasvir is necessary, the dose of atorvastatin should not exceed 10 mg.
Use of atorvastatin is not recommended in patients taking letermovir co-administered with cyclosporine.
Pharmacokinetic drug interactions that result in increased systemic concentration of atorvastatin have also been noted with other human immunodeficiency virus (HIV) protease inhibitors (lopinavir/ritonavir, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, fosamprenavir/ritonavir and nelfinavir), hepatitis C virus (HCV) protease inhibitors (boceprevir, elbasvir/grazoprevir, simeprevir), clarithromycin, itraconazole, and letermovir. Caution should be used when co-prescribing atorvastatin, and appropriate clinical assessment is recommended to ensure that the lowest dose of atorvastatin necessary is employed (see Skeletal Muscle Effects under Precautions and Interactions).
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