Hyperlipidemia (Heterozygous Familial and Nonfamilial) and
Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a
large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage
range of LIPITOR is 10 to 80 mg once daily. LIPITOR can be administered as a single dose
at any time of the day, with or without food. The starting dose and maintenance doses of
LIPITOR should be individualized according to patient characteristics such as goal of
therapy and response (see current NCEP Guidelines). After initiation and/or upon titration
of LIPITOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted
accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age)
The recommended starting dose of LIPITOR 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 current NCEP Pediatric Panel
Guidelines, Clinical Pharmacology, and Indications and Usage]. Adjustments should be made at
intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia
The dosage of LIPITOR in patients with homozygous FH is 10 to 80 mg daily. LIPITOR should be
used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients
or if such treatments are unavailable.
Concomitant Lipid-Lowering Therapy
LIPITOR may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be
be used with caution [see Warnings and Precautions, Skeletal Muscle, Drug Interactions].
Dosage in Patients With Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of LIPITOR;
thus, dosage adjustment in patients with renal dysfunction is not necessary
[see Warnings and Precautions, Skeletal Muscle, Clinical Pharmacology, Pharmacokinetics].
Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir
plus Saquinavir or Lopinavir plus Ritonavir
In patients taking cyclosporine, therapy should be limited to LIPITOR 10 mg once daily.
In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of ritonavir
plus saquinavir or lopinavir plus ritonavir, for doses of LIPITOR exceeding 20 mg, appropriate
clinical assessment is recommended to ensure that the lowest dose necessary of LIPITOR is
employed [see Warnings and Precautions, Skeletal Muscle, Drug Interactions].
DOSAGE FORMS AND STRENGTHS
White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium.