Lipitor Warnings & Precautions

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Lipitor - Warnings & Precautions [Atorvastatin]

Nursing Mothers

Nursing rat pups had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk. Because of the potential for adverse reactions in nursing infants, women taking Lipitor should not breast-feed (see CONTRAINDICATIONS).

Pediatric Use

Safety and effectiveness in patients 10-17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial of 6 months duration in adolescent boys and postmenarchal girls. Patients treated with Lipitor had an adverse experience profile generally similar to that of patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality assessment, were infections. Doses greater than 20 mg have not been studied in this patient population. In this limited controlled study, there was no detectable effect on growth or sexual maturation in boys or on menstrual cycle length in girls. (see CLINICAL PHARMACOLOGY, Clinical Studies section; ADVERSE REACTIONS, Pediatric Patients (10-17 years of age); and DOSAGE AND ADMINISTRATION, Heterozygous Familial

Hypercholesterolemia in Pediatric Patients (10-17 years of age).)

Adolescent females should be counseled on appropriate contraceptive methods while on Lipitor therapy (see CONTRAINDICATIONS and PRECAUTIONS, Pregnancy). Lipitor has not been studied in controlled clinical trials involving prepubertal patients or patients younger than 10 years of age.

Clinical efficacy with doses up to 80 mg/day for 1 year have been evaluated in an uncontrolled study of patients with homozygous FH including 8 pediatric patients. (see CLINICAL PHARMACOLOGY, Clinical Studies: Homozygous Familial Hypercholesterolemia.)

Geriatric Use

The safety and efficacy of atorvastatin (10-80 mg) in the geriatric population (65 years of age) was evaluated in the ACCESS study. In this 54-week open-label trial 1,958 patients initiated therapy with atorvastatin 10 mg. Of these, 835 were elderly (65 years) and 1,123 were nonelderly. The mean change in LDL-C from baseline after 6 weeks of treatment with atorvastatin 10 mg was -38.2% in the elderly patients versus -34.6% in the nonelderly group.

The rates of discontinuation due to adverse events were similar between the two age groups. There were no differences in clinically relevant laboratory abnormalities between the age groups.