RiteMED Atorvastatin Special Precautions

Atorvastatin is contraindicated in pregnancy and while breast-feeding. Women of childbearing potential should use appropriate contraceptive measures.
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 other underlying medical problems (see Indications).
Endocrine Function: HMG-CoA reductase inhibitors interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Clinical studies have shown that atorvastatin does not reduce basal plasma cortisol concentration or impair adrenal reserve. The effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Caution should be exercised if an HMG-COA reductase inhibitor is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.
Use in Children: Children aged 10-17 years: In patients aged <18 years, efficacy and safety have not been studied for treatment periods >52 weeks' duration and effects on long-term cardiovascular outcomes are unknown.
The effects of atorvastatin in children aged <10 years and premanarchal girls have not been investigated.
Long term effects on cognitive development, growth and pubertal maturation are unknown.