Pregnancy: The safety of methylphenidate for use during human pregnancy has not been established. No studies are available on the use of CONCERTA in pregnant women. CONCERTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Methylphenidate hydrochloride has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times the maximum recommended human dose on a mg/kg basis.
Teratogenic effects were not seen in rats at methylphenidate hydrochloride doses up to 30 mg/kg/day, resulting in an approximate systemic exposure to methylphenidate of nine to twelve times that seen in trials in volunteers and patients with the maximum recommended dose of CONCERTA, based on pharmacokinetic data.
Breast-feeding: Methylphenidate has been detected in human milk. Based on breast milk sampling from five mothers, methylphenidate concentrations in human milk resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage, and a milk to maternal plasma ratio ranging between 1.1 and 2.7. Caution should be exercised if CONCERTA is administered to a breast-feeding woman.
Fertility: Methylphenidate did not impair fertility in mice that received up to 160 mg/kg/day methylphenidate hydrochloride in an 18-week Continuous Breeding study.