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Dexmethylphenidate Pregnancy and Breastfeeding Warnings

Dexmethylphenidate is also known as: Focalin, Focalin XR

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexmethylphenidate Extended-Release Capsules while you are pregnant. It is not known if Dexmethylphenidate Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Dexmethylphenidate Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Dexmethylphenidate Pregnancy Warnings

Dexmethylphenidate has been assigned to pregnancy category C by the FDA. Animal studies have reported teratogenic effects including delayed skeletal ossification and decreased postweaning weight gain. There are no controlled data in human pregnancy. Dexmethylphenidate is only recommended for use during pregnancy when benefit outweighs risk.

Dexmethylphenidate Breastfeeding Warnings

Information from four published case reports on the use of racemic methylphenidate during breastfeeding suggest that at maternal doses of 35 to 80 mg/day, milk concentrations of methylphenidate range from undetectable to 15.4 ng/mL. Based on these limited data, the calculated infant daily dose for an exclusively breastfed infant would be about 0.4 to 2.9.9 mcg/kg/day or about 0.2% to 0.7% of the maternal weight adjusted dose.

Dexmethylphenidate has been detected in human milk. The manufacturer recommends caution be used when administering dexmethylphenidate to nursing women.

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