Dexmethylphenidate Pregnancy and Breastfeeding Warnings

Brand names: Focalin, Focalin XR

Medically reviewed by Drugs.com. Last updated on Aug 15, 2023.

Dexmethylphenidate Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

Administration of this drug to rats and rabbits at doses up to 20 and 100 mg/kg/day, respectively, during organogenesis did not show teratogenicity; administration of racemic methylphenidate in doses up to 200 mg/kg/day has been shown to have teratogenic effects in rabbits. Delayed fetal skeletal ossification was observed at 20 mg/kg/day in rats. Administration throughout pregnancy and lactation to rats at doses estimated to be 5 times the maximum recommended human dose showed decreased postweaning weight gain in male offspring, but no other effects on postnatal development. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Dexmethylphenidate Breastfeeding Warnings

This drug is the more pharmacologically active d-enantiomer of racemic methylphenidate. No information is available on the clinical use of this drug during lactation, however, it has been estimated that a fully breastfed infant would receive a relative dose of 0.2% to 0.7% of the maternal weight adjusted dose.

Caution is recommended

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Breastfed infants should be monitored for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
-Long term neurodevelopmental effects on infants from CNS stimulant exposure are not known.

See references

Further information

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