Dexmethylphenidate

The Basics

What is Dexmethylphenidate?

Used as part of a treatment program to control symptoms of ADHD.

Brand names for Dexmethylphenidate

Focalin

How Dexmethylphenidate is classified

Adrenergic Agents, Central Nervous System Stimulants, Dopamine Agents, Sympathomimetics

Dexmethylphenidate During Pregnancy

Dexmethylphenidate pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dexmethylphenidate while pregnant

In studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels (AUCs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose (MRHD) of 20 mg/day. Racemic methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. Adequate and well-controlled studies in pregnant women have not been conducted. Focalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Dexmethylphenidate While Breastfeeding

What are recommendations for lactation if you're taking Dexmethylphenidate?

Dexmethylphenidate is an isomer of methylphenidate. No information is available on the clinical use of dexmethylphenidate during breastfeeding; however, the manufacturer estimates that a fully breastfed infant would receive a relative dose of 0.2 to 0.7% of the maternal weight adjusted dose. In dosages prescribed for medical indications, limited evidence indicates that methylphenidate levels in milk are very low and not detectable in infant serum. The effects of methylphenidate in milk on the neurological development of the infant have not been well studied. If methylphenidate is required by the mother, it is not a reason to discontinue breastfeeding.[1] It is possible that large dosages of methylphenidate might interfere with milk production, especially in women whose lactation is not well established.

Maternal / infant drug levels

Dexmethylphenidate is an isomer of methylphenidate. No information is available on the clinical use of dexmethylphenidate during breastfeeding; however, the manufacturer estimates that a fully breastfed infant would receive a relative dose of 0.2 to 0.7% of the maternal weight adjusted dose. In dosages prescribed for medical indications, limited evidence indicates that methylphenidate levels in milk are very low and not detectable in infant serum. The effects of methylphenidate in milk on the neurological development of the infant have not been well studied. If methylphenidate is required by the mother, it is not a reason to discontinue breastfeeding.[1] It is possible that large dosages of methylphenidate might interfere with milk production, especially in women whose lactation is not well established.

Possible effects of Dexmethylphenidate on milk supply

Methylphenidate reduces serum prolactin,[7] but no studies have been located as of the revision date on the effect of methylphenidate or dexmethylphenidate on milk production. The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

A 15-year-old girl had been receiving methylphenidate 54 mg daily in an osmotic release tablet (OROS) for 2 years. Sertraline was started for depression at 50 mg daily and increased to 100 mg daily along with haloperidol 0.5 mg daily. After 12 weeks of therapy, inattentativeness at school and headaches prompted a change from the OROS product to a modified-release methylphenidate product (brand not specified) at 30 mg daily, then increasing to 50 mg daily. Three days after the increase in dosage, the girl had spontaneous milk flow from both breasts and subsequently had an elevated serum prolactin of 67.7 mcg/L. Methylphenidate and haloperidol were discontinued, but sertraline was continued. One week later, galactorrhea resolved completely. Fifteen days after drug discontinuation, the girl’s prolactin level was in the normal range at 19.4 mcg/L.[8]

Possible alternatives to Dexmethylphenidate

Amphetamine, Methylphenidate.