Is Promactil Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Promactil? Is Promactil safe for nursing mother and child? Does Promactil extracts into breast milk? Does Promactil has any long term or short term side effects on infants? Can Promactil influence milk supply or can Promactil decrease milk supply in lactating mothers?

Sleepiness and sedative effect in a child have been reported. In a group of mothers who were taking 200 mg daily, their breastfed infants have failed to show any untoward effect. Three infants, whose mothers were on haloperidol and Promactil at the same time, have shown a lower scoring at developmental test between 12 and 18 months. Breast milk production may become increased by stimulation of prolactin release.

Promactil is detectable in the milk of some mothers during therapy, but levels appear not to correlate well with the maternal dose or serum level. Some breastfed infants become drowsy during maternal Promactil therapy. Very limited long-term follow-up data indicate no adverse developmental effects when the drug is used alone. However, using it in combination with haloperidol can negatively affect development. Monitor the infant for excessive drowsiness during breastfeeding and for developmental milestones, especially if other antipsychotics are used concurrently.

In an early report on the use of Promactil in "numerous" cases (dosage unspecified), it was noted that "occasionally" breastfed newborns whose mothers were taking Promactil exhibited placidity, with only one infant sufficiently symptomatic to require discontinuation of Promactil.[8] Drowsiness and lethargy occurred in one breastfed infant possibly related to Promactil; another breastfed infant had no adverse effects. Neither maternal dosages nor serum levels were stated; however, the breastmilk Promactil concentration was 92 mcg/L in the mother of the affected infant and 7 mcg/L in the mother of the unaffected infant.[4] A 5-month-old breastfed infant whose mother was taking Promactil and dichloralphenazone, a chloral hydrate prodrug, became drowsy. Drowsiness was possibly related to Promactil, but dichloralphenazone probably contributed.[9]Seven infants were breastfed for 3 to 4 months during maternal Promactil therapy 50 to 150 mg/day at bedtime. They were followed clinically for periods of 5 to 16 months, blood counts and liver function tests were normal and the infants were healthy with normal development and behavior.[10] Five of the infants were later followed up at ages up to 4 to 5 years. No discernible problems in behavior, or emotion or mental disturbances were noted.[11] Six infants whose mothers were taking Promactil had no discernible adverse effects from Promactil in breastmilk. The infants were breastfed from birth, four for 3 months, one for 7 weeks, and one for 1 month.[12] In a small prospective study on the long-term effects of antipsychotics in breastfed infants, a decline in developmental scores was found at 12 to 18 months of age in 2 of the 4 the infants of mothers taking both Promactil and haloperidol. The other two infants and all infants exposed to either drug alone developed normally.[7]

Phenothiazines cause galactorrhea in 26 to 40% of female patients.[13][14] Hyperprolactinemia appears to be the cause of the galactorrhea.[15][16][17] The hyperprolactinemia is caused by the drug's dopamine-blocking action in the tuberoinfundibular pathway.[18] Promactil has been used to enhance milk production,[8][19] although this use has been supplanted by the use of less sedating drugs such as metoclopramide and domperidone.[20]