Question

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?

Promactil lactation summary

Promactil usage has low risk in breastfeeding
  • DrLact safety Score for Promactil is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of Promactil may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that Promactil may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of Promactil low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using Promactil We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Promactil usage in lactation

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.

Answer by DrLact: About Promactil usage in lactation

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.

Promactil Side Effects in Breastfeeding

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]

Promactil Possible Effects in Breastfeeding

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]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.