Question

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

Ampliactil lactation summary

Ampliactil usage has low risk in breastfeeding
  • DrLact safety Score for Ampliactil is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of Ampliactil may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that Ampliactil may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of Ampliactil low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using Ampliactil 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 Ampliactil 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 Ampliactil 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 Ampliactil usage in lactation

Ampliactil 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 Ampliactil 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.

Ampliactil Side Effects in Breastfeeding

In an early report on the use of Ampliactil in "numerous" cases (dosage unspecified), it was noted that "occasionally" breastfed newborns whose mothers were taking Ampliactil exhibited placidity, with only one infant sufficiently symptomatic to require discontinuation of Ampliactil.[8] Drowsiness and lethargy occurred in one breastfed infant possibly related to Ampliactil; another breastfed infant had no adverse effects. Neither maternal dosages nor serum levels were stated; however, the breastmilk Ampliactil 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 Ampliactil and dichloralphenazone, a chloral hydrate prodrug, became drowsy. Drowsiness was possibly related to Ampliactil, but dichloralphenazone probably contributed.[9]Seven infants were breastfed for 3 to 4 months during maternal Ampliactil 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 Ampliactil had no discernible adverse effects from Ampliactil 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 Ampliactil and haloperidol. The other two infants and all infants exposed to either drug alone developed normally.[7]

Ampliactil 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] Ampliactil 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]
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