Is Sulpiride safe while breastfeeding?

Effects on the breastfed infant

In a study of 14 women given sulpiride 50 mg 3 times daily for 4 weeks, no side effects were reported in their breastfed infants.[ 5 ] In a study of 24 nursing mothers who received sulpiride 50 mg 3 times daily for 2 weeks, no side effects were reported in their breastfed infants.[ 4 ] In a study comparing sulpiride to placebo for enhancement of milk production, infant weight gain was greater in the infants of treated women up to day 15, but there was no difference in weight gain between the groups thereafter.[ 9 ]

Effects on milk supply

Sulpiride increases serum prolactin and may cause galactorrhea at a higher rate than other psychotropic drugs.[ 10 - 14 ] The levo- isomer, levosulpiride, which is available abroad, has also caused hyperprolactinemia and galactorrhea.[ 15 ] Several studies have been published on the use of sulpiride in enhancing milk supply.[ 4 , 5 , 7 , 9 , 10 , 16 , 17 ] Most of the studies have serious design flaws. Although these studies were all placebo controlled, only 3 studies were blinded and randomized. In one study, 28 women were randomized to sulpiride 50 mg (n = 14) or placebo (n = 14) 3 times daily for 4 weeks. Women were within 4 months postpartum and had identified themselves as having insufficient milk. The two groups were fairly well matched at the initiation of the trial, except that mothers in the placebo group had been supplementing for longer than women in the sulpiride group, 33 and 22 days, respectively. Mothers in both groups fed their infants an average of 5.3 times daily. Mothers were given no instruction on breastfeeding technique. Serum prolactin rose in sulpiride-treated patients to about 400 mcg/L and fell slightly in placebo-treated patients. However, neither milk yields at the beginning of the study nor increases in yield showed any relationship to increases in serum prolactin. Infant weight gain was greater in the treated patients at the end of the study (1081 vs 795 grams); however, most of the infants in both groups were given supplementary feedings, so it is impossible to tell if the weight gain in the sulpiride group was caused by increased milk production or by the supplementation.[ 5 ] A study of 66 primiparous mothers with normal infants who expressed a desire to breastfeed, received sulpiride 100 mg 3 times daily for the first 4 days postpartum, then 50 mg 3 times daily for the next 86 days. Mothers who received sulpiride maintained elevated baseline serum prolactin levels of 117 to 119 mcg/L throughout the 90-day study period. Mothers takin

Levels in milk

Maternal Levels. In a study reported only in abstract form, sulpiride was not detected in milk (study details and assay limit not stated) with maternal dosages of up to 200 mg daily.[ 6 ] Twenty women were taking sulpiride 50 mg twice daily by mouth to enhance milk production. A single milk sample from each woman was taken at 2 hours after the morning dose between the 3rd to the 7th day of therapy. The average milk sulpiride concentration was 970 mcg/L (range 260 to 1970 mcg/L).[ 7 ] This translates to an average daily maximum infant dosage of 146 mcg/kg (range 39 to 297 mcg/kg) in the infant or 8.7% (range 2 to 18%) of the weight-adjusted maternal dosage. Single doses of sulpiride of either 3 mg (n = 5) or 10 mg (n = 4) were given to nursing mothers. After 3 mg, peak milk concentrations ranged from 10 to 37 mcg/L and trough concentrations ranged from 9 to 13 mcg/L. After 10 mg, peak milk concentrations ranged from 37 to 293 mcg/L and trough concentrations ranged from 29 to 85 mcg/L. The authors calculated that a 24-hlur dose to the infant would range from 1.2 to 9.9 mcg after a 3 mg maternal dose and from 3.8 to 46.3 mcg after a 10 mg maternal dose.[ 3 ] A woman with dissociative disorder and persistent dysthymic depression was treated during pregnancy with brotizolam 0.25 mg daily, propericiazine 10 mg daily, and zolpidem 5 mg daily. Zolpidem was discontinued at week 28 and sulpiride 100 mg daily was begun at week 33. Milk samples taken at 7.5 and 11.5 hours after the previous dose on day 9 postpartum contained 445.8 and 192.2 mcg/L of sulpiride, respectively.[ 8 ] Infant Levels. Relevant published information was not found as of the revision date.

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