Medications used to treat gastrointestinal symptoms are often prescribed during breastfeeding. However, there is little information describing the transfer into human milk for many of these drugs. Some of the gastrointestinal agents can be administrated during breastfeeding: antacids, sulcrafate, Helicobacter pylori therapy, domperidone, metoclopramide and carminatives. Other groups of gastrointestinal medications are drugs of choice: famotidine as H2-receptor blocker, omeprazole and pantoprazole as proton-pump inhibitors, bulking agents and osmotic laxative as laxatives, and meclizine as an antiemetic. Lipid reducers, appetite suppressants and chenodeoxycholic acid are contraindicated during breastfeeding. As a general rule, the progress of infants exposed to maternal gastrointestinal drugs during breastfeeding should be monitored appropriately.

Gastritis and ulcer medications

Antacids

Classic antacids such as sodium hydrogen carbonate , aluminum phosphate , calcium carbonate and carbaldrate , whose effect is similar to aluminum hydroxide , are only absorbed by the mother to a very limited degree. This also applies to the combination preparations of aluminum and magnesium such as hydrotalcite , magaldrate and almasilate . There are no available data on trials involving aluminum or other antacids during breastfeeding. Also, long-term use has not been evaluated.

Combinations of, for instance, calcium carbonate and magnesium salts, of an aluminum-containing substance such as algeldrate and magnesium salts, of alginic acid combinations, or combinations with licorice root, appear to be safe when therapeutic doses are used.

Recommendation

Antacids can be used during breastfeeding. Fixed combinations of aluminum and magnesium salts as well as combination preparations are preferable, whereby attention should be paid to keeping to a therapeutic dose.

H 2 -Receptor-blocker

Cimetidine , famotidine and ranitidine block H 2 -histamine-receptors in the stomach lining/gastric mucosa; this leads to reduced secretion of hydrochloric acid.

Cimetidine and ranitidine reach relatively high concentrations in mother’s milk. According to a study of 12 women who received single doses of 100, 600 or 1200 mg, cimetidine was actively transported into the milk with an M/P ratio of about 5. An infant received, on average, 6–7% of the maternal weight-related dose, though at maximum it was as much as 20% ( ).

With nizatidine therapy, a maximum of 5% of the maternal weight-related dose can be secreted into the milk ( ). This was reported in five mothers who received 150 mg every 12 hours for five doses.

Also with maternal therapy of ranitidine, 150–300 mg/day, a relative dose of up to 20% can reach the infant. The M/P ratio varies between 1 and over 20 (survey in ).

With famotidine the relative dose in the milk was lower than 2%, according to a study of eight mothers receiving a single dose of 40 mg ( ).

Recommendation

Famotidine is the H 2 blocker of choice during breastfeeding.

Proton-pump inhibitors (PPIs)

PPIs, such as omeprazole , esomeprazole , an isomer of omeprazole, lansoprazole , pantoprazole and rabeprazole block acid secretion in the stomach.

In a case report on omeprazole, a maximum weight-adjusted dose for a fully breastfed infant was measured at less than 7% ( ). According to a case report, pantoprazole only transfers into the mother’s milk in small amounts (2.8% of the maternal plasma levels). After 40 mg maternal dose the relative infant dose was under 1% ( ). In both these cases, the infants were clinically unremarkable.

Recommendation

Pantoprazole and omeprazole are the PPI of choice during breastfeeding.

Further ulcer medications

Sucralfate is only minimally absorbed enterally. There are no data available on the passage into the mother’s milk. This also applies to the so-called M1-receptor blocker, pirenzepine , the prostaglandin derivative, misoprostol and for bismuth nitrate .

Recommendation

Sucralfate can be administered during breastfeeding. The other medications should be avoided.

Helicobacter pylori therapy

Recommendation

Helicobacter therapy consisting of a PPI, clarithromycin and metronidazole or amoxicillin can be carried out during breastfeeding ( Chapter 4.4 ).

Peristaltic stimulators

The antiemetic metoclopramide eases the emptying of the stomach and increases milk production via its central antidopaminergic action. It may be used occasionally for 1 to 4 weeks in a dose of 3 × 10–15 mg/day to promote milk production ( ).

Numerous studies using metoclopramide to increase milk production were published. Many of them assessed a small sample size and used an inadequate clinical design. The young infant whose mother took 10–15 mg/3 × daily for many weeks received a maximum of 4.7% of a weight-related child’s dose. In only one case among more than 20 mother–child pairs could the substance be measured in the infant’s plasma ( ). No symptoms or disturbances of pituitary regulation were observed in breastfed children ( ). In a randomized double-blind study, investigated more than 60 mothers of preterm newborns who received either metoclopramide or a placebo, with respect to the amount of milk and duration of lactation. There were no significant differences between the two groups. In a more recent randomized double-blind study metoclopramide (10 mg/3 × daily) and placebo were taken for 8 days beginning within 36 hours of delivery ( ), with no significant difference between the two groups with regard to milk secretion. These two well-planned studies used metoclopramide early after delivery (within 96 hours and 36 hours), corresponding times of high plasma levels of prolactin. This means that metoclopramide should not be expected to work as a galactagogue when plasma prolactin levels are high. By contrast, in other cases, metoclopramide was used successfully (survey in ). A woman with agenesis of the uterus, whose fertilized egg cells were successfully carried by a surrogate mother, expressed a wish during the pregnancy to breastfeed the baby after birth. She received 10 mg metoclopramide 3 × a day from week 28 until delivery. The effect was confirmed by concentrations of the serum prolactin and estradiol. In addition, the nipples were stimulated with a breast pump. The woman successfully breastfed the baby until the age of 3 months. However, due to insufficient milk, supplementation (with formula) was necessary ( ).

The peripheral dopamine antagonist domperidone is present only in a minimal concentration in the milk. No more than 0.4% of the maternal weight-related dose was calculated to be present in the milk ( ). The moderately high molecular mass of 426 and a protein binding of >90% are grounds for the low relative dose determined for the child. By comparison to metoclopramide, domperidone is less able to cross the blood–brain barrier. Therefore the risk for central nervous system side effects is low and such symptoms have not, as yet, been observed in breastfed infants. The argument presented in the US as an objection against domperidone treatment – that it could lead to cardiac arrest – refers to experiences with patients treated with high doses administered by i.v., which are not comparable with the usual oral therapy of the mother and the breastfed infant. To increase milk production, 10 mg/3 × daily for 1–2 weeks (off-label) are recommended ( ). A double blind study of seven women exposed to domperidone, and nine women using a placebo while breastfeeding premature infants showed that with domperidone, the amount of milk could be increased by 49.5 mL per day ( ). In a further study, the milk production and the milk composition of mothers of premature infants who received either domperidone ( n = 21) or a placebo ( n = 24) were compared ( ). The volume of milk with domperidone could be increased satisfactorily with only a minimal change in the composition of the milk. However, a significant difference was a somewhat higher proportion of calcium and carbohydrates in the domperidone milk samples. Two meta-analyses of randomized controlled trials on domperidone as a galactagogue concluded that it does indeed increase milk production in comparison with a placebo ( ).

Two small studies compared two dosages of domperidone (10 mg/3 × daily versus 20 mg/3 × daily). Both dosages increased milk production, but there was no statistically significant difference in milk volume between the two groups ( ). Dosages greater than 30 mg daily should be used carefully because of the risk of arrhythmias.

Recommendation

Domperidone and metoclopramide may be used during breastfeeding (preferably after complete initiation of lactation and/or measuring of plasma prolactin levels). Galactagogue medication should never replace evaluation and counseling on modifiable factors that affect milk production.

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