Is Diphenoxylate Hydrochloride compatible with breastfeeding? Do we have alternatives for Diphenoxylate Hydrochloride?

Diphenoxylate Hydrochloride

August 30, 2018 (Low Risk)

An opioid, synthetic derivative of pethidine with little or no analgesic effect. It acts by decreasing intestinal motility and with it the frequency and fluidity of bowel movements.
Used orally every 6 hours for the symptomatic treatment of acute diarrhea.

Since the last update we did not found published data on its excretion in breastmilk.

Although the manufacturer warns that its active metabolite could be excreted in breastmilk (Pfizer 2017), several expert authors believe that excretion in breastmilk is minimal (Hale 2017 p289, Chen 2010).

In order to prevent its abuse it is often associated with atropine, which could affect breastfed children (Gattuso 1994). However, the American Academy of Pediatrics classifies atropine as compatible with breastfeeding (AAP 2001).

Its indiscriminate use in gastroenteritis is not justifiable. Most gastroenteritis does not require medication: good hydration and maintaining a normal diet is sufficient.

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in case of prematurity.

Alternatives

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Дифеноксилата Гидрохлорид (Cyrillic)
  • 塩酸ジフェノキシラート (Japanese)
  • Chlorhydrate de Diphénoxylate (French)
  • C30 H32 N2 O2 (Molecular formula)
  • Ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate hydrochloride (Chemical name)
  • A07DA01 (ATC Code/s)

References

  1. Pfizer. Diphenoxylate. Drug Summary. 2017 Full text (in our servers)
  2. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  3. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010Abstract Full text (link to original source) Full text (in our servers)
  4. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001Abstract Full text (link to original source) Full text (in our servers)
  5. Gattuso JM, Kamm MA. Adverse effects of drugs used in the management of constipation and diarrhoea. Drug Saf. 1994Abstract