Last update Jan. 4, 2024

G02CB01; N04BC01

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

An ergot derivative alkaloid which is a prolactin inhibitor with dopaminergic activity, indicated for the treatment of prolactinomas and Parkinson's disease. Inhibits milk production by lowering prolactin level (Eglash 2014). Oral administration two to three times a day.

Severe and frequent side effects, that are even increased in the postpartum, are: hypertension, seizures, stroke, myocardial infarction and psychiatric disorders (Snellen 2016, Bernard 2015, Seeman 2015, Fedrizzi 2015, Kirsch 2001, Hopp 1996, Iffy 1996)) and thereof the indication to suppress lactation has been questioned by medical societies (Sénat 2016, Marcellin 2015, Oladapo 2012-2009) withdrawn in many countries (Nguyen 2015), switching to cabergoline has been proposed (Eglash 2014) along with non-pharmacological measures. (Prescrire Int. 2013, Wong 1985)

Pharmacokinetic data (moderately high molecular weight and high binding capacity to plasma proteins) explain the observed almost zero excretion into breastmilk (Peters 1985) or below detection limits (<0.2 micrograms / L).

In addition, its low oral bioavailability makes insignificant its absorption from breastmilk to the infant’s plasma.

A successful breastfeeding has been described on about 30 cases of hypergalactia-prolactinoma-hyperprolactinemia that were treated with a daily dose of 2.5 to 5 mg of Bromocriptine with no effects noticed on the infants. (Liu 2018, Verma 2006, Cheng 1996, Canales 1981)

Nor side effects occurred on 14 infants whose mothers received 2.5 mg of bromocriptine from 5th to 8th day after birth to treat an alleged galactorrhea. (Peters 1985)

The risk to breastfeeding is due to its ability to suppress milk production, not to the effects it may have on the infant, which have not been observed.

If Bromocriptine was eventually administered to suppress lactation but afterwards the mother is willing to resuming breastfeeding, the mother can do it immediately, trying to minimize the drug effect by frequent suckling the child to stimulate milk production.


See below the information of this related product:

Alternatives

  • Cabergoline ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Tradenames

Main tradenames from several countries containing G02CB01; N04BC01 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 6 %
Molecular weight 751 daltons
Protein Binding 90 - 96 %
VD 0.87 l/Kg
Tmax 1 - 3 hours
4.5 - 20 hours
Theoretical Dose 0 mg/Kg/d

References

  1. (ABM) Johnson HM, Eglash A, Mitchell KB, Leeper K, Smillie CM, Moore-Ostby L, Manson N, Simon L; Academy of Breastfeeding Medicine.. ABM Clinical Protocol #32: Management of Hyperlactation. Breastfeed Med. 2020 Mar;15(3):129-134. Abstract Full text (link to original source)
  2. Liu X, Liu Y, Gao J, Feng M, Bao X, Deng K, Yao Y, Wang R. Combination Treatment with Bromocriptine and Metformin in Patients with Bromocriptine-Resistant Prolactinomas: Pilot Study. World Neurosurg. 2018 Jul;115:94-98. Abstract
  3. Sénat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, Deffieux X, Diers F, Doret M, Ducroux-Schouwey C, Fuchs F, Gascoin G, Lebot C, Marcellin L, Plu-Bureau G, Raccah-Tebeka B, Simon E, Bréart G, Marpeau L. Postpartum practice: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2016 Abstract
  4. Snellen M, Power J, Blankley G, Galbally M. Pharmacological lactation suppression with D2 receptor agonists and risk of postpartum psychosis: A systematic review. Aust N Z J Obstet Gynaecol. 2016 Abstract
  5. Serrano Aguayo P, García de Quirós Muñoz JM, Bretón Lesmes I, Cózar León MV. Tratamiento de enfermedades endocrinológicas durante la lactancia. [Endocrinologic diseases management during breastfeeding.] Med Clin (Barc). 2015 Jan 20;144(2):73-9. Abstract
  6. Bernard N, Jantzem H, Becker M, Pecriaux C, Bénard-Laribière A, Montastruc JL, Descotes J, Vial T; French Network of Regional Pharmacovigilance Centres. Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey. BJOG. 2015 Abstract
  7. Seeman MV. Transient psychosis in women on clomiphene, bromocriptine, domperidone and related endocrine drugs. Gynecol Endocrinol. 2015 Abstract
  8. Marcellin L, Chantry AA. [Breast-feeding (part II): Lactation inhibition--Guidelines for clinical practice]. J Gynecol Obstet Biol Reprod (Paris). 2015 Abstract
  9. [No authors listed] Inhibiting the onset of lactation. Is cabergoline an alternative to bromocriptine? Prescrire Int. 2015 Abstract
  10. Christine Nguyen. Clarifying Questions from Bromocriptine Mesylate. Food and Drug Administration. Center for Drug Evaluation and Research. Pharmacy compounding advisory Committee (PCAC). 2015 Full text (in our servers)
  11. Sénat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, Deffieux X, Diers F, Doret M, Ducroux-Schouwey C, Fuchs F, Gascoin G, Lebot C, Marcellin L, Plu-Bureau G, Raccah-Tebeka B, Simon E, Bréart G, Marpeau L. [Post-partum: Guidelines for clinical practice--Short text]. J Gynecol Obstet Biol Reprod (Paris). 2015 Dec;44(10):1157-66. Abstract
  12. AEMPS. Bromocriptina. Ficha técnica. 2014 Full text (in our servers)
  13. Eglash A. Treatment of maternal hypergalactia. Breastfeed Med. 2014 Abstract Full text (link to original source) Full text (in our servers)
  14. [No authors listed] Do not use drugs to prevent onset of lactation. Relieve the discomfort and wait. Prescrire Int. 2013 Abstract
  15. Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005937. doi: 10.1002/14651858.CD005937.pub3. Full text (link to original source)
  16. Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2012 Abstract
  17. Oladapo OT, Fawole B. Treatments for suppression of lactation. Cochrane Database Syst Rev. 2009 Abstract
  18. Verma S, Shah D, Faridi MM. Breastfeeding a baby with mother on Bromocripine. Indian J Pediatr. 2006 Abstract
  19. Kirsch C, Iffy L, Zito GE, McArdle JJ. The role of hypertension in bromocriptine-related puerperal intracranial hemorrhage. Neuroradiology. 2001 Abstract
  20. Hopp L, Weisse AB, Iffy L. Acute myocardial infarction in a healthy mother using bromocriptine for milk suppression. Can J Cardiol. 1996 Abstract
  21. Cheng W, Zhang Z. [Management of pituitary adenoma in pregnancy]. Zhonghua Fu Chan Ke Za Zhi. 1996 Abstract
  22. Hopp L, Haider B, Iffy L. Myocardial infarction postpartum in patients taking bromocriptine for the prevention of breast engorgement. Int J Cardiol. 1996 Abstract
  23. Iffy L, McArdle JJ, Ganesh V. Intracerebral hemorrhage in normotensive mothers using bromocriptine postpartum. Zentralbl Gynakol. 1996 Abstract
  24. Iffy L, Lindenthal J, Mcardle JJ, Ganesh V. Severe cerebral accidents postpartum in patients taking bromocriptine for milk suppression. Isr J Med Sci. 1996 Abstract
  25. Pasinetti E, Schivardi MR, Falsetti L, Gastaldi A. [Effects of therapy and pregnancy on hyperprolactemia caused by a pituitary adenoma. A clinical case]. Minerva Ginecol. 1989 Abstract
  26. Peters F, Geisthövel F, Breckwoldt M. Serum prolactin levels in women with excessive milk production. Normalization by transitory prolactin inhibition. Acta Endocrinol (Copenh). 1985 Abstract
  27. Wong S, Stepp-Gilbert E. Lactation suppression. Nonpharmaceutical versus pharmaceutical method. J Obstet Gynecol Neonatal Nurs. 1985 Abstract
  28. Canales ES, García IC, Ruíz JE, Zárate A. Bromocriptine as prophylactic therapy in prolactinoma during pregnancy. Fertil Steril. 1981 Abstract

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