Last update April 15, 2024

Bisoprolol fumarate

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Bisoprolol fumarate is a cardioselective beta-blocker administered orally once daily in the treatment of hypertension and angina pectoris, in patients with chronic stable heart failure and in the secondary prevention of myocardial infarction. (AEMPS 2015, FDA 2007)

In a published case of a woman started on bisoprolol at 6 days postpartum, bisoprolol levels were undetectable (<1 mcg / L) in all milk samples 11-18 days after initiation. (Khurana 2014)

No problems have been observed in infants whose mothers were taking it (Duke 2019). Two of 11 infants whose mothers were taking Bisoprolol had drowsiness and one had poor weight gain. None had developmental problems. (De Haan 2023, cited by LactMed)

The pharmacokinetic characteristics of bisoprolol: low percentage binding to plasma proteins (AEMPS 2015, FDA 2007, Leopold 1986), moderate liposolubility, long half-life and relatively high renal excretion (FDA 2007) make bisoprolol less favorable for nursing mothers. compared to other beta-blockers (Kearney 2018, Riant 1986), although its molecular weight could limit passage into milk. (Briggs 2017 p157-158)

Some authors suggest that bisoprolol is a second option for breastfeeding mothers with postpartum cardiomyopathy when metoprolol succinate is not available (Kearney 2018); others mention a switch from metoprolol to bisoprolol in some patients. (Barasa 2018)

The use of bisoprolol is probably considered compatible during breastfeeding by some experts (Hale, Malachias 2016), but until more published data on this drug in relation to breastfeeding are known safer alternatives may be preferable, especially during the neonatal period and in case of prematurity. 

Some authors do not consider beta-blockers to be drugs of choice for the treatment of hypertension, unless there is another concurrent indication, such as migraine or angina prophylaxis. Caution is needed if bisoprolol is used in mothers of premature infants. (Anderson 2018)

The protective role of breastfeeding against maternal hypertension has been demonstrated. (Park 2018)


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Alternatives

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

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Other names

Bisoprolol fumarate in other languages or writings:

Groups

Bisoprolol fumarate belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Bisoprolol fumarate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 - 90 %
Molecular weight 767 daltons
Protein Binding 30 %
VD 3.5 l/Kg
pKa 9.5 -
Tmax 2 - 4 hours
9 - 12 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. De-Haan T, Hazan A, Kaduri NB, Kohn E, Berlin M, Berkovitch M. Bisoprolol during breastfeeding: A prospective case series. Neurotoxicol Teratol 2023;98.
  3. Duke ME, Britten FL, Pretorius CJ, McWhinney BC, Ungerer JPJ, Barrett HL, Donovan P. Maternal Metyrapone Use During Breastfeeding: Safe for the Breastfed Infant. J Endocr Soc. 2019 Mar 18;3(5):973-978. Abstract
  4. Barasa A, Goloskokova V, Ladfors L, Patel H, Schaufelberger M. Symptomatic recovery and pharmacological management in a clinical cohort with peripartum cardiomyopathy. J Matern Fetal Neonatal Med. 2018 Abstract
  5. Park S, Choi NK. Breastfeeding and Maternal Hypertension. Am J Hypertens. 2018 Abstract
  6. Anderson PO. Treating Hypertension During Breastfeeding. Breastfeed Med. 2018 Abstract
  7. Kearney L, Wright P, Fhadil S, Thomas M. Postpartum Cardiomyopathy and Considerations for Breastfeeding. Card Fail Rev. 2018 Abstract Full text (link to original source) Full text (in our servers)
  8. Malachias MV, Figueiredo CE, Sass N, Antonello IC, Torloni MR, Bortolotto MRF L. 7th Brazilian Guideline of Arterial Hypertension: Chapter 9 - Arterial Hypertension in pregnancy Arq Bras Cardiol. 2016 Abstract Full text (link to original source)
  9. AEMPS-Teva. Bisoprolol. Ficha técnica. 2015 Full text (in our servers)
  10. Khurana R, Bin Jardan YA, Wilkie J, Brocks DR. Breast milk concentrations of amiodarone, desethylamiodarone, and bisoprolol following short-term drug exposure: two case reports. J Clin Pharmacol. 2014 Abstract
  11. Tamargo Menéndez J, Delpón Mosquera E. Farmacología de los bloqueantes de los receptores β-adrenérgicos. Curso βeta 2011 de Actualización en Betabloqueantes. 2011 Full text (in our servers)
  12. FDA-Duramed Pharm. Bisoprolol (Zebeta). Drug Summary. 2007 Full text (in our servers)
  13. Riant P, Urien S, Albengres E, Duche JC, Tillement JP. High plasma protein binding as a parameter in the selection of betablockers for lactating women. Biochem Pharmacol. 1986 Abstract
  14. Leopold G. Balanced pharmacokinetics and metabolism of bisoprolol. J Cardiovasc Pharmacol. 1986 Abstract

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