Last update: Jan. 15, 2019

(C18 H31 NO4)2, C4 H4 O4

Low Risk for breastfeeding


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

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

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

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

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

The use of bisoprolol is considered likely to be compatible during breastfeeding by some experts (Hale 2019 p77-78, Malachias 2016), but until there is more published information on this drug in relation to breastfeeding, safer known 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 simultaneous indication, such as migraine or prophylaxis of angina. Caution is needed if bisoprolol is used in mothers of premature babies (Anderson 2018).

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


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Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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Other names

(C18 H31 NO4)2, C4 H4 O4 is Bisoprolol fumarate in Molecular formula.

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Group

(C18 H31 NO4)2, C4 H4 O4 belongs to this group or family:

Tradenames

Main tradenames from several countries containing (C18 H31 NO4)2, C4 H4 O4 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
T1/2 9 - 12 hours

References

  1. Hale TW. Hale's Medications & Mothers' Milk. Springer Publishing Company. 2019
  2. Anderson PO. Treating Hypertension During Breastfeeding. Breastfeed Med. 2018 Abstract
  3. 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)
  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. 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) Full text (in our servers)
  7. AEMPS-Teva. Bisoprolol. Ficha técnica. 2015 Full text (in our servers)
  8. 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
  9. 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)
  10. FDA-Duramed Pharm. Bisoprolol (Zebeta). Drug Summary. 2007 Full text (in our servers)
  11. Leopold G. Balanced pharmacokinetics and metabolism of bisoprolol. J Cardiovasc Pharmacol. 1986 Abstract
  12. 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

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