Last update March 11, 2022

Flumazenil, Flumazepil

Likely Compatibility

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

Benzodiazepine receptor antagonist that blocks the neurological effects of benzodiazepines. Used in anesthesia to reverse sedation and in benzodiazepine overdose. intravenous administration.

At the date of the last update we did not find any published data on its excretion in breast milk.

Its large volume of distribution would make excretion in breast milk difficult.

Its very low oral bioavailability minimizes the passage into plasma of the infant from ingested breast milk, except in the premature and in the immediate neonatal period in which there may be greater intestinal permeability.

Very well tolerated drug with few side effects and few serious.

Authorized use in Neonatology and Pediatrics. (Kreshak 2012, Zaw 2001, Dixon 1998, Richard 1991)

Several medical societies, experts and expert consensus consider the use of this medication to be probably compatible during breastfeeding. (Hale, Briggs 2015, Mahadevan 2006)

Alternatives

We do not have alternatives for Flumazenil, Flumazepil.

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.

Other names

Flumazenil, Flumazepil in other languages or writings:

Tradenames

Main tradenames from several countries containing Flumazenil, Flumazepil in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 16 - 20 %
Molecular weight 303 daltons
Protein Binding 50 %
VD 0.5 - 1.1 l/Kg
pKa 1.7 -
Tmax 0.1 - 0.17 hours
0.8 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. AEMPS. Flumazenil. Ficha técnica. 2020 Full text (in our servers)
  3. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  4. Sandoz. Flumazenil. Drug Summary. 2013 Full text (in our servers)
  5. Kreshak AA, Tomaszewski CA, Clark RF, Cantrell FL. Flumazenil administration in poisoned pediatric patients. Pediatr Emerg Care. 2012 May;28(5):448-50. Abstract
  6. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  7. Zaw W, Knoppert DC, da Silva O. Flumazenil's reversal of myoclonic-like movements associated with midazolam in term newborns. Pharmacotherapy. 2001 May;21(5):642-6. Abstract
  8. Dixon JC, Speidel BD, Dixon JJ. Neonatal flumazenil therapy reverses maternal diazepam. Acta Paediatr. 1998 Feb;87(2):225-6. Abstract
  9. Richard P, Autret E, Bardol J, Soyez C, Barbier P, Jonville AP, Ramponi N. The use of flumazenil in a neonate. J Toxicol Clin Toxicol. 1991;29(1):137-40. Abstract

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