Last update July 31, 2022

Methylene blue

Likely Compatibility

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

It is a thiazine dye that is used intravenously (a single dose of 1-2 mg/kg, maximum 100 mg)) in the treatment of methemoglobinemia (secondary to nitrites, anilines, cyanides and other toxins), neurotoxicity due to ifosfamide, refractory vasoplegic shock and, locally, in diagnostic or surgical procedures (detection of fistulae, sentinel lymph node biopsy, and parathyroid gland staining). It is also an antiseptic component in preparations for topical application to the eyes, mouth, pharynx and skin. (Martindale, Pushparajah 2021)

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

The paucity of known pharmacokinetic data does not allow prediction of possible excretion in breast milk.

Authorized use in Pediatrics, including newborns. (1-2 mg/kg).

Given the low plasma levels of methylene blue after a treatment dose (Shah-Khan 2012, Repici 2012, Pruthi 2011, Gillman 2011), the maximum concentration that it would reach in breast milk would imply a theoretical dose for the infant that is much lower than that used in Pediatrics.

Avoid it on those patients suffering of G-6-P dehydrogenasa deficiency. Monitor premature or infant less than 1 month for side-effects (haemolysis and jaundice). (WHO 2002)

TOPICAL USE:

The small dose and poor plasma absorption of most topical ophthalmological preparations make it unlikely that significant amounts will transfer into breastmilk. Topical use of Methylene blue is compatible with breastfeeding.

Alternatives

We do not have alternatives for Methylene blue.

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

Methylene blue is also known as


Methylene blue in other languages or writings:

Tradenames

Main tradenames from several countries containing Methylene blue in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 - 97 %
Molecular weight 374 / 320 daltons
VD 2.1 (1 - 3.7) l/Kg
Tmax oral: 1 - 2 hours
5 - 6; oral: 207; subare: 11 hours

References

  1. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: https://www.medicinescomplete.com 2022 Abstract
  2. Pushparajah Mak RS, Liebelt EL. Methylene Blue: An Antidote for Methemoglobinemia and Beyond. Pediatr Emerg Care. 2021 Sep 1;37(9):474-477. Abstract
  3. Repici A, Di Stefano AF, Radicioni MM, Jas V, Moro L, Danese S. Methylene blue MMX tablets for chromoendoscopy. Safety tolerability and bioavailability in healthy volunteers. Contemp Clin Trials. 2012 Mar;33(2):260-7. Abstract
  4. Shah-Khan MG, Lovely J, Degnim AC. Safety of methylene blue dye for lymphatic mapping in patients taking selective serotonin reuptake inhibitors. Am J Surg. 2012 Nov;204(5):798-9. Abstract
  5. Gillman PK. CNS toxicity involving methylene blue: the exemplar for understanding and predicting drug interactions that precipitate serotonin toxicity. J Psychopharmacol. 2011 Mar;25(3):429-36. Abstract
  6. Pruthi S, Haakenson C, Brost BC, Bryant K, Reid JM, Singh R, Netzel B, Boughey JC, Degnim AC. Pharmacokinetics of methylene blue dye for lymphatic mapping in breast cancer-implications for use in pregnancy. Am J Surg. 2011 Jan;201(1):70-5. Abstract
  7. Walter-Sack I, Rengelshausen J, Oberwittler H, Burhenne J, Mueller O, Meissner P, Mikus G. High absolute bioavailability of methylene blue given as an aqueous oral formulation. Eur J Clin Pharmacol. 2009 Feb;65(2):179-89. Abstract
  8. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  9. Peter C, Hongwan D, Küpfer A, Lauterburg BH. Pharmacokinetics and organ distribution of intravenous and oral methylene blue. Eur J Clin Pharmacol. 2000 Jun;56(3):247-50. Abstract

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