Last update: Dec. 31, 2018

Nimesulide

High Risk for breastfeeding


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

Drug approval was cautionary withheld in many countries since 2002 because of increase risk of severe liver toxicity (Bissoli 2010, Walker 2008, Tan 2007, Maciá 2002). The FDA never approved it for use in the USA.
The EMA (European Medicines Agency) introduced limitations for use by narrowing indication profile, shortening duration of treatment, age restriction for younger than 12 year, and avoiding it in pregnancy and breastfeeding (EMA 2010).

Since the last update we have not found any published data on its excretion in breast milk.

Its high plasma protein binding make excretion into breast milk unlikely. However, anti-inflammatory drugs that are known to be safer for both the mother and the infant should be preferred.

TOPICAL USE:
When topical preparations are used (gel, cream, oral mouthwash etc.), the percentage of the drug that actually reaches the blood circulation is very small. Topically used nimesulide is not expected to have a significant excretion into breastmilk.
This form of administration would be compatible with breastfeeding.

Alternatives

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.

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

Nimesulide in other languages or writings:

Tradenames

Main tradenames from several countries containing Nimesulide in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 64 %
Molecular weight 308 daltons
Protein Binding 98 %
Tmax 2 - 3 hours
T1/2 3 - 6 hours

References

  1. Rafa. Nimesulide. Drug Summary. 2012 Full text (in our servers)
  2. Agencia Europea del Medicamento (EMeA). Nimesulida. Revisión del perfil de seguridad. 2010 Full text (in our servers)
  3. European Medicine Agency (EMeA). Nimesulide. AMENDMENTS OF THE SUMMARY OF \ PRODUCT CHARACTERISTICS 2010 Full text (in our servers)
  4. Bissoli F. Nimesulide-induced hepatotoxicity and fatal hepatic failure. Singapore Med J. 2008 Abstract Full text (in our servers)
  5. Walker SL, Kennedy F, Niamh N, McCormick PA. Nimesulide associated fulminant hepatic failure. Pharmacoepidemiol Drug Saf. 2008 Abstract
  6. Tan HH, Ong WM, Lai SH, Chow WC. Nimesulide-induced hepatotoxicity and fatal hepatic failure. Singapore Med J. 2007 Abstract Full text (in our servers)
  7. Maciá MA, Carvajal A, del Pozo JG, Vera E, del Pino A. Hepatotoxicity associated with nimesulide: data from the Spanish Pharmacovigilance System. Clin Pharmacol Ther. 2002 Abstract

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