Last update Jan. 20, 2022

Terbinafine

Low Risk

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

Antifungal indicated for fungal infections of the skin, scalp and nails.

ORAL ADMINISTRATION:

Pharmacokinetics data (low oral bioavailability, high volume of distribution and high protein-binding capacity) explains the scanty excretion into breast milk observed.

In addition, its low oral bioavailability (Novartis 2018) would make even more difficult any pass of this drug through ingested milk to the infant's blood, except in newborns or premature who would show a higher intestinal absorption.  (Thieme 1986 in Lactmed)

Avoid using in prematures who are under treatment with caffeine or theophylline because terbinafine alters its metabolic degradation and increases plasma concentration. (Novartis 2016, Mactal 2001)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (LactMed, Hale, Butler 2014, Mactal 2001), especially during the neonatal period and in the event of prematurity.

TOPICAL ADMINISTRATION: Fully compatible with breastfeeding. (Leachman 2006)

Since topical absorption is less than 5 %, a significant excretion into breast milk after application on skin is not expected.

Do not use on the breast to prevent ingestion by the infant, otherwise apply after a feeding and wipe it out thoroughly with water before next feeding.

It is recommended to avoid using on the nipple creams, gels and other products intended for use on skin that may contain paraffin (mineral oil) in order to keep from absorption the infant. (Concin 2008, Noti 2003)

Alternatives

  • Ciclopirox ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Fluconazole ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Laser Rays ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Terbinafine in other languages or writings:

Tradenames

Main tradenames from several countries containing Terbinafine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40 %
Molecular weight 291 daltons
Protein Binding 99 %
VD 28 l/Kg
pKa 7.1 -
Tmax 2 hours
27 - 31 hours
M/P ratio 7 -
Theoretical Dose 0.55 mg/Kg/d
Relative Dose 3.8 - 6.6 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. AEMPS-Novartis. Terbinafina tópica. Ficha técnica. 2018 Full text (in our servers)
  4. AEMPS-Novartis. Terbinafina oral. Ficha técnica. 2018 Full text (in our servers)
  5. Novartis. Terbinafine. Drug Summary. 2016 Full text (in our servers)
  6. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  7. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  8. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 Abstract
  9. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract
  10. Mactal-Haaf C, Hoffman M, Kuchta A. Use of anti-infective agents during lactation, Part 3: Antivirals, antifungals, and urinary antiseptics. J Hum Lact. 2001 Abstract
  11. Schatz F, Haberl H. Analytical methods for the determination of terbinafine and its metabolites in human plasma, milk and urine. Arzneimittelforschung. 1989 Abstract
  12. Thieme G, Peuckert U. Report on a pharmacokinetic study of SF 86-327 in healthy females in the ablactation period. Sandoz document number 303-019. (information taken from report in Lactmed online access ). 1986

Total visits

96,154

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM