Last update Oct. 20, 2016

Isoniazid

Compatible

Safe product and/or breastfeeding is the best option.

It is excreted into breast milk in clinically non-significant amount, in any case, much lower than the doses commonly used in newborns and infants (Snider 1984, Singh 2008).

No significant problems have been observed in infants whose mothers were treated. (Drobac 2005). An infant whose mother was treated with anti-TBC drugs during pregnancy and lactation for 7 months, presented moderately high levels of liver transaminases along with a normal clinical and developmental course (Peters 2008).

The plasma levels measured in any of those infants were undetectable or very low.

Several medical societies and consensus of expert panels consider safe the use of this medication while breastfeeding (Dautzenberg 1988, Tran 1998, Blumberg 2003, Schram 2005, WHO 2007, Singh 2008, Baquero-Artigao 2015, Malhamé 2016).
American Academy of Pediatrics: medication usually compatible with breastfeeding.
WHO List of Essential Medicines 2002: compatible with breastfeeding.

The addition of Vitamin B6 (Pyridoxine) to treatment of mother-infant dyad should be evaluated, especially in cases of malnutrition, diabetes, other diseases or a new pregnancy (Blumberg 2003, Steichen 2006, Baquero-Artigao 2015, 2016 Principi Di 2016).

Alternatives

We do not have alternatives for Isoniazid since it is relatively safe.

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

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Other names

Isoniazid is also known as


Isoniazid in other languages or writings:

Group

Isoniazid belongs to this group or family:

Tradenames

Main tradenames from several countries containing Isoniazid in its composition:

List of 23 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 137 daltons
Protein Binding 10 - 15 %
Tmax 1 - 2 hours
T½ 1 - 4 hours
M/P ratio 1 - 3 -
Theoretical Dose 0.04 - 0.12 mg/Kg/d
Relative Dose 0.2 - 2 %
Ped.Relat.Dose 0.4 - 1.2 %

References

  1. Algharably EA, Kreutz R, Gundert-Remy U. Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data. Pharmaceutics. 2023 Apr 13;15(4). pii: 1228. Abstract Full text (link to original source)
  2. Garessus EDG, Mielke H, Gundert-Remy U. Exposure of Infants to Isoniazid via Breast Milk After Maternal Drug Intake of Recommended Doses Is Clinically Insignificant Irrespective of Metaboliser Status. A Physiologically-Based Pharmacokinetic (PBPK) Modelling Approach to Estimate Drug Exposure of Infants via Breast-Feeding. Front Pharmacol. 2019 Jan 22;10:5. Abstract
  3. Di Comite A, Esposito S, Villani A, Stronati M; Italian Pediatric TB Study Group. How to manage neonatal tuberculosis. J Perinatol. 2016 Abstract
  4. Baquero-Artigao F, Mellado Peña MJ, del Rosal Rabes T, Noguera Julián A, Goncé Mellgren A, de la Calle Fernández-Miranda M, Navarro Gómez ML; Working Group on gestational, congenital, and postnatal tuberculosis, Spanish Society of Pediatric Infectious Diseases (PFIC). Guía de la Sociedad Española de Infectología Pediátrica sobre tuberculosis en la embarazada y el recién nacido (ii): profilaxis y tratamiento. [Spanish Society for Pediatric Infectious Diseases guidelines on tuberculosis in pregnant women and neonates (ii): Prophylaxis and treatment]. An Pediatr (Barc). 2015 Abstract Full text (link to original source) Full text (in our servers)
  5. Mittal H, Das S, Faridi MM. Management of newborn infant born to mother suffering from tuberculosis: current recommendations & gaps in knowledge. Indian J Med Res. 2014 Abstract Full text (link to original source) Full text (in our servers)
  6. Arbex MA, Varella Mde C, Siqueira HR, Mello FA. Antituberculosis drugs: drug interactions, adverse effects, and use in special situations. Part 2: second line drugs. J Bras Pneumol. 2010 Sep-Oct;36(5):641-56. Abstract Full text (link to original source) Full text (in our servers)
  7. Singh N, Golani A, Patel Z, Maitra A. Transfer of isoniazid from circulation to breast milk in lactating women on chronic therapy for tuberculosis. Br J Clin Pharmacol. 2008 Abstract Full text (link to original source) Full text (in our servers)
  8. Peters C, Nienhaus A. [Case report--tuberculosis in a health care worker during pregnancy]. Pneumologie. 2008 Abstract
  9. WHO: World Health Organization Stop TB Partnership Childhood TB Subgroup. Chapter 4: childhood contact screening and management. Int J Tuberc Lung Dis. 2007 Abstract Full text (in our servers)
  10. Steichen O, Martinez-Almoyna L, De Broucker T. [Isoniazid induced neuropathy: consider prevention]. Rev Mal Respir. 2006 Abstract
  11. Schram AJ, Holm JP, van Altena R. [Two pregnant immigrant women with tuberculous peritonitis]. Ned Tijdschr Geneeskd. 2005 Abstract
  12. Drobac PC, del Castillo H, Sweetland A, Anca G, Joseph JK, Furin J, Shin S. Treatment of multidrug-resistant tuberculosis during pregnancy: long-term follow-up of 6 children with intrauterine exposure to second-line agents. Clin Infect Dis. 2005 Jun 1;40(11):1689-92. Epub 2005 Apr 18. Abstract Full text (link to original source) Full text (in our servers)
  13. CDC. (American Thoracic Society); CDC; Infectious Diseases Society of America. Treatment of tuberculosis. MMWR Recomm Rep. 2003 Abstract Full text (link to original source) Full text (in our servers)
  14. ATC. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Abstract Full text (link to original source) Full text (in our servers)
  15. 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)
  16. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  17. Tran JH, Montakantikul P. The safety of antituberculosis medications during breastfeeding. J Hum Lact. 1998 Dec;14(4):337-40. Review. Abstract
  18. Dautzenberg B, Grosset J. [Tuberculosis and pregnancy]. Rev Mal Respir. 1988 Abstract
  19. Snider DE Jr, Powell KE. Should women taking antituberculosis drugs breast-feed? Arch Intern Med. 1984 Abstract
  20. Gsellman RM. Isoniazid and the nursing mother. Am Fam Physician. 1982 Abstract

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