Last update Jan. 29, 2022

Sulfamethoxazole (SMX, SMZ)

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Antibacterial used alone or in combination with trimethoprim. Oral administration in two daily doses.

Excreted in non-significant levels into breast milk. (Miller 1974 y 1973)

No adverse effects have been shown in breastfed infants. (Ito 1993)

Caution with those neonates suffering of hyperbilirrubinemia or Glucose-6-phosphate dehydrogenase (G6PD) deficiency is required. Avoid use in affected patients Check-up for infant jaundice.

Although rare, the possibility of transient gastroenteritis due to alteration of the intestinal flora in infants whose mothers take antibacterial should be taken into account.(Ito 1993)

Expert authors consider the use of this madication to be compatible during breastfeeding. (Hale, LactMed, Schaefer2015, Mitrano 2009, Kaiser 2007, Chin 2001)

American Academy of Pediatrics: Maternal Medication Usually Compatible With Breastfeeding. (AAP 2001)

Eleventh WHO Model List of Essential Drugs 2002: Compatible with breastfeeding for older, healthy full- term infants. Avoid if possible if the infant is premature or less than 1 month old. Monitor the infant for side- effects (haemolysis and jaundice). Avoid in infant with G6PD deficiency. (OMS-UNICEF 2002)


See below the information of this related product:

Alternatives

  • Sulfisoxazole ( 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

Sulfamethoxazole (SMX, SMZ) in other languages or writings:

Tradenames

Main tradenames from several countries containing Sulfamethoxazole (SMX, SMZ) in its composition:

  • Abactrim™. Contains other elements than Sulfamethoxazole (SMX, SMZ) in its composition
  • Bactrim™. Contains other elements than Sulfamethoxazole (SMX, SMZ) in its composition
  • Cotribase
  • Cotrim™. Contains other elements than Sulfamethoxazole (SMX, SMZ) in its composition
  • Gamactrin
  • Gantanol
  • Pyramet™. Contains other elements than Sulfamethoxazole (SMX, SMZ) in its composition
  • Soltrim™. Contains other elements than Sulfamethoxazole (SMX, SMZ) in its composition

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 85 - 90 %
Molecular weight 253 daltons
Protein Binding 70 %
VD 0.19 l/Kg
pKa 6.16 -
Tmax 1 - 4 hours
10 (6 - 12) hours
M/P ratio 0.06 -
Theoretical Dose 0.3 - 0.8 mg/Kg/d
Relative Dose 1.2 - 5 %
Ped.Relat.Dose 1.2 - 2.5 %

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. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  3. Mitrano JA, Spooner LM, Belliveau P. Excretion of antimicrobials used to treat methicillin-resistant Staphylococcus aureus infections during lactation: safety in breastfeeding infants. Pharmacotherapy. 2009 Sep;29(9):1103-9. Abstract
  4. Kaiser J, McPherson V, Kaufman L, Huber T. Clinical inquiries. Which UTI therapies are safe and effective during breastfeeding? J Fam Pract. 2007 Abstract Full text (link to original source)
  5. Pérez-Trallero E, Iglesias L. Tetraciclinas, sulfamidas y metronidazol. [Tetracyclines, sulfonamides and metronidazole]. Enferm Infecc Microbiol Clin. 2003 Nov;21(9):520-8; quiz 529, 533. Review. Spanish. Abstract Full text (link to original source)
  6. 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 Full text (link to original source) Full text (in our servers)
  7. Chin KG, McPherson CE 3rd, Hoffman M, Kuchta A, Mactal-Haaf C. Use of anti-infective agents during lactation: Part 2--Aminoglycosides, macrolides, quinolones, sulfonamides, trimethoprim, tetracyclines, chloramphenicol, clindamycin, and metronidazole. J Hum Lact. 2001 Feb;17(1):54-65. Abstract
  8. 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)
  9. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. Abstract
  10. Miller RD, Salter AJ. \ The passage of trimethoprim/sulpha-methoxazole into breast milk and its significance. \ Proceedings of the Eighth International Congress of Chemotherapy, Athens. Hellenic Society for Chemotherapy, 1974:687-91. (cit. Briggs 2015) 1974
  11. Miller RD, Salter AJ. The passage of trimethoprim/sul­ famethoxazole into breast milk and its significance. In Daikos GK(ed): Proceedings of the 8th Congress of Chemotherapy, Athens, 1973, Hellenic Society, Athens,1973, p 687-691. (cit. Hale) 1973

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