Last update June 10, 2022

C21 H43 N5 O7

Compatible

Safe product and/or breastfeeding is the best option.

Aminoglycoside antibacterial with bactericidal action against aerobic gram-negative germs and some strains of staphylococci. It is poorly absorbed from the gastrointestinal tract. Indicated in serious infections, usually with another antibiotic. Administered intravenously or intramuscularly in one or two daily doses. It is also used topically, cutaneously, ophthalmologically or otologically.

It is excreted in breastmilk in insignificant amount. (Celiloglu 1994, Boda 1990, Ito 1970)

Plasma levels of infants of mothers treated with gentamicin were undetectable (Ito 1970) or very low (Celiloglu 1994), lower than the recommended trough level in the monitoring of gentamicin treatment.

No problems have been observed in infants of mothers treated with gentamicin, except for a case of bloody stools in a newborn whose mother was given clindamycin and gentamicin (Mann 1980) and a two-month-old infant who presented transient urticaria after the mother took amoxicillin-clavulanic and gentamicin to treat mastitis. (Cherif 2009)

Gentamicin, like all other aminoglycosides, has very low oral bioavailability (Chin 2001, Fulton 1992), which impedes transfer from breastmilk to infant plasma, except in premature infants and the immediate neonatal period when there may be greater intestinal permeability. (Nelson 1972)

It is important to take into account the possibility of gastroenteritis due to altered intestinal flora. (Arbex 2010).

TOPICAL USE: The small dose and the low plasma absorption of topical nasal, ophthalmological, otological and dermatological preparations prevent its transfer to breastmilk in significant amounts.(Niebyl 1992)

Expert authors consider the use of this medication during breastfeeding to be safe (Hale 2019, Briggs 2015, Rowe 2013, Schaefer 2007, Nahum 2006, Mahadevan 2006). American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001). List of WHO essential medicines: compatible with breastfeeding. (WHO / UNICEF 2002)

Alternatives

We do not have alternatives for C21 H43 N5 O7 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

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

C21 H43 N5 O7 is Gentamicin Sulfate in Molecular formula.

Is written in other languages:

Tradenames

Main tradenames from several countries containing C21 H43 N5 O7 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. < 1 %
Molecular weight 478 daltons
Protein Binding < 30 %
VD 0.2 - 0.3 l/Kg
pKa 12.5 -
Tmax 0.5 - 1.5 hours
2 - 3 hours
M/P ratio 0.1 - 0.4 -
Theoretical Dose 0.07 mg/Kg/d
Relative Dose 1 - 1.7 %
Ped.Relat.Dose 2.8 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. van Wattum JJ, Leferink TM, Wilffert B, Ter Horst PGJ. Antibiotics and lactation: An overview of relative infant doses and a systematic assessment of clinical studies. Basic Clin Pharmacol Toxicol. 2019 Jan;124(1):5-17. Abstract
  3. AEMPS-Galenicum Derma. Cuatrocrem. Ficha técnica. 2017 Full text (in our servers)
  4. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  5. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  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 Abstract Full text (link to original source) Full text (in our servers)
  7. Cherif F, El Aidli S, Kastalli S, Zaiem A, Daghfous Moula H, Lakhal M, Daghfous R. Drug induced urticaria via breastfeeding. in; Abstracts of the 13th Annual Meeting of French Society of Pharmacology and Therapeutics, 76th Annual Meeting of Society of Physiology, 30th Pharmacovigilance Meeting, 10th APNET Seminar and 7th CHU CIC Meeting, 15‐17 April 2009, Marseille, France Fundam Clin Pharmacol. 2009;23 (Suppl 1):37. Abstract 203
  8. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  9. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  10. Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gynecol. 2006 Abstract
  11. 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)
  12. 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)
  13. 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
  14. Celiloglu M, Celiker S, Guven H, Tuncok Y, Demir N, Erten O. Gentamicin excretion and uptake from breast milk by nursing infants. Obstet Gynecol. 1994 Abstract
  15. Niebyl JR. Use of antibiotics for ear, nose, and throat disorders in pregnancy and lactation. Am J Otolaryngol. 1992 Jul-Aug;13(4):187-92. Review. No abstract available. Abstract
  16. Fulton B, Moore LL. Antiinfectives in breastmilk. Part II: Sulfonamides, tetracyclines, macrolides, aminoglycosides and antimalarials. J Hum Lact. 1992 Dec;8(4):221-3. Review. No abstract available. Abstract
  17. Boda A. [Gentamycin concentration in the milk of a mother after treatment by implantation of a Septopal chain]. Orv Hetil. 1990 Abstract
  18. Mann CF. Clindamycin and breast-feeding. Pediatrics. 1980 Abstract
  19. Nelson JD, McCracken GH Jr. The current status of gentamicin for tne neonate and young infant. Am J Dis Child. 1972 Jul;124(1):13-4. No abstract available. Abstract
  20. Ito T. [Absorption, excretion and effects of gentamicin in newborn infants]. Jpn J Antibiot. 1970 Jun;23(3):298-311. Japanese. No abstract available. Abstract

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