Tobramycin use while Breastfeeding

Drugs containing Tobramycin: TobraDex, Tobi, Tobrex, Zylet, Nebcin, Tobradex ST, TOBI Podhaler, Tomycine, Bethkis, Tobrasol, Show all 14 »

Tobramycin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Tobramycin is poorly excreted into breastmilk. Newborn infants apparently absorb small amounts of other aminoglycosides, but serum levels with typical three times per day dosages are far below those attained when treating newborn infections and systemic effects of tobramycin are unlikely. Older infants would be expected to absorb even less tobramycin. Because there is little variability in the milk tobramycin levels during multiple daily dose regimens, timing breastfeeding with respect to the dose is of little or no benefit in reducing infant exposure. Data are not available with single daily dose regimens. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

Maternal use of an ear drop or eye drop that contains tobramycin presents little or no risk for the nursing infant [4]

Drug Levels

Maternal Levels. After a single 80 mg intramuscular dose of tobramycin in 5 women, milk levels were measured every hour for 6 hours. Only trace levels were detected in 4 of the samples from 1 to 8 hours after the dose. In the fifth woman, milk levels ranged from 0.4 to 0.52 mg/L over 8 hours, with the highest level found at 4 hours after the dose.[2]

In one patient who received 80 mg of tobramycin every 8 hours by intramuscular injection, milk levels were 0.6 mg/L 1 hour after the dose and 0.58 mg/L 8 hours after the dose.[3]

At 2 months postpartum, a woman was receiving intravenous tobramycin 150 mg 3 times daily plus meropenem for cystic fibrosis. Four days after beginning, milk tobramycin levels were undetectable (<0.18 mg/L) before the infusion and in 6 milk samples take from 1 to 5 hours after the infusion.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

An infant was breastfed (extent not stated) until the 4th month postpartum. At 2 months of age, his mother was given a 2-week course of tobramycin 150 mg three times daily plus meropenem for a cystic fibrosis exacerbation. infant displayed no change in stool pattern during the maternal treatment and had normal renal function at 6 months of age.[4][5]

Possible Effects on Lactation

Relevant published information was not found as of the revision date.

References

1. Niebyl JR. Use of antibiotics for ear, nose, and throat disorders in pregnancy and lactation. Am J Otolaryngol. 1992;13:187-92. PMID: 1503194

2. Takase Z, Shirafuji H, Uchida M et al. Laboratory and clinical studies on tobramycin in the field of obstetrics and gynecology. Chemotherapy. (Tokyo). 1975;23:1402-7.

3. Uwaydah M, Bibi S, Salman S. Therapeutic efficacy of tobramycin--a clinical and laboratory evaluation. J Antimicrob Chemother. 1975;1:429-37. PMID: 1107297

4. Festini F, Ciuti R, Taccetti G et al. Breast-feeding in a woman with cystic fibrosis undergoing antibiotic intravenous treatment. J Matern Fetal Neonatal Med. 2006;19:375-6. PMID: 16801316

5. Festini F, Ciuti R, Repetto T et al. Safety of breast-feeding during an IV tobramycin course for infants of CF women. Pediatr Pulmonol Suppl. 2004;27:288-9. Abstract.

Tobramycin Identification

Substance Name

Tobramycin

CAS Registry Number

32986-56-4

Drug Class

Antiinfective Agents
Antibacterial Agents
Aminoglycosides

Administrative Information

LactMed Record Number

259

Information from the National Library of Medicine's LactMed Database.

Last Revision Date

2011-01-04

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.