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Tobramycin Pregnancy and Breastfeeding Warnings

Tobramycin is also known as: Bethkis, Kitabis Pak, Nebcin, Nebcin Pediatric, TOBI Podhaler, Tobi

Medically reviewed on November 20, 2017

Tobramycin Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Aminoglycosides can cause fetal harm when used during pregnancy.

Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts recommend: Aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have failed to reveal evidence of teratogenicity when this drug was given subcutaneously. There are reports of total irreversible, bilateral congenital deafness in children whose mothers used streptomycin during pregnancy. Evidence of (probably reversible) damage to immature nephrons of the fetal kidney associated with use, and eighth cranial nerve damage associated with aminoglycoside exposure in utero have been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tobramycin Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (IM administration); Unknown (inhalation formulations)
Excreted into animal milk: Data not available (inhalation formulations)

Comments:
-Breastfed infants should be monitored for candidiasis and gastrointestinal side effects (e.g., diarrhea, thrush, diaper rash, antibiotic-associated colitis).
-Some experts recommend: Aminoglycosides should be considered potentially ototoxic and nephrotoxic to the breastfed infant.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  2. "Product Information. Tobi tobramycin solution for inhalation (tobramycin)" PathoGenesis, Skokie, IL.
  3. "Product Information. Nebcin (tobramycin)." Lilly, Eli and Company, Indianapolis, IN.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Nebcin (tobramycin)." Lilly, Eli and Company, Indianapolis, IN.
  2. "Product Information. Tobi tobramycin solution for inhalation (tobramycin)" PathoGenesis, Skokie, IL.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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