Tobrex Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk Summary: There are no adequate data available on use of this formulation in pregnant women to inform a drug-related risk.
Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts state that aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.
Animal studies have failed to reveal evidence of impaired fertility and fetal harm at doses up to 33 times the recommended human systemic dose. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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
Tobrex Breastfeeding Warnings
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 (systemic administration); Unknown (ophthalmic administration)
Excreted into animal milk: Data not available (ophthalmic administration)
Comments:
-The effects in the nursing infant are unknown.
-Systemically circulating levels of eye drop formulations of drug may be decreased by placing pressure over the tear duct in the corner of the eye over at least 1 minute; excess solution should be removed with tissues.
See references
