Pregnancy: There is no or limited data from the use of topical ocular tobramycin in pregnant women.
Human studies have not shown an association between the administration of tobramycin and malformations.
Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure.
Studies in animals have shown reproductive toxicity after systemic exposure and at dosages considered sufficiently in excess of the maximal human dose in therapeutic use derived from tobramycin eye drops so as to have limited clinical relevance (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Although systemic exposure to tobramycin from the topical route of administration is expected to be negligible, as a precautionary measure, it is preferable to avoid the use of Tobramycin during pregnancy. TOBREX should be used during pregnancy only if clearly needed.
Breast-feeding: Minimal exposure of tobramycin in breast milk in lactating women was found after intravenous or intramuscular administration of up to 150 mg TID of tobramycin. Even though there is no specific systemic exposure data for tobramycin after ophthalmic administration, given the much smaller doses of these drugs administered topically to the eye compared to the systemic doses noted previously with minimal transfer into breast milk, no effects on the breast fed newborn/infant are anticipated. Topical ocular tobramycin can be used during breast-feeding if the benefit to the mother is considered to outweigh the risk to the breast fed newborn/infant.
Fertility: Studies have not been performed to evaluate the effect of tobramycin administration on human or animal fertility. (See Pharmacology: Toxicology: Preclinical safety data under Actions.)