Fertility: Studies have not been conducted to evaluate the effect of tobramycin on human or animal fertility.
There is limited clinical data to evaluate the effect of dexamethasone on male or female fertility. Dexamethasone was free of adverse effects on fertility in a chorionic gonadotropin primed rat model.
Pregnancy: There are no or limited amount of data from the topical ocular use of tobramycin and dexamethasone in pregnant women. 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. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Studies in animals have shown reproductive toxicity after systemic administration of tobramycin and dexamethasone. These effects were observed at exposures considered sufficiently in excess of the maximum human ocular dosage delivered from the maternal use of the product. Tobramycin has not been shown to induce teratogenicity in rats or rabbits. The ocular administration of 0.1% dexamethasone resulted in fetal anomalies in rabbits (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Tobradex Ophthalmic Suspension and Ointment is not recommended during pregnancy.
Lactation: Tobramycin is excreted in human milk after systemic administration. No data is available on the passage of dexamethasone into human breast milk. It is unknown whether tobramycin and dexamethasone are excreted in human milk following topical ocular administration. It is not likely that the amount of Tobramycin and Dexamethasone would be detectable in human milk or be capable of producing clinical effects in the infant following topical use of the product.
A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.