Tobradex ST (Tobramycin 0.3% / Dexamethasone 0.05%)

Common Side Effects

Ocular, antibiotic component: Hypersensitivity and localized ocular toxicity, including eye pain, eyelid pruritus, eyelid edema, and conjunctival hyperemia, in under 4%, a figure the label attributes to topical ocular tobramycin rather than to the combination.
Ocular, steroid component: Increased IOP with possible glaucoma and infrequent optic nerve disorder, subcapsular cataract, and impaired healing; the label gives no incidence figures for the combination.
Non-ocular, clinical trials: Headache and increased blood pressure, among the events occurring at an incidence of 0.5% to 1%.
Secondary infection: Fungal corneal infection is particularly prone to develop coincidentally with long-term steroid application, and secondary bacterial infection follows suppression of host responses.
Postmarketing reports: Anaphylactic reaction, erythema multiforme.
Systemic, steroid component: Cushing's syndrome and adrenal suppression after dexamethasone in excess of the labeled dosing in predisposed patients, including children and patients on CYP3A4 inhibitors.
Systemic, aminoglycoside class: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy; aminoglycosides may aggravate muscle weakness in myasthenia gravis or Parkinson's disease.

Pregnancy & Lactation

Pregnancy: Ocular administration of 0.1% dexamethasone, twice this product's strength, produced fetal anomalies in 15.6% and 32.3% of 2 groups of pregnant rabbits, and chronic dexamethasone therapy produced fetal growth retardation and increased mortality in rats; tobramycin up to 100 mg/kg/day in rats and rabbits (equivalent to human doses of 16 and 32 mg/kg/day) showed no impaired fertility and no fetal harm. No adequate and well-controlled studies in pregnant women; prolonged or repeated corticoid use in pregnancy is associated with increased risk of intrauterine growth retardation, and infants of mothers who received substantial corticosteroid doses should be observed for hypoadrenalism.

Tobradex ST (Tobramycin 0.3% / Dexamethasone 0.05%) | EyeKnow O.D.