Dexamethasone/Tobramycin

DEA Class;  Rx

Common Brand Names; TobraDex, TobraDex ST

• Antibiotics/Corticosteroids, Ophthalmic

• Ocular lid itching and swelling
• Conjunctival erythema
• Elevation of intraocular pressure (IOP) with possible development of glaucoma
• Infrequent optic nerve damage
• Cataract formation
• Posterior subcapsular cataract formation
• Delayed wound healing
• Secondary infections
• Keratitis
• Anaphylactic reaction
• Erythema multiforme
• Dexamethasone: Cushing’s syndrome and adrenal suppression (after use of dexamethasone in excess of listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors)
• Aminoglycosides: Adverse reactions reported with systemic aminoglycosides include neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy; aminoglycosides may also aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson disease, because of their potential effect on neuromuscular function

Vision may be temporarily blurred following dosing with this medication exercise care when operating machinery or driving a motor vehicle

Do not touch dropper tip of bottle to any surface, as this may contaminate the contents

The drug contains benzalkonium chloride, an antimicrobial preservative, soft contact lenses may absorb; contact lenses should not be worn during the use of this drug

Sensitivity to topically administered aminoglycosides may occur; severity may vary from local effects to generalized reactions; discontinue use if sensitivity reactions occur

Bacterial keratitis reported from inadvertent contamination of multiple-dose ophthalmic solution

Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections

Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use

Discontinue use if sensitivity reaction to tobramycin develops

Corticosteroid use following cataract surgery may delay healing

Not for injection into eye

There are no adequate and well-controlled studies in pregnant women; however, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation; treatment should be used during pregnancy only if potential benefit justifies potential risk to fetus; infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; because many drugs are excreted in human milk, caution should be exercised when therapy is administered to a nursing woman