Classes
DEA Class; Rx
Common Brand Names; TobraDex, TobraDex ST
- Antibiotics/Corticosteroids, Ophthalmic
Description
Topical ophthalmic corticosteroid and aminoglycoside combination
Used for corticosteroid-responsive inflammatory ocular conditions that coexist with superficial bacterial infections
Localized adverse events most common
Indications
Indicated For the treatment of corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ophthalmic infection or a risk of bacterial infection exists, including bacterial conjunctivitis, chronic anterior uveitis, and corneal injury (corneal abrasion) from chemical, radiation or thermal burns, or penetration of foreign bodies.
Contraindications
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva
Mycobacterial infection of the eye
Fungal diseases of ocular structures
Hypersensitivity to a component of the medication
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
20 mL ophthalmic suspension or 8 g ophthalmic ointment per treatment course.
20 mL ophthalmic suspension or 8 g ophthalmic ointment per treatment course.
20 mL ophthalmic suspension or 8 g ophthalmic ointment per treatment course.
2 to 12 years: 20 mL ophthalmic suspension or 8 g ophthalmic ointment per treatment course.
1 year: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
dexamethasone/tobramycin
ophthalmic ointment
- 0.1%/0.3%
ophthalmic suspension
- 0.05%/0.3%
- 0.1%/0.3%