Classes
DEA Class; Rx
Common Brand Names; Maxitrol, Dexasporin
- Antibiotics/Corticosteroids, Ophthalmic
Description
Ophthalmic suspension or ointment for inflammatory and antibacterial combination
Used for inflammatory conditions of the eyes where there is high risk of infection or where infection coexists
Indications
Indicated for steroid-responsive inflammatory eye conditions in which dexamethasone is indicated & where bacterial infection or a risk of bacterial infection exists
Contraindications
Hypersensitivity
Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
Mycobacterial infection of the eye and fungal diseases of ocular structures
Adverse Effects
- Blurred vision
- Cataract
- Raised intraocular pressure
- Stinging
- Conjunctival hemorrhage
- Glaucoma
- Vitreous detachment
- Hives
- Rash
- Itching
- Eye pain
- Ulcerative keratitis
- Headache
- Stevens-Johnson syndrome
- Cushing’s syndrome and adrenal suppression (after use in excess of listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors)
Warnings
Monitor intraocular pressure if used >10 days
Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation
Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning, possibly leading to perforation
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication
Products containing neomycin sulfate may cause cutaneous sensitization; sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients; severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions; discontinue if hypersensitivity occurs
Acute purulent or parasitic infections of eye may be masked or activity enhanced by presence of corticosteroid medication
Pregnancy and Lactation
Dexamethasone shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of therapeutic dose
Systemically administered corticosteroids appear in human milk, could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Maximum Dosage
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
2 years and older: 48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
less than 2 years: 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%