Maxidex®
Dexamethasone 0.1% · ophthalmic suspension
Steroid
Approved uses
Steroid-responsive inflammation of the conjunctiva, cornea, and anterior segment
1 to 2 drops in the conjunctival sac; hourly in severe disease with taper as inflammation subsides, up to 4 to 6 times daily in mild disease; not more than one bottle before re-examination
Contraindications
- Acute, untreated bacterial infections.
- Mycobacterial ocular infection.
- Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva.
- Fungal disease of ocular structures.
- Hypersensitivity to any component of the preparation.
Available Forms0.1% suspension, 5 mL plastic dropper bottle.
Mechanism of ActionCorticosteroid; suppresses the inflammatory response to a wide range of agents, which is how it diminishes anterior segment edema and inflammation. The same action probably delays or slows healing and suppresses the host response, increasing the hazard of secondary ocular infection.
Warnings & Precautions
- Prolonged use: Ocular hypertension or glaucoma with optic nerve damage, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
- Host response suppression: Prolonged use increases the hazard of secondary ocular infection, and persistent fungal corneal infection should be considered after prolonged dosing.
- Infection masking: In acute purulent or parasitic ocular infection, corticosteroids may mask infection or enhance existing infection.
- Corneal or scleral thinning: Perforation has occurred with topical corticosteroids in diseases that thin these tissues.
- IOP monitoring at 10 days: Routine IOP monitoring is required with use of 10 days or longer, including in children and uncooperative patients.
- Herpes simplex: Contraindicated in epithelial (dendritic) keratitis; other forms of ocular herpes simplex require great caution and periodic slit lamp microscopy.
- Steroid IOP response: In a randomized fellow-eye trial in 20 children after strabismus surgery, 2 weeks of dexamethasone 0.1% gave mean IOP 17.95 mmHg versus 14.15 mmHg for rimexolone 1% in the fellow eye, with return toward baseline by week 6 and no high responders in the trial.
- Two-day reassessment: Re-evaluate if signs and symptoms fail to improve after 2 days.
- Soft contact lenses: Benzalkonium chloride 0.01% may be absorbed by soft lenses; do not instill while lenses are worn.
Common Side Effects
- Ocular: Ocular discomfort in approximately 10% and eye irritation in approximately 1% in clinical studies; keratitis, conjunctivitis, dry eye, photophobia, blurred vision, eye pruritus, foreign body sensation, increased lacrimation, eyelid margin crusting, and ocular hyperemia each below 1%.
- Ocular, serious: Glaucoma with optic nerve damage and visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe.
- Postmarketing, ocular: Corneal erosion, eye pain, eyelid ptosis, mydriasis, and hypersensitivity reactions; frequency cannot be estimated.
- Systemic: Headache and dizziness in postmarketing use; Cushing's syndrome and adrenal suppression after dosing in excess of label instructions in predisposed patients, including children and patients on CYP3A4 inhibitors.
Pregnancy & LactationPregnancy: Teratogenic in mice and rabbits after topical ocular application at multiples of the therapeutic dose, with fetal resorption and cleft palate in mice and head, ear, limb, and palate defects in rabbits; no adequate human studies, prolonged or repeated corticoid use in pregnancy is associated with intrauterine growth retardation, and infants exposed to substantial maternal corticosteroid doses should be watched for hypoadrenalism.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production; whether topical ocular dosing yields detectable milk levels is unknown, so use with caution.
Pediatric UseSafety and effectiveness established in all pediatric age groups, supported by adult trials plus pediatric safety data.