Composition

EPIDEXONE Eye/Ear Drops (Strerile Suspension):
Each 1 ml contains:
Dexamethasone ………………….
1 mg
Preservative:
Benzalkonium chloride ....................
0.04 mg
EPIDEXONE Strerile Eye Ointment::
Each 1 g contains:
Dexamethasone …………..….…..…….
0.5 mg

Therapeutic Indications

Eye:
Treatment of steroid-responsive inflammatory conditions of the conjunctiva, cornea, lids, and anterior segment of the globe.

Ear:
Treatment of steroid-responsive inflammatory conditions of the external auditory meatus, such as otitis externa.


Dosage and Administration

Eye:
EPIDEXONE Eye/Ear Drops:
Intial dose is 1 or 2 drops every hour during the day and every 2 hours during the night.
It may be reduced to 1 drop every 4 hours, when a satisfactory response is obtained; and later to 1 drop 3 times/day.

EPIDEXONE Strerile Eye Ointment:
Apply a thin strip (about 1 cm) to the affected eye(s) 3 or 4 times daily.

After a favorable response is obtained, the number of applications per day is reduced gradually prior to discontinuation.

Ear:
EPIDEXONE Eye/Ear Drops:
Initial dose is 3 or 4 drops 2 or 3 times/day.
Dosage may be reduced gradually when a favorable response is observed.
The ear canal may be packed with a gauze wick saturated with the product and replaced every 12-24 hours.


Contraindications

Hypersensitivity to the product.
Fungal diseases of ocular structures.

Vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva.

Mycobacterial infection of the eye (e.g.
ocular tuberculosis).

Following uncomplicated removal of a superficial corneal foreign body.


Warnings and Precautions

Prolonged therapy may result in elevated intra-ocular pressure (IOP), optic nerve damage, defects in visual acuity and fields of vision, or posterior subcapsular cataract formation.
Check IOP and lens frequently.

The use of steroids after cataract surgery may delay healing.

Prolonged use may cause secondary ocular infections.
Fungal infections of the cornea have been reported with long-term local steroid application.

Herpes zoster keratitis treatment with steroids requires great caution; frequent slit-lamp microscopy is mandatory.

There are no adequate studies in pregnancy or lactation; use only when clearly needed and when potential benefits outweigh potential hazards.

Safety and efficacy of the drug have not been established in children and should be used with caution below 2 years of age.

Contact lenses should be removed prior to administration of EPIDEXONE.
Lenses may be reinserted 15 minutes following adminstration of the drug.

EPIDEXONE Eye/Ear Drops should be used only during one month after opening.