A A A

Steridex (Ophthalmic Suspension)

COMPOSITION

Each ml contains:
Dexamethasone  U.S.P………………………….1.0mg.
with:  Benzalkonium chloride 0.01% edetate disodium, sodium chloride, polysorbate 80, sodium phosphate (dabasic), hydroxypropyl methylcellulose 0.5% & purified water.

DESCRIPTION

Dexamethasone is a synthetic adrenal steroid derived from prednisolone. It possesses glucocorticoid activity. Its potency is about 35 times that of cortisone.

CLINICAL PHARMACOLOGY

Dexamethasone is a corticosteroid with powerful anti-inflammatory action. It acts by inhibiting the inflammatory response to inciting agents of mechanical chemical or immunological nature. It exerts its principal effect on the inflammatory conditions of the anterior segment of the eye.

INDICATIONS

Steridex Ophthalmic Suspension is indicated for the treatment of corticosteroid responsive, non-infectious inflammatory conditions of the anterior segment of the eye and its adnexae such as:
Superficial keratitis, including punctate epithelial lesions (Thygeson type), phlectenular keratocnjunctivitis.
Deep keratitis, including interstitial or parenchymatous keratitis, acne rosacea keratitis sclerosing keratitis.
Herpes zoster ophthalmicus and iridocyclitis or mild acute iritis.
Conjunctivitis, including vernal, allergic, catarrhal, and nonpurulent.
Corneal injuries, such as aseptic thermal radiation, or chemical burns, and corneal injuries following surgical procedures of the penetration of foreign bodies.
Recurrent marginal ulceration of toxic or allergic etiology.
Post-operatively to reduce inflammatory reactions.

CONTRAINDICATIONS

It is contraindicated in epithelial herpes simplex (dendritic keratitis). Acute infectious stages of vaccinia, Varicella, and many other viral diseases of the cornea and conjunctiva.
Fungal diseases of ocular or auricular structures.
Mycobacterial infections of the eye and hypersensitivity to any component of this product.

ADVERSE EFFECTS

Steroids may mask, activate or enhance infection. If infections do not respond promptly, discontinue use until the infection has been adequately controlled by other measures. Prolonged use of topical steroids may result in overgrowth of non-susceptible organisms including fungi. Extended use of steroids may cause an increase in IOP in certain cases including most of those with family history of glaucoma. This may lead to optic nerve damage. Topical steroids when used in diseases causing thinning of cornea or sclera may lead to perforation of the globe. Extensive or prolonged use of topical steroids should be avoided during pregnancy.

DOSAGE AND ADMINISTRATION

Severe or acute inflammation: 1 or2 drops into the conjunctival sac (s) every 30 to 60 minutes as initial therapy, reducing the dosage every 2 to 4 hours, when favorable response is observed.
Chronic inflammation: 1 or 2 drops every 3 to 6 hours, or as frequently as necessary.
Allergic or minor inflammation: 1 or 2 drops every 3 to 4 hours until the desired response is obtained.

HOW SUPPLIED

Steridex Ophthalmic suspension is available as a sterile suspension in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 8˚C to 23˚C.