Dexamethasone Sodium Phosphate Ophthalmic Solution USP
Dexamethasone Sodium Phosphate USP
Eq. to Dexamethesone Phosphate 0.1% w/v
Benzalkonium Chloride solution BP 0.02% v/v
Aqueous Base q.s
Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone).
It suppresses the inflammatory response to a variety of agents and it probably delays or slows healing.
INDICATIONS & USES
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosecea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical or thermal burns, or penetration of foreign bodies.
DOSAGE AND ADMINISTRATION
Instill one or two drops of solutIon into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.
Epithelial herpes simplex keratitis (dendritic keratitis).
Acute infectious stages of vaccinia, vericella and many other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal diseases of ocular or auricular structures.
Hypersensitivity to any component of this product, including sulfites.
Perforation of a drum membrane.
WARNINGS & PRECAUTIONS
FOR EXTERNAL USE ONLY. NOT FOR INJECTION.
Prolonged use may result in ocular hypertension end/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye or ear, corticosteroids may mask infection or enhance existing infection. It these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Glaucoma with optic nerve damage, visual acuity and field defects, posterior sub capsular cataract formation, secondary ocular infection from pathogens including herpes simplex, perforation of the globe.
Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery.
Rarely stinging or burning may occur.
Store in a cool dark place. Do not freeze. Keep out of reach of children.
10 ml sterile plastic bottle.
DEEPCARE HEALTH PVT. LTD.
804, GIDC, Dholka.
Ahmedabad – 382 225
NAFDAC Reg. No.: B4-5335