IBN SINA PHARMACEUTICALS LTD.
DEXAMETHASONE + CHLORAMPHENICOL
For steroid-responsive inflammatory ocular conditions for which a corticosteriod is indicated and where bacterial infection or a risk of bacterial ocular infection exists. For inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in oedema and inflammation. For chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. It is also effective postoperatively.
Ophthalmic steroid - antibiotic combined preparations
Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It is also effective post-opertively. Chloramphenicol is a bacteriostatic antibiotic with a broad spectrum of action against both Gram-positive and Gram-negative bacteria as well as some other organisms.
1 or 2 drops is instilled into the affected eyes every 3 or 4 hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.
It is contraindicated in fungal, viral, tuberculous and other infections of the eye and in glaucoma. It is also contraindicated in patients hypersensitive to any component of this product. The use of anti-infective and steroid is always contraindicated after uncomplicated removal of a corneal foreign body.
Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain.
US FDA Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Dexamethasone ophthalmic solution is administered to a nursing woman.
If a rise of intraocular pressure occurs, the treatment has to be discontinued
Dexamethasone and Chloramphenicol Eye drops must be used under strict medical supervision. Because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours.
Store below 258 C preferably in a refrigerator; do not freeze, away from light. Keep out of reach of children.