Eye: This combination is used for acute purulent conjunctivitis, recent inflammation of both superficial and deep corneal layers, and corneal ulceration. It is also indicated in keratitis disciformis, deeper forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis, and corneal injuries caused by chemical, radiation, thermal burns, or foreign body penetration. It is suitable for steroid-responsive ocular inflammatory conditions where a corticosteroid is required and there is a bacterial infection or risk of bacterial infection. It may also be used for post-operative ocular inflammation and other inflammatory eye conditions associated with infection.

Ear: This combination is indicated for otitis externa, otitis media, and chronic suppurative otitis media.

Dexamethasone is a glucocorticoid with strong anti-inflammatory and anti-allergic properties. It is used topically to treat inflammatory conditions affecting the anterior segment of the eye. After oral administration, dexamethasone is rapidly absorbed, with a half-life of approximately 190 minutes. It can also be sufficiently absorbed through topical application to the skin and eyes to produce systemic effects.

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic effective against a wide range of both gram-negative and gram-positive bacteria. It works by binding to bacterial ribosomes and inhibiting protein synthesis at an early stage, thereby stopping bacterial growth.

Eye:

• Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
• Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

If chloramphenicol is absorbed from the eye while the patient is taking anticoagulants such as warfarin, it may enhance the effect of these medicines. The action of chloramphenicol may be reduced if it is used at the same time as phenobarbital. The therapeutic effect of dexamethasone may also be decreased when it is used together with phenytoin, phenobarbital, ephedrine, or rifampicin.

This combination is contraindicated in epithelial herpes simplex keratitis, as well as fungal, viral, tuberculous, and other ocular infections, and in glaucoma. It should not be used in patients who previously experienced myelosuppression following exposure to chloramphenicol. It is also contraindicated in individuals with hypersensitivity to chloramphenicol, dexamethasone phosphate, or any other components of the formulation.

Adverse effects associated with chloramphenicol may include temporary ocular burning or discomfort. Other reported reactions are stinging, redness, itching, conjunctivitis, foreign body sensation, sensitivity to light (photophobia), blurred vision, dryness, and eye pain. Local use of chloramphenicol may also lead to allergic sensitization. Additional possible effects include increased intraocular pressure with potential development of glaucoma, rare optic nerve damage, and posterior subcapsular cataract formation.

There are no sufficient or well-controlled studies in pregnant women. This medication should be used during pregnancy only when the expected benefit outweighs the potential risk to the fetus. Caution is advised when chloramphenicol and dexamethasone ophthalmic solution is used in breastfeeding mothers.

Persistent fungal infection of the cornea should be considered when corticosteroids are used for a prolonged period. Long-term use of steroid-containing products may lead to posterior subcapsular cataract formation and glaucoma, potentially causing optic nerve damage. Regular monitoring of intraocular pressure is therefore necessary. Prolonged antibiotic use may also result in overgrowth of non-susceptible organisms, including fungi. If a new infection develops during treatment, the medication should be discontinued and an alternative therapy should be started.

Ophthalmic steroid - antibiotic combined preparations

Store in a cool, dry place protected from light. Keep out of reach of children. Do not use after 30 days from the first opening.