Composition
I-Clo Eye Drops: Each ml sterile eye drop contains Chloramphenicol BP 5 mg and Dexamethasone Sodium Phosphate BP equivalent to Dexamethasone 1 mg.
Preservative: Phenyl Mercuric Nitrate 0.003%
Pharmacology
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. Dexamethasone is glucocorticoids. 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.
Indication
Acute purulent conjunctivitis, acute and chronic keratitis and conjunctivitis of an infectious, allergic but non-viral nature, infections of the anterior uvea (iritis, iridocyclitis), scleritis, episcleritis and myositis, post-operative management of cataract, glaucoma and strabismus.
Dosage & Administration
1 drop into the affected eyes every 3 or 4 hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued during 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.
Contraindicaton
Hypersensitivity to any ingredients of the product. Injuries and ulcerating conditions of the cornea, particularly those of viral origin (herpes simplex, vaccinia), purulent infections of the conjunctiva and eyelids, tuberculous infections, mycosis, glaucoma, severe blood disorders due to bone marrow depression and hepatic dysfunctions, new-born babies.
Precaution
Prolonged use of steroid containing product may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.
Side Effects
Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.
Use in Pregnancy and Lactation
Animal experiments with Chloramphenicol have shown adverse effects on the fetus. 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. It should be given in lactating mother if clearly indicated by the physician.
Storage
Store below 25⁰ C, protect from light & moisture. Do not use longer than 30 days after first opening. Keep out of the reach of children.
Packaging
I-Clo Eye Drops: Each dropper bottle contains 5 ml Sterile Eye Drops.
