Each ml Civodex eye/ear drops contains:
Active Substances: 1 mg Dexamethasone BP and Ciprofloxacin Hydrochloride BP equivalent to 3 mg Ciprofloxacin.
Preservative: Benzalkonium Chloride 0.1 mg.
Civodex is a sterile ophthalmic/otic solution containing Dexamethasone - a corticosteroid and Ciprofloxacin - a quinolone derivative for topical administration to the eyes and ears.
Clinical Pharmacology:
Dexamethasone reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A₂. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
Ophthalmic uses: Acute and chronic keratitis and conjunctivitis of an infectious, allergic but non-viral nature.
It is also indicated in chronic anterior uveities, scleritis, episcleritis, myositis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies.
Post-operative management of cataract, glaucoma, and strabismus.
Otic uses: It is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in acute otitis media and acute otitis externa.
The use of combination with an anti-infective component is indicated where the risk of superficial ocular/otic infection is high.
Eye drops: 1 drop into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
Ear drops: 4 drops two times daily into affected ear.
*Prescription only*
Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone.
Overdosage:
Not known and not likely.
Pregnancy: It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. So caution should be exercised when the combination is administered to a nursing woman.
Prolonged use may result in overgrowth of non-susceptible organisms including fungi; in ocular hypertension, damage to the optic nerve, defects in visual acuity and posterior sub capsular cataract formation may occur. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
Avoid contaminating with the tip with material from ear, fingers, or other sources.
Store at below 30°C in a dry place protected from light. Keep out of reach of children. Do not touch dropper tip to any surface. Do not use after one month of first opening of the bottle.