Ciflodex Ophthalmic Solution

Eye: This combination eye drop is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and chronic suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.

Dexamethasone is 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 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.

For Eye: 1 drop to be instilled 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.

For Ear:

• Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
• Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.

Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/ keratitis, Periocular/ facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.

Use in pregnancy: This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.

Aural steroid & antibiotic combined preparations

Use in children: Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.

Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use.