Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.

Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.

This is indicated in Steroid responsive inflammatory ocular conditions, Otitis media, Otitis externa, Ocular inflammation associated with infection, Post-operative inflammation of ear and eye, Corneal Ulcers, Bacterial Conjunctivitis

Eye: Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Eye: Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

Ear: Four drops instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.

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.

The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.

The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.

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.

Use in Special Populations

Paediatric Use:

• Ear: Safety and effectiveness of this suspension in pediatric (6 months of age and older) patients for ear application have been established.
• Eye: Safety and effectiveness of this suspension in pediatric patients for eye application have not been established.

Pregnancy & Lactation

Pregnancy Category C+D.Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: Excretion in breast milk unknown; not recommended.