CIPROP Eye/Ear drops

For the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Corneal ulcers: Pseudomonas aeruginosa, Serratia marcescens*, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans Group)*

Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae

* Efficacy for this organism was studied in fewer than 10 infections.

Dosage and Directions for use

The recommended dosage regimens for adults and children over the age of 2 years are as follows:

Eye drops:

Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is 2 drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteen day, place 2 drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelization has not occurred.

Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1-2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and 1-2 drops every 4 hours while awake for the next 5 days.

To apply the eye drops, shake the drops gently to be sure the medicine is well mixed. Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper.

Squeeze out a drop and close the eye. Apply gently pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct.

Ear drops:

For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection.

Hypersensitivity to quinolone group of antibacterials or another of the components of the formulation.

The most frequently reported side effect was local burning or discomfort. In corneal ulcer studies, with frequent administration of the drug, while crystalline precipitates were seen in approximately 17% of patients. Other reactions occurring in less than 10% of patients included lid margin crushing, hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin.

When taken internally, however, ciprofloxacin is known to interact with the following: Caffeine, cyclosporine, theophylline and warfarin.

Pregnancy: Safety in pregnant women has not been established

Lactation: It is not known whether topically applied ciprofloxacin is secreted in breast milk. However, caution should be exercised when administering to a nursing mother.

If irritation persists or increases, discontinue the use and consult the physician.

CIPROP EYE/EAR DROPS is sterile ophthalmic preparations of ciprofloxacin which is a potent, broad-spectrum, synthetic antibacterial agent belonging to the fluoroquinolone group. It exerts its bactericidal effect by inhibiting DNA gyrase, an essential enzyme involved in DNA replication.