Dosage Form: Opthalmic Solutions.
Ciprofloxacin 0.3% Eye/Ear Drops is indicated 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.
Bacterial Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae. It is also indicated in the treatment of keratitis, kerato-conjunctivitis, blepharitis, blepharo-conjunctivitis, dacryocistitis, prophylaxis of ocular infections due to Neisseria gonorrhea or Chlamydia trachomatis, prevention of ocular infections after removal of a corneal or physical agent before or after ocular surgery.
Ear: Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
As prescribed by physicians.
Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two 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 fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.
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 infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
Route of administration: Intra ocular.
Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.
Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.
Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.
Pregnancy & Lactation:
Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.
Precautions & Warnings:
Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
Use in Special Populations
Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.
Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs
Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
Manufactured by: Aristopharma Ltd.