CILOXAN STERILE OPHTHALMIC AND OTIC SOLUTION 0.3%

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

SOLUTION

**4 Dosage regimen and administration** **Eye drops** **Dosage regimen** **Corneal ulcers** Ciloxan Eye drops must be administered at the following intervals, even during night-time: - On the first day, instill 2 drops into the affected eye(s) every 15 minutes for the first 6 hours and then 2 drops into the affected eye(s) every 30 minutes for the remainder of the day. - On the second day, instill 2 drops into the affected eye(s) hourly. - On the third through the fourteenth day, place two drops into the affected eye(s) every 4 hours. - If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the attending physician. **Superficial bacterial infections of the eye and adnexa** - For the first two days instill one or two drops into the conjunctival sac of the infected eye(s) every two hours during daytime. - Then one or two drops every four hours during daytime until the bacterial infection is resolved. **Special populations** **Renal and hepatic impairment** No studies have been performed in patients with renal or hepatic impairment. **Pediatric patients** Safety and efficacy in pediatric patients below age of 1 have not been established. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy, and there is no evidence that ophthalmic dosage form has any effect on the weight bearing joints. **Ear drops** **Dosage regimen** First thoroughly clean the external auditory duct. It is more agreeable to administer the solution at room temperature, and better still at body temperature, because in this way vestibular stimulation is avoided. Apply the product dropwise in the external ear duct; the dosage is 3 to 4 drops, 2 to 4 times per day, or more frequently, if required. The patient should first lie on the opposite side in relation to the infection and should preferably remain lying in this position for 5 to 10 minutes. After local cleaning, an impregnated tent of gauze or a hydrophylic plug of cotton can also be inserted in the ear duct, and is generally left in place for 1 to 2 days, but should be impregnated to saturation with the product 2 times per day. In general, the duration of the treatment does not exceed 5 to 10 days. In some cases, the treatment can be prolonged, but, in such cases, it is advisable that the sensitivity of the local flora be demonstrated. As with all antibacterial preparations, prolonged use may lead to overgrowth with non-susceptible microorganisms or fungi. **Special populations** **Renal and hepatic impairment** No studies have been performed in patients with renal or hepatic impairment. **Pediatric patients** Safety and efficacy in pediatric patients below age of 1 have not been established. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy, and there is no evidence that ophthalmic dosage form has any effect on the weight bearing joints. **Method of administration** **Ciloxan Eye drops** - For ocular use only. - After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product. - To avoid contamination, the tip of the dropper / tube should not touch any surface and should also not come into contact with the eye as this may cause injury to the eye. - Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. - Patients should be advised not to wear contact lenses during treatment with CILOXAN Eye/Ear drops solution. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses prior to application of CILOXAN Eye/Ear drops solution and wait at least 15 minutes before reinsertion. - If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointment should be administered last. **Ciloxan Ear drops** - For otic use only. - To avoid contamination, the dropper tip should not touch the ear or any other surface. - The solution should be warmed by holding the bottle in the hand for a few minutes to avoid any unpleasant sensation which may result from the instillation of a cold suspension.