CILODEX OTIC SUSPENSION

3 Indications

Otic use

Cilodex® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

Acute otitis media in pediatric patients (age 6 months and older) with tympanostomy tubes (AOMT) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

5 Contraindications

• Hypersensitivity to the active substance, any of the excipients or other quinolones.
• Viral, fungal, and untreated parasitic otic infections.

4 Dosage regimen and administration

Dosage regimen

Acute Otitis Media in pediatric patients with tympanostomy tubes: 4 drops twice daily (BID) in the affected ear(s) for 7 days.

Special populations

Renal and hepatic impairment

When using Cilodex® Otic in patients with renal or hepatic impairment, dose adjustment is not necessary.

Pediatric patients

The safety and efficacy of Cilodex® Otic in pediatric patients below 6 months has not been established.

Method of administration

• For otic use only.
• The bottle must be shaken well before use.
• To avoid contamination, the dropper tip should not touch the ear or any other surface.
• The suspension should be warmed by holding the bottle in the hand for 1–2 minutes to avoid any unpleasant sensation which may result from the instillation of a cold suspension.
• The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds.