CILODEX OTIC SUSPENSION

SOLUTION

**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.