2.1 Important Administration Instructions

• CIPRODEX is for otic use (ears) only, and not for ophthalmic use, or for injection.
• Shake well immediately before use.

2.2 Dosage

For the Treatment of Acute Otitis Media in Pediatric Patients (age 6 months and older) With Tympanostomy Tubes

The recommended dosage regimen through tympanostomy tubes is as follows:

• Four drops [equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of dexamethasone)] instilled into the affected ear twice daily for seven days.
• The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, 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. Repeat, if necessary, for the opposite ear.
• Discard unused portion after therapy is completed.

For the Treatment of Acute Otitis Externa (age 6 months and older)

The recommended dosage regimen is as follows:

• Four drops [equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)] instilled into the affected ear twice daily for seven days.
• The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, 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.
• This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
• Discard unused portion after therapy is completed.