How is Ciprodex (ciprofloxacin and dexamethasone) Otic suspension supplied?

How Ciprodex (Ciprofloxacin and Dexamethasone) Otic Suspension is Supplied

Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) Otic Suspension is supplied as a 7.5 mL fill in a 10 mL LDPE natural bottle with a 30 µL LDPE natural nozzle and a HDPE white opaque screw-on cap with tamper evident ring. 1

Product Details

• Formulation: Sterile white to off-white homogenous suspension 1
• NDC Number: 53746-831-53 1
• Active Ingredients: Ciprofloxacin 0.3% and Dexamethasone 0.1% 1

Storage Requirements

• Store at 20° to 25°C (68° to 77°F) 1
• Excursions permitted between 15° to 30°C (59° to 86°F) 1
• Avoid freezing 1
• Protect from light 1

Clinical Use Information

Administration Guidelines

• Typical dosing is 4 drops into the affected ear(s) twice daily for 7 days 2
• For proper administration:
  • The ear canal should be cleared of inflammatory debris or obstructing cerumen 3
  • After instillation, the patient should remain with the affected ear upward for 3-5 minutes 3
  • Back-and-forth movement of the pinna or tragal pumping may help ensure filling of the ear canal 3

Clinical Applications

• Ciprodex is indicated for acute otitis externa and acute otitis media with tympanostomy tubes 4
• It is the only ototopical drop approved for use in both the middle ear and external auditory canal that combines a fluoroquinolone with a steroid 4
• The high concentration of ciprofloxacin (3000 µg/ml) exceeds the MIC of virtually all relevant organisms 4

Special Considerations

• For patients with a perforated tympanic membrane or tympanostomy tubes, Ciprodex is a non-ototoxic option, unlike aminoglycoside-containing preparations 3, 5
• The addition of dexamethasone to ciprofloxacin has been shown to:
  • Decrease granulation tissue 5
  • Improve clinical cure rates 5
  • Achieve greater rates of bacterial eradication compared to ciprofloxacin alone 5

Common Pitfalls and Caveats

• When using otic drops, ensure the bottle tip doesn't contact the ear to maintain sterility 3
• For patients with severe ear canal edema, placement of a wick may be necessary to facilitate drug delivery 3
• Avoid using cotton balls as wicks as they can fall apart and be retained in the ear canal 3
• After placing drops, the canal is best left open to dry and avoid trapping moisture 3