CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in:
Acute Otitis Media (AOM) in pediatric patients (age ≥ 6 months) with tympanostomy tubes due to Staphylococcusaureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
Acute Otitis Externa (AOE) in pediatric (age ≥ 6 months), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
CIPRODEX® Otic is for otic use only, and not for ophthalmic use, or for injection.
The recommended dosage is four drops into the affected ear twice daily for seven days.
IMPORTANT SAFETY INFORMATION
CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.
Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections and fungal otic infections.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: CIPRODEX® Otic should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.
Potential for Microbial Overgrowth with Prolonged Use: Prolonged use of CIPRODEX® Otic may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.
Continued or Recurrent Otorrhea: If otorrhea persists after a full course of therapy, or if two or more episodes occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
The most commonly reported adverse reactions in clinical trials were: