ciprofloxacin hydrochloride and hydrocortisone
Drug Details
- Generic Name
- ciprofloxacin hydrochloride and hydrocortisone
- Brand Names
- CIPRO HC, ciprofloxacin hydrochloride and hydrocortisone
- Application Number
- NDA020805
- Sponsor
- Asclemed USA, Inc.
- NDC Codes
- 5
- Dosage Forms
- SUSPENSION/ DROPS
- Routes
- AURICULAR (OTIC)
- Active Ingredients
- CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONE
Indications and Usage
INDICATIONS AND USAGE CIPRO ® HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .
Warnings
WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. CIPRO ® HC 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. Serious acute hypersensitivity reactions may require immediate emergency treatment. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions.