ciprofloxacin hydrochloride and hydrocortisone

FDA Drug Profile — ciprofloxacin hydrochloride and hydrocortisone, CIPRO HC

ciprofloxacin hydrochloride and hydrocortisone is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including ciprofloxacin hydrochloride and hydrocortisone, CIPRO HC. Available dosage form: suspension/ drops.

Drug Details

Generic Name
ciprofloxacin hydrochloride and hydrocortisone
Brand Names
ciprofloxacin hydrochloride and hydrocortisone, CIPRO HC
Application Number
NDA020805
Sponsor
Sandoz Inc
NDC Codes
6
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.