CIPRO HC
Generic: CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
Basic Information
Manufacturer
A-S Medication Solutions
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
AURICULAR (OTIC)
FDA Set ID
ab640d62-f470-4b50-818f-0c0a33904743
Indications & 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.
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.
Adverse Reactions
ADVERSE REACTIONS In Phase 3 clinical trials, a total of 564 patients were treated with CIPRO ® HC OTIC.
Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%).
The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia.
The following reactions have been identified during post-approval use of CIPRO ® HC OTIC in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to CIPRO ® HC OTIC, or a combination of these factors, include: dizziness, ear canal erythema, ear congestion, hypoacusis, and medication residue.
Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%).
The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia.
The following reactions have been identified during post-approval use of CIPRO ® HC OTIC in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to CIPRO ® HC OTIC, or a combination of these factors, include: dizziness, ear canal erythema, ear congestion, hypoacusis, and medication residue.