CIPRO HC 2 mg/mL
ciprofloxacin hydrochloride and hydrocortisone · SUSPENSION/ DROPS · Asclemed USA, Inc.
CIPRO HC is a suspension/ drops containing ciprofloxacin hydrochloride and hydrocortisone at 2 mg/mL, taken auricular (otic). Manufactured by Asclemed USA, Inc..
Key Facts
- Brand Name
- CIPRO HC
- Generic Name
- ciprofloxacin hydrochloride and hydrocortisone
- NDC Code (Product)
76420-273- Manufacturer
- Asclemed USA, Inc.
- Strength
- 2 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- NDA020805
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 03/15/1999
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 .
Dosage & Administration
DOSAGE AND ADMINISTRATION SHAKE WELL IMMEDIATELY BEFORE USING. For children (age 1 year and older) and adults, 3 drops of the suspension should be instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for 1-2 minutes to avoid the dizziness, which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
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.
Contraindications
CONTRAINDICATIONS CIPRO ® HC OTIC is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal, including varicella and herpes simplex infections.
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.
Frequently Asked Questions
What is CIPRO HC used for?
CIPRO HC contains ciprofloxacin hydrochloride and hydrocortisone. It is a suspension/ drops taken auricular (otic). Consult your doctor for specific uses.
Is CIPRO HC a controlled substance?
CIPRO HC is not classified as a controlled substance by the DEA.
What is the generic name for CIPRO HC?
The generic name for CIPRO HC is ciprofloxacin hydrochloride and hydrocortisone. There are 1 other brand versions of ciprofloxacin hydrochloride and hydrocortisone.
What is the NDC code for CIPRO HC 2 mg/mL?
The NDC (National Drug Code) for CIPRO HC 2 mg/mL is 76420-273, listed by Asclemed USA, Inc..