Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Otic:
Cipro HC: Ciprofloxacin hydrochloride 0.2% and hydrocortisone 1% (10 mL) [contains benzyl alcohol]
Use: Labeled Indications
Acute otitis externa: Treatment of acute otitis externa due to susceptible isolates of Staphylococcus aureus, Proteus mirabilis, and Pseudomonas aeruginosa.
Contraindications
Hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents; viral infections of the external canal, including varicella and herpes simplex infections; perforated tympanic membrane (known or suspected).
Dosage and Administration
Dosing: Adult
Acute otitis externa: Otic: Instill 3 drops into affected ear twice daily for 7 days.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Otitis externa, acute: Children and Adolescents: Otic: Instill 3 drops into the affected ear(s) twice daily for 7 days
Administration
For otic use only. Not for oral, nasal, or ocular use. Prior to instillation, bottle should be warmed by holding in hands for 1 to 2 minutes; dizziness can occur if a cold suspension is instilled. Shake suspension well immediately before using. Patient should lie with affected ear upward and remain in this position for 30 to 60 seconds following instillation. Repeat, if necessary, for the opposite ear.
Storage
Store below 25°C (77°F); avoid freezing. Protect from light.
Drug Interactions
There are no known significant interactions.
Test Interactions
See individual agents.
Adverse Reactions
1% to 10%: Central nervous system: Headache (1%)
<1%, postmarketing, and/or case reports: Alopecia, cough, fungal dermatitis, hypersensitivity reaction, hypoesthesia, migraine, paresthesia, pruritus, skin rash, urticaria
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity: Severe and occasionally fatal hypersensitivity reactions, including anaphylaxis, have occurred with systemic fluoroquinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.
- Infection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. If superinfection occurs, discontinue use and institute appropriate therapy.
- Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic fluoroquinolones. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Other warnings/precautions:
- Appropriate use: For otic use only; not intended for injection or ophthalmic use.
Pregnancy
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
