Version May 2024
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Ciprofloxacin and hydrocortisone: Pediatric drug information")
Otitis externa, acute: Children and Adolescents: Otic: Instill 3 drops into the affected ear(s) twice daily for 7 days
Children and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.
Children and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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
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).
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 Clostridioides 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.
In pediatric patients, use of quinolone ear drops after tympanostomy tube placement may increase the risk of tympanic rupture. A retrospective cohort study of over 96,000 patients (<18 years of age) compared patients who received a quinolone-containing ear drop (n=78,275) to those who received a neomycin plus hydrocortisone ear drop (n=18,320). Patients who received quinolone ear drops after tympanostomy tube placement had an increased incidence of tympanic perforation requiring tympanoplasty with an adjusted hazard ratio of 1.61 (95% confidence interval [CI]: 1.15 to 2.26); combination products containing corticosteroids may amplify adverse effect risk; monitor and counsel patients accordingly (Alrwisan 2017)
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]
No
Suspension (Cipro HC Otic)
0.2-1% (per mL): $43.74
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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.
Otic: Prior to use, warm suspension by holding bottle in hands for 1 to 2 minutes; shake suspension well before using; avoid contamination of the tip of the bottle to fingers, ear, or any surfaces; patient should lie with affected ear upward and maintain position for 30 to 60 seconds after suspension is instilled into the ear canal. Repeat, if necessary, for the opposite ear. Not for oral, nasal, or ophthalmic use.
Otitis externa, acute: Treatment of acute otitis externa in pediatric patients ≥1 year of age and adults due to susceptible isolates of Staphylococcus aureus, Proteus mirabilis, and Pseudomonas aeruginosa.
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with this combination.
Ciprofloxacin can be detected in breast milk following systemic administration. It is not known if serum levels of ciprofloxacin or hydrocortisone are high enough following otic administration to produce detectable quantities in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
See individual agents.
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