(sip roe FLOKS a sin & hye droe KOR ti sone)
Treatment of acute otitis externa, sometimes known as "swimmers ear " �
Viral infections of the external canal, including varicella and herpes simplex infections; perforated tympanic membrane; hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents.
Otitis externa: Otic: The recommended dosage for all patients is three drops of the suspension in the affected ear twice daily for 7 days; twice-daily dosing schedule is more convenient for patients than that of existing treatments with hydrocortisone, which are typically administered 3 or 4 times a day; a twice-daily dosage schedule may be especially helpful for parents and caregivers of young children
Refer to adult dosing.
Children ≥1 year: Refer to adult dosing.
No dosage adjustment provided in manufacturer 's labeling.
No dosage adjustment provided in manufacturer 's labeling.
Store below 25 � �C (77 � �F); avoid freezing. Protect from light.
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]
There are no known significant interactions.
See individual agents.
1% to 10%: Central nervous system: Headache (1%)
<1% (Limited to important or life-threatening): Alopecia, fungal dermatitis, hypersensitivity reaction, migraine, paresthesia
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. Prior to instillation, suspension should be warmed in hands to prevent dizziness which may occur following use of a cold solution.
C
Animal reproduction studies have not been conducted with this combination.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe ear irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.