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 dexamethasone: Pediatric drug information")
Otitis media, acute (with tympanostomy tubes): Infants ≥6 months, Children, and Adolescents: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days
Otitis externa, acute: Infants ≥6 months, Children, and Adolescents: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days
Infants ≥6 months, Children, and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.
Infants ≥6 months, 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. Adverse reaction reported in pediatric patients and adults. Also see individual agents.
1% to 10%:
Dermatologic: Pruritus of ear (≤2%)
Otic: Otalgia (≤3%)
<1%:
Gastrointestinal: Dysgeusia, oral candidiasis
Infection: Superinfection
Nervous system: Dizziness, irritability, tingling of the ears
Otic: Ear redness; ear residue, debris, or precipitate; eustachian tube congestion; hearing loss; tinnitus; tympanostomy tube blockage
Postmarketing:
Dermatologic: Erythematous rash, exfoliation of skin
Gastrointestinal: Vomiting
Hypersensitivity: Hypersensitivity reaction
Nervous system: Headache
Otic: Swelling of the ear
Hypersensitivity to ciprofloxacin, other fluoroquinolones, dexamethasone, or any component of the formulation; viral infection of the external canal, including herpes simplex infections; fungal otic infections.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other corticosteroids; parasitic otic infections.
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.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. 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.
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.
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 (Alrawisan 2017)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Otic:
Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL [DSC]) [contains benzalkonium chloride, edetate (edta) disodium]
Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL [DSC]) [contains benzalkonium chloride, edetate (edta) disodium, tyloxapol]
Generic: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL)
Yes
Suspension (Ciprofloxacin-dexAMETHasone Otic)
0.3-0.1% (per mL): $35.87 - $37.36
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Otic:
Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL) [contains benzalkonium chloride, edetate (edta) disodium, tyloxapol]
Generic: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL)
Otic: For otic use only; not intended for injection or ophthalmic use. Prior to instillation, bottle should be warmed 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 60 seconds following application.
Acute otitis media with tympanostomy tubes: Instill drops then gently press the tragus 5 times in a pumping motion to allow the drops to pass through the tube into the middle ear.
Acute otitis externa: Gently pull the outer ear lobe upward and backward to allow the drops to flow down into the ear canal.
For otic use only. To avoid dizziness which may result from the instillation of a cold solution, warm bottle in hand for 1 to 2 minutes prior to use. 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 60 seconds after suspension is instilled.
Acute otitis media with tympanostomy tubes: Instill drops then gently press the tragus 5 times in a pumping motion to allow the drops to pass through the tube into the middle ear.
Acute otitis externa: Gently pull the outer ear lobe upward and backward to allow the drops to flow down into the ear canal.
Otitis externa, acute: Treatment of acute otitis externa in pediatric patients ≥6 months of age and adults due to susceptible isolates of Staphylococcus aureus and Pseudomonas aeruginosa.
Otitis media, acute: Treatment of acute otitis media in pediatric patients ≥6 months of age with tympanostomy tubes due to susceptible isolates of S. aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and P. aeruginosa.
None known.
There are no known significant interactions.
Ciprofloxacin and dexamethasone have minimal systemic absorption following otic administration, limiting any potential exposure to the fetus.
It is not known if ciprofloxacin or dexamethasone are present in breast milk following otic administration. However, ciprofloxacin and dexamethasone have minimal systemic absorption following otic administration, limiting any potential exposure to a breastfed infant.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother
Resolution of infection; if infection persists after one week of treatment, obtain cultures to guide further treatment. If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, evaluate to exclude an underlying condition (eg, cholesteatoma, foreign body, tumor).
Ciprofloxacin: Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA.
Dexamethasone: Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.
Absorption: Otic: Ciprofloxacin: Peak: 0.1% of oral administration peak concentrations; Dexamethasone: Peak: 14% of oral administration peak concentrations
Time to peak, plasma: Otic: 15 minutes to 2 hours
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