Ciprofloxacin and Dexamethasone
Medically reviewed on Dec 13, 2018
(sip roe FLOKS a sin & deks a METH a sone)
- Ciprofloxacin Hydrochloride and Dexamethasone
- Dexamethasone and Ciprofloxacin
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL) [contains benzalkonium chloride]
Brand Names: U.S.
- Antibiotic, Otic
- Antibiotic/Corticosteroid, Otic
- Corticosteroid, Otic
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.
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
Use: Labeled Indications
Acute otitis media: Treatment of acute otitis media in pediatric patients ≥6 months of age with tympanostomy tubes due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa.
Acute otitis externa: Treatment of acute otitis externa in pediatric patients ≥6 months of age and adults due to susceptible isolates of Staphylococcus aureus and Pseudomonas aeruginosa.
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.
Acute otitis externa: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days
Refer to adult dosing.
Otitis media, acute (with typmanostomy 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
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. For acute otitis media, drops should be instilled directly into tympanostomy tube and tragus should be pumped 5 times to facilitate penetration into the middle ear.
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); avoid freezing. Protect from light.
There are no known significant interactions.
Also see individual agents.
1% to 10%:
Dermatologic: Pruritus of ear (2%)
Otic: Otalgia (≤3%)
<1%: Auditory impairment; crying; dizziness; dysgeusia; ear redness; ear residue, debris, or precipitate; eustachian tube congestion; irritability; oral candidiasis; superinfection; tingling of the ears, tinnitus; tympanostomy tube blockage
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.
• 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.
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).
Pregnancy Risk Factor
Animal reproduction studies have not been conducted with this combination. See individual agents.
• 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?)
• Patient may experience itching or ear discomfort or pain. Have patient report immediately to prescriber severe ear irritation, dizziness, tachycardia, or abnormal heartbeat (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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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Other brands: Ciprodex