Dosage Forms
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 disodium, tyloxapol]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
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
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.
Contraindications
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.
Dosage and Administration
Dosing: Adult
Acute otitis externa: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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
Administration
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.
Storage
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.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
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
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.
- 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.
Monitoring Parameters
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
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination. See individual agents.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
Frequently reported side effects of this drug
- Itching
- Ear discomfort or pain
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe ear irritation
- Dizziness
- Fast heartbeat
- Abnormal heartbeat
- 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.
