Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Otic [preservative free]:
Otovel: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (14 ea) [contains polysorbate 80]
Generic: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (14 ea)
Pharmacology
Mechanism of Action
Ciprofloxacin: Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA.
Fluocinolone: Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid.
Use: Labeled Indications
Acute otitis media: Treatment of acute otitis media with tympanostomy tubes (AOMT) due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients 6 months and older.
Contraindications
Hypersensitivity to ciprofloxacin, other fluoroquinolones, fluocinolone, other corticosteroids, or any component of the formulation; viral infection of the external ear canal, including varicella and herpes simplex infections; fungal otic infections
Dosage and Administration
Dosing: Adult
Acute otitis media in patients with tympanostomy tubes: Not indicated for use in adult patients; however, no major differences in safety/efficacy were observed between adult and pediatric patients.
Dosing: Pediatric
Acute otitis media in patients with tympanostomy tubes: Infants ≥6 months, Children, and Adolescents: Ciprofloxacin 0.3% fluocinolone 0.025% solution: Otic: Instill 0.25 mL (ciprofloxacin 0.75 mg/fluocinolone 0.0625 mg) into affected ear canal twice daily for 7 days
Administration
Otic: For otic use only; not for injection or ophthalmic use. Prior to use, warm solution by holding container in hands for 1 to 2 minutes. Patient should lie down with affected ear upward. Administer into ear canal. Gently pump tragus 4 times to facilitate penetration into the middle ear. Patients should remain on side for at least 1 minute to allow penetration of solution.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Dermatologic: Connective tissue disorder (excessive granulation tissue; 1%)
Local: Application site discharge (otorrhea: 5%)
Frequency not defined: Infection: Bacterial superinfection
<1%, postmarketing, and/or case reports: Auricular edema, candidiasis, dizziness, dysgeusia, equilibrium disturbance, eustachian tube congestion, exfoliation of skin, flushing, headache, hypersensitivity reaction, hypoacusis, otalgia, otic infection, paresthesia, pruritus of ear, tinnitus, tympanic membrane disease, tympanostomy tube blockage (device occlusion)
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity reactions: Severe hypersensitivity reactions have occurred with systemic quinolone 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 alternative 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 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 Considerations
Due to limited systemic absorption, exposure of ciprofloxacin or fluocinolone to the fetus is not expected following maternal otic administration.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
Frequently reported side effects of this drug
- Ear drainage
- Fluid draining from the ear
- Ear irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Dizziness
- Passing out
- Fast heartbeat
- Abnormal heartbeat
- Change in balance
- 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.
