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Ciprofloxacin and fluocinolone: Drug information

Ciprofloxacin and fluocinolone: Drug information
(For additional information see "Ciprofloxacin and fluocinolone: Patient drug information" and see "Ciprofloxacin and fluocinolone: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Otovel
Brand Names: Canada
  • Otixal Single Use
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Otic;
  • Antibiotic/Corticosteroid, Otic;
  • Corticosteroid, Otic
Dosing: Adult
Acute otitis media in patients with tympanostomy tubes

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Pediatric

(For additional information see "Ciprofloxacin and fluocinolone: Pediatric drug information")

Acute otitis media in patients with tympanostomy tubes

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

1% to 10%: Neuromuscular & skeletal: Connective tissue disorder (excessive granulation tissue: 1%)

<1%:

Dermatologic: Pruritus of ear

Nervous system: Balance impairment

Otic: Swelling of the ear, tympanic membrane disease

Postmarketing:

Cardiovascular: Flushing

Dermatologic: Exfoliation of skin

Gastrointestinal: Dysgeusia

Hypersensitivity: Hypersensitivity reaction

Infection: Candidiasis

Nervous system: Dizziness, headache, tingling of the ears

Otic: Eustachian tube congestion, hypoacusis, otalgia, tinnitus, tympanostomy tube blockage

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

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.

Warnings: Additional Pediatric Considerations

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 (Alrwisan 2017)

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Ciprofloxacin-Fluocinolone PF Otic)

0.3-0.025% (per each): $19.83

Solution (Otovel Otic)

0.3-0.025% (per each): $23.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Otic:

Otixal Single Use: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (0.25 mL) [contains polysorbate 80]

Administration: Adult

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.

Administration: Pediatric

Otic: For otic use only; not for injection or ophthalmic use. To avoid dizziness which may result from the instillation of a cold solution, warm solution by holding container in hands for 1 to 2 minutes. Patient should lie down with affected ear upward and maintain position for 60 seconds after suspension is instilled. Administer into ear canal. Gently pump tragus 4 times to facilitate penetration into the middle ear.

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Due to limited systemic absorption, exposure of ciprofloxacin or fluocinolone to the fetus is not expected following maternal otic administration.

Breastfeeding Considerations

Due to limited systemic absorption, exposure of ciprofloxacin or fluocinolone to the nursing infant is not expected following maternal otic administration.

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).

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.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

  1. Alrwisan A, Antonelli PJ, Winterstein AG. Quinolone ear drops after tympanostomy tubes and the risk of eardrum perforation: a retrospective cohort study. Clin Infect Dis. 2017;64(8):1052-1058. [PubMed 28329128]
  2. Otovel (ciprofloxacin/fluorocinolone) [prescribing information]. Ridgeland, MS: WraSer LLC; June 2021.
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