Otitis externa, acute:
Otic solution 0.2% (Cetraxal): Children and Adolescents: Otic: Instill 0.25 mL (0.5 mg, contents of 1 single-dose container) into affected ear(s) twice daily (approximately 12 hours apart) for 7 days
Otic suspension 6% (Otiprio): Infants ≥6 months, Children, and Adolescents: Otic: Instill 0.2 mL (12 mg) suspension into each affected ear as a single dose. Note: Intended for administration by health care professional.
Otitis media with effusion, bilateral: Infants ≥6 months and Children undergoing tympanostomy tube placement: Otic suspension 6% (Otiprio): Intratympanic: Instill 0.1 mL (6 mg) into each affected ear following suctioning of middle ear effusion
There are no dosing adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosing adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Ciprofloxacin (otic): Drug information")
Acute otitis externa: Otic:
Solution 0.2%: Instill 0.25 mL (0.5 mg) solution (contents of 1 single-dose container) into affected ear twice daily for 7 days
Suspension 6%: Instill 0.2 mL (12 mg) suspension into affected ear as a single dose
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Otic, as hydrochloride [strength expressed as base, preservative free]:
Cetraxal: 0.2% (1 ea)
Generic: 0.2% (1 ea)
Suspension, Intratympanic [preservative free]:
Otiprio: 6% (1 mL)
May be product dependent
Otic:
Otitis externa, acute:
Otic solution (Cetraxal): For otic use only. Prior to use, warm solution by holding container in hands for at least 1 minute. Patient should lie down with affected ear upward. Patients should remain in the position for at least 1 minute to allow penetration of solution.
Otic suspension (Otiprio): For otic use; should only be administered by health care professional. Hold vial by aluminum seal to prevent gelation and shake the vial for 5 to 8 seconds until suspension is visually homogenous. Using an 18- to 21-gauge needle, withdraw 0.3 mL from vial into a 1 mL syringe. Prepare second dose for bilateral otitis externa (use separate syringe for each ear), using same vial; vials are single-patient use, discard unused portion. Replace preparation needle with a 20- to 24-gauge, 1.5-inch blunt, flexible catheter (or comparable administration needle/device); a separate administration catheter/needle should be used for each ear. After administration needle/catheter attached to the syringe, prime needle leaving the desired 0.2 mL dose. If gelation occurs during preparation, place vial back in refrigeration.
Otitis media with effusion, bilateral: Intratympanic: Otic suspension (Otiprio): For intratympanic use only during tympanostomy placement. Hold vial by aluminum seal to prevent gelation and shake vial for 5 to 8 seconds until suspension is visually homogenous. Using an 18- to 21-gauge needle, withdraw 0.3 mL from vial into a 1 mL syringe. Remove needle and attach a 20- to 24-gauge, 2- to 3-inch blunt, flexible catheter/needle to be used for administration. After administration needle/catheter attached, prime needle leaving the desired 0.1 mL dose. Prepare second dose for bilateral otitis media (use separate syringe for each ear and administration catheter/needle), using same vial; vials are single-patient use, discard unused portion. Replace preparation needles with administration needles (separate needles for each ear). If gelation occurs during preparation, place vial back in refrigeration.
Otic solution: For otic use only; not for injection, inhalation, or topical ophthalmic use. Wash hands prior to use. Administer approximately every 12 hours. Prior to use, warm solution by holding container in hands for at least 1 minute. Patient should lie down with affected ear upward and medication instilled. Patients should remain in the position for at least 1 minute to allow penetration of solution.
Otic suspension: Refer to manufacturer's product labeling for administration instructions; separate syringes should be used for each ear. Vials are for single-patient use; discard unused portion.
Solution: Store at 15°C to 25°C (59°F to 77°F). Store unused containers in pouch to protect from light.
Suspension: Store at 2°C to 8°C (36°F to 46°F) in original carton until prior to use to prevent thickening during preparation. Protect from light. If product thickens during preparation, place back in refrigerator. After preparation in a syringe, may store syringe on its side at room temperature or in the refrigerator; discard if not administered in 3 hours.
Cetraxal (0.2 % solution): Treatment of acute otitis externa (FDA approved in ages ≥1 year and adults)
Otiprio (6% suspension): Treatment of acute otitis externa (FDA approved in ages ≥6 months and adults); intratympanic treatment of bilateral otitis media with effusion in patients undergoing tympanostomy tube placement (FDA approved in pediatric patients ≥6 months)
Cetraxal may be confused with cefTRIAXone
Ciprofloxacin may be confused with cephalexin
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Irritability (infants and children: 5%), headache (2% to 3%)
Dermatologic: Pruritus of ear (2% to 3%)
Infection: Fungal superinfection (otic: 2% to 3%)
Local: Application site pain (2% to 3%)
Otic: Otitis media (2%)
Respiratory: Nasopharyngitis (infants and children: 5%), rhinorrhea (infants and children: 3%)
Hypersensitivity to ciprofloxacin, other quinolones, or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Severe hypersensitivity reactions have occurred with 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 quinolone antibiotics. 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: Solution: For otic use only; not for injection, inhalation, or topical ophthalmic use. If infection is not improved after 1 week, consider culture to identify organism.
• Appropriate use: Suspension: For intratympanic (otitis media) and otic (otitis externa) administration.
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)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program
There are no known significant interactions.
Animal reproduction studies have not been conducted with ciprofloxacin otic solution. When administered orally or IV, ciprofloxacin crosses the placenta (Giamarellou 1989; Ludlam 1997). The amount of ciprofloxacin available systemically following topical application of the otic drops is expected to be significantly less in comparison to oral or IV doses. Minimal risk to the fetus and mother is expected following maternal administration.
Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA
Solution (Cetraxal Otic)
0.2% (per each): $46.37
Solution (Ciprofloxacin HCl Otic)
0.2% (per each): $9.30
Suspension (Otiprio Intratympanic)
6% (per mL): $339.84
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