Dosage Forms
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)
Pharmacology
Mechanism of Action
Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA
Use: Labeled Indications
Acute otitis externa (0.2% solution; 6% suspension): Treatment of acute otitis externa caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus
Otitis media (6% suspension): Treatment of bilateral otitis media in pediatric patients ≥6 months of age with effusion undergoing tympanostomy tube placement
Contraindications
Hypersensitivity to ciprofloxacin, other quinolones, or any component of the formulation.
Dosage and Administration
Dosing: Adult
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
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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
Reconstitution
Refer to manufacturer's product labeling for preparation instructions.
Administration
Otic solution: For otic use only; not for injection, inhalation, or topical ophthalmic use. 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.
Storage
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.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
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%)
Warnings/Precautions
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.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
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.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
- It is used to treat certain people with ear infections who are getting tubes put in the ears.
Frequently reported side effects of this drug
- Headache
- Itching
- Nose irritation
- Throat irritation
- Irritability
- Runny nose
- Short-term pain
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe ear pain
- Severe ear irritation
- 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.
