Skip to Content

Ciprofloxacin (Otic)

Pronunciation

Pronunciation

(sip roe FLOKS a sin)

Index Terms

  • Ciprofloxacin HCl
  • Ciprofloxacin Hydrochloride

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)

Brand Names: U.S.

  • Cetraxal
  • Otiprio

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Otic

Pharmacology

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): 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 with effusion undergoing tympanostomy tube placement

Contraindications

Hypersensitivity to ciprofloxacin, other quinolones, or any component of the formulation.

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute otitis externa: Children ≥1 year and Adolescents: Otic solution 0.2%: Refer to adult dosing.

Otitis media with effusion, bilateral: Infants ≥6 months and Children undergoing tympanostomy tube placement: Otic suspension 6%: Intratympanic: 0.1 mL (6 mg) intratympanically into each affected ear following suctioning of middle ear effusion.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

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: For intratympanic administration only during tympanostomy placement. 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: Headache (2% to 3%)

Dermatologic: Pruritus of ear (2% to 3%)

Infection: Fungal superinfection (2% to 3%)

Local: Application site pain (2% to 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 administration only.

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 (Giamarellou1989; 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, itching, nose irritation, throat irritation, irritability, runny nose, or short-term pain. Have patient report immediately to prescriber severe ear pain or severe ear irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Hide