Medically reviewed by Drugs.com. Last updated on Jun 9, 2019.
(sip roe FLOKS a sin)
- Ciprofloxacin HCl
- Ciprofloxacin Hydrochloride
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.
- Antibiotic, Fluoroquinolone
- Antibiotic, Otic
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
Hypersensitivity to ciprofloxacin, other quinolones, or any component of the formulation.
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
Refer to adult dosing.
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
Refer to manufacturer's product labeling for preparation instructions.
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.
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.
There are no known significant interactions.
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%)
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.
• 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 Risk Factor
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.
• 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: otic anti-infectives