Skip to Content

Ofloxacin (Otic)

Pronunciation

Pronunciation

(oh FLOKS a sin)

Index Terms

  • Floxin Otic Singles

Dosage Forms

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

Solution, Otic:

Floxin Otic: 0.3% (5 mL, 10 mL) [contains benzalkonium chloride, sodium chloride]

Generic: 0.3% (5 mL, 10 mL)

Brand Names: U.S.

  • Floxin Otic

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Otic

Pharmacology

Inhibits DNA-Gyrase in susceptible organisms; bactericidal.

Absorption

Only small amounts are absorbed systemically after otic instillation.

Use: Labeled Indications

Otitis media, acute: Treatment of acute otitis media with tympanostomy tubes due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients 1 year and older.

Otitis media, chronic suppurative: Treatment of chronic supportive otitis media with perforated tympanic membranes due to susceptible isolates of Proteus mirabilis, P. aeruginosa, and S. aureus in patients 12 years and older.

Otitis externa: Treatment of otitis externa due to susceptible isolates of E. coli, P. aeruginosa, and S. aureus in adults and pediatric patients 6 months and older.

Contraindications

Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation

Dosing: Adult

Otitis media, chronic suppurative (with perforated tympanic membranes): Otic: Instill 10 drops into affected ear(s) twice daily for 14 days

Otitis externa: Otic: Instill 10 drops into affected ear(s) once daily for 7 days

Dosing: Pediatric

Otitis media, acute (with tympanostomy tubes): Otic: Children 1 to 12 years: Instill 5 drops into affected ear(s) twice daily for 10 days.

Otitis externa: Otic:

Infants ≥6 months and Children to ≤12 years: Instill 5 drops into affected ear(s) once daily for 7 days

Adolescents ≥13 years: Refer to adult dosing.

Otitis media, chronic suppurative (with perforated tympanic membranes): Otic: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

For otic use only; not for injection, inhalation, or topical 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 and medication instilled. Patients should remain in this position for 5 minutes to allow penetration of solution; repeat if necessary for the opposite ear. For acute otitis media and chronic suppurative otitis media, pump tragus 4 times to ensure penetration of medication.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%: Local: Application site reaction (≤17%)

1% to 10%:

Central nervous system: Paresthesia (1%), dizziness (≤1%), vertigo (≤1%)

Dermatologic: Pruritus (1% to 4%), skin rash (1%)

Gastrointestinal: Dysgeusia (7%)

<1% (Limited to important or life-threatening): Auditory disturbance (transient), diarrhea, fever, headache, hypertension, nausea, otorrhagia, psychiatric disturbance (transient), tinnitus, tremor, vomiting, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions (some fatal), including anaphylaxis, have occurred (some following the first does) with systemic fluoroquinolone 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.

Dosage form specific issues:

• Appropriate use: For otic use only; not for injection or for ophthalmic use. If infection is not improved after 1 week, consider culture to identify organism.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. When administered orally, ofloxacin crosses the placenta (Giamarellou 1989). The amount of ofloxacin available systemically following topical application of the otic drops is significantly less in comparison to oral doses.

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 change in taste. 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 health care 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