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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

Ofloxacin is a DNA gyrase inhibitor. DNA gyrase is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; bactericidal

Absorption

Only small amounts are absorbed systemically after otic instillation.

Use: Labeled Indications

Otitis externa, chronic suppurative otitis media, acute otitis media

Contraindications

Hypersensitivity to ofloxacin or other members of the quinolone group, such as oxolinic acid, cinoxacin, norfloxacin, and ciprofloxacin; hypersensitivity to any component of the formulation

Dosing: Adult

Otitis media, chronic suppurative with perforated tympanic membranes: Otic: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear twice daily for 14 days

Otitis externa: Otic: Instill 10 drops (or the contents of 2 single-dose containers) into affected ear(s) once daily for 7 days

Dosing: Pediatric

Not for systemic use.

Acute otitis media with tympanotomy tubes: Otic: Children 1-12 years: Instill 5 drops (or the contents of 1 single-dose container) into affected ear twice daily for 10 days.

Otitis externa: Otic:

Children 6 months to 13 years: Instill 5 drops (or the contents of 1 single-dose container) into affected ear(s) once daily for 7 days

Children ≥13 years: Refer to adult dosing.

Otitis media, chronic suppurative with perforated tympanic membranes: Otic: Children >12 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

Prior to use, warm solution by holding container in hands for 1-2 minutes. Patient should lie down with affected ear upward and medication instilled. Pump tragus 4 times to ensure penetration of medication. Patient should remain in this position for 5 minutes.

Storage

Solution: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Otic Singles™: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%: Local: Application site reaction (<1% to 17%)

1% to 10%:

Central nervous system: Dizziness (≤1%), vertigo (≤1%)

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

Gastrointestinal: Taste perversion (7%)

Neuromuscular & skeletal: Paresthesia (1%)

<1% (Limited to important or life-threatening): Diarrhea, fever, headache, hearing loss (transient), hypertension, nausea, otorrhagia, tinnitus, transient neuropsychiatric disturbances, tremor, vomiting, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy (primarily with systemic use). The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection is suspected, 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.

Dosage form specific issues:

• Otic use: Not for injection or for ophthalmic use.

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.

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