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Ofloxacin Otic (ofloxacin)

OTHER BRAND NAMES

Floxin Otic (Discontinued)

THERAPEUTIC CLASS

Fluoroquinolone

DEA CLASS

RX

INDICATIONS

Treatment of otitis externa in patients ≥6 months of age, chronic suppurative otitis media in patients ≥12 yrs of age with perforated tympanic membranes, and acute otitis media in patients ≥1 yr of age with tympanostomy tubes.

ADULT DOSAGE

Otitis Externa

Usual: 10 drops (0.5mL) into affected ear qd for 7 days

Otitis Media

Chronic Suppurative Otitis Media w/ Perforated Tympanic Membranes:
Usual: 10 drops (0.5mL) into affected ear bid for 14 days

PEDIATRIC DOSAGE

Otitis Externa

6 Months-13 Years:
Usual: 5 drops (0.25mL) into affected ear qd for 7 days
≥13 Years:
Usual: 10 drops (0.5mL) into affected ear qd for 7 days

Otitis Media

Chronic Suppurative Otitis Media w/ Perforated Tympanic Membranes:
≥12 Years: 
Usual: 10 drops (0.5mL) into affected ear bid for 14 days

Acute Otitis Media w/ Tympanostomy Tubes:
1-12 Years:
Usual: 5 drops (0.25mL) into affected ear bid for 10 days

ADMINISTRATION

Otic route

Instillation
1. Warm sol by holding bottle in hand for 1-2 min
2. Lie w/ affected ear upward then instill drops; maintain position for 5 min
3. For acute otitis media w/ tympanostomy tubes and chronic suppurative otitis media w/ perforated tympanostomy tubes, pump tragus 4X by pushing inward to facilitate penetration into the middle ear
4. Repeat for opposite ear if necessary

HOW SUPPLIED

Sol: 0.3% [5mL, 10mL]

WARNINGS/PRECAUTIONS

D/C if hypersensitivity reaction occurs. Prolonged use may result in overgrowth of nonsusceptible organisms; reevaluate if no improvement after one week. If otorrhea persists after a full course, or if two or more episodes occur within 6 months, further evaluation is recommended. Not for injection or ophthalmic use.

ADVERSE REACTIONS

Pruritus, application-site reaction, taste perversion.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Fluoroquinolone; exerts antibacterial activity by inhibiting DNA gyrase, an enzyme required for DNA replication, repair, deactivation, and transcription.

PHARMACOKINETICS

Absorption: (Perforated tympanic membrane) Cmax=10ng/mL.

ASSESSMENT

Assess for drug hypersensitivity, preexisting cholesteatoma, foreign body or tumor, pregnancy/nursing status.

MONITORING

Monitor for anaphylactic reactions, cardiovascular collapse, loss of consciousness, angioedema, airway obstruction, dyspnea, urticaria and itching, overgrowth of nonsusceptible organisms, for improvement/persistence of otorrhea.

PATIENT COUNSELING

Counsel to avoid touching applicator tip to fingers or other surfaces to avoid contamination. D/C and instruct to contact physician if signs of allergy occur. Instruct patients to warm bottle by holding for 1-2 min, to avoid dizziness that may result from instillation of a cold solution. Instruct to lie with affected ear upward, before instilling the drops; maintain position for 5 min. Instruct to repeat if necessary, for opposite ear.

STORAGE

20-25°C (68-77°F). Protect from light.

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