Skip to content

Ciprofloxacin/Fluocinolone Acetonide

    Brands

    DEA Class; Rx

    Common Brand Names; Otovel

    • Antibiotics/Corticosteroids, Otic

    Antibiotic and corticosteroid combination otic solution
    For acute otitis media due to susceptible organisms in pediatric patients aged 6 months and older with tympanostomy tubes
    Not for viral or fungal ear infections

    Indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) due to susceptible organisms.

    Known hypersensitivity to drug or components

    Viral infections of the external ear canal, including varicella and herpes simplex infections, and fungal otic infections

    • Otorrhea (5.4%)
    • Excessive granulation tissue (1.3%)
    • Ear infection (0.9%)
    • Ear pruritus (0.9%)
    • Tympanic membrane disorder (0.9%)
    • Auricular swelling (0.4%)
    • Balance disorder (0.4%)
    • Immune system disorders: Allergic reaction
    • Infections and infestations: Candidiasis
    • Nervous system disorders: Dysgeusia, paresthesia (tingling in ears), dizziness, headache
    • Ear and labyrinth disorders: Ear discomfort, hypoacusis, tinnitus, ear congestion
    • Vascular disorders: Flushing
    • Skin and subcutaneous tissue disorders: Skin exfoliation
    • Injury, poisoning and procedural complications: Device occlusion (tympanostomy tube obstruction)

    Hypersensitivity; discontinue at first appearance of skin rash or other hypersensitivity; serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported with systemic quinolones (see Contraindications)

    Prolonged use may result in microbial overgrowth of nonsusceptible bacteria and fungi; discontinue therapy if it occurs; institute alternative therapy

    If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, further evaluate to exclude other conditions (eg, cholesteatoma, foreign body, tumor)

    Tendon inflammation and/or rupture reported with systemic fluoroquinolones; exposure is substantially lower with otic administration; discontinue at first sign of tendon inflammation or pain

    Pregnancy

    Negligible systemic absorption following otic administration; not expected to result in fetal exposure if used during pregnancy

    Lactation

    Exposure to infant from mother not expected during breastfeeding

    Adults

    Not indicated.

    Geriatric

    Not indicated.

    Adolescents

    Not indicated.

    Children

    0.5 mL/ear/day.

    Infants

    6 months and older: 0.5 mL/ear/day.
    1 to 5 months: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Ciprofloxacin/fluocinolone acetonide

    otic suspension

    • 0.3%/0.025% (0.75mg/0.0625mg)/2.5mL