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Dexamethasone/Ciprofloxacin

    Brands

    DEA Class;  Rx

    Common Brand Names; Ciprodex

    • Antibiotics/Corticosteroids, Otic
     

    Fluoroquinolone/corticosteroid combination otic suspension used for the topical treatment of selected ear infections, including acute otitis media due to susceptible organisms in children with tympanostomy tubes aged 6 months and older; also used for acute otitis externa (e.g., swimmer’s ear).

    Indicated for the treatment of acute otitis media in children with tympanostomy tubes.

    For the treatment of acute otitis externa due to susceptible organisms.

    Hypersensitivity to any component (contains benzalkonium chloride)

    Fungal or viral infections of external canal, including varicella and herpes simplex virus infections

    Alopecia

    Dermatitis

    Dysgeusia

    Fungal dermatitis

    Headache

    Hyperesthesia

    Migraine headache

    Paresthesias

    Pruritus

    Rash

    Urticaria

    Discontinue if hypersensitivity or superinfection occurs

    Reevaluate if no improvement is noted after 1 week

    Prolonged use may result in overgrowth of non-susceptible bacteria and fungi

    Otorrhea may occur; if it persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor

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

    There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; because of minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration, product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women

    Not known whether ciprofloxacin and dexamethasone are present in human milk following topical otic administration

    Adults

    8 drops/day to affected ear(s).

    Elderly

    8 drops/day to affected ear(s).

    Adolescents

    8 drops/day to affected ear(s).

    Children

    8 drops/day to affected ear(s).

    Infants

    >= 6 months: 8 drops/day to affected ear(s).
    < 6 months: No maximum dosage information available; safety and efficacy have not been established.

    Ciprofloxacin/dexamethasone

    otic suspension

    • 0.3%/0.1%