Classes
DEA Class; Rx
Common Brand Names; Ciprodex
- Antibiotics/Corticosteroids, Otic
Description
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).
Indications
Indicated for the treatment of acute otitis media in children with tympanostomy tubes.
Contraindications
Hypersensitivity to any component (contains benzalkonium chloride)
Fungal or viral infections of external canal, including varicella and herpes simplex virus infections
Adverse Effects
Alopecia
Dermatitis
Dysgeusia
Fungal dermatitis
Headache
Hyperesthesia
Migraine headache
Paresthesias
Pruritus
Rash
Urticaria
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
8 drops/day to affected ear(s).
8 drops/day to affected ear(s).
8 drops/day to affected ear(s).
8 drops/day to affected ear(s).
>= 6 months: 8 drops/day to affected ear(s).
< 6 months: No maximum dosage information available; safety and efficacy have not been established.
How supplied
Ciprofloxacin/dexamethasone
otic suspension
- 0.3%/0.1%
