Classes
DEA Class; Rx
Common Brand Names; Otovel
- Antibiotics/Corticosteroids, Otic
Description
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
Indications
Contraindications
Known hypersensitivity to drug or components
Viral infections of the external ear canal, including varicella and herpes simplex infections, and fungal otic infections
Adverse Effects
- 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)
Warnings
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 and Lactation
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
Maximum Dosage
Not indicated.
Not indicated.
Not indicated.
0.5 mL/ear/day.
6 months and older: 0.5 mL/ear/day.
1 to 5 months: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Ciprofloxacin/fluocinolone acetonide
otic suspension
- 0.3%/0.025% (0.75mg/0.0625mg)/2.5mL
