Dosing & Uses
Not indicated
Dosage Forms & Strengths
ciprofloxacin/fluocinolone acetonide
otic suspension
- 0.3%/0.025% (0.75mg/0.0625mg)/2.5mL
Otitis Media
Indicated for acute otitis media with tympanostomy tubes (AOMT) in children aged ≥6 months caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa
<6 months: Safety and efficacy not established
≥6 months: Instill contents of 1 single-dose vial (0.25 mL) into affected ear canal BID for 7 days
Adverse Effects
1-10%
Otorrhea (5.4%)
Excessive granulation tissue (1.3%)
<1%
Ear infection (0.9%)
Ear pruritus (0.9%)
Tympanic membrane disorder (0.9%)
Auricular swelling (0.4%)
Balance disorder (0.4%)
Postmarketing Reports
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
Contraindications
Known hypersensitivity to drug or components
Viral infections of the external ear canal, including varicella and herpes simplex infections, and fungal otic infections
Cautions
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
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ciprofloxacin: Fluoroquinolone antibiotic, exerts anti-bacterial effects through DNA gyrase inhibition
Fluocinolone acetonide: Corticosteroid which inhibits local biosynthesis of prostaglandins; and thus, decreasing inflammation
Absorption
Negligible systemic absorption
Detectible plasma concentration (eg, 3 mcg/mL) at 7 days in one patient with bilateral administration
Administration
Otic Administration
For otic use only; not for ophthalmic use, or for injection
Wash hands with soap and water
Gently clean any fluid (discharge) from outer ear using a clean cloth or tissue; do not put a cotton swab or any other object in ear canal
Warm 1 vial by holding in hand for 1-2 minutes; this is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal
Instruct patient to lie with affected ear upward, and then instill medication
Pump tragus 4 times by pushing inward to facilitate penetration of the medication intomiddle ear
Maintain this position for 1 minute; repeat, if necessary, for opposite ear
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Protect from light; store unused vials in pouch and discard 7 days after opening the pouch
Do not open until ready to use
Discard vial after use
Images
Formulary
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