ciprofloxacin/fluocinolone acetonide, otic (Rx)

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)

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

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.

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

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