(sip roe FLOKS a sin & floo oh SIN oh lone)
Acute otitis media: Treatment of acute otitis media with tympanostomy tubes (AOMT) due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients 6 months and older.
Hypersensitivity to ciprofloxacin, other fluoroquinolones, fluocinolone, other corticosteroids, or any component of the formulation; viral infection of the external ear canal, including varicella and herpes simplex infections; fungal otic infections
Acute otitis media in patients with tympanostomy tubes: Not indicated for use in adult patients; however, no major differences in safety/efficacy were observed between adult and pediatric patients.
Acute otitis media in patients with tympanostomy tubes: Infants ≥6 months, Children, and Adolescents: Instill 0.25 mL (single dose container contents [ciprofloxacin 0.75 mg/fluocinolone 0.0625 mg]) into affected ear canal twice daily for 7 days.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Otic: For otic use only; not for injection or ophthalmic use. Prior to use, warm solution by holding container in hands for 1 to 2 minutes. Patient should lie down with affected ear upward. Administer into ear canal. Gently pump tragus 4 times to facilitate penetration into the middle ear. Patients should remain on side for at least 1 minute to allow penetration of solution.
Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Otic [preservative free]:
Otovel: Ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 % (14 ea) [contains polysorbate 80]
There are no known significant interactions.
Resolution of infection; if infection persists after one week of treatment, obtain cultures to guide further treatment. If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, evaluate to exclude an underlying condition (eg, cholesteatoma, foreign body, tumor).
1% to 10%:
Dermatologic: Excessive granulation tissue (1%)
Local: Application site discharge (otorrhea: 5%)
Frequency not defined: Infection: Bacterial superinfection
<1% (Limited to important or life-threatening): Auricular edema, candidiasis, dizziness, dysgeusia, equilibrium disturbance, eustachian tube congestion, exfoliation of skin, flushing, hypersensitivity reaction, hypoacusis, otalgia, otic infection, paresthesia, pruritus of ear, tinnitus, tympanic membrane disease, tympanostomy tube blockage (device occlusion)
Concerns related to adverse effects:
- Hypersensitivity reactions: Severe hypersensitivity reactions have occurred with systemic quinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.
- Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate alternative therapy.
- Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic fluoroquinolones. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.
Other warnings/precautions:
- Appropriate use: For otic use only; not for injection or ophthalmic use. Prior to instillation, suspension should be warmed in hands to prevent dizziness, which may occur following use of a cold solution.
Due to limited systemic absorption, exposure of ciprofloxacin or fluocinolone to the fetus is not expected following maternal otic administration.
Ciprofloxacin: Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA.
Fluocinolone: Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience ear drainage. Have patient report immediately to prescriber dizziness, passing out, tachycardia, or abnormal heartbeat (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.