OTOVEL

Otic Corticosteroid/anti-infective Combinations

For otic use only.
Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal.
The patient should lie with the affected ear upward, and then instill the medication.
Pump the tragus 4 times by pushing inward to facilitate penetration of the medication into the middle ear. Maintain this position for 1 minute. Repeat, if necessary, for the opposite ear.
Discard vial after use.

laryngeal edema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

edema / Delayed / Incidence not known
dyspnea / Early / Incidence not known
candidiasis / Delayed / Incidence not known
antimicrobial resistance / Delayed / Incidence not known

infection / Delayed / 0.9-0.9
pruritus / Rapid / 0.9-0.9
tinnitus / Delayed / Incidence not known
otalgia / Early / Incidence not known
flushing / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
dizziness / Early / Incidence not known
headache / Early / Incidence not known
paresthesias / Delayed / Incidence not known
dysgeusia / Early / Incidence not known

OTOVEL

Rx

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

Instill 0.25 mL (one single-dose vial) into the affected ear canal twice daily (approximately every 12 hours) for 7 days.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Ciprofloxacin; Fluocinolone products.

Ciprofloxacin, Fluocinolone/Ciprofloxacin, Fluocinolone Acetonide/OTOVEL Auricular (Otic) Sol: 0.3-0.025%

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.

Ciprofloxacin is a fluoroquinolone antibacterial; fluocinolone is a corticosteroid.
Ciprofloxacin: The bactericidal action of ciprofloxacin results from interference with the bacterial enzyme DNA gyrase (topoisomerase II), which is needed for the synthesis of bacterial DNA. Specifically, quinolones are thought to inhibit resealing of DNA double strand by A subunits, which leaves single-strand DNA exposed to exonucleolytic degradation. At clinically achievable concentrations, ciprofloxacin is not thought to inhibit human topoisomerase II.
Fluocinolone: Glucocorticoids prevent or suppress inflammation and immune responses when administered at pharmacological doses. At the molecular level, unbound glucocorticoids readily cross cell membranes and bind with high affinity to specific cytoplasmic receptors. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. Such actions can include inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. Some of the net effects include reduction in edema or scar tissue and a general suppression in immune response. The anti-inflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid.

Ciprofloxacin; fluocinolone otic solution is administered topically to the ear.

Otic Route
 
Systemic absorption of ciprofloxacin and fluocinolone after otic administration is minimal. In a pharmacokinetic analysis (n = 14), after 7 days of treatment with 0.25 mL of ciprofloxacin; fluocinolone otic solution twice daily, detectable plasma concentrations of ciprofloxacin (3 mcg/L) were observed in only 1 patient; however, this patient deviated from study protocol and also received treatment with ciprofloxacin 0.3% otic solution (comparator) in both ears. No detectable fluocinolone concentrations were observed.

Ciprofloxacin; fluocinolone is minimally absorbed following otic administration and maternal use during pregnancy is not expected to result in fetal exposure.

Ciprofloxacin; fluocinolone is minimally absorbed following otic administration and breast-feeding is not expected to result in exposure to the infant.