Otovel
(Ciprofloxacin And Fluocinolone Acetonide)Otovel Prescribing Information
OTOVEL is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to
- OTOVEL is for otic use only. It is not for ophthalmic use, or for injection.
The recommended dosage regimen is as follows:
- Instill the contents of one single-dose vial 0.25 mL into the affected ear canal twice daily (approximately every 12 hours) for 7 days. Use this dosing for patients aged 6 months of age and older.
- 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[see.]
INSTRUCTIONS FOR USE
OTOVEL (OH-toe-vel)
(ciprofloxacin and fluocinolone acetonide)
otic solutionRead this Instructions for Use that comes with OTOVEL before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Important information aboutOTOVEL:- OTOVEL is for use in the ear only (otic use). Do not inject OTOVEL or use OTOVEL in the eye.
- Use OTOVEL Solution exactly as your healthcare provider tells you to use it.
How should I use OTOVEL?Step 1.You or your caregiver should wash their hands with soap and water. Step 2.Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do notput a cotton swab or any other object in the ear canal.Step 3.Remove OTOVEL from the protective foil pouch. Pull apart 1 single-dose vial of OTOVEL as shown, by tearing along the dotted lines (perforations) until it is fully separated. Step 4.Warm the dose of OTOVEL by holding the vial in your hand for 1 to 2 minutes.Step 5.Twist off the vial cap in the direction of the arrow as shown. Step 6.The person receiving OTOVEL should be on his/her side with the infected ear up as shown. Step 7.Hold the vial of OTOVEL in your hand and place the vial close to the ear. Let the entire dose of OTOVEL fall into the affected ear. Step 8.Gently press the part of the ear known as the tragus 4 timesusing a pumping motion as shown. This will allow the drops of OTOVEL to enter the middle ear.Step 9.Remain on your side with the affected ear facing upward for 1 minute.Step 10.If your healthcare provider has told you to use OTOVEL in both ears, repeat Steps 2-9 for the other ear. Step 11.Safely throw away OTOVEL vials after use. This Instructions for Use has been approved by the Food and Drug Administration.
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Otic Solution: Each single-dose vial of OTOVEL (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.
OTOVEL is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide
In two studies in children with AOMT aged ≥ 6 months to 12 years, blood samples were taken in subgroups of 16 and 14 patients, at Visit 1 (prior to the first dose) and Visit 3 (within 1 and 2 hours after the last dose) respectively, to determine the plasma concentrations of ciprofloxacin and/or fluocinolone acetonide following administration of OTOVEL otic solution at the recommended dosage regimen of 0.25 mL twice daily. Pharmacokinetic (PK) analysis resulted in only 1 sample showing a detectable concentration of ciprofloxacin in plasma of 3.0 mcg/L after 7 days of treatment, and no detectable concentrations in plasma of fluocinolone acetonide were observed. However, the sample with detectable ciprofloxacin concentrations was from a patient who had bilateral AOMT (protocol deviation because all patients participating in the PK study were to have unilateral otorrhea) and who received treatment in both ears with ciprofloxacin 0.3% otic solution, the active comparator.
OTOVEL is contraindicated in:
- Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.
- Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.
- Hypersensitivity: Discontinue use at the first appearance of a skin rash or any other sign of hypersensitivity. ()
5.1 Hypersensitivity ReactionsOTOVEL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.
- Potential for Microbial Overgrowth:Prolonged use may result in the overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy. ()
5.2 Potential for Microbial Overgrowth with Prolonged UseProlonged use of OTOVEL may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.