OTOVEL

OTOVEL- ciprofloxacin and fluocinolone acetonide solution
Arbor Pharmaceuticals

1 INDICATIONS AND USAGE

OTOVEL is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

2 DOSAGE AND ADMINISTRATION

  • 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 ].

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

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.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

OTOVEL 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.

5.2 Potential for Microbial Overgrowth with Prolonged Use

Prolonged 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.

5.3 Continued or Recurrent Otorrhea

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 224 patients with AOMT were treated with OTOVEL for a median duration of 7 days. All the patients received at least one dose of OTOVEL. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO).

The most common adverse reactions that occurred in 1 or more patients are as follows:

Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the OTOVEL Group

Adverse Reactions1

Number (%) of Patients

OTOVEL

N=224

CIPRO

N=220

FLUO

N=213

Otorrhea

12 (5.4%)

9 (4.1%)

12 (5.6%)

Excessive granulation tissue

3 (1.3%)

0 (0.0%)

2 (0.9%)

Ear infection

2 (0.9%)

3 (1.4%)

1 (0.5%)

Ear pruritus

2 (0.9%)

1 (0.5%)

1 (0.5%)

Tympanic membrane disorder

2 (0.9%)

0 (0.0%)

0 (0.0%)

Auricular swelling

1 (0.4%)

1 (0.5%)

0 (0.0%)

Balance disorder

1 (0.4%)

0 (0.0%)

0 (0.0%)

1 Selected adverse reactions that occurred in ≥ 1 patient in the OTOVEL group derived from all reported adverse events that could be related to the study drug or the drug class.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • 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).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

OTOVEL is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3) ].

8.2 Lactation

Risk Summary

OTOVEL is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3) ].

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