Why OTOVEL?

OTOVEL: Single. Sterile. Simple

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is a prescription ear drop for children 6 months of age or older who have a type of middle ear infection called acute otitis media with tympanostomy tubes (AOMT) caused by certain bacteria. OTOVEL contains 2 different medicines. One is an antibiotic to treat the infection, and one is an anti-inflammatory to reduce pain and swelling.1 OTOVEL is the first and only antibiotic and steroid ear drop in single-use vials.2 It can be used in children as young as 6 months.1

In two clinical studies of pediatric patients with AOMT, children who took OTOVEL were clear of otorrhea in a median of 3.75 and 4.94 days, whereas those on antibiotic alone were not clear until a median of 7.69 and 6.83 days. The clinical studies also showed that the combination of medicines in OTOVEL had similar side effects as the separate medicines.1

OTOVEL is given twice a day for 7 days. Unlike other prescription ear drops, OTOVEL comes in 14 single-use vials—one for each dose. Each vial has a premeasured amount of medicine in it. That way your child gets an accurate amount of medicine every time. You don’t have to count drops, and each dose is sealed and sterile until you open the vial. To avoid dizziness caused by putting a cold solution into the ear, just hold the vial in your hand for 1 to 2 minutes before you give OTOVEL to your child. Once the vial is warmed, there’s no shaking or mixing required—you just open the vial and give the dose.1

Study Design:

The efficacy and tolerability of OTOVEL were evaluated in two phase III multicenter, randomized, double-blind, active-controlled, parallel-group studies of pediatric patients (N=331 per study) of either sex aged 6 months to 12 years with AOMT in at least one ear, who presented with otorrhea for 3 weeks or less, and with moderate or severe purulent otorrhea at inclusion. Exclusion criteria included: tympanostomy tubes (TT) placement 3 days or less before study entry; TT containing antiseptic or antibacterial activity; T-type tubes; otitis externa; suspected viral, fungal, or mycobacterial ear infection; use of topical or systemic antimicrobial, antifungal, or steroid agents within the previous 7 days of study entry; concurrent use of anti-inflammatory agents. The primary endpoint was time to cessation of otorrhea (TCO), defined as the first day on which otorrhea was absent and remained absent until the end of the study.3

▼ IMPORTANT SAFETY INFORMATION

Do not use OTOVEL if your child:

  • Is allergic to quinolones including ciprofloxacin, corticosteroids including fluocinolone acetonide, or any of the ingredients in OTOVEL.

  • Has an outer ear canal infection caused by certain viruses including chicken pox (varicella) and the herpes simplex virus, or has a fungal ear infection.

INDICATIONS

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is used in children 6 months of age and older, who have a tiny cylinder tube in their eardrum known as a tympanostomy tube to prevent excess fluid in the middle ear. Otovel is used to treat a type of middle ear infection called acute otitis media with tympanostomy tubes (AOMT) caused by certain bacteria.

IMPORTANT SAFETY INFORMATION

Do not use OTOVEL if your child:

  • Is allergic to quinolones including ciprofloxacin, corticosteroids including fluocinolone acetonide, or any of the ingredients in OTOVEL.

  • Has an outer ear canal infection caused by certain viruses including chicken pox (varicella) and the herpes simplex virus, or has a fungal ear infection.

Before using OTOVEL, tell your healthcare provider about all of your child’s medical conditions, including if they:

  • Are pregnant or plan to become pregnant, although OTOVEL is not expected to harm the baby.

  • Are breastfeeding or plan to breastfeed, although OTOVEL is not expected to pass into the breast milk to harm the baby.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Use OTOVEL exactly as your healthcare provider tells you. OTOVEL is for use in the ear only. Do not inject OTOVEL or use OTOVEL in the eye. If symptoms do not improve after 7 days of treatment with OTOVEL, contact your healthcare provider. Do not use OTOVEL for a condition for which it was not prescribed. Do not give OTOVEL to other people, even if they have the same symptoms. It may harm them.

Call your healthcare provider right away if:

  • Fluid continues to drain from the ear after finishing treatment with OTOVEL.

  • Fluid drains from the ear 2 or more times within 6 months after treatment has stopped.

OTOVEL may cause serious side effects, including allergic reactions. Stop using OTOVEL and contact your healthcare provider if any of the following signs or symptoms of an allergic reaction occur: hives, swelling of your face, lips, mouth, or tongue, rash, itching, trouble breathing, dizziness, fast heartbeat, or pounding in your chest.

The most common side effects of OTOVEL include fluid draining from the ear, ear infection, ear itching, extra tissue that grows on a part of your body that has been injured, swelling of the outer part of the ear, ear pain, or balance problems.

Tell your healthcare provider of any side effects that are bothersome or that do not go away. These are not all the possible side effects of OTOVEL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, ask your healthcare provider or pharmacist, or consult the full Prescribing Information.

References: 1. OTOVEL [package insert]. Ridgeland, MS: WraSer Pharmaceuticals. 2. US Food and Drug Administration. Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed July 15, 2016. 3. Spektor Z, Pumarola P, Ismail K, et al. Efficacy and safety of ciprofloxacin plus fluocinolone in otitis media with tympanostomy tubes in pediatric patients: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2017;143(4):341-349.