About AOMT

What is AOMT?

Acute otitis media in children with tympanostomy tubes (AOMT) is a bacterial middle ear infection that may occur at some point after ear tube insertion.1,2 It is called AOMT because it is a short-term, sudden onset infection of the ear specifically in those who have ear tubes. AOMT is different from an ear infection in children without ear tubes. The tubes allow the fluid buildup that would usually cause pain due to pressure on the eardrum to go through the tube instead, so the discharge drains to the outer ear.2 That’s why the first sign of AOMT, or this type of middle ear infection, in many children with ear tubes is a discharge from the ear, called otorrhea.3

Don't the tubes prevent ear infections?

Unfortunately, ear tubes are not a magic cure for recurrent ear infections. A study reported that 83% of children with ear tubes in place will have AOMT within 18 months.4

What do ear tubes do?

It is important to know what ear tubes will and won’t do. If your child is more likely than other children to get ear infections, tubes won’t prevent them from happening. What they will do is affect how many times your child gets an ear infection, how severe the infection is, and how long it lasts.4

Your child has probably had many ear infections, one after the other. Frequent ear infections can negatively impact both the child and the family, with multiple doctor visits, rounds and rounds of antibiotic treatment, and sleep interruptions due to ear pain. Many parents worry about hearing loss and antibiotic resistance over time. If a child has 3 acute otitis media episodes in 6 months, or 4 in 1 year with 1 episode in the preceding 6 months, the doctor will most likely recommend tympanostomy tubes, commonly known as ear tubes.1

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 know 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. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: tympanostomy tubes in children—executive summary. Otolaryngol Head Neck Surg. 2013;149(1):8-16. 2. van Dongen TM, van der Heijden GJ, Venekamp RP, Rovers MM, Schilder AG. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med. 2014;370(8):723-733. 3. Schmelzle J, Birtwhistle RV, Tan AK. Acute otitis media in children with tympanostomy tubes.Can Fam Physician. 2008;54(8):1123-1127. 4. Dohar JE. Tympanostomy tubes: not the magic bullet for acute otitis media. http://www.medscape.org/viewarticle/730700. Published October 21, 2010. Accessed March 23, 2016.