Nonverbal signs of infection

Unhappy infant tugging on ear, a possible sign of an ear infection
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Babies can show nonverbal signs of pain or discomfort by tugging on their ears. This may indicate that the infant has an ear infection. Other nonverbal signs of a middle ear infection may include fever, difficulty sleeping, crying, and irritability. A common sign of a middle ear infection in a child with ear tubes is ear drainage.

▼ 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.