OTOVEL: Single-use vials designed for dosing precision1

  • Each vial is only opened when you need it—you’ll know that every dose is sterile, precise, and preservative free

  • Each vial is ready to use—no drop counting. No mixing or shaking required

How to give your child OTOVEL1

OTOVEL® (ciprofloxacin and fluocinolone acetonide) was designed to help make dosing as simple as possible for you and your child.

  • Give OTOVEL to your child twice a day for 7 days. OTOVEL is only for use in the ear. You should use OTOVEL exactly as your doctor directs. Doses should be given about 12 hours apart (for example, 8 AM and 8 PM)

  • Warm OTOVEL in your hands for 1 to 2 minutes prior to giving the dose. Putting cold liquid into the ear can cause dizziness

  • Pull the upper ear back gently while you give the dose, as that helps to provide a clear path to the inner ear

  • Once you’ve given the full dose of OTOVEL, the tragus should be pumped 4 times to help the medicine get to affected area. The tragus is the small piece of cartilage in front of the outer ear canal. After you pump the tragus, have your child lie still in place for 1 to 2 minutes

Please see Medication Guide for detailed dosing instructions.

OPEN
open the otovel package
SQUEEZE
squeeze the otovel package
PUMP
pump the otovel drops into the ear

See the dosing video

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.

Reference: 1. OTOVEL [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC.