Otovel

Otovel 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 is a single product containing 2 medications: ciprofloxacin and fluocinolone. Ciprofloxacin belongs to a group of antibiotics called fluoroquinolones which work to kill bacteria. Fluocinolone belongs to a group of drugs called corticosteroids and works to reduce inflammation (swelling) in the ear. 

Otovel comes as an ear drop in single-use vials. Otovel is given twice daily for 7 days. 

Common side effects include drainage from the ear, ear itching, ear pain, or changes in balance. 

Otovel is a prescription medication used to treat AOMT caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. These are the most common bacteria to cause ear infections in children. Otovel can be used in children 6 months or older who have tubes in their ears. The tubes are placed to help prevent fluid build up in the middle ear. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Otovel. See the “Otovel Precautions” section.

Common side effects of Otovel include the following:

• fluid discharge from the ear
• ear itching
• ear pain
• balance problems
• ear infection
• swelling of outer ear
• extra tissue growth in areas where you are injured 

After coming on the market, additional potential side effects have been reported:

• fungal infection
• tingling in the ears
• dizziness
• ringing in the ears
• flushing, or redness in the face or ears

This is not a complete list of Otovel side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Otovel including the following:

Hypersensitivity Reactions. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Potential for Microbial Overgrowth with Prolonged Use. Otovel should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant or unresponsive to this medication. Take Otovel for the duration prescribed by your doctor.

Continued Otorrhea (fluid drainage from ear). Monitor fluid leaking from ear. If two or more episodes occur within 6 months, contact your doctor immediately.

Do not take Otovel if you:

• are allergic to Otovel or to any of its ingredients
• have a viral infection in the ear canal 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Otovel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Otovel, tell your doctor about all of your child's medical conditions. Especially tell your doctor if he/she is:

• allergic to Otovel or to any of its ingredients
• pregnant or plans to become pregnant
• breastfeeding or plans to breastfeed

Tell your doctor about all the medicines your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if your child is pregnant or plans to become pregnant.

There are no well-done studies that have been done in humans with Otovel, but use in pregnant women is not expected to cause any harm in their babies based on how Otovel works in the body. 

Tell your doctor if your child is breastfeeding or plans to breastfeed.

Otovel was not detected in human breast milk, therefore Otovel use in pregnant women should be safe for mother and baby. 

Take Otovel exactly as prescribed.

• 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
• 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

If you miss a dose, give the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and give the next dose at the regular time. Do not give two doses of Otovel at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Otovel is dosed the same in all ages over 6 months. The recommended dose of Otovel for the treatment of AOMT is 0.25 mL per dose. 

Due to the way Otovel is packaged and prepared, overdose is unlikely. However, if overdose is suspected, seek emergency medical attention.

Otove should be stored the following way:

• Keep at room temperature
• Protect from light
• Keep unused vial in pouch
• Throw away vials 7 days after opening the pouch

Keep Otovel and all medicines out of the reach of children.