Otiprio

Otiprio is a prescription medication used to treat otitis media with effusion (fluid buildup of the middle ear) in children who are undergoing surgery to have tubes placed in their ears. This medication is also used to treat children with acute otitis externa (outer ear canal infection). 

It belongs to a group of antibiotics called fluoroquinolones, which work by killing the bacteria that cause infections.

This medication is available as a solution to be given by a needle. It is administered into the affected ear by a healthcare professional as a one time dose. 

Common side effects of Otiprio include swelling of nasal passages, irritability, and runny nose.

Otiprio is a prescription medication used to treat:

• otitis media with effusion (fluid buildup of the middle ear) in children 6 months and older who are undergoing surgery to have tubes placed in their ears
• children age 6 months and older who have acute otitis externa (outer ear canal infection) due to certain bacteria

It is not known if this medication is safe and effective in children under 6 months of age.

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

Serious side effects have been reported with Otiprio. See "Drug Precautions" section.

Common side effects include:

• swelling of the nasal passages
• irritability
• runny nose
• itching of the ear
• headache
• ear discomfort

This is not a complete list of Otiprio side effects. Tell your doctor about any side effect that bothers you, or that does 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 determined 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 Otiprio, including:

• a potential for microbial overgrowth. Otiprio may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, consult your doctor.
• ear drainage. There may be drainage from the ear the first few days following ear tube surgery, but if the ear becomes painful, continuous ear discharge is noted, or a fever develops, consult your doctor.

Do not take Otiprio if you are allergic to ciprofloxacin, to other quinolones, or to any of the components of Otiprio. Active ingredient: ciprofloxacin. Inactive ingredients: poloxamer 407, sodium chloride, tromethamine, hydrochloric acid, and water.

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 Otiprio, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Otiprio, tell your doctor about all of your medical conditions. Especially tell your doctor allergic to ciprofloxacin, to other quinolones, or to any of the components of Otiprio.

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

Tell your doctor if you are pregnant or plan to become pregnant.

Animal studies have not been conducted with Otiprio. No adequate and well-controlled studies have been performed in pregnant women. Because of the negligible systemic exposure associated with the clinical administration of Otiprio, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Ciprofloxacin, the active ingredient in Otiprio, is excreted in human milk with systemic administration. However, because of the negligible systemic exposure after otic application, nursing infants of mothers receiving Otiprio should not be affected.

This medication is available in an injectable form to be given directly into the ear by a healthcare professional.

When treating otitis media with effusion (fluid buildup of the middle ear) in children undergoing ear tube surgery, Otiprio is administered into the tympanic membrane of the affected ear, as a one time dose, and is given by your child’s doctor during ear tube surgery. 

When treating acute otitis externa (outer ear canal infection) due to certain bacteria, Otiprio is administered by your child's doctor to the external ear canal of each affected ear as a one time dose. 

The dose will depend on what is being treated. 

The recommended dose of Otipiro for the treatment of otitis media with effusion (fluid buildup of the middle ear) is a single 0.1 mL dose to each affected ear. 

The recommended dose of Otipiro for the treatment of acute otitis externa is a single 0.2mL dose to the affected ear. 

If Otiprio is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.