Important Safety Information and Indication

Who should not use OTIPRIO

OTIPRIO should not be used if your child is allergic to ciprofloxacin, quinolones, or to any of the ingredients in OTIPRIO. Active ingredient: ciprofloxacin.

OTIPRIO is a prescription medicine for the treatment of bilateral otitis media with effusion in children 6 months and older who need ear tubes

When giving post-surgery ear drops

The Struggle Is Real
Mother struggling giving ear medicine to her crying child

When giving post-surgery ear drops

OTIPRIO is a single-dose antibiotic given during ear tube surgery by your child’s doctor, not by you


ENT checking the ears of a child with bilateral otitis media with effusion

What is OTIPRIO?

OTIPRIO—the first and only single-dose antibiotic treatment given by your child’s doctor during ear tube surgery

OTIPRIO contains a quinolone antibacterial medicine called ciprofloxacin [sip"ro-flok'sah-sin].

OTIPRIO is used in children 6 months and older who have bilateral otitis media with effusion (fluid buildup of the middle ear) and need ear tubes. It is not known if OTIPRIO is safe and effective in children under 6 months of age.

OTIPRIO is not for children who are allergic to ciprofloxacin, quinolones, or any of the ingredients in OTIPRIO.

Challenges caregivers face when giving antibiotic ear drops to children

Why OTIPRIO?

Giving your child antibiotic drops can be challenging

According to medical guidelines, antibiotic ear drops are often prescribed after ear tube surgery. And like a lot of parents, you may find it a struggle to give your child ear drops multiple times a day over many days.


Video about Jacob, a patient who received OTIPRIO during ear tube surgery.

“Doctor Gergits introduced me to a single-dose medicine called OTIPRIO…that he would administer to Jacob while he was placing his ear tubes.”

Image of child playing with a test tube

How OTIPRIO works

OTIPRIO changes from a liquid to a gel when it is inside the middle ear. This temperature-sensitive technology helps OTIPRIO stay in place.

If use of OTIPRIO causes continuous growth of bacteria and fungi that are resistant to antibiotics, your child’s healthcare professional will treat your child’s infection with a different medication.

The most common side effects that occurred during the testing of OTIPRIO include: swelling of the nasal passages (nasopharyngitis), irritability, and runny nose (rhinorrhea).

Image of OTIPRIO Conversation Starter form to bring when you talk to your doctor

Let’s get started

Download your OTIPRIO Conversation Starter and share your responses with your child’s doctor

Make sure to bring your answers to your child’s next doctor’s visit and ask about OTIPRIO.

Reference: 1. Data on file, Otonomy, Inc.

IMPORTANT SAFETY INFORMATION

Who should not use OTIPRIO

OTIPRIO should not be used if your child is allergic to ciprofloxacin, quinolones, or to any of the ingredients in OTIPRIO. Active ingredient: ciprofloxacin. Inactive ingredients: poloxamer 407, sodium chloride, tromethamine, hydrochloric acid, and water.

What should I tell my child’s healthcare professional before they get OTIPRIO

Before getting OTIPRIO, tell your healthcare professional about all of your child’s medical conditions.

Tell your healthcare professional about all the medicines your child takes, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Know the medicines your child takes. Keep a list of them to show your healthcare professional.

What are the possible side effects of OTIPRIO

Use of OTIPRIO may cause continuous growth of bacteria and fungi that are resistant to antibiotics. If this happens, your child’s healthcare professional will treat the infection with a different medicine.

The most common side effects that occurred during the testing of OTIPRIO include: swelling of the nasal passages (nasopharyngitis), irritability, and runny nose (rhinorrhea).

Tell your child’s healthcare professional if your child has any side effect that bothers them or does not go away.

These are not all the possible side effects of OTIPRIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or you may contact OTONOMY at 1‑800‑826-6411.

General information about the safe and effective use of OTIPRIO

There may be fluid draining from the ear the first few days following ear tube surgery, but if the ear becomes painful, or continuous ear fluid is seen, or a fever develops, talk to your child’s doctor.

What is OTIPRIO® (ciprofloxacin otic suspension)

OTIPRIO is a prescription medicine used in the ear only (otic use) that contains a quinolone antibacterial (also known as an antibiotic) medicine called ciprofloxacin. OTIPRIO is used in children 6 months and older who have a type of middle ear condition called otitis media with effusion and need ear tubes (also known as tympanostomy tubes).

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

During the ear tube placement surgery, the physician will inject OTIPRIO once into each ear.