Important Safety Information and Indications

Who should not use OTIPRIO

OTIPRIO should not be used in patients who are 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.

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 in patients who are 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 healthcare professional before getting treated with OTIPRIO?

Before getting OTIPRIO, tell your healthcare professional about all of your medical conditions, including if: you are pregnant or plan to become pregnant, although OTIPRIO is not expected to harm the baby; or if you are breastfeeding or plan to breastfeed, although OTIPRIO is not expected to pass into the breast milk to harm the baby.

Tell your healthcare professional about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 healthcare professional will treat the infection with a different medicine.

The most common side effects that occurred during the clinical testing of OTIPRIO in children with middle ear effusion were swelling of the nasal passages, irritability, and runny nose. In clinical testing of OTIPRIO in patients with acute otitis externa, the most common side effects were ear itching, headache, inflammation of the middle ear, and ear discomfort. These are not all the possible side effects of OTIPRIO. Tell your healthcare professional if you have any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1‑800-FDA-1088.

General information about the safe and effective use of OTIPRIO

Ear tube surgery in children: Fluid may drain from the ear the first few days following surgery, but if the ear becomes painful, or continuous ear fluid is seen, or a fever develops, talk to your child’s doctor.

Acute otitis externa: If the ear continues to be painful, swollen or itchy after a week, talk with your doctor.

What is OTIPRIO® (ciprofloxacin otic suspension)?

OTIPRIO is a prescription medicine used in the ear only that contains a quinolone antibacterial (also known as an antibiotic) medicine called ciprofloxacin. OTIPRIO can be used to:

  • Treat children age 6 months and older who have a type of middle ear condition called otitis media with effusion (fluid buildup of the middle ear) and need ear tubes
  • Treat patients age 6 months and older who have acute otitis externa (outer ear canal infection) due to certain bacteria

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

OTIPRIO is given by a healthcare professional only.