IMPORTANT SAFETY INFORMATION
Who should not use OTIPRIO ciprofloxacin ear drops with tubes
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.
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