Otiprio

Otiprio is a prescription medication used to treat otitis media with effusion (ear infections) in children who are undergoing surgery to have tubes placed in their ears. 

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:

• nasopharyngitis
• irritability
• rhinorrhea

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.

Before taking 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 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 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.

The recommended dose of Otipiro for the treatment of otitis media with effusion (ear infections) is 0.3 mL of ciprofloxacin 6% suspension injected into the tympanic membrane of each ear.

You should not use this medicine if you are allergic to ciprofloxacin (Cipro) or similar antibiotics, such as gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, or ofloxacin.

It is not known whether ciprofloxacin used in the ears will harm an unborn baby. Your body may not absorb ear medicine in amounts large enough to get into your bloodstream. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ciprofloxacin used in the ears could pass into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice. Cetraxal ear drops are not approved for use by a child younger than 1 year old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Ciprofloxacin otic is for use only in the ears.

Cetraxal ear drops should be used 2 times daily for 7 days, unless your doctor tells you otherwise. Your doses should be spaced at least 12 hours apart.

Wash your hands before using the ear drops.

To use the ear drops:

• Warm the container by holding it in your hands for at least 1 minute. Using ciprofloxacin otic that is cold may cause dizziness when you place the medicine into your ear.

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

• Hold the dropper upside down over your ear. Squeeze the bottle until all of the medicine drops into the ear.

• Stay lying down or with your ear facing upward for at least 1 minute to allow the medicine to reach the back of your ear canal.

• If you are treating both ears, repeat these steps using a second bottle of ear drops.

Each bottle of Cetraxal ear drops contains enough medicine for only one ear. If you are treating both ears, use a separate bottle for each ear. You will receive a supply of 14 bottles for the full 7-day treatment of both ears. Throw away a container after one use, even if there is still some medicine left in it.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store the medicine at room temperature away from moisture, heat, and light. Keep each single-use ear drop container in the foil pouch until you are ready to give a dose.

Your child's doctor will place a single dose of Otiprio in each affected ear during ear tube surgery. You will not be given a supply of Otiprio to use at home.

For the first few days after ear tube surgery, your child may have some drainage from the ear(s). Call your doctor if the child has a fever, ear pain, or drainage that lasts longer than a few days.

A doctor or other healthcare professional will give your child this medicine. This medicine is to be given through a needle into your child's middle ear.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to ciprofloxacin otic: intratympanic suspension

Other dosage forms:

• otic solution

Along with its needed effects, ciprofloxacin otic (the active ingredient contained in Otiprio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ciprofloxacin otic:

• Fever
• headache
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Some side effects of ciprofloxacin otic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Irritability