Otovel otic

Ciprofloxacin is an antibiotic that treats infections caused by bacteria.

Fluocinolone is a steroid that reduces the actions of chemicals in the body that cause inflammation.

Ciprofloxacin and fluocinolone otic (for the ear) is a combination medicine used to treat an middle ear infection (also called otitis media). This medicine is for use in children who have ear tubes in place and who are at least 6 months old.

Ciprofloxacin and fluocinolone otic may also be used for purposes not listed in this medication guide.

It is not likely that other drugs you take orally or inject will have an effect on ciprofloxacin and fluocinolone used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not give this medication for longer than prescribed. Contact the doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your child's current condition only. Do not use it later for another infection unless the doctor directs you to do so. A different medication may be necessary in that case.

It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless the doctor tells you otherwise.

Missed Dose

If you miss a dose, give it as soon as you remember. If it is near the time of the next dose, skip themissed dose. Give the next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature in the original pouch to protect from light and moisture. Discard any unused vials 7 days after opening the pouch. Do not open a vial until you are ready to give it. Discard each vial after use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult the pharmacist or local waste disposal company.Information last revised August 2016. Copyright(c) 2016 First Databank, Inc.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• A fast heartbeat.
• A heartbeat that does not feel normal.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Fluid draining from the ear.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.