How does this medication work? What will it do for me?

This is a combination product that contains two medications: ciprofloxacin and fluocinolone. Ciprofloxacin is an antibiotic that belongs to the family of medications known as fluoroquinolones. It is used to treat infections caused by certain bacteria. Fluocinolone belongs to a family of medications known as corticosteroids. Corticosteroids reduce inflammation.

Ciprofloxacin - fluocinolone ear drops are used to treat bacterial middle ear infections in children 6 months and older who have tubes in their ears.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each single-use vial holding 0.25 mL of sterile, preservative-free otic solution contains 0.75 mg (3 mg/mL) of ciprofloxacin as ciprofloxacin hydrochloride and 0.0625 mg (0.25 mg/mL) of fluocinolone acetonide. Nonmedicinal ingredients: polysorbate 80, glyciern, povidone K90F, and purified water.

How should I use this medication?

The recommended dose of ciprofloxacin - fluocinolone ear drops is the contents of 1 single-use vial instilled into the ear canal, 2 times a day, approximately every 12 hours, for 7 days. Consult your doctor if the infection has not improved after 1 week of treatment.

To instill the contents into the ear, first warm the container in your hands for 1 to 2 minutes. This will help reduce dizziness caused by putting cold solution into the ear. Have the child lie with the affected ear upward and instill the medication into the ear canal. Gently press on the tragus (the small pointed cartilage in front of the ear canal) 4 times to encourage the medication to enter the middle ear. Your child should continue to lie on that side for 1 minute. Safely discard the container.

If the drops are needed in the other ear, repeat the process for the other side. Ask your doctor or pharmacist to show you the correct method for using this medication.

Finish all this medication, even if your child has started to feel better.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Open the pouch containing the vials only when you are going to start using the medication. Store remaining vials in the pouch and discard any remaining vials 7 days after the pouch is opened.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to fluocinolone, ciprofloxacin, or any ingredients of the medication
  • are allergic to any of the medications belonging to the class of medications called quinolones (e.g., levofloxacin, moxifloxacin, ofloxacin, norfloxacin, nalidixic acid)
  • have fungal or viral infections of the external ear, including chicken pox and herpes simplex

Do not give this medication to infants under 6 months of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • ear itching
  • ear pain
  • ear swelling

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • discharge from the ear

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Ciprofloxacin may cause a skin rash. If you notice skin rashes, skin blisters, itchy skin, hives, or other signs of an allergic reaction, stop using the medication and contact your doctor immediately.

Ciprofloxacin can cause serious and occasionally fatal allergic reactions. If you notice your child having difficulty breathing, swelling of the face and throat, or itchiness, get medical help immediately.

Overgrowth of organisms: As with other antibiotics, treatment with this medication may allow normal fungus, yeast, or types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections. If the infection is not improved after one week of use, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if ciprofloxacin - fluocinolone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children who are less than 6 months of age.

What other drugs could interact with this medication?

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

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