What are Ciprodex ear drops?

Ciprodex ear drops contain a combination of ciprofloxacin and dexamethasone. Ciprofloxacin is a quinolone antibiotic that treats infections caused by bacteria. Dexamethasone is a corticosteroid. It reduces the actions of chemicals in the body that cause inflammation.

Ciprodex ear drops is a prescription medicine used to treat middle ear infections inside the ear (also called otitis media), and infections of the outer ear canal (also called otitis externa).

It is not known if Ciprodex ear drops are safe and effective in children under 6 months of age.

You should not use Ciprodex ear drops if you have a viral infection affecting your ear canal, including herpes or chickenpox.

Do not use this medication in the eyes or take it by mouth. Ciprodex is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

Take Ciprodex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Shake the medicine well just before each use.

You may warm Ciprodex ear drops before use by holding the bottle in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness, especially in a child who has ear tubes in place.

Wash your hands before using ear drops.

To use the Ciprodex ear drops:

• 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 and drop the correct number of drops into the ear.

• Stay lying down or with your head tilted for at least 2 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.

• Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Use Ciprodex 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.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have new symptoms.

Store Ciprodex ear drops at room temperature away from moisture, heat, and light. Do not freeze. Throw away any unused medicine after your treatment is finished.

Usual Adult Dose of Ciprodex for Otitis Externa:

Recommended dose: 4 drops in the affected ear(s) 2 times a day
Duration of therapy: 7 days

Comments:
-Patients should lie with the affected ear upward before administration. Once instilled, the tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Use:
-Treatment of acute otitis externa in patients due to Staphylococcus aureus and/or Pseudomonas aeruginosa

Usual Pediatric Dose of Ciprodex for Otitis Media:

6 months and older:
-Recommended dose: 4 drops in the affected ear(s) 2 times a day
-Duration of therapy: 7 days

Comments:
-Patients should lie with the affected ear upward before administration. Once instilled, the tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Uses:
-Treatment of acute otitis media in patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, and/or Pseudomonas aeruginosa
-Treatment of acute otitis externa in patients due to S aureus and/or P aeruginosa

Usual Pediatric Dose of Ciprodex for Otitis Externa:

6 months and older:
-Recommended dose: 4 drops in the affected ear(s) 2 times a day
-Duration of therapy: 7 days

Comments:
-Patients should lie with the affected ear upward before administration. Once instilled, the tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Uses:
-Treatment of acute otitis media in patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, and/or Pseudomonas aeruginosa
-Treatment of acute otitis externa in patients due to S aureus and/or P aeruginosa

You should not use Ciprodex if you are allergic to ciprofloxacin or dexamethasone, or if you have:

• a viral or fungal infection affecting your ear canal, including herpes; or

• if you are allergic to any antibiotic similar to ciprofloxacin, such as gatifloxacin, levofloxacin, moxifloxacin, Cipro, Levaquin, and others.

To make sure Ciprodex is safe for you, tell your doctor if you have:

• severe ear pain; or

• hearing problems.

Tell your doctor if you are pregnant or breastfeeding.

Ciprodex should not be used on a child younger than 6 months old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

An overdose of Ciprodex ear drops is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting Ciprodex ear drops in your eyes.

Avoid getting water in your ears while bathing or showering. Avoid swimming while you are treating an ear infection.

Do not use other ear medications unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction to Ciprodex: rash, hives, itching; dizziness, fast heartbeats, fluttering in your chest; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have drainage from your ears after you stop using this medicine, especially if it occurs 2 or more times within 6 months after you stop.

Common Ciprodex side effects may include:

• ear itching or pain, ear discomfort or fullness;

• unusual taste in your mouth;

• feeling irritable;

• rash; or

• a buildup of debris in the ear canal.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.