Ciprofloxacin is an antibiotic. Dexamethasone is a steroid.

Ciprofloxacin and dexamethasone otic (for the ear) is a combination medicine used to treat infections inside the ear (also called otitis media), and infections of the ear canal (also called otitis externa).

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

You should not use this medicine if you have a viral infection affecting your ear canal, including herpes..

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Shake the medicine well just before each use.

You may warm the medicine 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 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 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.

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

Store 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 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 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 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 ciprofloxacin and dexamethasone otic 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.

Tell your doctor if you have ever had:

• severe ear pain; or

• hearing problems.

Tell your doctor if you are pregnant or breastfeeding.

Ciprofloxacin and dexamethasone 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 ciprofloxacin and dexamethasone otic 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze and protect from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid getting the medicine 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: 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 ciprofloxacin and dexamethasone otic, especially if it occurs 2 or more times within 6 months after you stop.

Common side effects of ciprofloxacin and dexamethasone otic 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.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Your prescription is probably not refillable.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Ciprodex® (containing Ciprofloxacin, Dexamethasone)