Ciprofloxacin is an antibiotic that treats infections caused by bacteria.

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

Ciprofloxacin and hydrocortisone otic (for the ear) is a combination medicine used to treat infections in the ear canal. ciprofloxacin and hydrocortisone will not treat an inner ear infection (also called otitis media).

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

You should not use ciprofloxacin and hydrocortisone if you have a hole in your ear drum (ruptured ear drum).

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

For best results, remove any ear wax or other debris before using this medicine. Ask your doctor about safe methods of ear wax removal.

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.

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 30 to 60 seconds. 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. Throw away any unused medicine after your treatment is finished.

Usual Adult Dose for Acute Otitis Externa:

Ciprofloxacin 2 mg-hydrocortisone 10 mg otic suspension: Instill 3 drops into 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 patient should remain in this position for at least 30 to 60 seconds.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Use: Treatment of acute otitis externa due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis

Usual Pediatric Dose for Acute Otitis Externa:

1 year and older:
Ciprofloxacin 2 mg-hydrocortisone 10 mg otic suspension: Instill 3 drops into the affected ear(s) 2 times a day
-Duration of therapy: 7 days

Comments:
-The safety and efficacy of this drug was established in patients 2 years and older; efficacy was extrapolated for use in patients 1 year and older based on this data.
-Patients should lie with the affected ear upward before administration. Once instilled, the patient should remain in this position for at least 30 to 60 seconds.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Use: Treatment of acute otitis externa due to susceptible strains of P aeruginosa, S aureus, and P mirabilis

You should not use ciprofloxacin and hydrocortisone if you are allergic to ciprofloxacin or hydrocortisone, or if you have:

• a hole in your ear drum (ruptured ear drum); or

• a viral infection affecting your ear canal, including herpes or chickenpox.

You should not use this medicine if you are allergic to any antibiotic similar to ciprofloxacin (Cipro), such as gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

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

• severe ear pain;

• a latex allergy;

• hearing problems; or

• fever.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether this medicine passes into breast milk or if it could affect a nursing baby. You should not breast-feed while using this medicine.

Ciprofloxacin and hydrocortisone should not be used on a child younger than 1 year old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of ciprofloxacin and hydrocortisone 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.

This medicine is for use only in the ears. Avoid getting the medicine in your eyes, mouth, and nose, or on your lips. Rinse with water if this medicine gets in or on these areas.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• redness in or around your ear;

• feeling of fullness in your ear;

• problems with hearing;

• the first sign of any skin rash, no matter how mild; or

• severe burning or other irritation after using the ear drops.

Common side effects of ciprofloxacin and hydrocortisone may include:

• headache;

• mild itching after using the ear drops.

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.