Cetraxal ear drops contain ciprofloxacin, an antibiotic belonging to a group of drugs called fluoroquinolones. Ciprofloxacin fights bacteria in the body.

Cetraxal ear drops is used to treat ear infections that affect the outer ear canal (also called otitis externa). This type of ear infection is sometimes called "swimmer's ear".

The Otiprio brand of this medicine is used to treat inner ear infections (also called otitis media) in children who are having ear tube surgery.

Cetraxal may also be used for purposes not listed in this medication guide.

Use Cetraxal for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve after using Cetraxal, or if your symptoms get worse.

You should not use Cetraxal if you are allergic to ciprofloxacin (Cipro). Avoid getting Cetraxal in your mouth or eyes or on the skin. If it does get into any of these areas, rinse with water. Stop using this medication and call your doctor at once if you have any skin rash (no matter how mild), white patches in your mouth or throat, or vaginal itching or discharge.

Before taking this medicine

You should not use Cetraxal ear drops if you are allergic to ciprofloxacin (Cipro) or similar antibiotics, such as gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, or ofloxacin.

It is not known whether ciprofloxacin used in the ears will harm an unborn baby. Your body may not absorb ear medicine in amounts large enough to get into your bloodstream. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ciprofloxacin used in the ears could pass into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give Cetraxal to a child without medical advice. Cetraxal ear drops are not approved for use by a child younger than 1 year old.

Use Cetraxal exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Cetraxal ear drops should be used 2 times daily for 7 days, unless your doctor tells you otherwise. Your doses should be spaced at least 12 hours apart.

Wash your hands before using the ear drops.

To use the Cetraxal ear drops:

• Warm the container by holding it in your hands for at least 1 minute. Using Cetraxal ear drops that are cold may cause dizziness when you place the medicine into your ear.

• 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 Cetraxal to a child.

• Hold the dropper upside down over your ear. Squeeze the bottle until all of the medicine drops into the ear.

• Stay lying down or with your ear facing upward for at least 1 minute to allow the medicine to reach the back of your ear canal.

• If you are treating both ears, repeat these steps using a second bottle of ear drops.

Each bottle of Cetraxal ear drops contains enough medicine for only one ear. If you are treating both ears, use a separate bottle for each ear. You will receive a supply of 14 bottles for the full 7-day treatment of both ears. Throw away a container after one use, even if there is still some medicine left in it.

Use Cetraxal 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.

Store the medicine at room temperature away from moisture, heat, and light. Keep each Cetraxal single-use ear drop container in the foil pouch until you are ready to give a dose.

For the first few days after ear tube surgery, your child may have some drainage from the ear(s). Call your doctor if the child has a fever, ear pain, or drainage that lasts longer than a few days.

Usual Adult Dose for Acute Otitis Externa:

Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
(ciprofloxacin 0.5 mg in 0.25 mL in each single use container).

Usual Pediatric Dose for Acute Otitis Externa:

1 year or older:
Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
(ciprofloxacin 0.5 mg in 0.25 mL in each single use container).

You should not use Cetraxal ear drops if you are allergic to ciprofloxacin (Cipro) or similar antibiotics, such as gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, or ofloxacin.

It is not known whether ciprofloxacin used in the ears will harm an unborn baby. Your body may not absorb ear medicine in amounts large enough to get into your bloodstream. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ciprofloxacin used in the ears could pass into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give Cetraxal to a child without medical advice. Cetraxal ear drops are not approved for use by 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 Cetraxal 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 Cetraxal in your eyes.

If Cetraxal ear drops get into your eyes, nose, or mouth, rinse with water.

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

Stop using the ear drops and call your doctor at once if you have:

• a skin rash (no matter how mild); or

• new ear drainage with severe itching (may be signs of a yeast infection).

Common Cetraxal side effects may include:

• itching or pain after using the ear drops;

• fussiness or irritability;

• headache; or

• stuffy nose and sore throat.

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.