Cetraxal

Generic name: Ciprofloxacin Otic
Drug class: Otic anti-infectives

Usage of Cetraxal

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.

Cetraxal side effects

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.

Before taking Cetraxal

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.

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How to use Cetraxal

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).

Warnings

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.

What other drugs will affect Cetraxal

It is not likely that other drugs you take orally or inject will have an effect on ciprofloxacin used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Disclaimer

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