"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
CIPROFLOXACIN SOLUTION - OTIC
COMMON BRAND NAME(S): Cetraxal
USES: Ciprofloxacin is used to treat bacterial ear infections (swimmer's ear or ear canal infections). It works by stopping the growth of bacteria. This medication belongs to a class of drugs called quinolone antibiotics.
This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
HOW TO USE: Learn all preparation and usage instructions before using this medication. For accuracy and to avoid contamination, have another person give the drops if possible. Hold the container in your hand for a few minutes to warm it. This will minimize dizziness. Wash your hands before opening/using the medication. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface.
Use this medication in the infected ear twice daily (every 12 hours) for 7 days or as directed by your doctor. Use in the ear only. Do not use in the eyes, inject, or inhale the medication.
Lie on your side or tilt your head with the ear to be treated facing upward. Hold the container directly over the ear, and empty the contents of the single-use container into the ear canal. While placing the solution into the ear of an adult, the earlobe should be gently pulled up and back to allow the drops to flow down into the ear canal. For children, gently pull the earlobe down and back. Keep the head tilted with the treated ear upward for at least 1 minute or insert a soft cotton plug if so directed. Discard any unused solution after each application. Do not reuse.
Repeat the above steps for the other ear if so directed.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed, even if symptoms disappear after a few days. Stopping this medication too early may allow bacteria to continue to grow, which may result in a return of the infection.
Inform your doctor if your condition persists or worsens after 7 days of treatment.
Additional Cetraxal Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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