"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 "...
(ciprofloxacin) Otic Solution 0.2%
CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL (ciprofloxacin otic solution) is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.
Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3•HCl•H2O, and molecular weight is 385.82.
The chemical structure of ciprofloxacin hydrochloride is:
What are the possible side effects of ciprofloxacin otic (Cetraxal)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- the first sign of any skin rash, no matter how mild;
- white patches in your mouth or throat; or
- vaginal itching or discharge.
Less serious side effects may include:
- headache; or
- itching, pain, or mild irritation after using the ear drops.
What are the precautions when taking ciprofloxacin otic solution (Cetraxal)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it or to other quinolone antibiotics (such as ofloxacin, levofloxacin), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether ciprofloxacin in this ear drop passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before...
Last reviewed on RxList: 12/8/2016
This monograph has been modified to include the generic and brand name in many instances.
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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