"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 "...
(ofloxacin otic) Solution 0.3%
FLOXIN® Otic (ofloxacin otic) solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is:
FLOXIN® Otic (ofloxacin otic solution) contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH to 6.5±0.5.
What are the possible side effects of ofloxacin otic (Floxin Otic)?
Stop using ofloxacin otic and seek emergency medical attention or contact your doctor if you experience:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- skin rash; or
- ear drainage, discharge, or worsening pain.
Other less serious side effects may also occur such as ear discomfort or itching, and headache. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.
Side effects other than those listed here may also occur. Talk to...
What are the precautions when taking ofloxacin otic solution (Floxin Otic)?
Before using ofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), 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, especially of: other ear problems, two or more ear infections within 6 months.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication should be used only when...
Last reviewed on RxList: 11/28/2016
This monograph has been modified to include the generic and brand name in many instances.
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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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