Floxin Otic

DRUG DESCRIPTION

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®  (ofloxacin otic) Structural Formula Illustration

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...

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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...

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Floxin Otic Consumer (continued)

SIDE EFFECTS: Mild irritation/discomfort in the ear, dizziness, headache, earache, or changes in taste may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: tingling/numbness.

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes.

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Floxin Otic Patient Information Including Side Effects

Brand Names: Floxin Otic

Generic Name: ofloxacin otic (Pronunciation: oh FLOCKS a sin OH tic)

  • What is ofloxacin otic (Floxin Otic)?
  • What are the possible side effects of ofloxacin otic (Floxin Otic)?
  • What is the most important information I should know about ofloxacin otic (Floxin Otic)?
  • What should I discuss with my healthcare provider before using ofloxacin otic (Floxin Otic)?
  • How should I use ofloxacin otic (Floxin Otic)?
  • What happens if I miss a dose (Floxin Otic)?
  • What happens if I overdose (Floxin Otic)?
  • What should I avoid while using ofloxacin (Floxin Otic)?
  • What other drugs will affect my ofloxacin otic (Floxin Otic)?
  • Where can I get more information?

What is ofloxacin otic (Floxin Otic)?

Ofloxacin is a fluoroquinolone antibiotic. Ofloxacin fights bacteria in the body.

Ofloxacin is used to treat ear infections.

Ofloxacin otic may also be used for purposes other than those listed in this medication guide.

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 your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ofloxacin otic (Floxin Otic)?

Do not use this medication in the eyes or take it by mouth. Ofloxacin otic is intended for use in the ears only.

Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

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