In the U.S.—

• Antibacterial, otic

Ofloxacin ( oh-FLOX-a-sin) belongs to the family of medicines called antibiotics. Ofloxacin otic solution is used to treat infections of the ear canal. It also is used to treat infections of the middle ear in patients with nonintact tympanic membranes (holes or tubes in the eardrums).

This medicine is available only with your doctor's prescription, in the following dosage form:

Otic
• Otic solution (eardrops) (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ofloxacin otic preparations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any medicine containing ofloxacin (including tablets, injections, eye drops, and eardrops) or to any related antibiotics such as cinoxacin (e.g., Cinobac), ciprofloxacin (e.g., Ciloxan or Cipro), enoxacin (e.g., Penetrax), levofloxacin (e.g., Levaquin), lomefloxacin (e.g., Maxaquin), nalidixic acid (e.g., NegGram), norfloxacin (e.g., Chibroxin or Noroxin), or trovafloxacin/alatrofloxacin (e.g., Trovan). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Otic ofloxacin has not been studied in pregnant women. Studies in animals that were given high doses of ofloxacin by mouth have shown that ofloxacin can cause birth defects or other problems. However, ofloxacin has not been shown to cause birth defects or other problems when given in doses comparable to the amount of ofloxacin that is found in the eardrops. Before you use this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether otic ofloxacin passes into breast milk. However, ofloxacin given by mouth does pass into breast milk. Because there is a potential for serious adverse reactions from ofloxacin in nursing babies, mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Use is not recommended in infants younger than 1 year of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of otic ofloxacin in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking or using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Ofloxacin eardrops comes with patient information and instructions (Medication Guide). Be sure to read these instructions before using the eardrops . If you have any questions, check with your doctor or health care professional.

To use:

• Hold the bottle in your hands for 1 or 2 minutes to warm up the solution before putting it in your ear. Otherwise, putting cold solution in your ear could cause you to become dizzy.
• Wash your hands with soap and water.
• Gently clean any discharge that can be removed easily from the outer ear, but do not insert any object or swab into the ear canal.
• If you are using the eardrops for a middle ear infection—Drop the medicine into the ear canal. Then, gently press the tragus of the ear (see the diagram in the Medication Guide) four times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear.
• If you are using the eardrops for an ear canal infection—Gently pull the outer ear up and back for adults (down and back for children) to straighten the ear canal. This will allow the eardrops to flow down into the ear canal.
• Keep the ear facing up for about 5 minutes to allow the medicine to come into contact with the infection.
• If both ears are being treated, turn over after 5 minutes, and repeat the application for the other ear.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing—

The dose of ofloxacin otic will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ofloxacin otic. If your dose is different, do not change it unless your doctor tells you to do so.

• For eardrops dosage form:
  • For ear infections:
    • Adults and teenagers (12 years of age and older)—Place 10 drops in each affected ear two times a day for ten to fourteen days, depending on the infection.
    • Children 1 to 12 years of age—Place 5 drops in each affected ear two times a day for ten days.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Oral and systemic ofloxacin and other similar antibiotics have sometimes caused a severe allergic reaction. It is not known if otic ofloxacin may cause this reaction. However, stop using this medicine and check with your doctor immediately if you notice skin rash or itching, shortness of breath, or swelling of the face or neck.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Dizziness 
  
  

• Rare
  • Bleeding from the ear;  fast heartbeat ;  fever;  headache;  ringing in the ear;  runny or stuffy nose;  sore throat 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • Change in taste;  earache;  numbness or tingling 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.