In the U.S.—

• Antibacterial-corticosteroid (otic)

Ciprofloxacin (sip-roe-FLOX-a-sin) and dexamethasone (dex-a-METH-a-sone) is a combination of two medicines used to treat ear infections. One of the medicines is an antibiotic (medicine used to fight infection) and the other is a corticosteroid (cortisone-like medicine). The antibiotic (ciprofloxacin) is used to fight ear infections. The corticosteroid (dexamethasone) is used to relieve the redness, itching, and swelling caused by ear infections.

This medicine is used to treat middle ear infection with drainage through a tube in children 6 months of age and older. A middle ear infection is an infection caused by bacteria behind the eardrum. People who have a tube in the eardrum may notice drainage from the ear canal.

This medicine is also used to treat outer ear canal infections in patients 6 months of age or older. An outer ear canal infection, also known as “Swimmer's Ear,” is a bacterial infection of the outer ear canal. The ear canal and outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

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

• Otic suspension (ear drops) (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 ciprofloxacin and dexamethasone combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ciprofloxacin (e.g., Cipro) or any related medicines, such as nalidixic acid, norfloxacin (e.g., Noroxin) or ofloxacin (e.g., Floxin),. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has not been studied in pregnant women. It should be used with caution in pregnant women. Be sure your doctor knows if you are pregnant or plan on becoming pregnant while you are using this medicine.

Breast-feeding—It is not known whether this medicine passes into human breast milk. Similar medicines pass into breast milk after they have been taken by mouth. Because there is a potential for unwanted effects in nursing babies, mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—There is no specific information comparing use of ciprofloxacin and dexamethasone combination in children younger than 6 months of age with use in other age groups. This medicine should not be used in children under 6 months of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way they do in younger people of if they cause different side effects or problems in older people. It is not expected to cause different side effects or problems in older people than it does in younger adults.

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 any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Viral ear infections (infections caused by a virus)—This medicine should not be used in patients with viral ear infections of the outer ear canal.

This medicine is to be used in the ear only. It is not approved for use in the eye. Do not take by mouth. If this medicine is accidently swallowed call your doctor right away.

It is important that the infected ear(s) remain clean and dry. When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless your doctor has instructed you otherwise.

To use:

• Wash hands thoroughly with soap and water
• Hold the bottle of ear drops in the hand for one or two minutes to warm the medicine, then shake well.
• Lie down on your side with your infected ear facing up.
• Put drops in infected 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.
• For Patients with Middle Ear Infection with Tubes: While the person getting the ear drops lies on their side the person giving the drops should gently press the small projection in front of the outside opening of the ear 5 times in a pumping motion. This will allow the drops to pass through the tube and into the middle ear.
• For patients with Outer Ear Infection (“Swimmer's Ear”): While the person getting the ear drops lies on their side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal.
• The person who just had the ear drops should stay on their side for at least one minute. Repeat the above steps if both ears are infected.
• When you have completed your course of therapy (usually 7 days), throw away the medicine that you did not use.

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. If the ear drops are not used for as long as the doctor recommended your infection can return.

Dosing—

The dose of ciprofloxacin and dexamethasone may be different for different patients. Follow your doctor's orders or the directions on the label.Do not change your dose unless your doctor tells you to do so.

• For ear drops dosage form:
  • For ear infections:
    • Adults and children 6 months of age and older—Place four drops in the ear canal of infected ear two times a day for seven days.
    • Children younger than 6 months 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. Do not double doses.

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 week, or if they become worse, check with your doctor.

If you experience a rash or an allergic reaction to this medicine, stop using it and call your doctor immediately.

Along with its needed effects, a medicine may cause some unwanted effects.

Some 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
  • Ear discomfort;  ear pain;  itching skin on the ear 
  
  

• Rare
  • Bitter, sour or unusual taste in mouth;  ear congestion;  ear debris;  ear residue;  redness of skin 
  
  

• superimposed ear infection (second ear infection)  

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