In the U.S.—

In Canada—

• Antibacterial, otic

Chloramphenicol (klor-am-FEN-i-kole) belongs to the family of medicines called antibiotics. Chloramphenicol otic drops are used to treat infections of the ear canal. This medicine may be used alone or with other medicines that are taken by mouth for ear canal infections.

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

Otic
• Solution (U.S. and Canada)

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 chloramphenicol otic, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to chloramphenicol. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Chloramphenicol otic solution has not been studied in pregnant women. However, using this medication during pregnancy or labor may increase health risks for the child (See Children ).

Breast-feeding—Chloramphenicol passes into breast milk. Mothers receiving chloramphenicol should not breast-feed their infants.

Children—Gray syndrome may be especially likely to occur in children, who are usually more sensitive than adults to the effects of chloramphenicol. Report any of these effects to your health care professional: blue tone to the skin, changes in blood pressure or heart rate, eating problems, irregular breathing, passage of loose green stools, or stomach bloating with or without vomiting. Your health care professional should monitor blood levels of chloramphenicol if possible.

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 this medicine 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 using any other prescription or nonprescription (over-the-counter [OTC]) medicine. Chloramphenicol may increase the blood levels of these medications: alfentanil, chlorpropamide, phenobarbital, phenytoin, tolbutamide, and warfarin. Phenobarbital and rifampin may reduce the blood levels of chloramphenicol. Concurrent use of chloramphenicol with vitamin B ₁₂ , folic acid, iron preparations and myelosuppressive agents may inhibit the formation of bone marrow.

• Opening in your ear drum—This medicine may cause unwanted effects if it goes past the ear drum into the middle ear
• Sensitivity reaction to chloramphenicol

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 1 or 2 minutes to allow the medicine to come into contact with the infection. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out.
• To keep the medicine as germ-free as possible, do not touch the dropper 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 begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing—

The dose of otic chloramphenicol 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 otic chloramphenicol. If your dose is different, do not change it unless your doctor tells you to do so.

• For otic solution (ear drops) dosage form:
  • For infections of the ear canal:
    • Adults and children—Use 2 or 3 drops in the affected ear two to three times a day.

Missed dose—

If you miss a dose of this medicine, apply 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.

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:

• Rare--may also occur weeks or months after you stop using this medicine
  • Bluish tone to the skin ;  changes in blood pressure or heart rate;  eating problems;  irregular breathing ;  pale skin;  passage of loose green stools;  sore throat and fever;  stomach bloating with or without vomiting;  unusual bleeding or bruising;  unusual tiredness or weakness 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Blindness or changes in vision;  burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine;  diarrhea;  fever;  hallucinations;  headache;  mental confusion;  mild depression;  nausea;  stomach pain;  swollen mouth and tongue ;  unpleasant taste;  vomiting  
  
  

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