Pronunciation:

klor-am-FEN-i-kol

Brand Names:

• Chloromycetin
• Sopamycetin

Classifications:

Chemical—

Chloramphenicol (class)

Uses of This Medicine:

Chloramphenicol 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Rifampin
• Tacrolimus
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ceftazidime
• Chlorpropamide
• Cyanocobalamin
• Cyclosporine
• Dicumarol
• Fosphenytoin
• Phenytoin
• Rifapentine
• Tetanus Toxoid
• Tolbutamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

Proper Use of This Medicine:

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

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

Side Effects of This Medicine:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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