Pronunciation:

klor-am-FEN-i-kol

Brand Names:

• Chloromycetin Sodium Succinate
• Chloromycetin

Dosage Forms:

• Powder for Solution

Warnings:

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug .

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Chloramphenicol (class)

Uses of This Medicine:

Chloramphenicol is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth.

Chloramphenicol is used to treat serious infections in different parts of the body. It is sometimes given with other antibiotics. However, chloramphenicol should not be used for colds, flu, other virus infections, sore throats or other minor infections, or to prevent infections.

Chloramphenicol should only be used for serious infections in which other medicines do not work. This medicine may cause some serious side effects, including blood problems and eye problems. Symptoms of the blood problems include pale skin, sore throat and fever, unusual bleeding or bruising, and unusual tiredness or weakness. You and your doctor should talk about the good this medicine will do as well as the risks of taking it .

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—

Newborn infants are especially sensitive to the side effects of chloramphenicol because they cannot remove the medicine from their body as well as older children and adults.

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 chloramphenicol 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
• Citalopram
• 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
• Rifampin
• 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:

• Anemia, bleeding, or other blood problems—Chloramphenicol may cause blood problems

• Liver disease—Patients with liver disease may have an increased risk of side effects

Proper Use of This Medicine:

Chloramphenicol is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals), unless otherwise directed by your doctor.

For patients taking the oral liquid form of this medicine:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. 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 infections caused by bacteria:
  • For oral dosage forms (capsules and suspension):
    • Adults and teenagers—Dose is based on body weight. The usual dose is 12.5 milligrams (mg) per kilogram (kg) (5.7 mg per pound) of body weight every six hours.
    • Children—
      • Infants up to 2 weeks of age: Dose is based on body weight. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.
      • Infants 2 weeks of age and older: Dose is based on body weight. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight every six hours; or 25 mg per kg (11.4 mg per pound) of body weight every twelve hours.
  • For injection dosage form:
    • Adults and teenagers—Dose is based on body weight. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight every six hours.
    • Children—
      • Infants up to 2 weeks of age: Dose is based on body weight. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.
      • Infants 2 weeks of age and older: Dose is based on body weight. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight every six hours; or 25 mg per kg (11.4 mg per pound) of body weight every twelve hours.

Missed dose—

If you miss a dose of this medicine, take 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—

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.

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

Chloramphenicol may cause blood problems. These problems may result in a greater chance of infection, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work, whenever possible, should be done before you begin taking this medicine or delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

For diabetic patients:

• This medicine may cause false test results with urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

(in babies only)

Bloated stomach

drowsiness

gray skin color

low body temperature

uneven breathing

unresponsiveness

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

Less common

Pale skin

sore throat and fever

unusual bleeding or bruising

unusual tiredness or weakness (the above side effects may also occur up to weeks or months after you stop taking this medicine)

Rare

Confusion, delirium, or headache

eye pain, blurred vision, or loss of vision

numbness, tingling, burning pain, or weakness in the hands or feet

skin rash, fever, or difficulty in breathing

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Diarrhea

nausea or 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.