Chloramphenicol Injection

Name: Chloramphenicol Injection

How should this medicine be used?

Chloramphenicol injection comes as a liquid to be injected into a vein by a doctor or nurse in a hospital. It is usually given every 6 hours. The length of your treatment depends on the type of infection being treated. After your condition improves, your doctor may switch you to another antibiotic that you can take by mouth to complete your treatment.

You should begin to feel better during the first few days of treatment with chloramphenicol injection. If your symptoms do not improve or get worse, tell your doctor.

Use chloramphenicol injection for as long as your doctor tells you, even if you feel better. If you stop using chloramphenicol injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Chloramphenicol injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • tongue or mouth sores
  • headache
  • depression
  • confusion

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • hives
  • rash
  • itching
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty swallowing or breathing
  • watery or bloody stools (up to 2 months after your treatment)
  • stomach cramps
  • muscle aches or weakness
  • sweating
  • feelings of numbness, pain, or tingling in an arm or leg
  • sudden changes in vision
  • pain with eye movement

Chloramphenicol injection may cause a condition called gray syndrome in premature and newborn infants. There have also been reports of gray syndrome in children up to age 2 and in newborns whose mothers were treated with chloramphenicol injection during labor. Symptoms, which usually occur after 3 to 4 days of treatment, may include: stomach bloating, vomiting, blue lips and skin due to lack of oxygen in the blood, low blood pressure, difficulty breathing, and death. If treatment is stopped at the first sign of any symptoms, the symptoms may go away, and the infant may recover completely. Talk to your doctor about the risks of using this medication during labor or to treat babies and young children.

Chloramphenicol injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Brand names

  • Chloromycetin® Injection
  • Mychel-S® Injection

Adverse reactions

Blood Dyscrasias

The most serious adverse effect of chloramphenicol is bone marrow depression.  Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol.  An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplasia or hypoplasia.  Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.

A reversible type of bone marrow depression, which is dose related, may occur.  This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol.

An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.

In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.

There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.

Paroxysmal nocturnal hemoglobinuria has been reported.

Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving chloramphenicol.  Optic and peripheral neuritis have been reported, usually following long-term therapy.  If this occurs, the drug should be promptly withdrawn.

Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur.  Herxheimer’s reactions have occurred during therapy for typhoid fever.

"Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.”  One case of gray syndrome has been reported in a neonate born to a mother having received chloramphenicol during labor.  One case has been reported in a 3-month-old infant.  The following summarizes the clinical and laboratory studies that have been made on these patients:

   a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.

   b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.

   c) The symptoms appeared in the following order:

       (1) abdominal distension with or without emesis;

       (2) progressive pallid cyanosis;

       (3) vasomotor collapse, frequently accompanied by irregular respiration;

       (4) death within a few hours of onset of these symptoms.

   d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

   e) Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).

   f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

Dosage and administration

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity.  Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.

As soon as feasible an oral dosage form of another appropriate antibiotic should be substituted for intravenous chloramphenicol sodium succinate.

The following method of administration is recommended:

Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval.  This is prepared by the addition of 10 mL of an aqueous diluent such as water for injection or 5% dextrose injection.

Adults

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals.  In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.  Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug.  In instances of impaired metabolic processes, dosages should be adjusted accordingly.  (See discussion under Neonates.)  Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.

Pediatric Patients

Dosage of 50 mg/kg/day divided into 4 doses at 6-hour intervals yields blood levels in the range effective against most susceptible organisms.  Severe infections (e.g., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible.  Children with impaired liver or kidney function may retain excessive amounts of the drug.

Neonates

(See section titled ‘‘Gray Syndrome’’ under ADVERSE REACTIONS.)

A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated.  Increased dosage in these individuals, demanded by severe infections, should be given only to maintain the blood concentration within a therapeutically effective range.  After the first two weeks of life, full-term neonates ordinarily may receive up to a total of 50 mg/kg/day equally divided into 4 doses at 6-hour intervals.  These dosage recommendations are extremely important because blood concentration in all premature and full-term neonates under two weeks of age differs from that of other infant neonates.  This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys.

When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.

Pediatric Patients with Immature Metabolic Processes

In young infants and other pediatric patients in whom immature metabolic functions are suspected, a dose of 25 mg/kg/day will usually produce therapeutic concentrations of the drug in the blood.  In this group particularly, the concentration of the drug in the blood should be carefully followed by microtechniques.

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