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Chloramphenicol Sodium Succinate

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Chloramphenicol Sodium Succinate

Indications
Dosage
How Supplied

INDICATIONS

In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicolmust be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of chloramphenicol rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.

Acute infections caused by Salmonella typhi*

It is not recommended for the routine treatment of the typhoid carrier state.

Serious infections caused by susceptible strains in accordance with the concepts expressed above

  1. Salmonella species
  2. H. influenzae, specially meningeal infections
  3. Rickettsia
  4. Lymphogranuloma-psittacosis group
  5. Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections
  6. Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.

Cystic fibrosis regimens

*In treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.

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 (chloramphenicol sodium succinate (chloramphenicol sodium succinate (chloramphenicol sodium succinate injection) injection) injection) .

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 (information available on request).

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 (eg, 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 infants 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. (Information available on request.)

HOW SUPPLIED

NDC 61570-405-71 (Steri-Vial® No 57)

Chloromycetin Sodium Succinate is freeze-dried in the vial and supplied in Steri-Vials (rubberdiaphragm- capped vials). When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Available in packages of 10 vials.

Store between 15° and 25°C (59° and 77°F).

Prescribing Information as of April 2007. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly owned subsidiary of King Pharmaceuticals, Inc.). Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307. FDA revision date: 12/05/02

Last reviewed on RxList: 8/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
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