Description IMPORTANT CONSIDERATIONS IN PRESCRIBING INJECTABLE CHLORAMPHENICOL SODIUM SUCCINATE.
CHLORAMPHENICOL SODIUM SUCCINATE IS INTENDED FOR INTRAVENOUS USE ONLY.
IT HAS BEEN DEMONSTRATED TO BE INEFFECTIVE WHEN GIVEN INTRAMUSCULARLY.
Chloramphenicol sodium succinate for injection must be hydrolyzed to its microbiologically active form, and there is a lag in achieving adequate blood levels compared with the base given intravenously.
The oral form of chloramphenicol is readily absorbed and adequate blood levels are achieved and maintained on the recommended dosage.
Patients started on intravenous chloramphenicol sodium succinate for injection should be changed to the oral form as soon as practicable.
Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated.
Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section).
When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1g/10mL).
Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium.
The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[b- hydroxy-a-(hydroxymethyl)-pnitrophenethyl] acetamide a-(sodium succinate).
The empirical and structural formulas are: Formula1.jpg
How Supplied Chloromycetin Sodium Succinate for Injection, USP is freeze-dried in the vial.
When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL).
1115 63323-011-15 Available in packages of 10 vials.
Store between 20° and 25°C (68° and 77°F).
[See USP Controlled room Temperature].
APP Pharmaceuticals, LLC Schaumburg, IL 60173
INDICATIONS AND USAGE
Indications and Usage In accord with the concepts in the Warning Box and this 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: a) Salmonella species b) H.
influenzae, specially meningeal infections c) Rickettsia d) Lymphogranuloma-psittacosis group e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections f) 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.
Boxed Warning WARNING Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol.
In addition, 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.
Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE section.
It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.
Precautions: It is essential that adequate blood studies be made during treatment with the drug.
While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia.
To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.
DOSAGE AND ADMINISTRATION
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 Newborn Infants.) 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).
Children 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.
Newborn Infants (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.
Infants and Children 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.)