A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Chloromycetin Indications, Dosage, Storage, Stability - Chloramphenicol
Chloromycetin Indications, Dosage, Storage, Stability - Chloramphenicol
INDICATIONS
In accord with the concepts in the WARNINGS:
WARNING box and this INDICATIONS
section, chloramphenicol
must 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 WARNINGS:
WARNING box.
- 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, specifically meningeal infections
- c) Rickettsia
- d) Lymphogranuloma-psittacosis group
- e) Various gram-negative
bacteria causing
bacteremia, meningitis
or other gram-negative
infections.
- f) Other susceptible
organisms which have been demonstrated to be resistant to all
other appropriate
antimicrobial
agents.
- Cystic fibrosis
regimens
*In the treatment
of typhoid fever
some authorities recommended 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
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 chloramphenicol
should be substituted for the IV
form because adequate blood
levels are achieved with chioramphenicol by mouth.
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.
DOSAGE
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.
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 (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.
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 infants 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
infants and full-term infants under two weeks of age
differs from that of other infants. 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 children 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.
HOW SUPPLIED
Sterile Chloramphenicol Sodium Succinate, 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). Available
in packages of 10 vials.
Preservative Free.
Store at controlled room
temperature 15°-30°
C (59°-86° F).
CAUTION: Federal law
prohibits dispensing without prescription.
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