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
Claforan Indications, Dosage, Storage, Stability - Cefotaxime
Claforan Indications, Dosage, Storage, Stability - Cefotaxime
INDICATIONS
Treatment
CLAFORAN is indicated for the treatment
of patients with serious infections caused by susceptible
strains of the designated microorganisms in the diseases listed below.
Lower respiratory
tract infections, including
pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus
pneumoniae), Streptococcus pyogenes* (Group A streptococci)
and other streptococci
(excluding enterococci, e.g., Streptococcus faecalis), Staphylococcus
aureus (penicillinase and non-penicillinase producing), Escherichia
coli, Klebsiella species,
Haemophilus influenzae (including ampicillin
resistant strains), Haemophilus parainfluenzae, Proteus mirabilis,
Serratia marcescens*, Enterobacter species, indole
positive Proteus and
Pseudomonas species (including P. aeruginosa).
Genitourinary infections. Urinary tract infections caused by Enterococcus
species, Staphylococcus
epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase
producing), Citrobacter species,
Enterobacter species,
Escherichia coli, Klebsiella species,
Proteus mirabilis, Proteus vulgaris*, Proteus inconstans
group B, Morganella morganii*,
Providencia rettgeri*, Serratia marcescens and Pseudomonas
species (including P. aeruginosa). Also, uncomplicated gonorrhea
(cervical/urethral and rectal) caused by Neisseria gonorrhoeae,
including penicillinase
producing strains.
Gynecologic infections, including pelvic inflammatory disease,
endometritis and pelvic
cellulitis caused by Staphylococcus
epidermidis, Streptococcus species,
Enterococcus species, Enterobacter species*, Klebsiella
species*, Escherichia coli, Proteus mirabilis, Bacteroides
species (including Bacteroides
fragilis*), Clostridium species,
and anaerobic cocci (including Peptostreptoccus species
and Peptococcus species) and Fusobacterium species
(including F. nucleatum*).
CLAFORAN, like other cephalosporins, has no
activity against Chlamydia
trachomatis. Therefore, when cephalosporins are used in the treatment
of patients with pelvic inflammatory
disease and C. trachomatis
is one of the suspected pathogens, appropriate
antichlamydial coverage should be added.
Bacteremia/Septicemia caused by Escherichia coli, Klebsiella
species, and Serratia marcescens,
Staphylococcus aureus and Streptococcus species
(including S. pneumoniae).
Skin and skin structure
infections caused by Staphylococcus aureus (penicillinase and
non-penicillinase producing), Staphylococcus epidermidis, Streptococcus
pyogenes (Group A streptococci) and other streptococci, Enterococcus
species, Acinetobacter
species*, Escherichia coli, Citrobacter species
(including C. freundii*), Enterobacter species,
Klebsiella species, Proteus mirabilis, Proteus vulgaris*,
Morganella morganii, Providencia rettgeri*, Pseudomonas
species, Serratia marcescens,
Bacteroides species,
and anaerobic cocci
(including Peptostreptococcus* species and Peptococcus species).
Intra-abdominal infections including peritonitis caused by Streptococcus
species*, Escherichia coli, Klebsiella species, Bacteroides
species, and anaerobic
cocci (including Peptostreptococcus*
species and Peptococcus* species) Proteus mirabilis*, and
Clostridium species*.
Bone and/or joint infections
caused by Staphylococcus aureus (penicillinase and non-penicillinase
producing strains), Streptococcus species
(including S. pyogenes*), Pseudomonas species
(including P. aeruginosa*), and Proteus mirabilis*.
Central nervous system
infections, e.g., meningitis and ventriculitis, caused by Neisseria
meningitidis, Haemophilus influenzae, Streptococcus pneumoniae,
Klebsiella pneumoniae* and Escherichia coli*.
(*) Efficacy for this organism,
in this organ system, has been studied in fewer than 10 infections.
Although many strains of enterococci (e.g., S. faecalis)
and Pseudomonas species
are resistant to cefotaxime sodium
in vitro, CLAFORAN has been used successfully in treating patients
with infections caused by susceptible
organisms.
Specimens for bacteriologic
culture should be obtained
prior to therapy in order to
isolate and identify causative
organisms and to determine their susceptibilities to CLAFORAN Therapy
may be instituted before results of susceptibility studies are known;
however, once these results become available, the antibiotic
treatment should be adjusted
accordingly.
In certain cases of confirmed or suspected gram-positive
or gram-negative sepsis or in patients with other serious infections in
which the causative organism has not been identified, CLAFORAN may be
used concomitantly with an aminoglycoside. The dosage
recommended in the labeling
of both antibiotics may be given and depends on the severity of the infection
and the patient's condition. Renal function
should be carefully monitored, especially if higher dosages of the aminoglycosides
are to be administered or if therapy is prolonged, because of the potential
nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible
that nephrotoxicity may be potentiated if CLAFORAN is used concomitantly
with an aminoglycoside.
Prevention
The administration
of CLAFORAN preoperatively reduces the incidence
of certain infections in patients undergoing surgical
procedures (e.g., abdominal or vaginal
hysterectomy, gastrointestinal
and genitourinary tract
surgery) that may be classified as contaminated or potentially contaminated.
In patients undergoing cesarean section, intraoperative
(after clamping the umbilical
cord) and postoperative use of CLAFORAN may also reduce
the incidence of certain postoperative infections. See
DOSAGE AND ADMINISTRATION
section.
Effective use for elective surgery
depends on the time of administration.
To achieve effective tissue
levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See
DOSAGE AND ADMINISTRATION
section.
For patients undergoing gastrointestinal
surgery, preoperative bowel
preparation by mechanical cleansing as well as with a non-absorbable antibiotic
(e.g., neomycin) is recommended.
If there are signs of infection,
specimens for culture should
be obtained for identification
of the causative organism
so that appropriate therapy
may be instituted.
DOSAGE AND ADMINISTRATION
Adults
Dosage and route of administration
should be determined by susceptibility of the causative organisms, severity
of the infection, and the
condition of the patient (see
table for dosage
guideline). CLAFORAN may be administered IM or IV
after reconstitution. Premixed CLAFORAN Injection is intended for IV
administration after
thawing. The maximum daily
dosage should not exceed 12
grams.
|
GUIDELINES FOR DOSAGE OF CLAFORAN
|
| Type of Infection |
Daily Dose
(grams)
|
Frequency and Route
|
| Gonococcal urethritis/cervicitis in males and females |
0.5
|
0.5 gram IM (single
dose)
|
| Rectal gonorrhea
in females |
0.5
|
0.5 gram IM (single
dose)
|
| Rectal gonorrhea
in males |
1
|
1 gram IM (single dose)
|
| Uncomplicated Infections |
2
|
1 gram every 12 hours
IM or IV
|
| Moderate to severe infections |
3-6
|
1-2 grams every 8 hours IM or IV
|
| Infections commonly needing antibiotics in higher dosage |
|
| (e.g., septicemia) |
6-8
|
2 grams every 6-8 hours IV
|
| Life-threatening infections |
up to 12
|
2 grams every 4 hours IV
|
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial
coverage should be added, because cefotaxime sodium has no
activity against this organism.
To prevent postoperative infection
in contaminated or potentially contaminated surgery, the recommended dose
is a single 1 gram IM or IV
administered 30 to 90 minutes prior to start of surgery.
Cesarean Section Patients
The first dose of 1 gram
is administered intravenously as soon as the umbilical cord is clamped.
The second and third doses should be given as 1 gram
intravenously or intramuscularly at 6 and 12 hours after the first dose.
Neonates, Infants, and Children
The following dosage schedule
is recommended:
| Neonates (birth to 1 month): |
| 0-1 week of age |
50 mg/kg per
dose every 12 hours IV |
| 1-4 weeks of age |
50 mg/kg per
dose every 8 hours IV |
It is not necessary to differentiate between premature and normal-gestational
age infants.
Infants and Children (1 month to 12 years): For body weights less than
50 kg, the recommended daily dose
is 50 to 180 mg/kg IM or IV body
weight divided into four to six equal doses. The higher dosages should
be used for more severe or serious infections, including meningitis. For
body weights 50 kg or more, the
usual adult dosage
should be used; the maximum
daily dosage should not exceed 12 grams.
Impaired Renal Function - see PRECAUTIONS
section.
NOTE: As with antibiotic
therapy in general, administration
of CLAFORAN should be continued for a minimum
of 48 to 72 hours after the patient
defervesces or after evidence
of bacterial eradication
has been obtained; a minimum of 10 days of treatment
is recommended for infections caused by Group A beta-hemolytic streptococci
in order to guard
against the risk of rheumatic
fever or glomerulonephritis; frequent bacteriologic
and clinical appraisal is
necessary during therapy of
chronic urinary
tract infection
and may be required for several months after therapy
has been completed; persistent infections may require treatment
of several weeks and doses smaller than those indicated above should not
be used.
|
PREPARATION OF CLAFORAN STERILE
|
| CLAFORAN for IM or IV
administration should be reconstituted as follows: |
|
Strength
|
Diluent
(mL)
|
Withdrawable
Volume (mL)
|
Approximate
Concentration
(mg/mL)
|
| 500 mg vial*
(IM) |
2
|
2.2
|
230
|
| 1 g vial* (IM) |
3
|
3.4
|
300
|
| 2 g vial* (IM) |
5
|
6.0
|
330
|
| . |
| 500 mg vial*
(IV) |
10
|
10.2
|
50
|
| 1 g vial* (IV) |
10
|
10.4
|
95
|
| 2 g vial* (IV) |
10
|
11.0
|
180
|
| . |
| 1 g infusion |
50-100
|
50-100
|
20-10
|
| 2 g infusion |
50-100
|
50-100
|
40-20
|
| . |
| 10 g bottle |
47
|
52.0
|
200
|
| 10 g bottle |
97
|
102.0
|
100
|
(*) in conventional vials
Shake to dissolve; inspect
for particulate matter
and discoloration prior to use. Solutions of CLAFORAN range
from very pale yellow to light
amber, depending on concentration,
diluent used, and length
and condition of storage.
For intramuscular
use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic
Water for Injection as described above.
For intravenous use:
Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.
Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride
Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY
and STABILITY section.
Pharmacy Bulk Package: Reconstitute with 47 mL of diluent
for an approximate concentration
of 200 mg/mL or 97 mL of diluent
for an approximate concentration of 100 mg/mL. Stock solutions may be
further diluted for IV infusion
with diluents as listed in COMPATIBILITY STABILITY section.
NOTE: Solution of CLAFORAN must not be admixed with aminoglycoside
solutions. If CLAFORAN and aminoglycosides are to be administered to the
same patient, they must be administered separately and not as mixed
injection.
A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS
ISOTONIC.
IM Administration: As with
all IM preparations, CLAFORAN should be injected
well within the body of a relatively large muscle
such as the upper outer quadrant
of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid
inadvertent injection into
a blood vessel. Individual IM
doses of 2 grams may be given if the dose
is divided and is administered in different intramuscular
sites.
IV Administration: The IV
route is preferable for patients with bacteremia, bacterial septicemia,
peritonitis, meningitis,
or other severe or life-threatening infections, or for patients who may
be p.o. risks because of lowered
resistance resulting from
such debilitating conditions as malnutrition, trauma, surgery,
diabetes, heart
failure, or malignancy,
particularly if shock is present
or impending.
For intermittent IV
administration, a solution
containing 1 gram or 2 grams
in 10 mL of Sterile Water for Injection can be injected
over a period of three to five
minutes. Cefotaxime should not be administered over a period of less than
three minutes. (See WARNINGS).
With an infusion system,
it may also be given over a longer period
of time through the tubing system
by which the patient may be
receiving other IV solutions. However, during infusion
of the solution containing
CLAFORAN, it is advisable to discontinue temporarily the administration
of other solutions at the same site.
For the administration
of higher doses by continuous IV
infusion, a solution of CLAFORAN
may be added to IV bottles containing
the solutions discussed below.
DIRECTIONS FOR USE OF CLAFORAN (cefotaxime sodium
injection) IN GALAXY CONTAINER (PL 2040 PLASTIC)
CLAFORAN Injection in Galaxy containers (PL 2040 plastic) is for continuous
or intermittent infusion
using sterile equipment.
Storage
Store in a freezer capable of maintaining a temperature
of -20° C / -4° F.
Thawing of Plastic Container
Thaw frozen container at
room temperature
or under refrigeration
(at or below 5° C). [DO NOT FORCE T.A.
BY IMMERSION IN WATER BATHS OR
BY MICROWAVE IRRADIATION.]
Check for minute leaks by squeezing container
firmly. If leaks are detected, discard solution
as sterility may be impaired.
DO NOT ADD SUPPLEMENTARY MEDICATION.
The container should be
visually inspected. Components of the solution may precipitate
in the frozen state and will
dissolve upon reaching room
temperature with little or no agitation.
Potency is not affected. Agitate after solution
has reached room temperature.
If after visual inspection
the solution remains cloudy
or if an insoluble precipitate
is noted or if any seals or outlet
ports are not intact, the container
should be discarded.
The thawed solution is stable
for 10 days under refrigeration
(at or below 5° C) or 24 hours at or below 22° C. Do not refreeze
thawed antibiotics.
CAUTION: Do not use plastic
containers in series connections.
Such use could result in air embolism
due to residual air
being drawn from the primary container before administration
of the fluid from the secondary
container is complete.
Preparation for Intravenous Administration:
Suspend container from
eyelet support.
Remove protector from outlet
proof at bottom of container.
Attach administration
set. Refer to complete directions accompanying set.
PREPARATION OF CLAFORAN STERILE IN ADD-VANTAGE® SYSTEM**
CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of
5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage® diluent
container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.
COMPATIBILITY AND STABILITY
Solutions of CLAFORAN Sterile reconstituted as described above (Preparation
of CLAFORAN Sterile) remain chemically stable
(potency remains above 90%) as follows when stored in original containers
and disposable plastic syringes:
| Strength |
|
Reconstituted
Concentration
mg/mL |
|
Stability at or
below 22° C |
|
Stability under
Refrigeration
(at or below 5° C) |
| |
Original
Containers |
Plastic
Syringes |
| 500 mg vial
IM |
|
200 |
|
12 hours |
|
7 days |
5 days |
| 1 g vial IM |
|
300 |
|
12 hours |
|
7 days |
5 days |
| 2 g vial IM |
|
330 |
|
12 hours |
|
7 days |
5 days |
| |
| 500 mg vial
IV |
|
50 |
|
24 hours |
|
7 days |
5 days |
| 1 g vial IV |
|
95 |
|
24 hours |
|
7 days |
5 days |
| 2 g vial IV |
|
180 |
|
2 hours |
|
7 days |
5 days |
| |
| 1 g infusion
bottle |
|
10-20 |
|
24 hours |
|
10 days |
|
| 2 g infusion
bottle |
|
20-40 |
|
24 hours |
|
10 days |
|
Reconstituted solutions stored in original containers and plastic
syringes remain stable for
13 weeks frozen.
For the 10 g bottle withdraw reconstituted contents immediately. However,
if it is not possible, aliquoting operations must be completed within
four hours of reconstitution. Discard the reconstituted stock
solution 4 hours after initial
entry.
Reconstituted solutions may be further diluted up to 1000 mL with the
following solutions and maintain satisfactory potency
for 24 hours at or below 22° C, and at least 5 days under refrigeration
(at or below 5° C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose
Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose
and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride
Injection; Lactated Ringers Solution; Sodium Lactate Injection (M/6);
10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection
without Electrolytes.
Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection
or 5% Dextrose Injection in Viaflex® plastic
containers maintain satisfactory potency for 24 hours at or below 22°
C, 5 days under refrigeration (at or below 5° C) and 13 weeks frozen.
Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection
or 5% Dextrose Injection in the ADD-Vantage® flexible containers maintain
satisfactory potency for 24 hours at or below 22° C. DO NOT FREEZE.
NOTE: CLAFORAN solutions exhibit maximum
stability in the pH
5-7 range. Solutions of CLAFORAN should not be prepared with diluents
having a pH above 7.5, such as Sodium Bicarbonate Injection.
HOW SUPPLIED
Sterile CLAFORAN is a dry off-white to pale yellow crystalline powder
supplied in vials and bottles containing cefotaxime sodium as follows:
500 mg cefotaxime (free acid
equivalent) in vials in packages of 10 (NDC 0039-0017-10).
1 g cefotaxime (free acid
equivalent) in vials in packages of 10 (NDC 0039-0018-10), packages of
25 (NDC 0039-0018-25), packages of 50 (NDC 0039-0018-50); infusion bottles
in packages of 10 (NDC 0039-0018-11).
2 g cefotaxime (free acid
equivalent) in vials in packages of 10 (NDC 0039-0019-10), packages of
25 (NDC 0039-0019-25), packages of 50 (NDC 0039-0019-50); infusion bottles
in packages of 10 (NDC 0039-0019-11).
10 g cefotaxime (free acid
equivalent) in bottles (NDC 0039-0020-01).
1 g cefotaxime (free acid
equivalent) in ADD-Vantage® System vials in packages of 25 (NDC 0039-0023-25)
and 50 (NDC 0039-0023-50).
2 g cefotaxime (free acid
equivalent) in ADD-Vantage® System vials in packages of 25 (NDC 0039-0024-25)
and 50 (NDC 0039-0024-50).
ADD-Vantage® System diluents (5% Dextrose or 0.9% Sodium Chloride)
are available from Abbott Laboratories.
NOTE: CLAFORAN in the dry state
should be stored below 30° C. The dry material as well as solutions
tend to darken depending on storage conditions and should be protected
from elevated temperatures and excessive light.
Premixed CLAFORAN Injection is supplied as a frozen, iso-osmotic, sterile,
nonpyrogenic solution in
50 mL single dose Galaxy®
containers (PL 2040 plastic) as follows:
1 g cefotaxime (free acid
equivalent) in packages of 12 (NDC 0039-0037-05) 2G3518.
2 g cefotaxime (free acid
equivalent) in packages of 12 (NDC 0039-0038-05) 2G3519.
NOTE: Store Premixed CLAFORAN Injection at or below -20° C / -4°
F. [See DIRECTIONS FOR USE OF CLAFORAN (cefotaxime sodium
injection) IN GALAXY® CONTAINERS (PL 2040 PLASTIC)].
CLAFORAN Injection supplied as a frozen, iso-osmotic, sterile,
nonpyrogenic solution in Galaxy® containers (PL 2040 plastic).
REFERENCES
- Bauer, A.W.; Kirby, W.M.M.; Sherris, J.C.; and Turck,
M. Antibiotic Susceptibility Testing by a Standardized Single Disk Method,
Am. J. Clin. Pathol., 45:493, 1966; Standardized Disc Susceptibility
Test, Federal Register, 39:19182-4, 1974. National Committee for Clinical
Laboratory Standards. Approved Standard: ASM-2, Performance Standards
for Antimicrobial Disc Susceptibility Tests. July, 1975.
- Cockcroft, D.W. and Gault, M.H.: Predication of Creatinine
Clearance from Serum Creatinine. Nephron 16:31-41, 1976.
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