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Treatment:
XORIN is indicated for the treatment of patients
with
serious infections caused by susceptible strains.
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(1) Lower respiratory tract
infections |
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including pneumonia, caused by Streptococcus
pneumoniae , Streptococcus pyogenes Group A streptococci) and |
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Staphylococcusaureus (penicillinase and non-penicillinase producing) |
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Escherichia coli, Klebsiella species,
Haemophilus influenzae (including ampicillin resistant strains), |
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Haemophilus parainfluenzae, Proteus mirabilis, Enterobacter speces indole positive Proteus. |
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(2) Genitourinary
infections.
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Urinary tract infections caused by Enterococcus
species, Staphylococcus epidermidis, Staphylococcus aureus,
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(penicillinase and non-penicillinase producing),
Citrobacter species, Enterobacter species, Escherichia col
Serratia marcescens, Klebsiella species, Proteus mirabilis, Proteus vulgar
Also, uncomplicated gonorrhea (cervical/urethral) caused by Neisseria
gonorrhoeae, including |
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penicillinase producing strains |
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(3) Central nervous
system infections,
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e.g., meningitis and ventriculitis, caused by Neisseria meningitidis,
Haemophilus influenzae, Streptococcus |
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pneumoniae, Klebsiella pneumoniae. |
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(4) Bacteremia/Septicemia |
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caused
by Escherichia coli, Klebsiella species, and Serratia marcescens,
Staphylococcus aureus |
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and Streptococcus species
(including S. pneumonia)
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(5) Skin and
skin structure infections
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caused by Staphylococcus aureus (penicillinase and
non-penicillinase producing),
Staphylococcus epidermidis, Streptococcus pyogenes (Group A
streptococci)
Enterococcus species, Acinetobacter species,
Escherichia coli, Citrobacter species , Enterobacter species,
Klebsiella species,
Proteus mirabilis, Proteus vulgaris,
Morganella morganii, Providencia rettgeri, Serratia marcescens, Bacteroides
species, and anaerobic cocci |
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(including Peptostreptococcus species
and Peptococcus species. |
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(6) Intra-abdominal
infections
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including peritonitis caused by Streptococcus
species, Escherichia coli, Klebsiella species, Bacteroides
species |
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and anaerobic cocci (Peptostreptococcus and Peptococcus species) ,
and Clostridium species |
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Prevention: |
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The administration of XORIN preoperatively
reduces the incidence of certain infections in patients undergoing surgical
procedures. |
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that may be classified as contaminated or potentially contaminated. |
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In patients
undergoing cesarean section, intraoperative (after clamping the umbilical
cord) and postoperative use of XORIN may also reduce the incidence of
certain postoperative infections.
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DOSAGE AND ADMINISTRATION |
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Uncomplicated
infections
1 gram
every 12 hours I.M. or I.V. |
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Moderate
to severe infections
1-2 grams
every 12 hours I.M. or I.V. |
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Life-threatening
infections
2 grams every 6-8
hours I.V. |
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To prevent
postoperative infection in contaminated or potentially contaminated surgery,
the recommended dose |
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is a single 1
gram I.M. or I.V. administered 30 to 90 minutes prior to start of surgery |
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Cesarean
Section Patients |
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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 |
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1 gram
intravenously or intramuscularly
at 6 and 12 hours after the first dose. |
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Neonates, Infants, and Children
The following dosage schedule is recommended:
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For
body weights 50 kg or more,
the usual adult dosage
should be used |
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For
body weights less than 50 kg,
the
recommended daily dose 50 to 180 mg/kg body weight I.M.
or I.V. divided into equal doses.
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1-4 weeks of age
50 mg/kg per dose every 8 hours I.V. |
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0-1 week of age
50 mg/kg per dose every 12 hours I.V. |
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Although there is no clinical evidence supporting the necessity of changing
the dosage of
cefotaxime sodium in patients with renal dysfunction,it is suggested that
the
dose of cefotaxime sodium be halved in patients with estimated creatinine
clearances of less than 20 mL/min. |
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Pregnancy&
Teratogenic Effects:
This drug
should be used during pregnancy only if clearly needed. |
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Nursing
Mothers:
Caution
should be exercised when XORIN is administered.
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WARNINGS
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| BEFORE
THERAPY WITH XORIN, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER
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THE PATIENT HAS HYPERSENSITIVITY
REACTIONS TO CEFOTAXIME SODIUM, CEPHALOSPORINS,
THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH HYPERSENSITIVITY
REACTIONS |
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TO
PENICILLIN. IF AN ALLERGIC REACTION OCCURS, DISCONTINUE TREATMENT WITH THE
DRUG.
SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER
EMERGENCY MEASURES. |
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Pseudomembranous colitis has been reported with nearly all antibacterial
agents, |
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including cefotaxime.
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Treatment with
antibacterial agents alters the normal flora of the colon |
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and may permit
overgrowth of Clostridia. Studies indicate that a toxin |
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produced by
Clostridium difficile is one primary cause of antibiotic |
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associated colitis.
When the colitis is not relieved by drug
discontinuance |
or when it is severe, oral vancomycin is the treatment of
choice
for antibiotic-associated pseudomembranous colitis produced by
C. difficile |
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Preparation of Xorin Sterile
: |
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Diluent (mL) |
Volume
(mL) |
Conc.(mg/mL) |
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500 mg vial
(I.M.) |
2 |
2.2 |
230 |
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1g vial (I.M.) |
3 |
3.4 |
300 |
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500 mg vial
(I.V.) |
10 |
10.2 |
50 |
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1g vial (I.V.) |
10 |
10.4 |
95 |
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1g infusion |
50-100 |
50-100 |
20-10 |
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For
intramuscular use:
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Reconstitute
VIALS with Sterile Water for Injection. |
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For
intravenous use: |
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Reconstitute VIALS with at least 10 mL of Sterile Water for
Injection. Reconstitute INFUSION BOTTLES with 50 or |
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100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
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| NOTE:
Solutions of Xorin must not be admixed
with aminoglycoside solutions. |
For I.V. administration, a solution containing 1 gram or 2
grams in 10 mL of Sterile Water for Injection
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can be injected over a period of three to five minutes.
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Stability |
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Solutions
of Xorin Sterile reconstituted as described remain chemically stable
as follows :
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Stability at 22°C |
Stability under
Refrigeration
(at or below 5°C) |
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500 mg vial I.M. |
12 hours |
7 days |
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1g vial I.M. |
12 hours |
7 days |
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500 mg vial I.V. |
24 hours |
7 days |
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1g vial I.V. |
24 hours |
7 days |
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1g infusion bottle |
24 hours |
10 days |
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I.M. Administration: |
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As
with all I.M. preparations, XORIN should be injected well within the
body of a relatively |
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large
muscle such as the upper outer quadrant of the buttock ; |
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aspiration
is necessary to avoid inadvertent injection into a blood vessel. |
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I.V.
Administration: |
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The
I.V. route is preferable for patients with bacteremia, bacterial
septicemia, peritonitis, meningitis,
& life-threatening infections. Also for patients who are suffering
from diabetes, heart failure,
or malignancy. the I.V. route is prefed. |
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