Prescribing Information as of October 1996

Sterile CLAFORAN® (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 7 2 (Z)-(o-methyloxime), acetate (ester). CLAFORAN contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of CLAFORAN range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.


CLAFORAN is supplied as a dry powder in conventional and ADD-Vantage® System compatible vials, infusion bottles, pharmacy bulk package bottles, and as a frozen, premixed, iso-osmotic injection in a buffered diluent solution in plastic containers. CLAFORAN, equivalent to 1 gram and 2 grams cefotaxime, is supplied as frozen, premixed iso-osmotic injections in plastic containers. Solutions range from very pale yellow to light amber. Dextrose Hydrous, USP has been added to adjust osmolality (approximately 1.7 g and 700 mg to the 1 g and 2 g cefotaxime dosages, respectively). The injections are buffered with sodium citrate hydrous, USP. The pH is adjusted with hydrochloric acid and may be adjusted with sodium hydroxide.

The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

Following IM administration of a single 500 mg or 1 g dose of CLAFORAN to normal volunteers, mean peak serum concentrations of 11.7 and 20.5 µg/mL respectively were attained within 30 minutes and declined with an elimination half-life of approximately 1 hour. There was a dose-dependent increase in serum levels after the IV administration of 500 mg, 1 g, and 2 g of CLAFORAN (38.9, 101.7, and 214.4 µg/mL respectively) without alteration in the elimination half-life. There is no evidence of accumulation following repetitive IV infusion of 1 g doses every 6 hours for 14 days as there are no alterations of serum or renal clearance. About 60% of the administered dose was recovered from urine during the first 6 hours following the start of the infusion.

Approximately 20-36% of an intravenously administered dose of 14 C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15-25% as the desacetyl derivative, the major metabolite. The desacetyl metabolite has been shown to contribute to the bactericidal activity. Two other urinary metabolites (M 2 and M 3 ) account for about 20-25%. They lack bactericidal activity.

A single 50 mg/kg dose of CLAFORAN was administered as an intravenous infusion over a 10- to 15-minute period to 29 newborn infants grouped according to birth weight and age. The mean half-life of cefotaxime in infants with lower birth weights (</=1500 grams), regardless of age, was longer (4.6 hours) than the mean half-life (3.4 hours) in infants whose birth weight was greater than 1500 grams. Mean serum clearance was also smaller in the lower birth weight infants. Although the differences in mean half-life values are statistically significant for weight, they are not clinically important. Therefore, dosage should be based solely on age. (See DOSAGE AND ADMINISTRATION section.)

Additionally, no disulfiram-like reactions were reported in a study conducted in 22 healthy volunteers administered CLAFORAN and ethanol.


The bactericidal activity of cefotaxime sodium results from inhibition of cell wall synthesis. Cefotaxime sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. CLAFORAN has a high degree of stability in the presence of beta-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Cefotaxime sodium has been shown to be a potent inhibitor of (beta)-lactamases produced by certain gram-negative bacteria. Cefotaxime sodium is usually active against the following microorganisms both in vitro and in clinical infections (see ).

Aerobes, Gram-positive: Staphylococcus aureus, including penicillinase and non-penicillinase producing strains, Staphylococcus epidermidis, Enterococcus species Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B streptococci), Streptococcus pneumoniae (formerly Diplococcus pneumoniae ).

Aerobes, Gram-negative: Citrobacter species Enterobacter species Escherichia coli, Haemophilus influenzae (including ampicillin-resistant H. influenzae ), Haemophilus parainfluenzae, Klebsiella species (including K. pneumoniae ), Neisseria gonorrhoeae (including penicillinase and non-penicillinase producing strains), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Proteus inconstans Group B, Morganella morganii, Providencia rettgeri, Serratia species, and Acinetobacter species

NOTE:  Many strains of the above organisms that are multiply resistant to other antibiotics, e.g. penicillins, cephalosporins, and aminoglycosides, are susceptible to cefotaxime sodium.

Cefotaxime sodium is active against some strains of Pseudomonas aeruginosa.

Anaerobes:   Bacteroides species, including some strains of B. fragilis, Clostridium species (NOTE: Most strains of C. difficile are resistant.), Peptococcus species Peptostreptococcus species, and Fusobacterium species (including F. nucleatum ).

Cefotaxime sodium is highly stable in vitro to four of the five major classes of (beta)-lactamases described by Richmond et al., including type IIIa (TEM) which is produced by many gram-negative bacteria. The drug is also stable to (beta)-lactamase (penicillinase) produced by staphylococci. In addition, cefotaxime sodium shows high affinity for penicillin-binding proteins in the cell wall, including PBP: Ib and III.

Cefotaxime sodium also demonstrates in vitro activity against the following microorganisms although clinical significance is unknown: Salmonella species (including S. typhi ), Providencia species, and Shigella species

Cefotaxime sodium and aminoglycosides have been shown to be synergistic in vitro against some strains of Pseudomonas aeruginosa.

Susceptibility Tests

Quantitative methods that require measurement of zone diameters give the most precise estimate of antibiotic susceptibility. One such procedure 1 has been recommended for use with discs to test susceptibility to cefotaxime sodium. Interpretation involves correlation of the diameters obtained in the disc test with minimum inhibitory concentration (MIC) values for cefotaxime sodium.

Reports from the laboratory giving results of the standardized single-disc susceptibility test using a 30 µg cefotaxime sodium disc should be interpreted according to the following criteria:

Susceptible organisms produce zones of 20 mm or greater, indicating that the tested organism is likely to respond to therapy.

Organisms that produce zones of 15 to 19 mm are expected to be susceptible if high dosage is used or if the infection is confined to tissues and fluids (e.g. urine) in which high antibiotic levels are attained.

Resistant organisms produce zones of 14 mm or less, indicating that other therapy should be selected.

Organisms should be tested with the cefotaxime sodium disc, since cefotaxime sodium has been shown by in vitro tests to be active against certain strains found resistant when other beta lactam discs are used. The cefotaxime sodium disc should not be used for testing susceptibility to other cephalosporins. Organisms having zones of less than 18 mm around the cephalothin disc are not necessarily of intermediate susceptibility or resistant to cefotaxime sodium.

A bacterial isolate may be considered susceptible if the MIC value for cefotaxime sodium is not more than 16 µg/mL. Organisms are considered resistant to cefotaxime sodium if the MIC is equal to or greater than 64 µg/mL. Organisms having an MIC value of less than 64 µg/mL but greater than 16 µg/mL are expected to be susceptible if high dosage is used or if the infection is confined to tissues and fluids (e.g., urine) in which high antibiotic levels are attained.


CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

(1) 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 ).

(2) 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.

(3) 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 Peptostreptococcus 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.

(4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species Serratia marcescens, Staphylococcus aureus, and Streptococcus species (including S. pneumoniae ).

(5) 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

(6) 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

(7) 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*.

(8) 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' 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.


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.


CLAFORAN is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium or the cephalosporin group of antibiotics.


During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter. Therefore, cefotaxime should only be administered as instructed in the DOSAGE AND ADMINISTRATION section.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefotaxime, and may range from mild to life threatening. Therefore, it is important to consider its diagnosis in patients with diarrhea subsequent to the admimistration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of colitis may respond to drug discontinuance alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile 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. Other causes of colitis should also be considered.


CLAFORAN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when CLAFORAN is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism.

Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime sodium in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime sodium be halved in patients with estimated creatinine clearances of less than 20 mL/min/1.73 m 2 .

When only serum creatinine is available, the following formula 2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Weight (kg) × (140 - age)
72 × serum creatinine
0.85 × above value

As with other antibiotics, prolonged use of CLAFORAN may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient' condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

As with other beta-lactam antibiotics, granulocytopenia and, more rarely, agranulocytosis may develop during treatment with CLAFORAN, particularly if given over long periods. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored.

CLAFORAN, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of CLAFORAN responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of CLAFORAN may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.

Drug Interactions:   Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Carcinogenesis, Mutagenesis: Long-term studies in animals have not been performed to evaluate carcinogenic potential. Mutagenic tests included a micronucleus and an Ames test. Both tests were negative for mutagenic effects.

Pregnancy (Category B):   Reproduction studies have been performed in mice and rats at doses up to 30 times the usual human dose and have revealed no evidence of impaired fertility or harm to the fetus because of cefotaxime sodium. However, there are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects:   Use of the drug in women of child-bearing potential requires that the anticipated benefit be weighed against the possible risks.

In perinatal and postnatal studies with rats, the pups in the group given 1200 mg/kg of CLAFORAN were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

Nursing Mothers:   CLAFORAN is excreted in human milk in low concentrations. Caution should be exercised when CLAFORAN is administered to a nursing woman.

Pediatric Use:   See Precautions above regarding perivascular extravasation. The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic in single dose Galaxy® containers (premixed CLAFORAN Injection) has not been determined.


CLAFORAN is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:

  Local (4.3%)--Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.

  Hypersensitivity (2.4%)--Rash, pruritus, fever, and eosinophilia and less frequently urticaria and anaphylaxis.

  Gastrointestinal (1.4%)--Colitis, diarrhea, nausea, and vomiting.

  Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

  Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:

  Cardiovascular System--Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

  Hematologic System--Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN (cefotaxime sodium injection) and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.

  Genitourinary System--Moniliasis, vaginitis.

  Central Nervous System--Headache.

  Liver--Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase levels have been reported.

  Kidney--As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with CLAFORAN.



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.

        Type of Infection
Daily Dose
    Frequency and Route
Gonococcal urethritis/cervicitis in
males and females
0.5 gram IM (single dose)
Rectal gonorrhea in females
0.5 gram IM (single dose)
Rectal gonorrhea in males
1 gram IM (single dose)
Uncomplicated Infections
1 gram every 12 hours IM or IV
Moderate to severe infections
1-2 grams every 8 hours IM or IV
Infections commonly needing
antibiotics in higher dosage
(e.g., septicemia)
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
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.

CLAFORAN for IM or IV administration should be reconstituted as follows:
Volume (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 AND 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.


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 poor 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 .) 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.


CLAFORAN Injection in Galaxy containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.


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 THAW 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.


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:

  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.


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.


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:

Stability at or
below 22° C
Stability under Refrigeration
(at or below 5° C)
500 mg vial IM
12 hours
7 days
5 days
1 g vial IM
12 hours
7 days
5 days
2 g vial IM
12 hours
7 days
5 days
500 mg vial IV
24 hours
7 days
5 days
1 g vial IV
24 hours
7 days
5 days
2 g vial IV
12 hours
7 days
5 days
24 hours
10 days
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.


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) is manufactured for Hoechst-Roussel Pharmaceuticals, a Division of Hoechst Marion Roussel, Inc. by Baxter Healthcare Corporation.


  1. 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.
  2. Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine. Nephron 16:31-41, 1976.

Sterile cefotaxime sodium US Patents 4,152,432; 4,224,371; 4,298,606; cefotaxime sodium injection US Patents 4,152,432; 4,298,606.


Galaxy and PL 2040 REG TM Baxter International Inc.

ADD-Vantage REG TM Abbott Laboratories.

US Patents ADD-Vantage System: 4,614,267; 4,614,515; 4,757,911; 4,703,864; 4,784,658; 4,784,259; 4,948,000; 4,936,445.

Prescribing Information as of October 1996

Hoechst-Roussel Pharmaceuticals

Division of Hoechst Marion Roussel, Inc.

Kansas City, MO 64137 USA


NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.