Cefotaxime

AdultsDosage 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). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION    Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV   
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
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 PatientsThe 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 ChildrenThe 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. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection 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 Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:

Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection 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.

NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection 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 CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, Cefotaxime for injection 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 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 Cefotaxime for injection, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) 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 220C

Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes

500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

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 0C, and at least 5 days under refrigeration (at or below 5 0C): 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 Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. AdultsDosage 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). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION    Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV   
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
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 PatientsThe 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 ChildrenThe 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. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection 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 Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:

Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection 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.

NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection 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 CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, Cefotaxime for injection 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 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 Cefotaxime for injection, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) 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 220C

Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes

500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

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 0C, and at least 5 days under refrigeration (at or below 5 0C): 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 Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

AdultsDosage 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). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION    Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV   
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
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 PatientsThe 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 ChildrenThe 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. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection 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 Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:

Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection 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.

NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection 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 CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, Cefotaxime for injection 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 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 Cefotaxime for injection, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) 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 220C

Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes

500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

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 0C, and at least 5 days under refrigeration (at or below 5 0C): 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 Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. AdultsDosage 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). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION    Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV   
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
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 PatientsThe 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 ChildrenThe 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. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection 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 Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:

Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection 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.

NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection 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 CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, Cefotaxime for injection 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 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 Cefotaxime for injection, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) 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 220C

Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes

500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

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 0C, and at least 5 days under refrigeration (at or below 5 0C): 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 Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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). Cefotaxime may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION 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.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

Impaired Renal Function

See PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of cefotaxime 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 cefotaxime for injection sterile

Cefotaxime 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

(*) in conventional vials

Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime 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.

NOTE: Solutions of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime 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 CEFOTAXIME IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, cefotaxime 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 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 cefotaxime, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.

Compatibility and Stability

Solutions of cefotaxime reconstituted as described above (Preparation of cefotaxime for injection 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 22ºC

Stability under
Refrigeration
(at or below 5ºC)

 Original Containers Plastic Syringes  500 mg vial IM 230 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  12 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.

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 Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime solutions exhibit maximum stability in the pH 5-7 range. Solutions of cefotaxime should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Dosing references to the intramuscular route of administration are for informational purposes only.

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). Cefotaxime may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION 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.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

Impaired Renal Function

See PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of cefotaxime 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.

DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE:

The 10 gram Pharmacy Bulk Package should be penetrated ONLY ONE TIME utilizing a suitable sterile transfer device or dispensing set and should be reconstituted with 47 mL of diluent for an approximate concentration of 200 mg/mL (withdrawable volume 52 mL) or 97 mL of diluent for an approximate concentration of 100 mg/mL withdrawable volume 102 mL), in a suitable work area such as a laminar flow hood, using aseptic technique. Shake to dissolve; inspect for particulate matter and discoloration prior to use. Stock solutions may be further diluted for IV infusion with diluents as listed in COMPATIBILITY AND STABILITY section. The reconstituted content of the 10 g Pharmacy Bulk Package should be withdrawn immediately, using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. 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. Solutions of cefotaxime range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion

NOTE: Solutions of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime 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 CEFOTAXIME IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

IM Administration: As with all IM preparations, cefotaxime 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 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 cefotaxime, 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 cefotaxime may be added to IV bottles containing the solutions discussed below.

COMPATIBILITY AND STABILITY

Solutions of cefotaxime reconstituted as described above (DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE) should be discarded 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 Ringer’s Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.

NOTE: Cefotaxime solutions exhibit maximum stability in the pH 5-7 range. Solutions of cefotaxime should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.