CEFOTAXIME
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cefotaxime sodium injection, powder, for solution
Pfizer Laboratories, Division of Pfizer Inc
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime sodium and other antibacterial drugs, cefotaxime sodium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
MIC (mcg/mL) | Interpretation |
---|---|
≤8 16-32 ≥64 | Susceptible (S) Intermediate (I) Resistant (R) |
MIC (mcg/mL) | Interpretationc |
---|---|
≤2 | Susceptible (S) |
MIC (mcg/mL) | Interpretation |
---|---|
≤0.5 1 ≥2 | Susceptible (S) Intermediate (I) Resistant (R) |
MIC (mcg/mL) | Interpretationc |
---|---|
≤0.5 | Susceptible (S) |
Microorganism | MIC (mcg/mL) |
---|---|
Escherichia coli ATCC 25922 Staphylococcus aureus ATCC 29213 Pseudomonas aeruginosa ATCC 27853 Haemophilus influenzaea ATCC 49247 Streptococcus pneumoniaeb ATCC 49619 Neisseria gonorrhoeaec ATCC 49226 | 0.06-0.25 1-4 4-16 0.12-0.5 0.06-0.25 0.015-0.06 |
MIC (mcg/mL) | Interpretation |
---|---|
≥23 15-22 ≤14 | Susceptible (S) Intermediate (I) Resistant (R) |
Zone Diameter (mm) | Interpretationc |
---|---|
≥26 | Susceptible (S) |
Zone Diameter (mm) | Interpretation |
---|---|
≥28 26-27 ≤25 | Susceptible (S) Intermediate (I) Resistant (R) |
Zone Diameter (mm) | Interpretationc |
---|---|
≥31 | Susceptible (S) |
Microorganism | Zone Diameter (mm) |
---|---|
Escherichia coli ATCC 25922 Staphylococcus aureus ATCC 25923 Pseudomonas aeruginosa ATCC 27853 Haemophilus influenzaea ATCC 49247 Neisseria gonorrhoeaeb ATCC 49226 | 29-35 25-31 18-22 31-39 38-48 |
MIC (mcg/mL) | Interpretation |
---|---|
≤16 32 ≥64 | Susceptible (S) Intermediate (I) Resistant (R) |
Microorganism | MIC (mcg/mL) |
---|---|
a. Ranges applicable only to tests performed by agar dilution method. |
|
Bacteroides fragilisa ATCC 25285 Bacteroides thetaiotaomicron ATCC 29741 Eubacterium lantem ATCC 43055 | 8-32 16-64 64-256 |
Cefotaxime for injection is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.
The acute toxicity of cefotaxime was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups. Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefotaxime sodium overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine. There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including cefotaxime. No specific antidote exists. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION | ||
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Type of Infection
| Daily Dose
(grams) | Frequency and Route
|
Uncomplicated infections | 2 | 1 gram every 12 hours IV |
Moderate to severe infections | 3-6 | 1 to 2 grams every 8 hours IV |
Infections commonly needing antibiotics in higher dosage (e.g., septicemia) | 6-8 |
2 grams every 6 to 8 hours IV |
Life-threatening infections | up to 12 | 2 grams every 4 hours IV |
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 at 6 and 12 hours after the first dose.
Bottle Size | Amount of Diluent | Withdrawable Volume | Approximate Concentration |
---|---|---|---|
10 grams | 47 mL | 52 mL | 1 gram/5 mL |
97 mL | 102 mL | 1 gram/10 mL |
Ten Pharmacy Bulk Package bottles per carton NDC 0069-0028-01
CEFOTAXIME
cefotaxime sodium injection, powder, for solution |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065516 | 11/05/2009 | 01/31/2012 |
Labeler - Pfizer Laboratories, Division of Pfizer Inc (134489525) |
Revised: 11/2012 Pfizer Laboratories, Division of Pfizer Inc