CEFOTAXIME
-
cefotaxime sodium injection, powder, for solution
Pfizer Laboratories, Division of Pfizer Inc
----------
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) |
---|---|
Bacteroides fragilisa ATCC 25285 Bacteroides thetaiotaomicron ATCC 29741 Eubacterium lantem ATCC 43055 | 8-32 16-64 64-256 |
Type of Infection | Daily Dose (grams) | Frequency and Route |
---|---|---|
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION | ||
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 to 2 grams every 8 hours IM or IV 2 grams every 6 to 8 hours IV 2 grams every 4 hours IV |
Strength | Diluent (mL) | Withdrawable Volume (mL) | Approximate Concentration (mg/mL) |
---|---|---|---|
(*) in conventional vials |
|||
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 |
Strength | Reconstituted Concentration mg/mL | Stability at or below 22°C | Stability under Refrigeration (at or below 5°C) Original Containers | Plastic Syringes |
---|---|---|---|---|
500 mg vial IM 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 |
Code No.: 78/MD/AP/96/F/B/R
CEFOTAXIME
cefotaxime sodium injection, powder, for solution |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065517 | 11/05/2009 | 01/31/2012 |
CEFOTAXIME
cefotaxime sodium injection, powder, for solution |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065517 | 11/05/2009 | 01/31/2012 |
CEFOTAXIME
cefotaxime sodium injection, powder, for solution |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065517 | 11/05/2009 | 01/31/2012 |
Labeler - Pfizer Laboratories, Division of Pfizer Inc (134489525) |
Revised: 11/2012 Pfizer Laboratories, Division of Pfizer Inc