Cefotaxime sodium is available as a powder in vials containing the equivalent of 500 mg, 1 g, or 2 g of cefotaxime as the sodium salt3903 and a pharmacy bulk package containing 10 g of cefotaxime as the sodium salt.3904
For intravenous administration, the contents of any size vial may be reconstituted with 10 mL of sterile water for injection; the reconstituted solution should be diluted in up to 1000 mL of a compatible solution for intravenous infusion.3903 (See Table 1.) For intramuscular injection, reconstitute with sterile water for injection or bacteriostatic water for injection in the amounts shown in Table 1.3903 Shake vials to dissolve the contents and inspect for particulate matter or discoloration.3903
Table 1. Reconstitution of Cefotaxime Sodium3903
| Vial Size, Route of Administration | Volume of Diluent | Withdrawable Volume | Approximate Concentration |
|---|---|---|---|
| 500 mg, intravenous | 10 mL | 10.2 mL | 50 mg/mL |
| 1 g, intravenous | 10 mL | 10.4 mL | 95 mg/mL |
| 2 g, intravenous | 10 mL | 11 mL | 180 mg/mL |
| 500 mg, intramuscular | 2 mL | 2.2 mL | 230 mg/mL |
| 1 g, intramuscular | 3 mL | 3.4 mL | 300 mg/mL |
| 2 g, intramuscular | 5 mL | 6 mL | 330 mg/mL |
The 10-g pharmacy bulk package should be reconstituted with 47 or 97 mL of a compatible diluent to yield a cefotaxime concentration of 200 or 100 mg/mL, respectively.3904 Shake to dissolve the contents and inspect for particulate matter or discoloration.3904 The reconstituted solution should be diluted in up to 1000 mL of a compatible solution for intravenous infusion.3904
pH
Injectable solutions of the drug have pH values ranging from 5 to 7.5.3903
Tonicity
A solution of cefotaxime sodium 1 g/14 mL of sterile water for injection is isotonic.3903
Osmolality
The osmolality of cefotaxime sodium 1, 2, and 3 g was calculated for the following dilutions:1054
| Osmolality (mOsm/kg) | ||
|---|---|---|
| Cefotaxime in Diluent | 50 mL | 100 mL |
| 1 g in Dextrose 5% | 350 | 319 |
| 1 g in Sodium chloride 0.9% | 375 | 344 |
| 2 g in Dextrose 5% | 343 | 327 |
| 2 g in Sodium chloride 0.9% | 406 | 351 |
| 3 g in Dextrose 5% | 433 | 344 |
| 3 g in Sodium chloride 0.9% | 458 | 382 |
The osmolality of cefotaxime sodium (Hoechst) 50 mg/mL was determined to be 326 mOsm/kg in dextrose 5% and 333 mOsm/kg in sodium chloride 0.9%.1375
The following maximum cefotaxime sodium concentrations were recommended to achieve osmolalities suitable for peripheral infusion in fluid-restricted patients:1180
| Diluent | Maximum Concentration (mg/mL) | Osmolality (mOsm/kg) |
|---|---|---|
| Dextrose 5% | 86 | 577 |
| Sodium chloride 0.9% | 73 | 555 |
| Sterile water for injection | 147 | 525 |
Sodium Content
Cefotaxime sodium contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity.3903
Trade Name(s)
Claforan
Cefotaxime sodium may be administered by intramuscular or direct intravenous injection or by intravenous infusion.3903 Intramuscular doses of 2 g should be divided between different injection sites.3903 For direct intravenous injection, the reconstituted solution should be administered over 3 to 5 minutes directly into the vein or into the tubing of a running compatible infusion solution.3903 For continuous infusion, the reconstituted solution may be diluted in up to 1000 mL of a compatible solution.3903
Solutions prepared from bulk pharmacy packages are intended only for intravenous infusion after dilution in a compatible solution.3904
The manufacturer states that cefotaxime sodium should not be admixed with aminoglycosides; however, they may be administered separately to the same patient.792; 3903
Intact vials should be stored at controlled room temperature.3903 Cefotaxime sodium powder is off-white to pale yellow in color.3903 Reconstituted solutions may range from light yellow to amber, depending on the diluent, concentration, and storage conditions.3903 Both the dry material and solutions may darken and should be protected from elevated temperatures and excessive light.3903
When reconstituted as described in the Products section, cefotaxime sodium is stable in the original containers as indicated in Table 2.
Table 2. Manufacturer’s Recommended Storage Times of Reconstituted Cefotaxime Sodium3903
| Storage Temperature | |||
|---|---|---|---|
| Vial Size | Concentration | 22°C | 5°C |
| 500 mg | 230 mg/mL | 12 hr | 7 days |
| 500 mg | 50 mg/mL | 24 hr | 7 days |
| 1 g | 300 mg/mL | 12 hr | 7 days |
| 1 g | 95 mg/mL | 24 hr | 7 days |
Solutions diluted in up to 1000 mL of a manufacturer-recommended solution for infusion are stable for 24 hours at or below 22°C or 5 days under refrigeration.3903
Reconstituted solutions prepared from pharmacy bulk packages should be further diluted for infusion within 4 hours after initial entry into the vial.3904 Unused portions of pharmacy bulk packages should be discarded after 4 hours of initial entry.3904 Solutions further diluted in up to 1000 mL of a manufacturer-recommended solution for infusion are stable for 24 hours at or below 22°C or 5 days under refrigeration.3904
Cefotaxime sodium (Hoechst-Roussel) 1 g/10 mL reconstituted with sterile water for injection or 1 g/50 mL in dextrose 5% in PVC bags exhibited no visible changes in 24 hours at 5 and 25°C. Although increased levels of particulate matter were observed in most solutions, the increases were significant only in solutions stored at 25°C.986
The stability of cefotaxime sodium (Hoechst-Roussel) 125 mg/L in peritoneal dialysis solutions (Dianeal 137 and PD2) with heparin sodium 500 units/L was evaluated at 25°C by microbiological assay. Approximately 95 ± 6% activity remained after 24 hours.1228
The stability of cefotaxime sodium (Hoechst-Roussel) 1 mg/mL in Dianeal PD-1 with dextrose 1.5 and 4.25% (Travenol) was reported. At 25°C, the drug exhibited an 8% loss in 24 hours and a 16% loss in 48 hours in both solutions. Storage at 37°C for 12 hours resulted in 11 and 14% losses in the solutions containing dextrose 1.5% and dextrose 4.25%, respectively.1481
pH Effects
The primary factor in the stability of cefotaxime sodium is solution pH.792 Cefotaxime sodium solutions are most stable at a pH of 5 to 7.3903 The theoretical pH of minimum decomposition is 5.13.793 However, between pH 3 and 7, the hydrolysis rate is virtually independent of pH.1072 Determination of decomposition kinetics in various aqueous buffer systems at 25°C showed 10% decomposition occurring in 24 hours or longer over a pH range of 3.9 to 7.6. At pH 2.2 and 8.4, 10% decomposition occurred in about 13 hours.793
The manufacturer recommends that cefotaxime sodium not be diluted in solutions with a pH greater than 7.5.3903
Freezing Solutions
Reconstituted solutions are stated to be stable in the original containers or in plastic syringes for 13 weeks frozen.3903
Syringes
Reconstituted solutions are stated to be stable in plastic syringes for 5 days under refrigeration.3903
Cefotaxime sodium (Aventis) 50 mg/mL in sodium chloride 0.9% packaged in 5-mL polypropylene plastic syringes is visually compatible and undergoes about 10% loss in 2 days at 25°C and about 3% loss in 18 days at 5°C.2371
Sorption
Cefotaxime sodium (Aventis) 50 mg/mL in sodium chloride 0.9% packaged in polypropylene plastic syringes exhibited no evidence of sorption when compared to glass containers.2371
Central Venous Catheter
Cefotaxime sodium (Hoechst-Roussel) 5 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Delivery of the cefotaxime sodium ranged from 93 to 95% of the initial concentration among the 3 lumens. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
For a list of references cited in the text of this monograph, search the monograph titled References.