Cefotaxime

CEFOTAXIME (CLAFORAN ®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

DOSAGE AND ADMINISTRATION
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). CLAFORAN may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

Renal dosing:
>50/ Usual dose
10-50/ q8-12h
<10/ q24h

HD: 0.5 to 2g ivpb q24h AD.
PD: 1g ivpb q24h.

GUIDELINES FOR DOSAGE OF CLAFORAN

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.

Preparation of CLAFORAN Sterile
CLAFORAN for IM or IV administration should be reconstituted as follows:

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. For other diluents, see COMPATIBILITY AND STABILITY section.

NOTE: Solutions 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.

A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

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. 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.

Preparation of CLAFORAN Sterile in ADD-Vantage System
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.

Compatibility and Stability

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:

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.

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.

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

HOW SUPPLIED
Sterile CLAFORAN is a dry off-white to pale yellow crystalline powder supplied in vials containing cefotaxime sodium as follows:

1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0018-49).

2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0019-49).

1 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0023-49).

2 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0024-49).

ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium Chloride) are available from Abbott Laboratories.

Also available:
Pharmacy Bulk Package:

10g cefotaxime (free acid equivalent) in bottles (NDC 0039-0020-49)

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.

Revised May 2007

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.

© 2007 sanofi-aventis U.S. LLC