CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
- Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
- Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Providencia rettgeri, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains.
- Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum).
CLAFORAN, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
- Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia).
- Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and nonpenicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species).
- Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis, and Clostridium species.
- Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and nonpenicillinase producing strains), Streptococcus species (including S. pyogenes), Pseudomonas species (including P. aeruginosa), and Proteus mirabilis.
- Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli.
() Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.
Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms.
Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, CLAFORAN may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if CLAFORAN is used concomitantly with an aminoglycoside.
The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.
In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section.
Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section.
For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
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. Premixed CLAFORAN Injection is intended for IV administration after thawing. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CLAFORAN
|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.
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 CLAFORAN 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 CLAFORAN Sterile
CLAFORAN 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|
|1g vial (IM)||3||3.4||300|
|2g vial (IM)||5||6.0||330|
|500 mg vial (IV)||10||10.2||50|
|1g vial (IV)||10||10.4||95|
|2g vial (IV)||10||11.0||180|
|() in conventional vials|
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. 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 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. (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 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.
Directions for use of CLAFORAN Injection in Galaxy Container (PL 2040 Plastic)
CLAFORAN Injection in Galaxy containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.
Store in a freezer capable of maintaining a temperature of -20°C/-4°F.
Thawing of Plastic Container
Thaw frozen container at room temperature or under refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]
Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.
DO NOT ADD SUPPLEMENTARY MEDICATION.
The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.
The thawed solution is stable for 10 days under refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze thawed antibiotics.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for Intravenous Administration:
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
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:
|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||230||12 hours||7 days||5 days|
|1g vial IM||300||12 hours||7 days||5 days|
|2g vial IM||330||12 hours||7 days||5 days|
|500 mg vial IV||50||24 hours||7 days||5 days|
|1g vial IV||95||24 hours||7 days||5 days|
|2g vial IV||180||12 hours||7 days||5 days|
|1g infusion bottle||10-20||24 hours||10 days|
|2g 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 oxacillin renal dosage for cipro 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.
Sterile CLAFORAN is a dry off-white to pale yellow crystalline powder supplied in vials and bottles containing cefotaxime sodium as follows:
500 mg cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0017-10).
1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0018-10), packages of 25 (NDC 0039-0018-25), packages of 50 (NDC 0039-0018-50); infusion bottles in packages of 10 (NDC 0039-0018-11).
2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0019-10), packages of 25 (NDC 0039-0019-25), packages of 50 (NDC 0039-0019-50); infusion bottles in packages of 10 (NDC 0039-0019-11).
1 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 00390023-25) and 50 (NDC 0039-0023-50).
2 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 00390024-25) and 50 (NDC 0039-0024-50).
ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium Chloride) are available from Abbott Laboratories.
Pharmacy Bulk Package:
10g cefotaxime (free acid equivalent) in bottles (NDC 0039-0020-01)
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.
Premixed CLAFORAN Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL single dose Galaxy containers (PL 2040 plastic) as follows:
1 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0037-05) 2G3518.
2 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0038-05) 2G3519.
NOTE: Store Premixed CLAFORAN Injection at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CLAFORAN (cefotaxime injection) IN GALAXY CONTAINERS (PL 2040 PLASTIC)].
CLAFORAN Injection supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in Galaxy containers (PL 2040 plastic) is manufactured for sanofi-aventis U.S. LLC by Baxter Healthcare Corporation.
Revised February 2014. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, Claforan Injection in Galaxy Containers: Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807
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