Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017
PRECAUTIONS General Prescribing CLAFORAN in
CLAFORAN should be prescribed with
Continued dosage should be determined by degree of renal
Although there is
The serum creatinine should represent a
(140 - age) Males: 72?
serum creatinine Females: 0.85?
above value As with other antibiotics,
Repeated evaluation of the patient 's condition is essential.
If superinfection occurs during therapy,
Leukopenia, neutropenia, granulocytopenia and, more rarely,
For courses of treatment lasting longer than 10 days,
CLAFORAN, like other parenteral anti-infective drugs, may be locally
In most cases, perivascular extravasation of CLAFORAN responds to changing of the infusion site.
To minimize the
Information for patients Patients should be counseled that antibacterial drugs including CLAFORAN should only be used to treat bacterial
They do not treat
When CLAFORAN is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may (1)
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Drug Interactions As with other cephalosporins, CLAFORAN may potentiate the nephrotoxic effects of nephrotoxic drugs such as aminoglycosides, NSAIDs, and furosemide.
Probenecid interferes with the renal tubular transfer of cefotaxime,
Administration of cefotaxime in
Drug/Laboratory Test Interactions Cephalosporins, including cefotaxime sodium, are known to occasionally induce a
A false-positive reaction for glucose in the
(e.g., CLINISTIX or TesTape).
Carcinogenesis, Mutagenesis Lifetime studies in animals to evaluate carcinogenic
CLAFORAN was not mutagenic in the mouse micronucleus test or in the Ames test.
Pregnancy Teratogenic Effects Pregnancy Category B: Reproduction studies have been performed in pregnant mice
Although cefotaxime has been reported to cross the placental
Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nonteratogenic Effects Use of
In perinatal and
Nursing Mothers CLAFORAN is excreted in human milk in low concentrations.
Pediatric Use See Precautions above regarding perivascular extravasation.
Geriatric Use Of the 1409 subjects in clinical studies of cefotaxime, 632 (45 %) were 65 and over, while 258 (18 %) were 75 and over.
Because elderly patients are more likely to have
The most frequent
Hypersensitivity (2.4 %) - Rash, pruritus, fever, eosinophilia.
Gastrointestinal (1.4 %) - Colitis, diarrhea,
Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.
Some individuals have developed
Genitourinary System - Moniliasis, vaginitis.
Liver - Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported.
Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with CLAFORAN. Post-Marketing Experience The following
Because these reactions were reported voluntarily from
Cardiovascular System - Potentially
Dizziness has also been reported.
Cutaneous - As with other cephalosporins, isolated cases of
Hematologic System - Hemolytic anemia, agranulocytosis, thrombocytopenia, pancytopenia,
Hypersensitivity - Anaphylaxis (e.g., angioedema, bronchospasm,
Kidney - Interstitial nephritis, transient elevations of creatinine,
Liver - Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin.
Cephalosporin Class Labeling In addition to the
Several cephalosporins have been implicated in triggering seizures, particularly in
See DOSAGE AND ADMINISTRATION and OVERDOSAGE.
If seizures associated with drug therapy occur,
Anticonvulsant therapy can be given if clinically indicated.
DOSAGE AND ADMINISTRATION Adults Dosage and route of administration should be determined by
CLAFORAN may be administered IM or IV after reconstitution.
Premixed CLAFORAN Injection is intended for IV administration after thawing.
GUIDELINES FOR DOSAGE OF CLAFORAN Type of
If C. trachomatis is a suspected pathogen,
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
Infants and Children (1 month to 12 years): For body weights less than 50 kg, the
The higher dosages should be used for more
For body weights 50 kg or more, the usual adult dosage should be used;
Because elderly patients are more likely to have
(See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.
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;
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 vialin conventional vials (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 1g infusion 50-100 50-100 20-10 2g infusion 50-100 50-100 40-20 Shake to dissolve; inspect for particulate matter and
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
A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC. IM Administration As with all IM preparations,
Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
Cefotaxime should not be administered over a period of less than three
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
For the administration of higher doses by continuous IV infusion,
Directions for use of CLAFORAN Injection in Galaxy® Container (PL 2040 Plastic) CLAFORAN Injection in Galaxy® Containers (PL 2040 plastic) is for continuous or
[DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]
Check for minute leaks by squeezing
If leaks are detected,
NOT ADD SUPPLEMENTARY
The container should be visually inspected.
Components of the solution may precipitate in the
Agitate after solution has reached room temperature.
If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if
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.
Such use could result in air embolism due to residual air being drawn from the primary container before
Preparation for Intravenous Administration Suspend container from eyelet support.
Remove protector from outlet port at bottom of container.
Attach administration 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.
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
Solutions of CLAFORAN Sterile reconstituted in 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection in Viaflex® plastic containers maintain
Solutions of CLAFORAN Sterile reconstituted in 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection in the ADD-Vantage
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
|Date Last Revised||30-04-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||NOTE: Store Premixed CLAFORAN Injection at or below -20°C/-4°F. [See Directions for use of CLAFORAN 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.|
|Marketing authorisation holder||Sanofi-Aventis U.S. LLC|