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BEFORE THERAPY WITH CEFOTAXIME (cefotaxime for injection) FOR INJECTION USP AND DEXTROSE INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTAXIME (cefotaxime for injection) SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO PENICILLIN. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOTAXIME (cefotaxime for injection) FOR INJECTION USP AND DEXTROSE INJECTION OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime (cefotaxime for injection) through a central venous catheter. Therefore, cefotaxime (cefotaxime for injection) should only be administered as instructed in the DOSAGE AND ADMINISTRATION section.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Prescribing Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when cefotaxime (cefotaxime for injection) is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism.
It is suggested that, based upon the data available from published studies the dose of cefotaxime (cefotaxime for injection) sodium be halved in patients with estimated creatinine clearances of less than 20 mL/min/1.73 m2.
When only serum creatinine is available, the following formula6 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
|Males:||Weight (kg) x (140 - age)|
|72 x serum creatinine|
|Females:||0.85 x above value|
As with other antibiotics, prolonged use of cefotaxime (cefotaxime for injection) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
As with other beta-lactam antibiotics, granulocytopenia and, more rarely, agranulocytosis may develop during treatment with cefotaxime (cefotaxime for injection) , particularly if given over long periods. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored.
Cefotaxime (cefotaxime for injection) , like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of cefotaxime (cefotaxime for injection) responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of cefotaxime (cefotaxime for injection) may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.
As with other dextrose-containing solutions, Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.
If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.
Use only if solution is clear and container and seals are intact.
Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefotaxime (cefotaxime for injection) was not mutagenic in the mouse micronucleus test or in the Ames' test. Cefotaxime (cefotaxime for injection) did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day (0.2 times the maximum recommended human dose based on mg/m2) or in mice when administered intravenously at doses up to 2000 mg/kg/day (0.7 times the recommended human dose based on mg/m2).
Pregnancy: Teratogenic Effects: Pregnancy Category B:
Reproduction studies have been performed in pregnant mice given cefotaxime (cefotaxime for injection) intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m2) or in pregnant rats when administered intravenously at doses up to 1200 mg/kg/day (0.8 times the recommended human dose based on mg/m2). No evidence of embryotoxicity or teratogenicity was seen in these studies. There are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use of the drug in women of child-bearing potential requires that the anticipated benefit be weighed against the possible risks.
In perinatal and postnatal studies with rats, the pups in the group given 1200 mg/kg/day of cefotaxime (cefotaxime for injection) were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.
Cefotaxime (cefotaxime for injection) is excreted in human milk in low concentrations. Caution should be exercised when cefotaxime (cefotaxime for injection) is administered to a nursing woman.
See PRECAUTIONS above regarding perivascular extravasation.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of cefotaxime (cefotaxime for injection) . To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of cefotaxime (cefotaxime for injection) .
Of the 1409 subjects in clinical studies of cefotaxime (cefotaxime for injection) , 632 (45%) were 65 and over, while 258 (18%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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).
6) Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31-41, 1976.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/3/2007
Additional Cefotaxime Information
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