Clatacef Special Precautions

Arrhythmia: During postmarketing surveillance, a potentially life-threatening arrhythmia was reported in each of 6 patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter. Therefore, only administer cefotaxime as instructed.
Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefotaxime, and may range from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis. After the diagnosis of pseudomembranous colitis has been established, initiate appropriate therapeutic measures. Mild cases of colitis may respond to drug discontinuance alone. In moderate to severe cases, consider management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. When the colitis is not relieved by drug discontinuance or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Also consider other causes of colitis. Prescribe cefotaxime with caution in individuals with a history of GI disease, particularly colitis.
Hematologic effects: As with other beta-lactam antibiotics, granulocytopenia and, more rarely, agranulocytosis may develop during treatment with cefotaxime, particularly if given over long periods. For courses of treatment lasting greater than 10 days, monitor blood counts.
Extravasation: Cefotaxime, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of cefotaxime responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of cefotaxime may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, regularly monitor infusion sites and change when appropriate.
Drug-resistant bacteria: Prescribing cefotaxime 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.
Hypersensitivity reactions: Before therapy with cefotaxime is instituted, carefully determine whether the patient has had previous hypersensitivity reactions to cefotaxime, cephalosporins, penicillins, or other drugs. Give this product with caution to patients with type I hypersensitivity reactions to penicillin. Administer antibiotics with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to cefotaxime occurs, discontinue treatment with the drug. Serious hypersensitivity reactions may require epinephrine and other emergency measures.
Renal function impairment: 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, reduce the total daily dose when cefotaxime is administered to such patients.
Determine continued dosage by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime be halved in patients with estimated Ccrs of less than 20 mL/min/1.73 m2. When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into Ccr.
The serum creatinine should represent a steady state of renal function.
Ccr calculation: Men: Weight (kg) x 140 - age/72 x serum creatinine.
Women: 0.85 x previous value.
Superinfection: As with other antibiotics, prolonged use of cefotaxime may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, take appropriate measures.
Carcinogenesis: Lifetime studies in animals to evaluate carcinogenic potential have not been conducted.
Mutagenesis: Cefotaxime was not mutagenic in the mouse micronucleus test or in the Ames' test.
Fertility impairment: Cefotaxime did not impair fertility to rats when administered subcutaneously at dosages up to 250 mg/kg/day (0.2 times the maximum recommended human dosage based on mg/m²) or in mice when administered IV at dosages up to 2,000 mg/kg/day (0.7 times the recommended human dose based on mg/m²).
Effects on ability to drive and use machine: Cefotaxime has been associated with dizziness, which may affect the ability to drive or operate machinery.
Use in Children: The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic in single-dose Galaxy containers (premixed cefotaxime injection) has not been determined.
Use in the Elderly: 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, take care in dose selection; it may be useful to monitor renal function. Of the 1,409 subjects in clinical studies of cefotaxime, 632 (45%) were 65 years of age and older, while 258 (18%) were 75 years of age and older. No overall differences in safety or efficacy 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 in some older individuals cannot be ruled out.