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Cefobid

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Cefobid

WARNINGS

BEFORE THERAPY WITH CEFOBID (sterile cefoperazone) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE THE USE OF SUBCUTANEOUS EPINEPHRINE AND OTHER EMERGENCY MEASURES.

PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH THE USE OF CEPHALOSPORINS (AND OTHER BROAD-SPECTRUM ANTIBIOTICS); THEREFORE, IT IS IMPORTANT TO CONSIDER ITS DIAGNOSIS IN PATIENTS WHO DEVELOP DIARRHEA IN ASSOCIATION WITH ANTIBIOTIC USE.

Treatment with broad-spectrum antibiotics alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis. Cholestyramine and colestipol resins have been shown to bind the toxin in vitro.

Mild cases of colitis may respond to drug discontinuance alone.

Moderate to severe cases should be managed with fluid, electrolyte, and protein supplementation as indicated.

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. Other causes of colitis should also be considered.

PRECAUTIONS

Although transient elevations of the BUN and serum creatinine have been observed, CEFOBID (sterile cefoperazone) alone does not appear to cause significant nephrotoxicity. However, concomitant administration of aminoglycosides and other cephalosporins has caused nephrotoxicity.

CEFOBID (sterile cefoperazone) is extensively excreted in bile. The serum half-life of CEFOBID (sterile cefoperazone) is increased 2–4 fold in patients with hepatic disease and/or biliary obstruction. In general, total daily dosage above 4 g should not be necessary in such patients. If higher dosages are used, serum concentrations should be monitored.

Because renal excretion is not the main route of elimination of CEFOBID (see CLINICAL PHARMACOLOGY), patients with renal failure require no adjustment in dosage when usual doses are administered. When high doses of CEFOBID (sterile cefoperazone) are used, concentrations of drug in the serum should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly.

The half-life of CEFOBID (sterile cefoperazone) is reduced slightly during hemodialysis. Thus, dosing should be scheduled to follow a dialysis period. In patients with both hepatic dysfunction and significant renal disease, CEFOBID (sterile cefoperazone) dosage should not exceed 1–2 g daily without close monitoring of serum concentrations.

As with other antibiotics, vitamin K deficiency has occurred rarely in patients treated with CEFOBID (sterile cefoperazone) . The mechanism is most probably related to the suppression of gut flora which normally synthesize this vitamin. Those at risk include patients with a poor nutritional status, malabsorption states (e.g., cystic fibrosis), alcoholism, and patients on prolonged hyper-alimentation regimens (administered either intravenously or via a naso-gastric tube). Prothrombin time should be monitored in these patients and exogenous vitamin K administered as indicated.

A disulfiram-like reaction characterized by flushing, sweating, headache, and tachycardia has been reported when alcohol (beer, wine) was ingested within 72 hours after CEFOBID (sterile cefoperazone) administration. Patients should be cautioned about the ingestion of alcoholic beverages following the administration of CEFOBID (sterile cefoperazone) . A similar reaction has been reported with other cephalosporins.

Prolonged use of CEFOBID (sterile cefoperazone) may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

CEFOBID (sterile cefoperazone) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. The maximum duration of CEFOBID (sterile cefoperazone) animal toxicity studies is six months. In none of the in vivo or in vitro genetic toxicology studies did CEFOBID (sterile cefoperazone) show any mutagenic potential at either the chromosomal or subchromosomal level. CEFOBID (sterile cefoperazone) produced no impairment of fertility and had no effects on general reproductive performance or fetal development when administered subcutaneously at daily doses up to 500 to 1000 mg/kg prior to and during mating, and to pregnant female rats during gestation. These doses are 10 to 20 times the estimated usual single clinical dose. CEFOBID (sterile cefoperazone) had adverse effects on the testes of prepubertal rats at all doses tested. Subcutaneous administration of 1000 mg/kg per day (approximately 16 times the average adult human dose) resulted in reduced testicular weight, arrested spermatogenesis, reduced germinal cell population and vacuolation of Sertoli cell cytoplasm. The severity of lesions was dose dependent in the 100 to 1000 mg/kg per day range; the low dose caused a minor decrease in spermatocytes. This effect has not been observed in adult rats. Histologically the lesions were reversible at all but the highest dosage levels. However, these studies did not evaluate subsequent development of reproductive function in the rats. The relationship of these findings to humans is unknown.

Usage in Pregnancy

Pregnancy Category B

Reproduction studies have been performed in mice, rats and monkeys at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to CEFOBID (sterile cefoperazone) . There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Usage in Nursing Mothers

Only low concentrations of CEFOBID (sterile cefoperazone) are excreted in human milk. Although CEFOBID (sterile cefoperazone) passes poorly into breast milk of nursing mothers, caution should be exercised when CEFOBID (sterile cefoperazone) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established. For information concerning testicular changes in prepubertal rats, see Carcinogenesis, Mutagenesis, Impairment of Fertility.

Geriatric Use

Clinical studies of CEFOBID® (sterile cefoperazone sodium) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 8/24/2009
This monograph has been modified to include the generic and brand name in many instances.

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