FDA label 985a19ac-24e8-46e5-bb2d-6aa162025b46

WARNINGS In penicillin-sensitive patients, cephalosporin derivatives should be used with great caution. There is clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins, and there are instances of patients who have had reactions to both drug classes (including anaphylaxis after parenteral use). Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics, including cephradine, cautiously and then only when absolutely necessary. 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.

ADVERSE REACTIONS As with other cephalosporins, untoward reactions are limited essentially to gastrointestinal disturbances and, on occasion, to hypersensitivity phenomena. The latter are more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported following the use of cephradine: Gastrointestinal: Symptoms of pseudomembranous colitis can appear during antibiotic treatment. Nausea and vomiting have been reported rarely. Skin and Hypersensitivity Reactions: Mild urticaria or skin rash, pruritus, and joint pains were reported by very few patients. Hematologic: Mild, transient eosinophilia, leukopenia, and neutropenia have been reported. Liver: Transient mild rise of SGOT, SGPT, and total bilirubin have been observed with no evidence of hepatocellular damage. Renal: Transitory rises in BUN have been observed in some patients treated with cephalosporins; their frequency increases in patients over 50 years old. In adults for whom serum creatinine determinations were performed, the rise in BUN was not accompanied by a rise in serum creatinine. Other adverse reactions have included dizziness and tightness in the chest and candidal vaginitis.