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warnings
Warnings Before therapy with Cefazolin Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or other drugs. If this product is given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefazolin Injection, USP occurs, discontinue treatment with the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefazolin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alter the normal flora of the colon and may permit overgrown of clostridia. Studies indicate that a toxin produced by Clostridium difficile is on primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Adverse Reactions The following reactions have been reported: Gastrointestinal Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely. Allergic Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic Neutropenia, leukopenia, thrombocytopenia, thrombocythemia. Hepatic and Renal Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed without clinical evidence of renal or hepatic impairment. Local Reactions Rare instances of phlebitis have been reported at site of injection. Pain at teh site of injection after intramuscular administration has occurred infrequently. Some induration has occurred. Other Reactions Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis).