openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS BEFORE THERAPY WITH CEFAZOLIN FOR INJECTION, 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 FOR 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 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, 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, BUN and alkaline phosphatase levels have been observed without clinical evidence of renal or hepatic impairment. Local Reactions: Rare instances of phlebitis have been reported at the site of injection. Pain at the 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). DOSAGE AND ADMINISTRATION Usual Adult Dosage Type of infection Dose Frequency Moderate to severe infections 500 mg to Every 6 to 8 hours 1 gram Mild infections caused by susceptible gram 250 mg to Every 8 hours + cocci 500 mg Acute, uncomplicated urinary tract infections 1 gram Every 12 hours Pneumococcal pneumonia 500 mg Every 12 hours Severe, life-threatening infections (e.g., 1 gram to Every 6 hours endocarditis, septicemia)* 1.5 grams * In rare instances, doses of up to 12 grams of cefazolin per day have been used. Perioperative Prophylactic Use To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are; 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of the surgery. Dosage Adjustment for Patients with Reduced Renal Function Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses, Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis; See Human Pharmacology . Pediatric Dosage In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into three or four equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended. Pediatric Dosage Guide 25 mg/kg/day divided 25 mg/kg/day divided Weight into 3 doses into 4 doses Vol. (mL) Vol. (mL) Approximate needed with Approximate needed with single dose dilution of single dose dilution of Lbs Kg mg/q8h 125 mg/mL mg/q6h 125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9.0 75 mg 0.60 mL 55 mg 0.45 mL 30 13.6 115 mg 0.90 mL 85 mg 0.70 mL 40 18.1 150 mg 1.20 mL 115 mg 0.90 mL 50 22.7 190 mg 1.50 mL 140 mg 1.10 mL 50 mg/kg/day divided 50 mg/kg/day divided Weight into 3 doses into 4 doses Vol. (mL) Vol. (mL) Approximate needed with Approximate needed with single dose dilution of single dose dilution of Lbs Kg mg/q8h 225 mg/rnL mg/q6h 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9.0 150 mg 0.70 mL 110 mg 0.50 mL 30 13.6 225 mg 1.00 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1.00 mL 50 22.7 375 mg 1.70 mL 265 mg 1.25 mL In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min,), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.