Cefazolin
Principio activo: CEFAZOLIN
Vía de administración
INTRAMUSCULAR, INTRAVENOUS
Países disponibles
US
Indicaciones
INDICATIONS AND USAGE Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species , H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli , various strains of streptococci, P. mirabilis , Klebsiella species, and S. aureus . Bone and Joint Infections: Due to S. aureus . Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli , P. mirabilis , Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae , S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis , E. coli , and Klebsiella species. Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24‑hour period after the surgical procedure. 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 surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.) To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Posología
DOSAGE AND ADMINISTRATION Usual Adult Dosage: Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours * In rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. Perioperative Prophylactic Use : To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: a. 1 gram I.V. or I.M. administered ½ hour to 1 hour prior to the start of surgery. b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram I.V. or I.M. during surgery (administration modified depending on the duration of the operative procedure). c. 500 mg to 1 gram I.V. or I.M. every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just prior (1/2 hour to 1 hour) 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 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 CLINICAL 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 3 or 4 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 for Injection in these patients is not recommended. Pediatric Dosage Guide Weight 25 mg/kg/day Divided into 3 Doses 25 mg/kg/day Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of 125 mg/mL 10 20 30 40 50 4.5 9 13.6 18.1 22.7 40 mg 75 mg 115 mg 150 mg 190 mg 0.35 mL 0.6 mL 0.9 mL 1.2 mL 1.5 mL 30 mg 55 mg 85 mg 115 mg 140 mg 0.25 mL 0.45 mL 0.7 mL 0.9 mL 1.1 mL Weight 50 mg/kg/day Divided into 3 Doses 50 mg/kg/day Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of 225 mg/mL 10 20 30 40 50 4.5 9 13.6 18.1 22.7 75 mg 150 mg 225 mg 300 mg 375 mg 0.35 mL 0.7 m
Contraindicaciones
CONTRAINDICATIONS CEFAZOLIN FOR INJECTION IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
Embarazo y lactancia
Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats, mice, and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefazolin for Injection. 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.
Efectos adversos
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: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received. Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received. Local Reactions: Rare instances of phlebitis have been reported at 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). To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov .
Fuente: OpenFDA (enlace oficial).Última actualización: 2026-05-04T10:51:45.747219+00:00. Este resumen es apoyo a la decisión clínica, no sustituye juicio profesional ni la ficha técnica oficial del laboratorio.
Editor en Jefe: Dr. Alexander Jesús Figueredo Izaguirre — RP #108356