Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Cefazolin Sodium (UNII: P380M0454Z) (Cefazolin - UNII:IHS69L0Y4T)
General Injectables & Vaccines, Inc
Cefazolin Sodium
Cefazolin 1 g in 3 mL
INTRAVENOUS
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectivness of Cefazolin for Injection, USP and other antibacterial drugs. Cefazolin for Injection, USP 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. Cefazolin for Injection, USP is indicated for the treatment of the following infections when caused by susceptible bacteria. 1.1 Respiratory Tract Infections Respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes. Injectable benzatine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including prophylaxis of rheumatic fever. Cefazolin is effective i
Cefazolin for Injection, USP is supplied as a sterile, white to off-white crystalline powder. Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin. As with other cephalosporins, cefazolin tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- CEFAZOLIN FOR INJECTION USP 1 GRAM HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEFAZOLIN FOR INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFAZOLIN FOR INJECTION, USP. CEFAZOLIN FOR INJECTION, USP, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1973 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 BACTERIA. INDICATIONS AND USAGE Cefazolin for Injection, USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Respiratory tract infections. (1.1) Urinary tract infections. (1.2) Skin and skin structure infections. (1.3) Billiary tract infections. (1.4) Bone and joint infections. (1.5) Genital infections. (1.6) Septicemia. (1.7) Endocarditis. (1.8) Perioperative prophylaxis. (1.9) DOSAGE AND ADMINISTRATION For intravenous or intramuscular use. (2) *In rare instances, doses of up to 12 grams of cefazolin per day have been used. DOSAGE FORMS AND STRENGTHS 1 g per vial (3) CONTRAINDICATIONS Hypersensitivity to cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams. (4.1) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. (5.1) Use in Patients with Renal Impairment: Dose adjustment required for patients with CrCl less than 55 mL/min. (5.2) _Clostridium difficile-_associated Diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. (5.3) ADVERSE REACTIONS Most common Adverse Reactions: Gastrointestin Aqra d-dokument sħiħ