Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)
General Injectables & Vaccines, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness 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 serious infections due to susceptible organisms. 1.1 Respiratory Tract Infections 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 to be the drug of choice in treatment and prevention of strep
Cefazolin for Injection, USP is supplied as a sterile white or off-white powder or 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°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION GENERAL INJECTABLES & VACCINES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEFAZOLIN FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFAZOLIN FOR INJECTION. CEFAZOLIN FOR INJECTION, 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: (1) Respiratory tract infections. (1.1) Urinary tract infections. (1.2) Skin and skin structure infections. (1.3) Biliary 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) (2) *In rare instances, doses of up to 12 grams of cefazolin per day have been used. Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal to 55 mL/min. (2.1) 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 (2) DOSAGE FORMS AND STRENGTHS 1 g per vial.(3) CONTRAINDICATIONS Cefazolin for injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. WARNINGS AND PRECAUTI Izlasiet visu dokumentu