Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)
Apotex Corporation
INTRAVENOUS
PRESCRIPTION DRUG
Cefazolin for injection, USP is indicated in the treatment of the following serious infections 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 to be 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 s
Cefazolin for injection, USP, is supplied in 10 grams Pharmacy Bulk Package. As with other cephalosporins, Cefazolin for Injection tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Before reconstitution PROTECT FROM LIGHT.
Abbreviated New Drug Application
CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION APOTEX CORPORATION ---------- CEFAZOLIN FOR INJECTION, USP PHARMACY BULK PACKAGE- NOT FOR DIRECT INFUSION ONLY 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. DESCRIPTION Cefazolin for injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of (6_R_,7_R_)-3- {[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl}-8-oxo-7-[2-(1H-tetrazol-1- yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C H N NaO S and molecular weight is 476.49. Structural Formula: Each vial contains 48 mg (2 mEq) of sodium/1 gram of cefazolin sodium. Cefazolin for injection, USP is white to off-white crystalline powder. Cefazolin for Injection, USP is supplied in 10 grams Pharmacy Bulk Packages. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin. After reconstitution with either 45 mL or 96 mL of diluent the concentration is 1 gram cefazolin per 5 mL or 1 gram cefazolin per 10 mL, respectively. The pH of the reconstituted solution is between 4.0 and 6.0. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION. CLINICAL PHARMACOLOGY After intramuscular administration of Cefazolin for Injection to normal volunteers, the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours following a 500-mg dose, and 64 14 13 8 4 3 concentrations were 37 Lesen Sie das vollständige Dokument