देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
Cefazolin sodium (UNII: P380M0454Z) (Cefazolin - UNII:IHS69L0Y4T)
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)
Cefazolin
INJECTION, POWDER, FOR SOLUTION
10 g
INTRAVENOUS
PRESCRIPTION DRUG
Cefazolin for injection 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 is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for injection 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.
Cefazolin for injection, USP Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin. Cefazolin for injection is available as follows: 10 vials 10 grams/100 mL vials per carton (NDC 63304-941-10). 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.
CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.) ---------- CEFAZOLIN FOR INJECTION USP "PHARMACY BULK PACKAGE- NOT FOR DIRECT INFUSION" 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 is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 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. 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. A Pharmacy Bulk Package is sterile dosage form for parenteral use that contains many single doses. The contents are restricted for use in a pharmacy admixture service and are intended for the preparation of admixtures for intravenous use. NOT FOR DIRECT INJECTION. FURTHER DILUTION IS REQUIRED BEFORE USE. CLINICAL PHARMACOLOGY Studies have shown that following intravenous administration of Cefazolin for injection to normal volunteers, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1 gram dose. The serum half-life for Cefazolin for injection is approximately 1.8 hours following IV administration. In a study (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), Cefazolin for injection produced a steady serum level at the third hour of approximately 28 mcg/ पूरा दस्तावेज़ पढ़ें