头孢他啶英文说明书.pdf

PRODUCT INFORMATION 1 CEPTAZ ? 2 (ceftazidime for injection) 3 L-arginine formulation 4 5 For Intravenous or Intramuscular Use 6 7 DESCRIPTION: Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for 8 parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1- 9 carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[]oct-2- 10 en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6 α,7 β(Z)]]. It has the following structure: 11 12 13 14 The empirical formula is C 22 H 32 N 6 O 12 S 2, representing a molecular weight of . 15 CEPTAZ is a sterile, dry mixture of ceftazidime pentahydrate and L-arginine. The L-arginine 16 is at a concentration of 349 mg/g of ceftazidime activity. CEPTAZ dissolves without the 17 evolution of gas. The product contains no sodium ion. Solutions of CEPTAZ range in color from 18 light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted 19 solutions usually ranges from 5 to . 20 21 CLINICAL PHARMACOLOGY: After intravenous (IV) administration of 500-mg and 1-g 22 doses of ceftazidime over 5 minutes to normal adult male volunteers, mean peak serum 23 concentrations of 45 and 90 mcg/mL, respectively, were achieved. After IV infusion of 500-mg, 24 1-g, and 2-g doses of ceftazidime over 20 to 30 minutes to normal adult male volunteers, mean 25 peak serum concentrations of 42, 69, and 170 mcg/mL, respectively, were achieved. The average 26 serum concentrations following IV infusion of 500-mg, 1-g, and 2-g doses to these volunteers 27 CEPTAZ ? (ceftazidime for injection) L-arginine formulation 27 over an 8-hour interval are given in Table 1. 28 29 Table 1 30 Ceftazidime Serum Concentrations (mcg/mL) IV Dose h 1 h 2 h 4 h 8 h 500 mg 42 25 12 6 2 1 g 60 39 23 11 3 2 g 129 75 42 13 5 31 The absorption and elimination of ceftazidime were dir