Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ceftazidime (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301)
Sagent Pharmaceuticals
ceftazidime
CEFTAZIDIME ANHYDROUS 6 g in 30 mL
INTRAVENOUS
PRESCRIPTION DRUG
Ceftazidime for injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - Lower Respiratory Tract Infections , including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae , including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains). - Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci). - Urinary Tract Infections , both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter s
Ceftazidime for injection, USP in the dry state should be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] and protected from light. Ceftazidime for Injection, USP is a white to cream-colored crystalline powder supplied in Pharmacy Bulk Package Bottles as follows: *Equivalent to anhydrous ceftazidime. Sterile, Nonpyrogenic, Preservative-free The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION SAGENT PHARMACEUTICALS ---------- CEFTAZIDIME FOR INJECTION, USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION PREMIERProRx Rx only FOR INTRAVENOUS USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection and other antibacterial drugs, ceftazidime for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4- thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structural formula: The molecular formula is C H N O S •5H O, representing a molecular weight of 636.65. Ceftazidime for injection, USP is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. Ceftazidime for injection, USP is a white to cream-colored crystalline powder. Solutions of ceftazidime for injection, USP range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8. ® 22 22 6 7 2 2 Ceftazidime for injection, USP in sterile crystalline form is supplied in 6 gram Pharmacy Bulk Package bottles equivalent to 6 grams of anhydrous ceftazidime. The Pharmacy Bulk Package bottle contains 708 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq) per gram of ceftazidime. The 6 g Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for Đọc toàn bộ tài liệu