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 or prevent infections that are proven or strongly suspected to be caused by bacteria.
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)]].
The molecular formula is C H N O S, representing a molecular weight of 636.6. 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 (2.3mEq)/g of ceftazidime activity.
Ceftazidime for injection, USP in sterile crystalline form is supplied in single-dose vials equivalent to 1g or 2 g of anhydrous ceftazidime. 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.
Antibiotic Class: Third-Generation Cephalosporin
Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitides, Neisseria gonorrhoeae, E.Coli, P. aeruginosa
Mechanism of Action:
Cephalosporins exert bactericidal activity by interfering with bacterial cell wall synthesis and inhibiting cross-linking of the peptidoglycan. The cephalosporins are also thought to play a role in the activation of bacterical cell autolysins which may contribute to bacterial celllysis.
Indication and usage
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:
1. 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).
2. 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).
3. Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli.
4. Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillinsusceptible strains).
5. Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains).
6. Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.
7. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
8. Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitides. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.
Hematologic: Hypoprothrombinemia, Neutropenia, Leukopenia, Thrombocytopenia
GI: Diarrhea, C. difficile disease
Renal: Interstitial nephritis
Ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.
Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ceftazidime for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when ceftazidime is administered to a nursing woman.
Dosage: IV: 1g, 2g, 6g, 10g, 500mg
Dosing in adults: Bone and/or joint infection: 2 g IV q12h
Intra-abdominal infection: 2 g IV q8h
Meningitis: 2g IV q8h
Pneumonia: 0.5-1g IV q8h
Uncomplicated UTI: 250mg IV/IM q12h
Complicated UTI: 500mg IV/IM q8-12h
Dosing in pediatrics: 75-150mg/kg/day divided q8h
Brand names/Manufacturer: CeptazÒ/Glaxo Smith Kline; FortazÒ/Glaxo Smith Kline; TazicefÒ/Bristol-Myers Squibb; TazidimeÒ/Eli Lilly;