CEFTAZIDIME injection, powder, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ceftazidime (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301)

Dostopno od:

Sagent Pharmaceuticals

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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 vials as follows: *Equivalent to anhydrous ceftazidime. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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CEFTAZIDIME FOR INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE
SAGENT
Rx only
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 in sterile crystalline form is supplied
in single-dose vials equivalent to 1
g 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.
CLINICAL PHARMACOLOGY
After IV administration of 500 mg and 1 g doses of ceftazidime over 5
minutes to normal adult male
volunteers, mean peak serum concentrations of 45 and 90 mcg/mL,
respectively, were achieved. After
IV infusion of 500 mg, 1 g, and 2 g doses of ceftazidime over 20 to 30
minutes to normal adult male
volunteers, mean peak serum concentrations of 42, 69