CEFTAZIDIME injection, powder, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Sagent Pharmaceuticals

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 spp.; Pr

Produkto santrauka:

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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFTAZIDIME FOR INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE
PREMIERProRx
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.
®
22
22
6
7 2
2
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