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:

WG Critical Care, LLC

INN (mednarodno ime):

CEFTAZIDIME

Sestava:

CEFTAZIDIME ANHYDROUS 1 g in 20 mL

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: 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 (methicillin-susceptible 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 meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae. Ceftazidime for injection, USP may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used. Ceftazidime for injection, USP may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient’s condition. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection, USP and other antibacterial drugs, ceftazidime for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs.

Povzetek izdelek:

Ceftazidime for injection, USP in the dry state should be stored at 20ºC to 25°C (68ºF 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: NDC 44567-235-25 1 gram* single-dose Vial (Carton of 25) NDC 44567-236-10 2 grams* single-dose Vial (Carton of 10) *Equivalent to anhydrous ceftazidime.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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CEFTAZIDIME FOR INJECTION
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, and 170 mcg/mL, respectively, were achieved.
The avera