CEFTAZIDIME- ceftazidime injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

CEFTAZIDIME

Composition:

CEFTAZIDIME ANHYDROUS 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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 antibiotics have been used. Ceftazidime for injection, USP may also be used concomitantly with other antibiotics, 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 antibiotics 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 f

Product summary:

Ceftazidime for injection, USP in the dry state should be stored at 20° to 25°C (68° 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 0781-3177-96 1 g* vial (Tray of 25) NDC 0781-3178-95 2 g* vial (Tray of 10) *Equivalent to anhydrous ceftazidime.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
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CEFTAZIDIME FOR INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR 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 or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic
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 , 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 (2.3
mEq)/g of ceftazidime activity.
Ceftazidime for injection, USP in sterile crystalline form is supplied
in 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 achieve