TAZICEF- 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:

Hospira, Inc.

INN (International Name):

CEFTAZIDIME

Composition:

CEFTAZIDIME ANHYDROUS 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tazicef (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: Tazicef (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. Tazicef (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 Tazicef (ceftazidime

Product summary:

Tazicef 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. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in ADD-Vantage® vials as follows:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TAZICEF- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
----------
TAZICEF
BRAND OF
CEFTAZIDIME FOR INJECTION, USP
_For Intravenous Use_
_in ADD-Vantage_
_Vials_
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Tazicef (ceftazidime) and other antibacterial drugs, Tazicef
(ceftazidime) 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 structure:
The molecular formula is C
H
N O
S , representing a molecular weight of 636.6.
Tazicef (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 51 mg (2.2 mEq)/g of
ceftazidime activity.
Tazicef in sterile crystalline form is supplied in ADD-Vantage vials
equivalent to 1 g or 2
g of anhydrous ceftazidime.
Solutions of Tazicef 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 7.5.
®
_® _
22
32
6
12 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
concentrations of 42, 69, and 170 mcg/mL, respectively, were achieved.
The average
serum concentrations following IV infusion of