CEFTAZIDIME AND DEXTROSE- ceftazidime injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

CEFTAZIDIME

Composition:

CEFTAZIDIME ANHYDROUS 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of lower respiratory tract infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae , including ampicillin-resistant isolates; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis ; Escherichia coli ; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae ; and Staphylococcus aureus (methicillin-susceptible isolates). Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of 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 isolates); and Streptococcus pyogenes (group A beta-hemolytic streptococci). Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of bacterial septicemia caused by Pseudomonas

Product summary:

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection. After reconstitution, the concentrations are equivalent to 1 g and 2 g of anhydrous ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case. Store the unactivated unit at 20-25°C (68-77°F).  Excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature.] Protect from light. Freezing solutions of Ceftazidime for Injection USP and Dextrose Injection USP is not recommended. Not made with natural rubber latex, PVC, or DEHP.  As with other cephalosporins, Ceftazidime for Injection USP and Dextrose Injection USP powder, as well as solutions, tend to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter.

Authorization status:

New Drug Application

Summary of Product characteristics

CEFTAZIDIME AND DEXTROSE- CEFTAZIDIME INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFTAZIDIME FOR INJECTION
AND DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CEFTAZIDIME FOR INJECTION AND DEXTROSE INJECTION.
CEFTAZIDIME FOR INJECTION AND DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1985
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ceftazidime for
Injection and Dextrose Injection and other antibacterial drugs,
Ceftazidime for Injection and Dextrose
Injection should be used only to treat or prevent infections that are
proven or strongly suspected to be
caused by bacteria. (1)
RECENT MAJOR CHANGES
Warnings and Precautions, Neurological Adverse Reactions (5.4) 10/2021
INDICATIONS AND USAGE
Ceftazidime for Injection and Dextrose Injection is a cephalosporin
antibacterial indicated in the treatment
of the following infections caused by susceptible isolates of the
designated microorganisms: Lower
respiratory tract infections (1.1); skin and skin-structure infections
(1.2); bacterial septicemia (1.3); bone
and joint infections (1.4); gynecologic infections (1.5);
intra-abdominal infections (1.6); central nervous
system infections (1.7).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ceftazidime for
Injection and Dextrose Injection and other antibacterial drugs,
Ceftazidime for Injection and Dextrose
Injection should be used only to treat or prevent infections that are
proven or strongly suspected to be
caused by bacteria. (1.8)
DOSAGE AND ADMINISTRATION
For intravenous use only over approximately 30 minutes. (2)
RECOMMENDED DOSAGE SCHEDULE FOR CREATININE CLEARANCE GREATER THAN 50
ML/MIN
ADULTS
DOSE
FREQUENCY
Bone and joint infections
2 grams IV
every 12hr
Uncomplicated pneumonia; mild skin and skin-structure infections
500 mg*–1 gram
IV
every 8hr
Serious gynecologic and intra-