Azactam

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Aztreonam 1 g; Aztreonam 1 g

Available from:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Aztreonam 1 g

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Aztreonam 1 g Excipient: Arginine Active: Aztreonam 1 g Excipient: Arginine

Units in package:

Vial, glass, 1 g, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Euticals SAS

Therapeutic indications:

For the treatment of infections caused by susceptible gram-negative microorganisms. It has been used successfully to treat: Urinary tract infections (including pyelonephritis and cystitis (initial and recurrent) and asymptomatic bacteriuria, including those due to the pathogens resistant to the aminoglycosides, cephalosporins or penicillins); lower respiratory tract infections (including pneumonia and bronchitis); bacteraemia/septicemia; bone and joint infections; skin and skin-structure infections (including those associated with postoperative wounds, ulcers and burns); intra-abdominal infections (including peritonitis); Gynaecologic infections (including pelvic inflammatory disease, endometritis, and pelvic cellulitis); gonorrhoea (acute uncomplicated urogenital or anorectal infections due to beta-lactamase producing or non-producing strains of N.gonorrhoeae). Before instituting treatment with Azactam, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to aztreonam. Treatment with Azactam may be started empirically before results of the susceptibility testing are available. Concurrent Therapy: In seriously ill patients, additional antibiotic therapy should be initiated concurrently with Azactam to provide broad-spectrum coverage before identification and susceptibility testing results of the causative organism(s) are known. Some patients with serious Pseudomonas infections may benefit from concurrent use of Azactam and an amino-glycoside because of synergistic action. These agents are also synergistic in vitro against many strains of Enterobacteriaceae, and other gram-negative aerobic baccilli. However, this enhanced activity is not predictable.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 1 g - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1986-03-13

Summary of Product characteristics

AZACTAM version number 7.0
1
DATA SHEET
1
PRODUCT NAME
AZACTAM
®
1g Powder for solution for Injection or infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g aztreonam
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZACTAM for Injection (aztreonam for Injection) is indicated for the
treatment of infections caused
by susceptible gram-negative microorganisms. It has been used
successfully to treat:
Urinary tract infections (including pyelonephritis and cystitis
(initial and recurrent) and asymptomatic
bacteriuria, including those due to the pathogens resistant to the
aminoglycosides, cephalosporins or
penicillins); lower respiratory tract infections (including pneumonia
and bronchitis);
bacteraemia/septicemia; bone and joint infections; skin and
skin-structure infections (including those
associated with postoperative wounds, ulcers and burns);
intra-abdominal infections (including
peritonitis); Gynaecologic infections (including pelvic inflammatory
disease, endometritis, and pelvic
cellulitis); gonorrhoea (acute uncomplicated urogenital or anorectal
infections due to beta-lactamase
producing or non-producing strains of N.gonorrhoeae).
Before instituting treatment with AZACTAM, appropriate specimens
should be obtained for isolation
of the causative organism(s) and for determination of susceptibility
to aztreonam. Treatment with
AZACTAM may be started empirically before results of the
susceptibility testing are available (See
CONCURRENT THERAPY
).
CONCURRENT THERAPY:
In seriously ill patients, additional antibiotic therapy should be
initiated concurrently with
AZACTAM to provide broad-spectrum coverage before identification and
susceptibility testing
results of the causative organism(s) are known.
Some patients with serious Pseudomonas infections may benefit from
concurrent use of AZACTAM
and an amino-glycoside because of synergistic action. These agents a