4.1 Therapeutic indications
The treatment of the following infections caused by susceptible aerobic Gram-negative micro-organisms:
Urinary tract infections: including pyelonephritis and cystitis (initial and recurrent) and asymptomatic bacteriuria, including those due to pathogens resistant to the aminoglycosides, cephalosporins or penicillins.
Gonorrhoea: acute uncomplicated urogenital or anorectal infections due to beta-lactamase producing or non-producing strains of N. gonorrhoeae.
Lower respiratory tract infections: including pneumonia, bronchitis and lung infections in patients with cystic fibrosis.
Meningitis caused by Haemophilus influenzae or Neisseria meningitidis. Since Azactam provides only Gram negative cover, it should not be given alone as initial blind therapy, but may be used with an antibiotic active against Gram positive organisms until the results of sensitivity tests are known.
Bone and joint infections.
Skin and soft tissue infections: including those associated with postoperative wounds, ulcers and burns.
Intra-abdominal infections: peritonitis.
Gynaecological infections: pelvic inflammatory disease, endometritis and pelvic cellulitis.
Azactam is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces.
Bacteriological studies to determine the causative organism(s) and their sensitivity to aztreonam should be performed. Therapy may be instituted prior to receiving the results of sensitivity tests.
In patients at risk of infections due to non-susceptible pathogens, 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. Based on these results, appropriate antibiotic therapy should be continued.
Patients with serious Pseudomonas infections may benefit from concurrent use of Azactam and an aminoglycoside because of their synergistic action. If such concurrent therapy is considered in these patients, susceptibility tests should be performed in vitro to determine the activity in combination. The usual monitoring of serum levels and renal function during aminoglycoside therapy applies.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).