Medicinal Products

AZACTAM 1 g

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Aztreonam
laboratory: Sanofi Synthelabo France

Powder for parenteral use
Box of 1 bottle of 1 g
All forms

Indication

Reserved for adults.
They arise from the antibacterial activity and pharmacokinetic characteristics of aztreonam. They take into account both the clinical studies that gave rise to this drug and its place in the range of antibacterial products currently available.
They are limited in adults:
- infections of the upper and lower urinary tract, complicated or not; acute prostatitis; gonococcal urethritis,
- severe infections with gram - sensitive bacteria (excluding meningitis): bronchopulmonary infections; septicemia; infections of the skin and soft tissues; intra-abdominal infections; gyneco-obstetric infections.
During the course, on the one hand, abdominal and gynecological-obstetric infections often with mixed flora, on the other hand, in the first-line treatments, in particular in bronchopulmonary infections and infections of the skin and soft tissues. aztreonam, because of its narrow spectrum, should be associated with another antibiotic.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
SPECTRUM OF BACTERIAL ACTIVITY:
- sensitive species:
. Gram-negative aerobes: Branhamella catarrhalis; Citrobacter freundii ; Citrobacter koseri ; Enterobacter ; Escherichia coli; Haemophilus influenzae; Klebsiella ; Morganella morganii; Neisseria; Proteus mirabilis; Proteus vulgaris; Providencia; Pseudomonas aeruginosa ; Salmonella; Serratia; Shigella; Yersinia .

Posology AZACTAM 1 g Powder for parenteral use Box of 1 vial of 1 g

AZACTAM is administered intramuscularly or intravenously. The choice of dosage and route of administration depends on the susceptibility of the causative organisms, the location and the severity of the infection.
- The intramuscular route is most particularly indicated:
. in acute cystitis or uncomplicated gonococcal infections at a single dose of 1 g;
. in high and / or complicated urinary tract infections, at the dosage of 1 g twice daily.
- For severe infections, AZACTAM will most often be used direct or short infusion at the usual dosage of 2 to 3 g per day (1 g every 12 to 8 hours).
- In severe infections, pseudomonas infections or germs of intermediate sensitivity, this dosage may be increased to 6 or 8 g maximum per 24 hours in 3 or 4 injections.
- In cases of multiple germs infections, the combination with an active antibiotic on Gram + and / or anaerobes is possible and desirable.
- Elderly: Elderly patients who normally have a creatinine clearance greater than 30 ml / min will therefore receive the normally recommended dose. If renal function is more impaired, the dosing regimen will be adjusted (see renal impairment).
- Renal failure: since aztreonam is eliminated mainly by the kidney, it is recommended to administer a normal initial dose and the following doses:
. Creatinine clearance greater than or equal to 30 ml / min: normal dose
. creatinine clearance between 10 and 30 ml / min: 1/2 dose
. creatinine clearance less than 10 ml / min: 1/4 dose
. hemodialysis patients: 1/8 dose after hemodialysis
In patients who, like hemodialysis, have a creatinine clearance corresponding to severe renal impairment (<10 ml / min), a loading dose of 1 or 2 g will be given initially. Maintenance doses will be one quarter of the initial dose, administered at fixed intervals of 6, 8 or 12 hours. For serious infections, one-eighth of the initial dose will be added after each hemodialysis.
Reconstitution: AZACTAM is administered intramuscularly or intravenously.
- Intramuscular route : AZACTAM will be dissolved in water for injection, no local anesthetic agent being necessary: ​​3 ml for 1 g.
For a good reconstitution, the solution must be shaken vigorously.
- Intravenous way :
. Direct intravenous injection: 1 g of aztreonam will be dissolved in 10 ml of water for injection. The solution will be injected slowly in 3 to 5 minutes.
. Infusion 20 to 60 minutes: After dissolution in 3 ml of water for injection, the solution will be diluted in the infusion solution chosen to obtain a dilution of 50 ml to 100 ml per gram of aztreonam.
. The injection can be administered into the infusion tubing provided that it stops the administration of any other drug (slow injection in 3 to 5 minutes).
Compatibilities: AZACTAM can be diluted in most infusion solutions, especially: sodium chloride 4.5 and 9 per thousand; glucose 5% and 10%; 5% and 10% mannitol solution.
AZACTAM should not be mixed with other medicines or antibiotics.
Major physicochemical incompatibilities: see incompatibilities.

Against indications

Allergy to aztreonam.

Azactam side effects

- Cutaneous manifestations of allergic origin.
- Digestive manifestations: nausea, vomiting, diarrhea.
- Transient hematologic manifestations: essentially eosinophilia.
- Hepatic manifestations: transient elevation of SGOT and SGPT, alkaline phosphatase.
- Local reaction at the injection site.

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