Attemz Special Precautions

Allergic reactions: Antibiotics, like other drugs, should be given with caution to any patients with a history of allergic reaction to structurally related compounds. If an allergic reaction occurs, discontinue the drug and institute supportive treatments as appropriate. Serious hypersensitivity reactions may require epinephrine and other emergency measures. Specific studies have not shown significant cross-reactivity between aztreonam and antibodies to penicillins or cephalosporins. The incidence of hypersensitivity to aztreonam in clinical trials has been low but caution should be exercised in patients with a history of hypersensitivity to beta-lactam antibiotics until further experience is gained.
Renal/hepatic impairment: As with some other beta-lactams there have been reports of encephalopathy with aztreonam (e.g. confusion, impairment of consciousness, epilepsy, movement disorders); particularly in patients with renal impairment and in association with beta-lactam overdose.
In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy.
Serious blood/skin disorders: Serious blood disorders (incl. pancytopenia) and skin disorders (incl. toxic epidermal necrolysis) have been reported with the use of aztreonam. In case of serious hemogram and skin changes, it is recommended to stop aztreonam.
Convulsions: Convulsions have rarely been reported during treatment with beta-lactams, including aztreonam (see Adverse Reactions).
Clostridium difficile associated diarrhoea: Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including aztreonam, and may range in severity from mild diarrhoea to fatal colitis. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Medication that inhibits intestinal peristalsis should not be given.
Concurrent therapy with other antimicrobial agents and aztreonam is recommended as initial therapy in patients who are at risk of having an infection due to pathogens that are not susceptible to aztreonam.
As with other antibiotics, in the treatment of acute pulmonary exacerbations in patients with cystic fibrosis, while clinical improvement is usually noted, lasting bacterial eradications may not be achieved.
Overgrowth of non-susceptible organisms: Therapy with aztreonam may result in overgrowth of non-susceptible organisms, including gram-positive organisms and fungi. Should superinfection occur during therapy, appropriate measures should be taken. In comparative studies, the number of patients treated for superinfections was similar to that of the control drugs used.
Prolongation of prothrombin time/increased activity of oral anticoagulants: Prolongation of prothrombin time has been reported rarely in patients receiving aztreonam. Additionally, numerous cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics, including beta-lactams. Severe infection or inflammation, and the age and general condition of the patient appear to be risk factors. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see Interactions and Adverse Reactions).
Concomitant use with aminoglycosides: If an aminoglycoside is used concurrently with aztreonam, especially if high dosages of the former are used or if therapy is prolonged, renal function should be monitored because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.
Arginine: Aztreonam for injection contains arginine. Studies in low birth weight infants have demonstrated that arginine administered in the aztreonam formulation may result in increases in serum arginine, insulin, and indirect bilirubin. The consequences of exposure to this amino acid during treatment of neonates have not been fully ascertained.
Interference with serological testing: A positive direct or indirect Coombs test may develop during treatment with aztreonam.
Effects on ability to drive and use machines: This medicine can have an important impact on the ability to drive and use of machines should encephalopathy occur (see Precautions and Overdosage).
Use in Children: Data on safety and effectiveness in neonates younger than one week are limited; use in this population needs to be carefully assessed.