AZACTAM (aztreonam)

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction

Drug Names

Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

VIVOTIF

Drug contraindication overview.

*Known hypersensitivity to aztreonam or any component of the formulation.

Adverse reaction overview.

Adverse effects reported with IV or IM aztreonam are similar to those reported with other beta-lactam antibiotics, and the drug generally is well tolerated. Adverse effects have been reported in 7% or less of patients receiving parenteral aztreonam and have required discontinuance in about 2% of patients.

The manufacturers state that use of IV aztreonam in children 9 months of age or older is supported by evidence from adequate and well-controlled studies in adults and additional efficacy, safety, and pharmacokinetic data from noncomparative clinical studies in pediatric patients. However, data are insufficient to date to determine safety and efficacy of IV aztreonam in pediatric patients 9 months of age or older for the treatment of septicemia or skin and skin structure infections (when skin infection suspected or known to be caused by Haemophilus influenzae type b). In addition, the manufacturers state that data are insufficient to date to evaluate IM administration of aztreonam in pediatric patients or use of the drug in pediatric patients with impaired renal function.

In clinical studies evaluating parenteral aztreonam in pediatric patients, discontinuance of the drug because of adverse effects was required in less than 1% of patients. Rash, diarrhea, and fever have been reported in 1-4.3% of pediatric patients.

In pediatric patients receiving IV aztreonam, pain was reported in 12% and erythema, induration, or phlebitis were reported in 0.9-2.9% of patients overall; in US patients, pain occurred in 1.5%

and other local reactions occurred in about 0.5%. Eosinophilia, neutropenia, or increased platelet count has been reported in 6.3,

3.2, or 3.6% of pediatric patients, respectively, and increased serum AST, ALT, or serum creatinine has been reported in 3.8-6.5%.

In US pediatric studies, neutropenia (absolute neutrophil count less than 1000/mm3) occurred in 11.3% of patients younger than 2 years of age receiving aztreonam in a dosage of 30 mg/kg every 6 hours and increased serum AST and ALT (greater than 3 times the upper limit of normal) occurred in 15-20% of patients 2 years of age or older receiving a dosage of 50 mg/kg every 6 hours. It is unclear whether the increased frequency of these adverse effects was related to increased severity of illness in the patients or aztreonam dosage administered.

Aztreonam has been used IM or IV in a limited number of neonates and infants as young as 1 month of age+ without unusual adverse effects. Safety and efficacy of aztreonam administered by oral inhalation via nebulization have not been established in pediatric patients younger than 7 years of age. The drug has been used by oral inhalation via nebulization for the treatment of newly acquired Ps.

aeruginosa respiratory tract infections in a limited number of cystic fibrosis patients 3 months through 6 years of age+ without unusual adverse effects. In clinical trials evaluating aztreonam inhalation therapy in cystic fibrosis patients 7 years of age or older, pyrexia was reported more frequently in pediatric patients than in adults.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None