• IM, IV: Treatment of serious gram-negative infections including:
  • Septicemia,
  • Skin and skin structure infections,
  • Intra-abdominal infections,
  • Gynecologic infections,
  • Respiratory tract infections,
  • Urinary tract infections.
• Useful for treatment of multiresistant strains of some bacteria including aerobic gram-negative pathogens.
• Inhaln: To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

Contraindicated in:

• Hypersensitivity
• Lactation: Lactation (IV/IM formulation).

Use Cautiously in:

• Renal impairment (dosage ↓ required if CCr 30 mL/min or less)
• Cross-sensitivity with penicillins or cephalosporins may occur rarely. Has been used safely in patients with a history of penicillin or cephalosporin allergy
• Patients with FEV₁ <25% or >75% predicted, or patients colonized with Burkholderia cepacia (safety and effectiveness not established)
• OB: Safety of IV/IM formulation not established in pregnancy. Systemic absorption of oral inhalation expected to be minimal
• Lactation: Systemic absorption of oral inhalation expected to be minimal
• Pedi: Children <7 yr (oral inhalation) (safety and effectiveness not established)
• Geri: Consider age-related ↓ in renal function in older adults.

CV: chest discomfort (oral inhalation).

Derm: rash.

EENT: nasal congestion (oral inhalation), nasopharyngeal pain (oral inhalation).

GI: abdominal pain (oral inhalation), CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), altered taste, diarrhea, nausea, vomiting.

Local: pain at IM site, phlebitis at IV site.

Neuro: SEIZURES.

Resp: cough (oral inhalation), wheezing (oral inhalation), bronchospasm (oral inhalation).

Misc: fever (inhalation), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , superinfection.

Drug-Drug:

• Levels may be ↑ by furosemide or probenecid.

(Generic available)

• Powder for injection: 1 g/vial; 2 g/vial;
• Lyophilized powder for use with diluent provided in Altera Nebulizer System only (Cayston): 75 mg/vial with 1 mL ampule of diluent (0.17% sodium chloride);

• IM, IV (Adults): Moderately severe infections: 1–2 g every 8–12 hr; severe or life-threatening infections (including those due to Pseudomonas aeruginosa): 2 g every 6–8 hr; urinary tract infections: 0.5–1 g every 8–12 hr.
• IV (Children 1 mo–16 yr): Mild to moderate infections: 30 mg/kg every 8 hr; moderate to severe infections: 30 mg/kg every 6–8 hr; cystic fibrosis: 50 mg/kg every 6–8 hr.
• IV (Neonates >2 kg): 30 mg/kg every 6–8 hr.
• IV (Neonates ≤2 kg): 30 mg/kg every 8–12 hr.
• Inhaln (Adults and Children >7 yr): 75 mg three times daily for 28 days.

Azactam, Cayston

• Binds to the bacterial cell wall membrane, causing cell death.

• Bactericidal action against susceptible bacteria.

Spectrum:

• Displays significant activity against gram-negative aerobic organisms only:
  • Escherichia coli,
  • Serratia,
  • Klebsiella oxytoca or pneumoniae,
  • Citrobacter,
  • Proteus mirabilis,
  • Pseudomonas aeruginosa,
  • Enterobacter,
  • Haemophilus influenzae.
• Not active against:
  • Staphylococcus aureus,
  • Enterococcus,
  • Bacteroides fragilis,
  • Streptococci.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: monobactams

Absorption: Well absorbed following IM administration. IV administration results in complete bioavailability. Low absorption follows administration by oral inhalation.

Distribution: Widely distributed to tissues. High concentrations achieved in sputum with inhalation.

Metabolism/Excretion: 60–70% excreted unchanged by the kidneys. 10% of inhaled dose excreted unchanged in urine. Small amounts metabolized by the liver.

Half-life: Adults— 1.5–2 hr; Children: 1.7 hr; Neonates: 2.4–9 hr (↑ in renal impairment).

(plasma concentrations)

• Advise patient to report the signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
• Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
• Advise patient to notify health care professional if new or worsening symptoms occur or if signs or symptoms of anaphylaxis occur.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Patients receiving IV aztreonam should consider temporarily discontinuing breastfeeding or using formula during therapy.
• Inhaln: Instruct patient to use aztreonam as directed for the full 28-day course, even if feeling better. If a dose is missed, take all 3 daily doses, as long as doses are at least 4 hr apart. Skipping doses or not completing full course of therapy may decrease effectiveness and increase likelihood of bacterial resistance not treatable in the future. Inform patient of the importance of using a bronchodilator prior to treatment and in use and cleaning of nebulizer. Advise patient to read Patient Information before starting therapy.

az-TREE-oh-nam

NDC Code^*

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-2560- AZACTAM
    • 0003-2560-16- 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-2570- AZACTAM
    • 0003-2570-16- 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• 61958- Gilead Sciences, Inc.
  • 61958-0901- Cayston
    • 61958-0901-1- 2 CARTON in 1 PACKAGE (61958-0901-1) > 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE

• 63323- Fresenius Kabi USA, LLC
  • 63323-401- Aztreonam
    • 63323-401-26- 10 VIAL in 1 TRAY (63323-401-26) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-401- Aztreonam
    • 63323-401-24- 10 VIAL in 1 TRAY (63323-401-24) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-401- Aztreonam
    • 63323-401-20- 10 VIAL in 1 TRAY (63323-401-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-402- Aztreonam
    • 63323-402-30- 10 VIAL in 1 TRAY (63323-402-30) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-402- Aztreonam
    • 63323-402-24- 10 VIAL in 1 TRAY (63323-402-24) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• 63323- Fresenius Kabi USA, LLC
  • 63323-402- Aztreonam
    • 63323-402-20- 10 VIAL in 1 TRAY (63323-402-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL