aztreonam

az-TREE-oh-nam

Therapeutic Classification: anti-infectives

Pharmacologic Classification: monobactams

IM:

REMS

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 patients with cystic fibrosis (CF) with Pseudomonas aeruginosa.

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

Therapeutic effects:

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.

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)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	60 min	6–8 hr
IV	rapid	end of infusion	6–8 hr
Inhaln	rapid	unknown	Several hr

Contraindicated in:

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

Use Cautiously in:

Severe renal impairment;
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), altered taste, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), 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.

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.

Renal Impairment

IV (Adults ): CCr 10–30 mL/min: 1–2 g initially; then 50% of usual dosage at usual interval; CCr <10 mL/min: 500 mg–2 g initially; then 25% of usual dosage at usual interval (⅛ of initial dose should also be given after each hemodialysis session).

(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% NaCl)

Assess infection at baseline and monitor for effectiveness of aztreonam throughout therapy.
Assess history of previous use and reaction to penicillins and cephalosporins prior to initiating therapy. Aztreonam can often still be used in patients allergic to these drugs.
Assess respiratory status prior to and following inhalation therapy.
Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Notify the health care professional immediately if these occur.
Monitor for diarrhea, abdominal cramping, fever, and bloody stools during and up to 8 wk after cessation of therapy. If CDAD suspected or confirmed, discontinue antibiotics not directed at Clostridium difficile and treat as clinically indicated.

Lab Test Considerations:

Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
May ↑ in AST, ALT, alkaline phosphatase, LDH, and serum creatinine. May ↑ prothrombin and partial thromboplastin times, and positive Coombs test.

After adding diluent to vial, shake immediately and vigorously. Solution is colorless to light straw yellow to slightly pink. Do not administer if discolored, cloudy, or contains particulates. Not for multidose use; discard unused solution. IV route is recommended if single dose >1 g or for severe or life-threatening infection.
IM: Reconstitution: Add at least 3 mL 0.9% NaCl or sterile or bacteriostatic water for injection to each gram of aztreonam. Stable at room temperature for 48 hr or 7 days if refrigerated.
- Administer into large, well-developed muscle.
Inhaln: Reconstitution: Open glass vial; remove metal ring, pull tab, and remove gray stopper. Twist tip of included diluent ampule and squeeze contents into glass vial. Replace stopper and swirl gently until contents are completely dissolved. Administer immediately after reconstitution using Altera Nebulizer System. Pour reconstituted solution into handset of nebulizer. Turn unit on. Place mouthpiece into mouth and breathe normally only through mouth. Administration takes 2–3 min. Do not use other nebulizers or mix with other medications. Refrigerate aztreonam and diluent; may be stored at room temperature for up to 28 days. Protect from light.
- Administer short-acting bronchodilator between 15 min and 4 hr or long-acting bronchodilator between 30 min and 12 hr prior to treatment. If taking multiple inhaled therapies, administer in the following order: bronchodilator, mucolytic, and lastly aztreonam.

IV Administration:

IV Push: Reconstitution: Add 6–10 mL of sterile water for injection into each vial.
Rate: Administer slowly over 3–5 min by direct injection or into tubing of a compatible solution.
Intermittent Infusion: Reconstitution: Add 3 mL of sterile water for injection into each vial.Diluent: Dilute further with 0.9% NaCl, Ringer’s or LR, D5W, D10W, D5/0.9% NaCl, D5/0.45% NaCl, D5/0.2% NaCl, D5/LR, or sodium lactate.Concentration: Do not exceed 50 mg/mL. Solution is stable for 48 hr at room temperature and 7 days refrigerated.
Rate: Infuse over 20–60 min.
Y-Site Compatibility:
- alemtuzumab
- allopurinol
- amikacin
- aminocaproic acid
- aminophylline
- anidulafungin
- argatroban
- arsenic trioxide
- ascorbic acid
- atracurium
- atropine
- benztropine
- bivalirudin
- bleomycin
- bumetanide
- buprenorphine
- butorphanol
- calcium chloride
- calcium gluconate
- cangrelor
- carboplatin
- carmustine
- caspofungin
- cefazolin
- cefepime
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftolozane/tazobactam
- ceftriaxone
- cefuroxime
- ciprofloxacin
- cisatracurium
- cisplatin
- clindamycin
- cyanocobalamin
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- daptomycin
- dexamethasone
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- dobutamine
- docetaxel
- dopamine
- doxorubicin hydrochloride
- doxorubicin liposomal
- doxycycline
- droperidol
- enalaprilat
- ephedrine
- epinephrine
- epirubicin
- epoetin alfa
- eptifibatide
- eravacycline
- ertapenem
- esmolol
- etoposide
- etoposide phosphate
- famotidine
- fentanyl
- filgrastim
- floxuridine
- fluconazole
- fludarabine
- fluorouracil
- folic acid
- foscarnet
- fosphenytoin
- furosemide
- gemcitabine
- gentamicin
- glycopyrrolate
- granisetron
- heparin
- hetastarch
- hydrocortisone
- hydromorphone
- idarubicin
- ifosfamide
- insulin, regular
- irinotecan
- isavuconazonium
- isoproterenol
- ketorolac
- labetalol
- leucovorin calcium
- levofloxacin
- lidocaine
- linezolid
- magnesium sulfate
- mannitol
- melphalan
- meperidine
- meropenem
- meropenem/vaborbactam
- mesna
- methadone
- methotrexate
- methylprednisolone
- metoclopramide
- metoprolol
- midazolam
- milrinone
- morphine
- multivitamin
- nafcillin
- nalbuphine
- naloxone
- nicardipine
- nitroglycerin
- nitroprusside
- norepinephrine
- octreotide
- ondansetron
- oxacillin
- oxaliplatin
- oxytocin
- paclitaxel
- palonosetron
- pamidronate
- pemetrexed
- penicillin G
- phenobarbital
- phentolamine
- phenylephrine
- phytonadione
- piperacillin/tazobactam
- plazomicin
- plicamycin
- potassium acetate
- potassium chloride
- procainamide
- propofol
- propranolol
- protamine
- pyridoxine
- remifentanil
- rituximab
- rocuronium
- sargramostim
- sodium acetate
- sodium bicarbonate
- succinylcholine
- sufentanil
- sulbactam/durlobactam
- tacrolimus
- tedizolid
- theophylline
- thiamine
- thiotepa
- tigecycline
- tirofiban
- tobramycin
- topotecan
- vasopressin
- vecuronium
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- zidovudine
- zoledronic acid
Y-Site Incompatibility:
- acyclovir
- amphotericin B deoxycholate
- amphotericin B liposomal
- azathioprine
- azithromycin
- chlorpromazine
- dantrolene
- daunorubicin
- diazepam
- diazoxide
- erythromycin
- ganciclovir
- gemtuzumab ozogamicin
- indomethacin
- letermovir
- lorazepam
- metronidazole
- mitomycin
- mitoxantrone
- mycophenolate
- oritavancin
- pantoprazole
- papaverine
- pentamidine
- pentobarbital
- phenytoin
- prochlorperazine
- trastuzumab

Advise patient to report 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 self-treat diarrhea.
Advise patient to notify health care professional of new or worsening symptoms of infection or if anaphylaxis occurs.
Rep: Advise women 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 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 three daily doses, as long as doses are ≥4 hr apart. Skipping doses or not completing full course of therapy may ↓ effectiveness and ↑ likelihood of bacterial resistance. 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.

Resolution of signs and symptoms of infection.
Improvement in respiratory symptoms in patients with CF.

Azactam, Cayston

NDC Code

0003- E.R. Squibb & 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 & 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

0409- Hospira, Inc.
- 0409-0829- Aztreonam
  - 0409-0829-01- 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0829-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0829-11)

0409- Hospira, Inc.
- 0409-0830- Aztreonam
  - 0409-0830-01- 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0830-11)

13538- Curia Italy S.r.l.
- 13538-001-
  - 13538-001-01- 200 kg in 1 DRUM (13538-001-01)

13538- Curia Italy S.r.l.
- 13538-008-
  - 13538-008-01- 200 kg in 1 DRUM (13538-008-01)

13538- Curia Italy S.r.l.
- 13538-009-
  - 13538-009-01- 200 kg in 1 DRUM (13538-009-01)

24525- Gilead Sciences, Inc.
- 24525-0025-
  24525-0025-1- 8 kg in 1 BAG (24525-0025-1)

24525- Gilead Sciences, Inc.
- 24525-0025-
  24525-0025-2- 6 kg in 1 BAG (24525-0025-2)

24525- Gilead Sciences, Inc.
- 24525-0025-
  24525-0025-3- 3.6 kg in 1 BAG (24525-0025-3)

50090- A-S Medication Solutions
- 50090-7494- AZACTAM
  50090-7494-0- 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-7494-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

52952- Guangan Kingday Pharma & Chem Co., Ltd.
- 52952-001-
  - 52952-001-00- 1 kg in 1 DRUM (52952-001-00)

54087- Hospira Australia Pty Ltd
- 54087-160-
  54087-160-12- 5 TRAY in 1 BOX (54087-160-12) / 200 VIAL in 1 TRAY (54087-160-11) / 1 POWDER, FOR SOLUTION in 1 VIAL (54087-160-10)

61126- Latina Pharma S.p.A.
- 61126-710-
  61126-710-01- 1 BAG in 1 DRUM (61126-710-01) / 1 BAG in 1 BAG (61126-710-02) / 1 kg in 1 BAG

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
  - 63323-401-20- 10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)

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 (63323-401-41)

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 (63323-401-21)

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 (63323-402-01)

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 (63323-402-41)

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 (63323-402-03)

73301- LSNE, Inc.
- 73301-008-
  - 73301-008-01- 2 mL in 1 VIAL (73301-008-01)

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