Azactam


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aztreonam, aztreonam lysine

Azactam, Cayston

Pharmacologic class: Monobactam

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Inhibits bacterial cell-wall synthesis during active multiplication by binding with penicillin-binding protein 3, resulting in cell-wall destruction

Availability

Inhalation solution: 75-mg single-use vial

Powder for injection: 500-mg vial, 1-g vial, 2-g vial, 1 g/50-ml I.V. bag, 2 g/50-ml I.V. bag

Indications and dosages

Cystic fibrosis in patients with Pseudomonas aeruginosa

Adults and children age 7 and older: 75 mg t.i.d. at least 4 hours apart for 28-day course, followed by 28 days off

Infections caused by susceptible gram-negative organisms

Adults: For urinary tract infections, 500 mg or 1 g I.M. or I.V. q 8 or 12 hours; for moderately severe systemic infections, 1 or 2 g I.M. or I.V. q 8 or 12 hours; for severe or life-threatening infections, 2 g I.M. or I.V. q 6 or 8 hours. Maximum dosage is 8 g/day.

Children: For mild to moderate infections, 30 mg/kg I.M. or I.V. q 8 hours; for moderate to severe infections, 30 mg/kg I.M. or I.V. q 6 or 8 hours. Maximum dosage is 120 mg/kg/day.

Dosage adjustment

• Severe renal failure

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• renal or hepatic impairment
• elderly patients
• pregnant or breastfeeding patients.

Administration

• Flush I.V. tubing with compatible solution before and after giving drug.
• Compatible solutions include 0.9% sodium chloride injection, 5% or 10% dextrose injection, Ringer's or lactated Ringer's injection, 5% dextrose and 0.9% sodium chloride injection, and 5% dextrose and 0.45% sodium chloride injection.
• After adding diluent to vial or infusion bottle, shake immediately and vigorously.
• For I.V. bolus injection, reconstitute powder for injection by adding 6 to 10 ml of sterile water for injection. Inject prescribed dosage into tubing of compatible I.V. solution slowly over 3 to 5 minutes.
• For intermittent I.V. infusion, reconstitute powder for injection by adding compatible I.V. solution to yield a concentration not exceeding 20 mg/ml. Administer prescribed dosage over 20 to 60 minutes.

Thaw commercially available frozen drug at room temperature and give by intermittent I.V. infusion only.
• For I.M. injection, reconstitute powder for injection by adding 3 ml of sterile water for injection or 0.9% sodium chloride injection.
• Give I.M. injection deep into large muscle mass.
• Reconstitute inhalation solution with 1 ml sterile diluent supplied and administer only with nebulizer supplied. Don't reconstitute until ready to administer.
• Know that patient should use a bronchodilator as prescribed before using inhalation solution.

Adverse reactions

CNS: dizziness, confusion, seizures

CV: phlebitis, thrombophlebitis

EENT: diplopia, tinnitus

GI: nausea, vomiting, diarrhea (including diarrhea associated with Clostridium difficile), pseudomembranous colitis

Hematologic: neutropenia, pancytopenia

Hepatic: hepatitis

Respiratory: bronchospasm

Skin: rash, toxic epidermal necrolysis

Other: altered taste, angioedema, anaphylaxis

Interactions

Drug-drug.Aminoglycosides: increased risk of nephrotoxicity and ototoxicity

Beta-lactamase-inducing antibiotics (such as cefoxitin, imipenem): antagonism with aztreonam

Furosemide, probenecid: increased aztreonam levels

Drug-diagnostic tests.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, eosinophils, platelets, prothrombin time (PT), partial thromboplastin time (PTT): increased values

Coombs' test: positive result

Neutrophils: decreased count

Patient monitoring

Assess patient closely for signs and symptoms of pseudomembranous colitis.

Monitor patient carefully for hypersensitivity reaction, especially if he's allergic to penicillin, carbapenems, or cephalosporins.
• Monitor CBC with differential, AST, ALT, PT, PTT, and serum creatinine values.
• Monitor renal and hepatic function.

Patient teaching

• Show patient how to reconstitute inhalation solution using diluent supplied and tell patient not to reconstitute until ready to use. Advise patient to use only the nebulizer supplied and to use a bronchodilator as prescribed before using inhalation solution.

Instruct patient to immediately report severe diarrhea or signs or symptoms of hypersensitivity reaction, such as rash or difficulty breathing.
• Tell female patient to notify prescriber if she is pregnant or breastfeeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

aztreonam

(az-tree-oh-nam) ,

Azactam

(trade name),

Cayston

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: monobactams
Pregnancy Category: B

Indications

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 multi-resistant strains of some bacteria including aerobic gram-negative pathogens. Inhalation: To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

Action

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

Therapeutic effects

Bactericidal action against susceptible bacteria.
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.

Pharmacokinetics

Absorption: Well absorbed following IM administration. Low absorption follows administration by inhalation.
Distribution: Widely distributed. Crosses the placenta and enters breast milk in low concentrations. High concentrations achieved in sputum with inhalation.
Protein Binding: 56%
Metabolism and 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).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IMrapid60 min6–8 hr
IVrapidend of infusion6–8 hr
InhalnrapidunknownSeveral hours

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
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); Obstetric / Lactation: Safety not established; Pediatric: Children <7 yr (inhalation) (safety and effectiveness not established); Geriatric: Consider age-related ↓ in renal function.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)

Ear, Eye, Nose, Throat

  • nasal congestion (inhalation) (most frequent)
  • nasopharyngeal pain (inhalation) (most frequent)

Cardiovascular

  • chest discomfort (inhalation)

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • abdominal pain (inhalation) (most frequent)
  • altered taste
  • diarrhea
  • nausea
  • vomiting

Respiratory

  • cough (inhalation) (most frequent)
  • wheezing (inhalation) (most frequent)
  • bronchospasm (inhalation)

Dermatologic

  • rash

Local

  • pain at IM site
  • phlebitis at IV site

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • fever (inhalation) (most frequent)
  • superinfection

Interactions

Drug-Drug interaction

Serum levels may be ↑ by furosemide or probenecid.

Route/Dosage

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

Renal Impairment

Intravenous (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 (1/8 of initial dose should also be given after each hemodialysis session).

Availability (generic available)

Injection: 500 mg/vial, 1 g/vial, 2 g vial
Premixed containers: 1 g/50 mL, 2 g/50 mL
Lyphilized 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)

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; wound appearance, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
  • Obtain a history before initiating therapy to determine previous use of and reactions to penicillins and cephalosporins. Patients allergic to these drugs may exhibit hypersensitivity reactions to aztreonam. However, aztreonam can often be used in these patients.
  • Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
  • 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 bowel function. Report diarrhea, abdominal cramping, fever, and bloody stools to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Lab Test Considerations: May cause ↑ in AST, ALT, alkaline phosphatase, LDH, and serum creatinine. May cause ↑ prothrombin and partial thromboplastin times, and positive Coombs’ test.

Potential Nursing Diagnoses

Risk for infection (Indications)
Ineffective airway clearance (Indications)

Implementation

  • After adding diluent to vial, shake immediately and vigorously. Not for multidose use; discard unused solution. IV route is recommended if single dose > 1 g or for severe or life-threatening infection.
  • Intramuscular: Use 15-mL vial and dilute each gram of aztreonam with at least 3 mL of 0.9% NaCl, or sterile or bacteriostatic water for injection. Stable at room temperature for 48 hr or 7 days if refrigerated.
    • Administer into large, well-developed muscle.
  • Intravenous Administration
  • Reconstitute 15 mL vial with 6–10 mL of sterile water for injection.
  • Rate: Administer slowly over 3–5 min by direct injection or into tubing of a compatible solution.
  • Intermittent Infusion: Reconstitute 15 mL vial with at 3 mL of Sterile Water for Injection. 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 if refrigerated. Solutions range from colorless to light, straw yellow or may develop a pink tint upon standing; this does not affect potency.
  • Rate: Infuse over 20–60 min.
  • Y-Site Compatibility: alemtuzumab, alfentanil, allopurinol, amifostine, amikacin, aminophylline, amphotericin B lipid complex, anadulafungin, argatroban, ascorbic acid, atracurium, atropine, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, daptomycin, dexamethasone sodium phosphate, dexmedetomidine, digoxin, diltiazem, dobutamine, docetaxel, dopamine, doxacurium, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, eptifibatide, ertapenem, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, floxuridine, fluconazole, fludarabine, fluorouracil, folic acid, foscarnet, furosemide, gemcitabine, gentamicin, glycopyrrolate, granisetron, heparin, hetastarch, hydrocortisone, hydromorphone, idarubicin, ifosfamide, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, mesna, metaraminol, methotrexate, methoxamine, methyldopate, methylprednisolone sodium succinate, metoclopramide, metoprolol, midazolam, milrinone, morphine, multivitamins, nafcillin, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxacillin, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pemetrexed, penicillin G, phenobarbital, phentolamine, phenylephrine, phytonadione, piperacillin/tazobactam, potassium acetate, potassium chloride, procainamide, propofol, propranolol, protamine, pyridoxime, ranitidine, remifentanil, rituximab, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, streptokinase, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiamine, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, tolazoline, trimetaphan, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: acyclovir, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B liposome, amsacrine, azathioprine, azithromycin, chlorpromazine, dantrolene, daunorubicin hydrochloride, diazepam, diazoxide, erythromycin, ganciclovir, indomethacin, lorazepam, metronidazole, mitomycin, mitoxantrone, mycophenolate, pantoprazole, papaverine, pentamidine, pentazocine, pentobarbital, phenytoin, prochlorperazine, streptozocin, trastuzumab
  • Inhalation: Open glass aztreonam vial by removing metal ring and pulling tab, and removing gray rubber stopper. Twist tip of diluent ampule and squeeze contents into glass aztreonam vial. Replace rubber 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. Do not administer IV or IM. Refrigerate azotreonam 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.

Patient/Family Teaching

  • 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 or signs of anaphylaxis occur.
  • Inhalation: 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 hrs 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 or nebulizer.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
  • Improvement in respiratory symptoms in patients with cystic fibrosis.

Azactam

(ə-zăk′təm)
A trademark for the drug aztreonam.

Azactam

A brand name for AZTREONAM.
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1 million for the full-year 2009, as an 18% increase in revenue from Tysabri was partially offset by the expected lower revenue from Maxipime, Azactam and Prialt.
Elan ceased distributing Azactam as of March 31, 2010 and will not earn any future revenues from this product.
These increases were primarily driven by increased revenue from Tysabri, offset by the expected lower revenues from Azactam and Prialt.
The increase in revenues from the BioNeurology business was driven by Tysabri, which more than offset the expected reduced revenues from Azactam and Prialt.
6 million operating loss before other net charges recorded by the BioNeurology business in the second quarter of 2009, and reflects the continued growth in Tysabri revenues offsetting the expected reduced revenues from Azactam and Prialt, in addition to an 18% reduction in combined SG&A and R&D expenses.
For the full-year 2009, revenue from Azactam decreased 16% to $81.
Elan will cease distributing Azactam as of March 31, 2010.
The increase was primarily driven by strong growth in Tysabri sales, which more than compensated for reduced sales of Azactam and Maxipime.
The decreases for both of the comparative periods principally reflect reduced sales and marketing costs and amortization expense related to Maxipime and Azactam.
2 million relating to the Maxipime and Azactam intangible assets, arising from the approval of a first generic cefepime hydrochloride in June 2007 and an anticipated approval for a generic form of Azactam.
3 million in the same period of 2007, principally reflecting reduced sales and marketing costs and amortization expense relating to Maxipime and Azactam, and the operating leverage associated with Tysabri, and can be analyzed as follows:
6 million in the same period of 2007, principally reflecting reduced amortization costs associated with Maxipime and Azactam and can be analyzed as follows: