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Aztreonam

Pronunciation

Pronunciation: az-TREE-oh-nam
Class: Monobactam

Trade Names

Azactam
- Injection (lyophilized cake) 500 mg (with approximately 780 mg of L-arginine per gram aztreonam)
- Injection (lyophilized cake) 1 g (with approximately 780 mg of L-arginine per gram aztreonam)
- Injection (lyophilized cake) 2 g (with approximately 780 mg of L-arginine per gram aztreonam)

Cayston
- Powder for inhalation (lyophilized) 75 mg

Pharmacology

Inhibits bacterial cell wall synthesis.

Slideshow: Flashback: FDA Drug Approvals 2013

Pharmacokinetics

Absorption

IV

C max is 54 mcg/mL (500 mg dose), 90 mcg/mL (1 g dose), and 204 mcg/mL (2 g dose) immediately after administration.

IM

T max is approximately 1 h; produces serum concentrations comparable with IV doses.

Inhalation

C max is 0.59 mcg/mL; T max is approximately 1 h.

Distribution

Vd is approximately 12.6 L; approximately 56% protein bound. Widely distributed to fluids and tissues, including CSF (inflamed meninges) and breast milk; crosses placenta.

Elimination

The half-life is approximately 1.7 h (2.1 h for inhalation); serum Cl is 91 mL/min; renal Cl is 56 mL/min; 60% to 70% is recovered in the urine within 8 h; approximately 12% recovered in the feces.

Special Populations

Renal Function Impairment

Serum half-life may be prolonged.

Hepatic Function Impairment

Serum half-life may be prolonged.

Elderly

Serum half-life may be prolonged.

Indications and Usage

Injection

Treatment of infections of urinary tract, lower respiratory tract, and skin and skin structure; intra-abdominal infections; gynecologic infections; surgical infections; and septicemia caused by susceptible microorganisms.

Inhalation

To improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa .

Unlabeled Uses

Treatment of acute, uncomplicated gonorrhea in patients with penicillin-resistant gonococci.

Contraindications

Known allergy to aztreonam.

Dosage and Administration

UTI
Adults

IM / IV 500 mg or 1 g every 8 to 12 h.

Systemic Infections
Adults

IM / IV 1 to 2 g every 6 to 12 h.

Children

IM / IV 30 to 50 mg/kg every 4 to 8 h.

Acute Uncomplicated Gonorrhea

IM 1 g. Max recommended dosage is 8 g/day.

Cystic fibrosis
Adults and Children 7 yr of age and older

Inhalation 75 mg 3 times daily (at least 4 h apart) for 28 days.

General Advice

  • Inhalation
  • For inhalation use only using the Altera Nebulizer System. Do not administer with any other nebulizer.
  • Use a bronchodilator before administration. Short-acting bronchodilators can be taken between 15 min and 4 h prior to each dose of aztreonam. Long-acting bronchodilators can be taken between 30 min and 12 h prior to administration of aztreonam. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and, lastly, aztreonam.
  • Refer to the manufacturer's prescribing information for preparation and administration instructions.
  • Do not mix with any other drugs in the Altera Nebulizer Handset.

Storage/Stability

Injection

Shake reconstituted solutions vigorously immediately after mixing. Reconstituted solutions not exceeding 2% are stable at room temperature for 48 h; stable under refrigeration for 7 days. Discard unused solutions. See the prescribing information for further storage and incompatibility information. Frozen infusion solutions may be stored for up to 3 mo at −4°F.

Inhalation

Store at 36° to 46°F; may be stored up to 77°F for up to 28 days. Do not separate the aztreonam vials from the diluent ampules. Protect from light. Do not use aztreonam if it has been stored at room temperature for more than 28 days.

Drug Interactions

Aminoglyclosides (eg, gentamicin)

If an aminoglycoside is used concurrently with aztreonam, especially if high dosages of the former are used or if therapy is prolonged, monitor renal function because of potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

Beta-lactamase–inducing antibiotics (eg, cefoxitin, imipenem)

May antagonize activity of aztreonam; do not use concurrently.

Incompatibility

Nafcillin sodium, cephradine, and metronidazole are incompatible in admixture.

Adverse Reactions

CNS

Injection

Seizures.

Dermatologic

Inhalation

Rash (2%).

Injection

Rash.

EENT

Inhalation

Nasal congestion (16%); pharyngolaryngeal pain (12%).

GI

Inhalation

Abdominal pain (7%); vomiting (6%).

Injection

Diarrhea; nausea; pseudomembranous colitis; vomiting.

Local

Phlebitis/thrombophlebitis after IV administration; pain/swelling at IM injection site.

Respiratory

Inhalation

Cough (54%); wheezing (16%); bronchospasm (3%).

Injection

Dyspnea.

Miscellaneous

Inhalation

Chest discomfort (8%); pyrexia (13%).

Injection

Fever.

Precautions

Monitor

Review culture and sensitivity of organism as available. Obtain baseline forced expiratory volume at 1 sec (FEV 1 ) prior to initiating inhalation therapy and as needed during therapy. Monitor patients for signs and symptoms of an allergic reaction.


Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy in children younger than 9 mo of age not established (injection); safety and efficacy in children younger than 7 yr of age not established (inhalation).

Hypersensitivity

Reactions range from mild to life-threatening. Administer cautiously to penicillin- or cephalosporin-sensitive patients because of possible cross reactivity.

Renal Function

Reduced dose required for aztreonam injection.

Superinfection

May result in overgrowth of nonsusceptible bacterial or fungal organisms.

Respiratory effects

Bronchospasm may occur with inhalation use. Patients whose FEV 1 increased during aztreonam inhalation therapy and then decreased after the treatment period were sometimes treated for pulmonary exacerbation. Consider baseline FEV 1 measured prior to aztreonam therapy and the presence of other symptoms when evaluating patients for pulmonary exacerbation.

Patient Information

  • Encourage patient to increase fluid intake to 2,000 to 3,000 mL/day, if allowed.
  • Inform patient to notify health care provider if rash or difficulty breathing is experienced.
  • If therapy is discontinued because of allergic reaction, explain significance of penicillin allergy and of potential problems with cephalosporins.
  • Caution patient against skipping doses or stopping treatment early, which could result in recurrence of symptoms and potential resistance of the organism to this drug.
  • Inhalation
  • Advise patients that aztreonam is for inhalation use only and should only be administered using the Altera Nebulizer System.
  • Instruct patients only to reconstitute aztreonam with the provided diluent and not to mix other drugs in the Altera Nebulizer Handset.
  • Inform patients if they miss a dose, to take all 3 daily doses as long as the doses are at least 4 hours apart.
  • Advise patients to use a bronchodilator prior to aztreonam. Advise patients taking several inhaled medications to use the medications in the following order: bronchodilator, mucolytics, and, lastly, aztreonam.

Copyright © 2009 Wolters Kluwer Health.

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