aztreonam inhalation (Rx)

Brand and Other Names:Cayston
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

inhalation solution

  • 75mg/single-use vial

Cystic Fibrosis (CF)

Indicated to improve respiratory symptoms in patients with CF infected with Pseudomonas aeruginosa

75 mg inhaled q8hr for 28 days; use only with Alterna nebulizer; do not repeat for 28 days after completion

Doses should be administered at least 4 h apart

Use bronchodilator before administration; administer short-acting beta agonists 15 min to 4 h before or long-acting beta agonists 30 min to 12 h before

If taking mucolytics, take after bronchodilators, but before aztreonam

Reconstitution and Storage

Store vials and diluent refrigerated at 2-8 degrees C (36-46 degrees F)

Once removed from refrigerator, may store at room temperature (up to 25 degree C; 77 degrees F) for up to 28 days

Use immediately upon reconstitution; do not reconstitute more than 1 dose at a time

Dosage Forms & Strengths

inhalation solution

  • 75mg/single-use vial

Cystic Fibrosis (CF)

Indicated to improve respiratory symptoms in patients with CF infected with Pseudomonas aeruginosa

<7 years: Safety/efficacy not established

>7 years: As adults, 75 mg inhaled q8hr for 28 days; use only with Alterna nebulizer; do not repeat for 28 days after completion

Doses should be administered at least 4 h apart

Use bronchodilator before administration; administer short-acting beta agonists 15 min to 4 h before or long-acting beta agonists 30 min to 12 h before

If taking mucolytics, take after bronchodilators, but before aztreonam

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Adverse Effects

>25%

Cough (54%)

10-25%

Nasal congestion ( 16%)

Wheezing (16%)

Pharyngolaryngeal pain (12%)

Pyrexia (13%)

1-10%

Chest discomfort (8%)

Abdominal pain (7%)

Vomiting (6%)

Bronchospasm (3%)

Rash (2%)

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Warnings

Contraindications

Hypersensitivity

Cautions

Allergic reactions observed in clinical trials, stop treatment if allergic reaction occurs

May cause bronchospasm, stop treatment if chest tightness develops during nebulizer use

Increases FEV1 during 28-day course, consider baseline FEV1 when evaluating whether post-treatment changes in FEV1 are caused by pulmonary exacerbation

Increased risk of drug-resistant bacteria in absence of known Pseudomonas aeruginosa

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Pregnancy & Lactation

Pregnancy

Available data on use in pregnant women is insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, systemic absorption of aztreonam following inhaled administration is expected to be minimal

There are risks to the mother associated with cystic fibrosis in pregnancy; cystic fibrosis may increase the risk for preterm delivery

Animal data

  • In animal reproduction studies with aztreonam for injection administered parenterally to pregnant rats and rabbits during organogenesis, there was no evidence of developmental toxicity; a peri/postnatal study in rats revealed no drug-induced changes in maternal, fetal, or neonatal parameters

Lactation

Following intravenous administration, drug is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum

Peak plasma concentrations of aztreonam following administration of 75 mg are approximately 1% of peak concentrations observed following IV administration (500 mg); systemic absorption of aztreonam following inhaled administration is expected to be minimal; there are no data on effects of drug on breastfed infant or effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on the breastfed infant from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Inhibits cell wall synthesis by binding to penicillin binding protein 3, which in turn inhibits cell wall biosynthesis; member of monobactam family

Pharmacokinetics

Half-Life: 1.7 hr (children); 1.7-2.9 hr (adults)

Absorption: Low systemic absorption

Mean Plasma Concentration: 0.59 mcg/mL (1 hr after single dose, approximately the peak plasma conc); 0.55 mcg/mL, 0.67 mcg/mL, 0.65 mcg/mL (1 hr after multiple doses on days 1, 14, and 28 respectively); in contrast, plasma concentration following 500 mg IV is 54 mcg/mL

Mean Sputum Concentration: 726 mcg/g (after single dose); 984 mcg/g, 793 mcg/g, 715 mcg/g (10 min after multiple doses on days 1, 14, and 28 respectively)

Peak Plasma Time: Approximately 1 hr

Protein Bound: 56%

Excretion: Urine (60-70%); feces (13-15%)

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.