Aztreonam Inhalation

Aztreonam Inhalation is a prescription medication used to improve respiratory symptoms in patients with cystic fibrosis infected with Pseudomonas aeruginosa.

• Aztreonam Inhalation is available under the following different brand names: Cayston.

Common side effects of Aztreonam Inhalation include:

• Mild stomach discomfort,
• Vomiting,
• Cough,
• Sore throat,
• Stuffy nose, and
• Low fever

Serious side effects of Aztreonam Inhalation include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Wheezing,
• Chest tightness,
• Trouble breathing right after using the medicine, and
• Worsening symptoms

Rare side effects of Aztreonam Inhalation include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Inhalation solution

• 75 mg/single-use vial

Cystic Fibrosis (CF)

Adult dosage

• 75 mg inhaled every 8 hours for 28 days; use only with Alterna nebulizer; do not repeat for 28 days after completion.
• Doses should be administered at least 4 hours apart.

Pediatric dosage

• Below 7 years: Safety/efficacy not established.
• Above 7 years: As adults, 75 mg inhaled every 8 hours for 28 days; use only with Alterna nebulizer; do not repeat for 28 days after completion.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Aztreonam Inhalation has no noted severe interactions with any other drugs.
• Aztreonam Inhalation has no noted serious interactions with any other drugs.
• Aztreonam Inhalation has no noted moderate interactions with any other drugs.
• Aztreonam Inhalation has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aztreonam Inhalation?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aztreonam Inhalation?”

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 the 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

Pregnancy and Lactation

• 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 of preterm delivery.
• Lactation
  • Following intravenous administration, the 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 intravenous administration (500 mg); systemic absorption of aztreonam following inhaled administration is expected to be minimal; there are no data on the effects of the 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 drugs or underlying maternal conditions.