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Aztreonam inhalation is an antibiotic that is used to treat lung infections in patients with cystic fibrosis. The medicine is breathed into the lungs through the mouth to treat infections caused by the Pseudomonas aeruginosa bacteria.

Aztreonam works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

This medicine should only be used with the Altera® Nebulizer System. The inhaled liquid and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may give you or your child additional medicines to use before the aztreonam inhalation liquid, such as bronchodilators or mucolytics. Bronchodilators help open the lungs so you can breathe easier. Mucolytics help clear the mucus from your lungs. Carefully follow your doctor's instructions about how to use your medicines. Aztreonam inhalation will work better if you use all of your medicines in the right order.

To use the inhalation solution:

• Mix the powder in the vial (glass container) with the saline or diluent liquid.
• Slowly swirl the vial until the powder has completely dissolved. If the liquid in the vial is cloudy or has specks in it, throw it away and mix a new dose.
• Place the mixed liquid in the medicine reservoir or nebulizer cup right away.
• Do not mix other medicines with the liquid in the nebulizer.
• Use the dose right away after it has been mixed.
• Use the mouthpiece of the nebulizer to breathe in the medicine.
• Use the nebulizer for 2 to 3 minutes, or until the liquid in the nebulizer cup is gone.
• Clean the nebulizer after each use and throw out the empty vial, rubber stopper, and saline container.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (solution in a nebulizer):
  • For lung infections:
    • Adults, teenagers, and children 7 years of age and older—One vial or container with 75 milligrams (mg) three times per day for 28 days in the nebulizer. You should space the doses at least 4 hours apart.
    • Children younger than 7 years of age—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you or your child miss a dose, you may still take all three daily doses of this medicine as long as the doses are at least 4 hours apart.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is best to store the unopened vials and saline ampules in the original carton in the refrigerator. You may also store the unopened vials at room temperature, away from heat and direct light, for up to 28 days. Do not store the liquid mixture after the powder is dissolved.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of aztreonam inhalation in children younger than 7 years of age. Safety and efficacy have not been established.

Appropriate studies on the relationship of age to the effects of aztreonam inhalation have not been performed in the geriatric population.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to beta-lactams (e.g., amoxicillin, cefdinir, cefuroxime, cephalexin, penicillin, Amoxil®, Augmentin®), history of or
• Bronchospasm—Use with caution. May make these conditions worse.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using the medicine.

Stop using this medicine and check with your doctor right away if you or your child develop a skin rash, hives, swelling of the face, tightness in the throat, or any allergic reaction to aztreonam.

If your or your child's symptoms do not improve or if they get worse, call your doctor.