Aztreonam inhalation

Name: Aztreonam inhalation

What is the most important information I should know about aztreonam?

You should not use this medication if you are allergic to aztreonam.

Before using aztreonam, tell your doctor if you are allergic to any type of antibiotic, especially a cephalosporin (Ceftin, Cefzil, Keflex, Omnicef, and others), a penicillin (Amoxil, Augmentin, Bactocill, Bicillin L-A, Dispermox, Dycill, Dynapen, Moxatag, Principen, PC Pen VK, Pen-V, Pfizerpen, Unasyn, and others), or similar antibiotics such as Invanz, Primaxin, or Merrem.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Aztreonam will not treat a viral infection such as the common cold or flu.

Aztreonam inhalation should be used only with an Altera brand nebulizer. Do not use any other type of nebulizer or inhaler device with this medication. Do not mix other medicines with aztreonam in the nebulizer.

If you use other inhaled medications, you may need to use them in a certain order while using aztreonam inhalation. Ask your doctor for specific instructions about when to use your other medications in relation to your aztreonam inhalation doses.

What should I discuss with my health care provider before using aztreonam?

You should not use this medication if you are allergic to aztreonam.

Before using aztreonam, tell your doctor if you are allergic to any type of antibiotic, especially:

  • cephalosporins such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others;

  • penicillins such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others; or

  • similar antibiotics such as ertapenem (Invanz), imipenem (Primaxin), or meropenem (Merrem).

FDA pregnancy category B. Aztreonam is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Aztreonam can pass into breast milk. Tell your doctor if you are breast-feeding a baby.

How should I use aztreonam?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Aztreonam inhalation should be used only with an Altera brand nebulizer. Do not use any other type of nebulizer or inhaler device with this medication. Do not mix other medicines with aztreonam in the nebulizer.

Aztreonam inhalation is a powder medicine that must be mixed with a liquid (diluent) just before using it. Be sure you understand how to properly mix the medication before pouring it into the nebulizer.

Prepare aztreonam in the nebulizer only when you are ready to give yourself a dose. Swirl the mixture gently until the powder has dissolved, then pour the mixture into the handset of the nebulizer. Use the medicine right away after placing it in the nebulizer. Do not save it for later use.

Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Each vial (bottle) of aztreonam and each ampule of diluent are for one use only. Throw away the empty bottle and ampule after mixing one dose, even if there is diluent left in the ampule.

Aztreonam inhalation is usually given 3 times daily for 28 days. Follow your doctor's dosing instructions very carefully. Your doses should be spaced at least 4 hours apart.

You may need to use a bronchodilator medication before each dose of aztreonam inhalation. Follow your doctor's instructions about the type of bronchodilator to use and when to use it.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Aztreonam will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you have.

Store the powder and diluent in the refrigerator, do not freeze.

After taking the powder and diluent out of the refrigerator, you may store them at room temperature away from moisture, heat, and light. This medicine must be used within 28 days if you keep it at room temperature.

Aztreonam side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing) right after using the medicine; or

  • any new or worsening symptoms.

Less serious side effects may include:

  • mild stomach discomfort, vomiting;

  • cough, sore throat;

  • stuffy nose; or

  • low fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before Using aztreonam

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 aztreonam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aztreonam 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.

Pediatric

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.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

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 aztreonam, 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 aztreonam 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

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

The presence of other medical problems may affect the use of aztreonam. 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.

Usual Pediatric Dose for Urinary Tract Infection

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Cystic Fibrosis

Inhalation:
7 years or older:
Initial dose: 75 mg via nebulizer over approximately 2 to 3 minutes 3 times a day for 28 days; doses should be at least 4 hours apart

Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off.

For patients on multiple inhaled therapies, the following order of administration is recommended: bronchodilator, mucolytics, and lastly, aztreonam for inhalation.

Liver Dose Adjustments

No adjustment recommended.

Dialysis

Parenteral: For serious or life-threatening infections, in addition to the maintenance doses, one-eighth of the initial dose should be given after each hemodialysis.

Inhalation: No adjustment recommended.

Other Comments

The maximum recommended parenteral dose is 8 g/day.

If necessary, doses of 1 g or less may be given intramuscularly in moderately severe infections; however, IM administration may be a problem for patients with end-stage renal disease if there is an underlying coagulopathy.

The IV route is recommended for patients requiring single doses greater than 1 g or those with bacterial septicemia, localized parenchymal abscess (e.g., intraabdominal abscess), peritonitis, or other severe systemic or life-threatening infections.

Generally, aztreonam should be continued for at least 48 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Persistent infections may require treatment for several weeks.

Following reconstitution, aztreonam for inhalation should be used at once using the Altera (R) Nebulizer System. It should not be used with any other nebulizer. Aztreonam for inhalation should not be mixed with any other drug in the Altera (R) Nebulizer Handset.

The use of a bronchodilator prior to administration of aztreonam for inhalation is recommended. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose and long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of aztreonam for inhalation.

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