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CAYSTON- aztreonam kit


  1. What Is Cayston?
  2. Who Should Not Take Cayston?
  3. Before Taking Cayston, Tell Your Doctor If You:
  4. How Should I Take Cayston?
  5. Severe Allergic Reactions. Stop Your Treatment With Cayston And Call Your Doctor Right Away If You Have Any Symptoms Of An Allergic Reaction, Including:
  6. What Are The Ingredients In Cayston?
  7. Patient Information

What Is Cayston? 

CAYSTON is a prescription inhaled antibiotic. CAYSTON is used to improve breathing symptoms in people with cystic fibrosis (CF) who havePseudomonas aeruginosa (P. aeruginosa)in their lungs.

CAYSTON is only for infections caused by bacteria. It is not for infections caused by viruses, such as the common cold.

CAYSTON is used only with the AlteraNebulizer System.

It is not known if CAYSTON is safe and effective in children under the age of 7.

Who Should Not Take Cayston? 

Do not take CAYSTON if you are allergic to aztreonam (AZACTAM).

Before Taking Cayston, Tell Your Doctor If You: 

  • are allergic to any antibiotics.
  • are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast feed. Talk to your doctor about the best way to breast feed your baby if you take CAYSTON.

Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How Should I Take Cayston? 

  • Take CAYSTON exactly as prescribed by your doctor.
  • The dose of CAYSTON for both adults and children 7 years of age and older is one vial of CAYSTON, mixed with one ampule of saline (diluent) 3 times a day.
  • Doses of CAYSTON should be taken at least 4 hours apart (for example: morning, after school, and before bed).
  • CAYSTON should be taken for 28 days.
  • CAYSTON is taken as a breathing treatment (inhalation) with the Altera Nebulizer System. Do not use any other nebulizer for your CAYSTON treatment.
  • You should use an inhaled bronchodilator (a type of medicine used to relax and open your airways) before taking a dose of CAYSTON. If you do not have an inhaled bronchodilator, ask your doctor to prescribe one for you.
  • If you are taking several medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments in this order:
    1)
    bronchodilator
    2)
    mucolytics (medicines to help clear mucus from your lungs)
    3)
    CAYSTON
  • You should take CAYSTON as prescribed, in courses of 28 days on CAYSTON, followed by at least 28 days off CAYSTON, as directed by your doctor.
  • Do not mix CAYSTON with any other medicines in your Altera Nebulizer System.
  • Do not mix CAYSTON with the saline until right before you are ready to use it. Do not mix more than one dose of CAYSTON at a time.
  • Each treatment should take about 2 to 3 minutes.
  • If you miss a dose of CAYSTON, you can still take all 3 daily doses as long as they are at least 4 hours apart.
  • It is important for you to finish taking the full 28-day course of CAYSTON even if you are feeling better. If you skip doses or do not finish the full 28-day course of CAYSTON, your infection may not be fully treated and CAYSTON may not work as well as a treatment for infections in the future.

Severe Allergic Reactions. Stop Your Treatment With Cayston And Call Your Doctor Right Away If You Have Any Symptoms Of An Allergic Reaction, Including: 

  • Rash or swelling of your face
  • Throat tightness
  • Trouble breathing right after treatment with CAYSTON (bronchospasm).To decrease the chance of this happening, be sure to use your inhaled bronchodilator medicine before each treatment with CAYSTON.

    • Each CAYSTON kit contains enough vials of CAYSTON and ampules of saline for 28 days of treatment. There are 4 extra saline ampules in case some saline spills.
    • Always keep your CAYSTON and saline together.
    • Store CAYSTON and saline in the refrigerator at 36 F to 46 F (2 C to 8 C) until needed.
    • When you remove CAYSTON and saline from the refrigerator, they may be stored at room temperature (less than 77 F) for up to 28 days. Do not use any CAYSTON that has been stored at room temperature for more than 28 days.
    • Keep CAYSTON away from light.
    • Do not use CAYSTON after the expiration date on the vial. Do not use the saline after the expiration date on the ampule.

    Keep CAYSTON and all medicines out of the reach of children.

    General information about CAYSTON

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CAYSTON for a condition for which it was not prescribed. Do not give CAYSTON to other people, even if they have the same symptoms that you have. It may harm them.

    This Patient Information leaflet summarizes the most important information about CAYSTON. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CAYSTON that is written for health professionals.

    For more information, call 1-877-7CAYSTON (1-877-722-9786).

  • What Are The Ingredients In Cayston? 

    Active ingredient: aztreonam

    Inactive ingredient: lysine, sodium chloride (diluent)

    Patient Information 

    SeeFDA-Approved Patient Labeling

    Patients should be advised that CAYSTON is for inhalation use only and that CAYSTON should only be administered using the Altera Nebulizer System. Patients should be instructed only to reconstitute CAYSTON with the provided diluent and not mix other drugs with CAYSTON in the Altera Nebulizer System.

    Patients should be advised to complete the full 28-day course of CAYSTON even if they are feeling better. Inform the patient that if they miss a dose, they should take all 3 daily doses as long as the doses are at least 4 hours apart.

    Patients should be advised to use a bronchodilator prior to administration of CAYSTON. Patients taking several inhaled medications should be advised to use the medications in the following order of administration: bronchodilator, mucolytics, and lastly, CAYSTON.

    Patients should be advised to tell their doctor if they have new or worsening symptoms. Patients who believe they are experiencing an allergic reaction to CAYSTON should be advised to contact their doctor immediately.

    Patients should be counseled that antibacterial drugs including CAYSTON should only be used to treat bacterial infections. They do not treat viral infection (e.g., the common cold). When CAYSTON is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CAYSTON or other antibacterial drugs in the future.

    Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404

    CAYSTON is a trademark of Gilead Sciences, Inc. All other trademarks referenced herein are the property of their respective owners.

    2019 Gilead Sciences, Inc. All rights reserved.

    50-814-GS-003



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