Consumer medicine information

CAYSTON®

Generic Name: aztreonam for inhalation

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

Read this leaflet carefully before you, or the person in your care starts taking CAYSTON. Also, read it each time you get your CAYSTON prescription refilled, in case something has changed.

This leaflet is only a summary and does not take the place of talking with your doctor or pharmacist about your medical condition or your treatment.

Talk to your doctor or pharmacist if you have any questions about CAYSTON.

Keep this leaflet with the medicine. You may need to read it again.

WHAT IS CAYSTON AND HOW DOES IT WORK?

  • CAYSTON is an antibiotic, belonging to a group of medicines called monobactams.
  • CAYSTON is used to help people who have Cystic Fibrosis (CF).
    CF is a genetic disease that affects a number of organs in the body. The lungs are often clogged with thick, sticky mucus that may lead to chronic airway infections. CAYSTON is not a cure for this disease.
  • CAYSTON is used to fight lung infections caused by bacteria such as Pseudomonas aeruginosa (P. aeruginosa).
  • When you inhale CAYSTON with your Altera™ Nebulizer System, it will enter your lungs and contact the P. aeruginosa bacteria that are present. CAYSTON works by decreasing the number of P. aeruginosa bacteria living in your lungs to improve your respiratory symptoms and lung function.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING CAYSTON?

Tell your doctor if:

  • you are allergic to aztreonam or lysine
  • you are allergic to any antibiotics
  • you are pregnant or planning on becoming pregnant
  • you are breast-feeding

Tell your doctor or pharmacist about all of your medical conditions.

Tell your doctor or pharmacist about all the medicines you take, including prescription and non-prescription medicines and dietary supplements.

Do not take CAYSTON if:

  • you are allergic to aztreonam or lysine
  • the expiry date (EXP) on the vial or the ampoule has passed
  • the solution of CAYSTON or the diluent are cloudy or if there are particles in the solutions
  • the package is torn or shows signs of tampering
  • it has been stored at room temperature for more than 28 days.

If you are not sure if you should use CAYSTON, talk to your doctor or pharmacist.

WHAT SHOULD I DO WHILE TAKING CAYSTON?

  • It is very important that you use CAYSTON regularly (3 times every day) for 28 days. Do not stop treatment even if you are feeling better unless told to do so by your doctor.
  • Only CAYSTON should be used in your Altera Nebulizer. Do not use any other medication in your Altera Nebulizer.
  • Do not drive or operate heavy machinery whilst taking CAYSTON.

HOW SHOULD I TAKE CAYSTON?

How much to use:

  • The recommended dose is one single-use vial mixed with one ampoule of saline diluent taken 3 times a day by inhalation for a 28-day treatment course.
  • Each of the 3 daily doses should be taken at least 4 hours apart.
  • The dose of CAYSTON is the same for adult patients and children 6 years of age or older.
  • Do not change your dose unless told to do so by your doctor.
  • No information is available on the use of CAYSTON in children under 6 years of age.

How to use it:

  • CAYSTON must only be inhaled through the mouth.
  • The full instructions for using the Altera Nebulizer System are given in a leaflet inside this pack.
  • You should take CAYSTON as directed by your doctor, in courses of 28 days on CAYSTON followed by at least 28 days off CAYSTON.
  • You can take your treatments at home, school, work, or any place where you are able to carry out the steps described in the leaflet inside this pack. Each dose should take approximately 2 to 3 minutes. If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart.
  • An inhaled bronchodilator (e.g. beta-agonist) should be used before you take each dose of CAYSTON. If you are taking several medicines, the recommended order is:
    1) bronchodilator
    2) chest physiotherapy
    3) other inhaled medications, then
    4) CAYSTON.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to the accident and emergency department at your nearest hospital if you think you or anyone else may have taken too much CAYSTON. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF CAYSTON?

The common possible side effects with CAYSTON include:

  • cough
  • nasal congestion
  • wheezing
  • sore throat
  • fever
  • chest discomfort
  • runny nose

The less common possible side effects include:

  • rash
  • bronchospasm (difficulty in breathing) immediately after inhalation.

Patients with Cystic Fibrosis can have many possible symptoms. Some of these symptoms may be related to your medications. If you have new or worsening symptoms, you should tell your doctor or pharmacist.

If you believe you are experiencing an allergic reaction to CAYSTON, stop using CAYSTON and tell your doctor immediately.

Ask your doctor or pharmacist to answer any questions you may have.

How do I store CAYSTON?

  • Keep CAYSTON and all other medications out of reach of children.
  • CAYSTON vials should be stored in a refrigerator (at 2°C to 8 °C), and not frozen. CAYSTON vials may also be stored at room temperature (below 25 °C) for up to 28 days.
  • Diluent ampoules may be refrigerated or stored at room temperature.
  • Do not use CAYSTON if it has been stored at room temperature for more than 28 days.
  • Do not leave CAYSTON in the car or on a window sill.
  • CAYSTON should be used immediately once mixed with the diluent. Do not prepare more than one dose at a time.

Altera Nebulizer Handset Replacement

Your handset has been tested and can be used for three 28-day courses of CAYSTON if used as directed. After this time, it is recommended that your Altera nebulizer handset, including the aerosol head, be replaced. If you notice that your Altera Nebulizer System performance has changed before this time (e.g. increase in nebulization time), please refer to the manufacturer’s Instructions for Use.

PRODUCT DESCRIPTION

What CAYSTON looks like

CAYSTON is a sterile powder that needs to be reconstituted (converted to liquid form) by adding a sterile saline diluent (0.17% w/v sodium chloride) before inhaling it through your Altera Nebulizer.

Each kit of CAYSTON contains 84 vials of CAYSTON and 88 diluent ampoules packed in 2 carton inserts each with a 14-day supply (42 vials of CAYSTON packaged in two trays and one tray of 44 diluent ampoules). The four additional diluent ampoules are provided in case of spillage.

What are the ingredients of CAYSTON?

  • aztreonam
  • lysine

AUST R 148384

SPONSOR

Gilead Sciences Pty Ltd
Level 6, 417 St Kilda Road
Melbourne, Victoria 3004

Date of Preparation: 3 September 2013

Published by MIMS March 2014