(aztreonam) for inhalation solution
Read this Patient Information
before you start taking CAYSTON and each time you get a refill. This
information does not take the place of talking with your doctor about your
medical condition or your treatment.
What is CAYSTON?
CAYSTON is a prescription
inhaled antibiotic. CAYSTON is used to improve breathing symptoms in people
with cystic fibrosis (CF) who have Pseudomonas 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
CAYSTON is used only with the Altera® Nebulizer 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®).
What should I tell my doctor
before taking CAYSTON?
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
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
- 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
- If you are taking several medicines or treatments to
treat your cystic fibrosis, you should take your medicines or other treatments
in this order:
- mucolytics (medicines to help clear mucus from your
- 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
- 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
- See the end of this Patient Information leaflet for the
Patient Instructions for Use on how to take CAYSTON the right way.
What are the possible side effects of CAYSTON?
CAYSTON can cause serious side effects, including:
- Severe allergic reactions. Stop your treatment with
CAYSTON and call your doctor right away if you have any symptoms of an allergic
- 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. See
“How should I take CAYSTON?”
Common side effects of CAYSTON include:
- Nasal congestion
- Sore throat
- Fever. Fever may be more common in children than in
- Chest discomfort
- Stomach area (abdominal) pain
Other possible side effects of CAYSTON include:
- Swelling or pain of joints
Tell your doctor if you have any new or worsening
symptoms while taking CAYSTON. Tell your doctor about any side effect that
bothers you or that does not go away.
These are not all the possible side effects of CAYSTON.
For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store 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
- 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
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
What are the ingredients in CAYSTON?
Active ingredient: aztreonam
Inactive ingredient: lysine, sodium chloride
Patient Instructions For Use
(aztreonam) for inhalation solution
Be sure that you read, understand and follow the Patient Instructions
for Use below for the right way to take CAYSTON. If you have any questions, ask
your doctor or pharmacist.
You will need the following supplies (Figure 1):
- 1 amber colored CAYSTON vial covered by a metal seal with
a blue cap
- 1 ampule of saline (diluent)
- Altera Nebulizer System
Check to make sure that your
Altera Nebulizer System works properly before starting Â your treatment with
CAYSTON. See the manufacturer’s instructions for use that comes Â with your Altera Nebulizer System. This should have
complete information about how to put together(assemble), prepare, use, and care
for your Altera Nebulizer System.
Step1 Preparing your CAYSTON
1. Mix (reconstitute) CAYSTON with
the saline only when ready to take a dose. Take one amber vial of CAYSTON and
one ampule of saline from the carton. Separate the saline ampules by gently
2. Look at the ampule of saline.
If it looks cloudy do not use it. Throw away this ampule and get another ampule
3. Gently tap the vial so that the
powder settles to the bottom of the vial. This helps you get the proper dose of
medicine. Follow Step A to Step D in Figure 2 below to open the vial:
Step A : With the blue cap tab facing toward
Â you, place the vial on a flat surface. Using one hand
to hold the vial steady, use the other hand to slowly flip up the blue
Step B : Pull the blue cap
down to a flat (horizontal) position (where the bottom of the Â blue cap faces
up), to prepare the metal seal for removal. Do not completely tear
through Â the metal seal.
Step C : While continuing to
hold the vial steady with one hand, use the other hand to slowly pull
the blue cap in a counterclockwise direction. Do not twist the Â blue cap.
Step D : When the metal seal
opens, continue to slowly pull the blue cap in a counterclockwise direction until the metal seal is completely
4. Safely throw away (dispose
of) the metal seal in household garbage. Carefully remove (but do not yet
discard) the rubber stopper. Â
5. Open the ampule of saline by
twisting off the tip. Squeeze out the contents completely into the vial (Figure
3). Next, close the vial with the rubber stopper and gently swirl the vial
until the powder has completely dissolved and the liquid is clear. Â
6. After mixing CAYSTON with
the saline, check to make sure the diluted medicine is clear. If it is cloudy
or has particles in it, do not use this medicine. Throw away this dose of
medicine and start over again with a new vial of CAYSTON and a new ampule of
7. Use CAYSTON right away after
you mix with the saline.
Step 2 Taking your CAYSTON
See the manufacturer’s instructions
for use that comes with your Altera Nebulizer System for complete instructions
on taking a treatment, and how to clean and disinfect your Altera Nebulizer Handset.
8. Make sure the handset is on
a flat, stable surface.
9. Remove the rubber stopper
from the vial, then pour all of the mixed CAYSTON and saline into the
Medication Reservoir of the handset (Figure 4). Be sure to completely empty the
vial, gently tapping the vial against the side of the Medication Reservoir if
necessary. Close the Medication Reservoir (Figure 5).
10. Begin your treatment by
sitting in a relaxed, upright position. Hold the handset level, and place the
Mouthpiece in your mouth. Close your lips around the Mouthpiece (Figure 6).
11. Breathe in and out normally
(inhale and exhale) through the Mouthpiece. Avoid breathing through your
nose. Continue to inhale and exhale comfortably until the treatment
12. The empty vial, stopper and
saline ampule should be disposed of in household garbage upon completion of
This Instructions for Use has
been approved by the U.S. Food and Drug Administration.