How to take BRONCHITOL®(mannitol) inhalation powder
BRONCHITOL Tolerance Test
BRONCHITOL is only for adults (18 years of age or older) who have passed the BRONCHITOL Tolerance Test (BTT). Before your doctor prescribes BRONCHITOL, a trained healthcare practitioner must administer the BTT. This test will identify whether you are hyperresponsive, or sensitive, to mannitol, the main ingredient in BRONCHITOL. If during the test the measurements of your lung function fall below a certain level, or you experience bronchospasm, then you should not be prescribed BRONCHITOL. In clinical trials, 92% of adult patients passed the BTT.
The BTT also lets you practice the correct way to use the inhaler and take the medication while under the supervision of a healthcare practitioner. Talk to your doctor if you have questions about starting treatment.
BRONCHITOL dosing and administration information
BRONCHITOL is for oral inhalation only. Do not swallow BRONCHITOL capsules. Capsules should only be used with the BRONCHITOL inhaler device. Use BRONCHITOL exactly as your healthcare practitioner tells you to use it.
- Use a short-acting bronchodilator 5–15 minutes before every dose of BRONCHITOL to open your airways so the medicine can reach your lungs
- The recommended dosage of BRONCHITOL is 400 mg twice a day
- A full dose requires you to inhale the contents of 10 capsules using the inhaler twice a day
- BRONCHITOL should be taken once in the morning and once in the evening
- The evening dose should be taken 2–3 hours before bedtime
- After 7 days of using the inhaler, throw it away and use a new one; a new inhaler is provided in every 7-day carton of BRONCHITOL
- If you do need to wash the inhaler during the 7 days, refer to the How to clean your BRONCHITOL inhaler instructions below
Dosing and administration video
Watch this video to learn more about the BTT, dosing, and administration. Also get helpful tips on how to take BRONCHITOL.
How to clean your BRONCHITOL inhaler
Your inhaler should give you the correct dose of medicine for 7 days without needing cleaning. However, if your inhaler does need cleaning:
- Make sure your inhaler is empty
- Wash your inhaler in warm water with the mouthpiece open
- Shake it until there are no large water droplets left in the inhaler
- Leave it to dry in the air by laying it on its side with the mouthpiece open
- Allow the inhaler to dry fully (or completely) after it has been washed
These instructions and additional information can be found in the Patient Instructions For Use.
Do not take BRONCHITOL if you have had an allergic reaction to mannitol or any parts of the BRONCHITOL capsule or if you do not pass the BRONCHITOL Tolerance Test (BTT).
Before you take BRONCHITOL, tell your healthcare provider about all your medical conditions, including if you have ever coughed up blood or had blood in your mucus (sputum); are pregnant or planning on becoming pregnant. It is not known if BRONCHITOL will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using BRONCHITOL; are breastfeeding or plan to breastfeed. It is not known if BRONCHITOL passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using BRONCHITOL.
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
BRONCHITOL may cause serious side effects, including sudden breathing problems immediately after inhaling your medicine; coughing up of blood (hemoptysis). Call your healthcare provider or get emergency medical care right away if you cough up a large amount of blood.
The most common side effects of BRONCHITOL include, cough, coughing up of blood, pain or irritation in the back of your mouth and throat and discomfort when swallowing, vomiting, fever, joint pain, bacteria in your sputum. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BRONCHITOL. You can ask your healthcare provider or pharmacist for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
(mannitol) inhalation powder
BRONCHITOL is a prescription medicine that is used along with other therapies to improve lung function in people 18 years of age and older with cystic fibrosis (CF).
BRONCHITOL is only for adults who have passed the BRONCHITOL Tolerance Test (BTT). Your first dose of BRONCHITOL is given during the BTT by your healthcare provider and tests if BRONCHITOL is right for you. Your healthcare provider will use equipment to monitor you and have medicine ready if you have bronchospasm during the test. If you have bronchospasm during your BTT, then you should not be prescribed BRONCHITOL.
BRONCHITOL should not be used in children and adolescents. It is not known if BRONCHITOL is safe and effective in children under 18 years of age.