Bronchitol

Generic name: mannitol
Dosage form: inhalation powder

Medically reviewed by  A Ras MD.

What is Bronchitol?

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 bronchospasms during the test. If you have bronchospasms 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.

Description

BRONCHITOL (mannitol) inhalation powder contains D-Mannitol (referred to throughout as mannitol) as the active ingredient. Mannitol is a hexahydric sugar alcohol, with the following chemical name hexane-1,2,3,4,5,6-hexol and chemical structure:

Mannitol is a white or almost white crystalline powder or free-flowing granules with an empirical formula of C6H14O6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism.

BRONCHITOL contains mannitol powder spray dried into particles of respirable size filled into clear, colorless hard gelatin capsules. There are no inactive ingredients in BRONCHITOL.

The accompanying white plastic inhaler is comprised of a mouthpiece, blue piercing buttons, capsule chamber, and a removable cap. A blister pack consists of 10 capsules, each containing 40 mg mannitol. After a capsule is placed in the capsule chamber and pierced by firmly pressing and releasing the buttons on the side of the device, the powder within the capsule becomes exposed and ready for dispersion into the airstream generated by the patient upon inhalation through the mouthpiece. Under standardized in vitro test conditions, the inhaler delivers 32.2 mg of mannitol per inhalation when tested at a flow rate of 60 L/min for 2 seconds. The actual amount of drug delivered to the lungs will depend on patient factors, such as inspiratory flow profile.

Mechanism of Action

The precise mechanism of action of BRONCHITOL in improving pulmonary function in cystic fibrosis patients is unknown.

Who should not take Bronchitol?

Do not take Bronchitol if you:

• have had an allergic reaction to mannitol or any parts of the Bronchitol capsule. See the end of this Patient Information guide for a complete list of ingredients in Bronchitol.
• do not pass the BTT.

What should I tell my healthcare provider before taking Bronchitol?

Before you use 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. Know the medicines you take. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Bronchitol?

See the step-by-step Patient Instructions for Use at the end of this Patient Information leaflet..

• Bronchitol is for oral inhalation only.
• Do not use Bronchitol until your healthcare provider has given you the BTT and approved you for treatment. Ask your healthcare provider or pharmacist if you have any questions.
• Use Bronchitol exactly as your healthcare provider tells you to use it.
• Do not swallow Bronchitol capsules. Bronchitol capsules should be used only with the provided inhaler device.
• An inhaled short-acting bronchodilator should be used 5 to15 minutes before every dose of Bronchitol.
• Use Bronchitol 2 times each day. Breathe in (inhale) through your mouth (oral inhalation) the capsule contents in 10 single Bronchitol capsules using the Bronchitol inhaler:
  • 1 time in the morning
  • 1 time at least 2 to 3 hours before bedtime
• If you use too much Bronchitol, call your healthcare provider or go to the nearest emergency room right away if you have any unusual symptoms, such as feelings that you cannot breathe, have wheezing, or cough a lot.
• Do not stop using Bronchitol or any other medicines unless told to do so by your healthcare provider because your symptoms might get worse.
• Your healthcare provider may change your medicines as needed.

Call your healthcare provider or get emergency medical care right away if your breathing problems get worse while taking Bronchitol.

What are the possible side effects of Bronchitol?

Bronchitol may cause serious side effects, including:

• sudden breathing problems immediately after inhaling your medicine. Use your short-acting bronchodilator or rescue medicine if you have sudden breathing problems. Get emergency medical care right away if your bronchodilator or rescue medicine does not relieve the symptoms.
• coughing up of blood (hemoptysis). This is a serious but common side effect. Coughing up blood in your mucus can happen while you are using Bronchitol. 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.

General information about the safe and effective use of Bronchitol

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

This guide summarizes the most important information about Bronchitol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Bronchitol that is written for health professionals.

How should I store Bronchitol?

• Store Bronchitol at room temperature between 68°F to 77°F (20°C to 25°C).
• If your Bronchitol capsules are stored at temperatures more than 86°F (30°C), throw them away.
• Do not freeze Bronchitol.
• Do not refrigerate Bronchitol.
• Throw away the Bronchitol inhaler after 7 days and get a new one.

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

What are the ingredients in Bronchitol?

Active ingredient: mannitol

Inactive ingredients: There are no inactive ingredients in Bronchitol.

Capsules: gelatin and water. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide E172

For more information about Bronchitol or how to use your inhaler, call 1-888-661-9260.

Label

Principal Display Panel – 40 mg Tolerance Test Carton Label

• Rx Only
• NDC 10122-212-04
• Bronchitol®
• (mannitol) inhalation powder
• Tolerance Test
• 40 mg per capsule
• FOR ORAL INHALATION ONLY
• Contents:

• 1 Blister Pack: 10 capsules
• 1 Bronchitol inhaler:
  For use with enclosed capsules only
• Tolerance Test Instructions
• Package Insert

• The Bronchitol Tolerance Test MUST be completed to
  identify bronchial hyperresponsiveness to mannitol
  prior to prescribing Bronchitol. Read Tolerance Test
  instructions for detailed procedure.
• Do Not Swallow Bronchitol Capsules
• Chiesi

SRC: NLM .