Active Ingredient: Mannitol
Mannitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
For this indication, competent medicine agencies globally authorize below treatments:
Respiratory (Inhalation)
800 - 800 mg
From 400 To 400 mg 2 time(s) per day every day
Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose.
The patient’s initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO2), and manage acute bronchospasm including appropriate use of resuscitation equipment.
The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement. All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Training the patient to practice correct inhaler technique during the initiation dose assessment is important.
The initiation dose assessment must be performed according to the following steps:
Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose
Step 2: Patient inhales 40 mg and SpO2 is monitored.
Step 3: Patient inhales 80 mg and SpO2 is monitored.
Step 4: Patient inhales 120 mg, FEV1 is measured and SpO2 is monitored.
Step 5: Patient inhales 160 mg, FEV1 is measured and SpO2 is monitored.
Step 6: Patients FEV1 is measured 15 minutes post initiation dose.
Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV1 has returned to baseline levels.
The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed. The patient must complete and pass the initiation dose assessment before starting treatment with mannitol.
A bronchodilator must be administered 5-15 minutes before each dose of mannitol.
The recommended dose of mannitol is 400 mg twice a day. This requires the inhalation of the contents of ten capsules via the inhaler device twice a day. The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.
For patients receiving several respiratory therapies, the recommended order is:
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