Mannitol (Inhaled)

INITIATION DOSE ASSESSMENT IS MANDATORY: the therapeutic dose regimen must not be prescribed until the patient has completed and passed an initiation dose assessment for bronchial hyperresponsiveness to inhaled mannitol, performed under the supervision of an experienced physician or trained health care professional equipped to perform spirometry, monitor SpO2 and manage acute bronchospasm (including resuscitation equipment). Pre-medicate with a bronchodilator 5-15 minutes before the initiation dose, after baseline FEV1 and SpO2 are measured; all FEV1 and SpO2 measurements are taken 60 seconds after dose inhalation. Steps: (1) measure baseline FEV1 and SpO2; (2) inhale 40 mg (1 x 40 mg capsule), monitor SpO2; (3) inhale 80 mg (2 x 40 mg), monitor SpO2; (4) inhale 120 mg (3 x 40 mg), measure FEV1 and monitor SpO2; (5) inhale 160 mg (4 x 40 mg), measure FEV1 and monitor SpO2; (6) measure FEV1 15 minutes post initiation dose. Monitor all patients until FEV1 returns to baseline. A bronchodilator must also be administered 5-15 minutes before EACH therapeutic dose. Each capsule is loaded into the device separately and inhaled with one or two breaths; discard each empty capsule before inserting the next with as little delay as possible. Replace the inhaler device after one week of use. For patients receiving several respiratory therapies the recommended order is: 1. bronchodilator, 2. Bronchitol, 3. physiotherapy/exercise, 4. dornase alfa (if applicable), 5. inhaled antibiotics (if applicable). Elderly (>=65 years): insufficient data to support a recommendation for or against dose adjustment. Paediatric: safety and efficacy in children and adolescents aged 6 to 18 years has not yet been established and no recommendation on a posology can be made; safety and efficacy in children under 6 years has not been established and no data are available. Note: the openFDA record in this bundle is for Osmitrol (intravenous mannitol, Baxter) — a different product, route and indication — and has deliberately NOT been used for any field here. Section 4.5 (interactions) was not fetched for the inhaled product, so no interaction list is given.