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Cystic fibrosis Clinical criteria: The treatment must be as monotherapy, AND Patient must be intolerant or inadequately responsive to dornase alfa. Population criteria: Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
“When inhaled, mannitol induces an increase in osmolarity in the airways similar to other bronchial provocation tests such as hypertonic saline, exercise and the hyperpnea of dry air. The increase in osmolarity is associated with the release of a wide variety of mediators of bronchoconstriction from inflammatory cells within the airways.”
“The elimination half-life in adults is approximately 1-2 hours.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.