Foster NEXThaler Dosage/Direction for Use

Foster NEXThaler is for inhalation use.
Asthma: Foster NEXThaler is not intended for the initial management of asthma. The dosage of Foster NEXThaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta₂-agonists and/or corticosteroids by individual inhalers should be prescribed.
Because of its extrafine particle size distribution, dose adjustment is required when patients are transferred to Foster NEXThaler inhalation powder from a formulation with a non-extrafine particle size distribution. When switching patients from previous treatments, it should be considered that the recommended total daily dose of beclometasone dipropionate for Foster NEXThaler is lower than that for current beclometasone dipropionate-containing non-extrafine products and should be adjusted to the needs of the individual patient. However, patients who are transferred to Foster NEXThaler inhalation powder from Foster pressurised inhalation solution do not need dose adjustment.
Patients should be regularly reassessed by a doctor, so that the dosage of Foster NEXThaler remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step-down could include the inhaled corticosteroid alone.
Patients should be advised to take Foster NEXThaler every day even when asymptomatic.
There are two treatment approaches: Maintenance therapy: Foster NEXThaler is taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator.
Maintenance and reliever therapy: Foster NEXThaler is taken as regular maintenance treatment and as needed in response to asthma symptoms.
Maintenance therapy: Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Dose recommendations for adults 18 years and above: One or two inhalations twice daily.
The maximum daily dose is 4 inhalations daily.
Maintenance and reliever therapy: Patients take their daily maintenance dose of Foster NEXThaler and in addition take Foster NEXThaler as needed in response to asthma symptoms. Patients should be advised to always have Foster NEXThaler available for rescue use.
Foster NEXThaler maintenance and reliever therapy should especially be considered for patients with: not fully controlled asthma and in need of reliever medication; asthma exacerbations in the past requiring medical intervention.
Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Foster NEXThaler as-needed inhalations.
Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening).
Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.
The maximum daily dose is 8 inhalations daily.
Patients requiring frequent use of rescue inhalations daily should be strongly recommended to seek medical advice. Their asthma should be reassessed and their maintenance therapy should be reconsidered.
Dose recommendations for children and adolescents under 18 years: The safety and efficacy of Foster NEXThaler in children and adolescents under 18 years of age have not yet been established. Foster NEXThaler should not be used in children aged 5-11 years, because of safety concerns. Available data in this age group are summarised in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions. Currently available clinical data in adolescents aged 12-17 years are summarised in Adverse Reactions and Pharmacology: Pharmacodynamics under Actions, but no recommendation on a posology can be made.
COPD: Dose recommendations for adults 18 years and above: Two inhalations twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients.
There are no data available for use of Foster NEXThaler in patients with hepatic or renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Nexthaler is a breath-operated inhaler. Moderate and severe asthmatic patients were shown to be able to produce sufficient inspiratory flow to trigger dose release from Nexthaler (see Pharmacology: Pharmacodynamics under Actions). The delivery of Foster with Nexthaler is flow-independent in the range of inspiratory flow that this patient population can achieve through the inhaler.
Correct use of the Nexthaler inhaler is essential in order for the treatment to be successful. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use as given in the leaflet. For the convenience of the prescriber these instructions are provided in Instructions for Use of Nexthaler Inhaler under Patient Counselling Information.
The number of doses shown in the window on the shell does not decrease on closing the cover if the patient has not inhaled through the inhaler.
The patient should be instructed to only open the inhaler's cover when needed. In the event that the patient has opened the inhaler but not inhaled, and the cover is closed, the dose is moved back to the powder reservoir within the inhaler; the following dose can be safely inhaled.
Patients should rinse their mouth or gargle with water or brush their teeth after inhaling (see Precautions).