Foster Nexthaler

Foster Nexthaler Dosage/Direction for Use

Manufacturer:

OEP Phils

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) is for inhalation use.
ASTHMA: Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) is not intended for the initial management of asthma. The dosage of the product 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 Beclometasone dipropionate/Formoterol fumarate dihydrate (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 the product 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 Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) inhalation powder from Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) pressurised inhalation solution do not need dose adjustment.
There are two treatment approaches: A. Maintenance therapy: Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) is taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator.
B. Maintenance and reliever therapy: Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) is taken as regular maintenance treatment and as needed in response to asthma symptoms.
A. 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.
B. Maintenance and reliever therapy: Patients take their daily maintenance dose of beclometasone dipropionate/formoterol fumarate dihydrate (Foster Nexthaler) and in addition take Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) as needed in response to asthma symptoms. Patients should be advised to always have beclometasone dipropionate/formoterol fumarate dihydrate (Foster Nexthaler) available for rescue use.
Beclometasone dipropionate/formoterol fumarate dihydrate (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 beclometasone dipropionate/formoterol fumarate dihydrate (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.
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 Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) in children and adolescents under 18 years of age have not yet been established. No data are available in children up to 11 years old. Currently available 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.
Patients should be regularly reassessed by a doctor, so that the dosage of Beclometasone dipropionate/Formoterol fumarate dihydrate (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 Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) every day even when asymptomatic.
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 Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) in patients with hepatic or renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: The device 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 the device (see Pharmacology: Pharmacodynamics under Actions). The delivery of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) with the device is flow-independent in the range of inspiratory flow that this patient population can achieve through the inhaler.
Correct use of the device 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.
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).
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