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Posology: Asthma: DuoResp Spiromax is not intended for the initial management of asthma.
DuoResp Spiromax is not an appropriate treatment for the adult or adolescent patient with only mild asthma.
The dosage of DuoResp Spiromax is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of DuoResp Spiromax. Patients should be reassessed regularly by their prescriber/health care provider so that the dose of DuoResp Spiromax remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
When it is appropriate to titrate down to a lower strength than is available for DuoResp Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required. When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.
160/4.5 mcg inhalation powder: For DuoResp Spiromax there are two treatment approaches: DuoResp Spiromax maintenance therapy: DuoResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
DuoResp Spiromax maintenance and reliever therapy: DuoResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
DuoResp Spiromax maintenance therapy and 320/9 mcg inhalation powder: Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Recommended doses: 160/4.5 mcg inhalation powder: Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Adolescents (12 years and older): 1-2 inhalations twice daily.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include DuoResp Spiromax given once daily, when in the opinion of the prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid would be required to maintain control.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
DuoResp Spiromax maintenance and reliever therapy: Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to symptoms. Patients should be advised to always have DuoResp Spiromax available for rescue use.
For patients taking DuoResp Spiromax as reliever, preventative use of DuoResp Spiromax for allergen- or exercise-induced bronchoconstriction should be discussed between physician and patient; the recommended use should take into consideration the frequency of need. In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used.
DuoResp Spiromax maintenance and reliever therapy should especially be considered for patients with: inadequate asthma control and in frequent need of a reliever inhaler; asthma exacerbations in the past requiring medical intervention.
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax as-needed inhalations.
Recommended doses: Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate. 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. Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
320/9 mcg inhalation powder: Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily.
Adolescents (12 years and older): 1 inhalation twice daily.
Patients should be regularly reassessed by their prescriber/healthcare provider, so that the dosage of DuoResp Spiromax remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
In usual practice when control of symptoms is achieved with the twice-daily regimen, titration to the lowest effective dose could include DuoResp Spiromax given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
DuoResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only. A lower strength of DuoResp Spiromax is available for the maintenance and reliever therapy regimen.
COPD: Recommended doses: 160/4.5 mcg inhalation powder: Adults (18 years and older): 2 inhalations twice daily.
320/9 mcg inhalation powder: Adults (18 years and older): 1 inhalation twice daily.
160/4.5 mcg inhalation powder and 320/9 mcg inhalation powder: Special populations: Elderly patients (≥65 years old): There are no special dosing requirements for elderly patients.
Patients with renal or hepatic impairment: There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
Paediatric population: The safety and efficacy of DuoResp Spiromax in paediatric patients below 12 years of age have not been established. No data are available.
This medicinal product is not recommended for use in children under the age of 12 years.
Method of administration: For inhalation use only.
Spiromax is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece.
Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose (see PHARMACOLOGY: Pharmacodynamics under Actions).
DuoResp Spiromax should be used correctly in order to achieve effective treatment. As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
The use of DuoResp Spiromax follows three steps: open, breathe and close which are outlined as follows.
Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler. Breathe in forcefully and deeply through the mouthpiece. Remove the Spiromax from mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Close: Breathe out gently and close the mouthpiece cover.
It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the "Breathe" step.
Patients should also be advised to rinse their mouth with water after inhaling (see Precautions). The patient may notice a taste when using DuoResp Spiromax due to the lactose excipient.
