Posology : מינונים

4.2 Posology and method of administration

Symbicort Turbuhaler is not intended for the initial management of asthma. The dosage of the components of Symbicort 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 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.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/health care provider so that the dosage of Symbicort remains optimal. 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.
For Symbicort there are two treatment approaches:
A. Symbicort maintenance therapy: Symbicort is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
B. Symbicort maintenance and reliever therapy: Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.
A. Symbicort maintenance therapy
Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses:
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 – 17 years): 1-2 inhalations twice daily.
Children (6 years and older): 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 Symbicort 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.
Children under 6 years: Symbicort is not recommended for children under 6 years of age.
B. Symbicort maintenance and reliever therapy
Patients take a daily maintenance dose of Symbicort and in addition take Symbicort as needed in response to symptoms. Patients should be advised to always have Symbicort available for rescue use.
Symbicort maintenance and reliever therapy should especially be considered for patients with: • inadequate asthma control and in frequent 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 Symbicort as-needed inhalations.
Recommended doses:
Adults (18 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. 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.
Children and adolesences under 18 years: Symbicort maintenance and reliever therapy is not recommended for children and adolescents.
General information
Special patient groups:
There are no special dosing requirements for elderly patients. There are no data available for use of Symbicort 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.
Instructions for correct use of Turbuhaler:
Turbuhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient
• to carefully read the instructions for use in the patient information leaflet which is packed together with each inhaler.
• to breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
• never to breathe out through the mouthpiece.
• to replace the cover of the Symbicort Turbuhaler after use, to rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush. If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations.

The patient may not taste or feel any medication when using Symbicort Turbuhaler due to the small amount of drug dispensed.