Symbicort Turbuhaler Dosage/Direction for Use

80/4.5 mcg and 320/9 mcg: Asthma: Symbicort 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.
80/4.5 mcg: For Symbicort there are two treatment approaches: Symbicort maintenance and reliever therapy: Patients take a daily maintenance dose of Symbicort and additional take Symbicort as needed in response to symptoms. Patients should be advised to always have Symbicort available for rescue use.
A. Symbicort maintenance therapy: Symbicort is taken as regular maintenance treatment with 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): 1-2 inhalations twice daily.
Patients should be regularly reassessed by a doctor, so that the dosage of Symbicort remains optimal. 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 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 Symbicort Turbuhaler given once daily.
Increasing use of a separate rapid-acting bronchodilators 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 additional take Symbicort as needed in response to symptoms. Patients should be advised to always have Symbicort available for rescue use.
Recommended doses: Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as 1 inhalation in the morning and evening or 2 inhalations in either the morning or evening. Patients should take 1 additional inhalations as needed in response to symptoms. If symptoms persist after a few minutes, an additional 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 (6 years and older): The usual maintenance dose is 1 inhalations once daily. Some patients may require a maintenance dose of 1 inhalations twice daily. Patients should take additional inhalations as needed in response to symptoms. A total daily dose of up to 8 inhalations may be used temporarily.
Children under 6 years: Symbicort is not recommended for children under 6 years of age.
160/4.5 mcg: Asthma: Symbicort can be used according to different treatment approaches: A. Symbicort anti-inflammatory reliever therapy (patients with mild disease).
B. Symbicort anti-inflammatory reliever plus maintenance therapy.
C. Symbicort maintenance therapy (fixed dose).
A. Symbicort anti-inflammatory reliever therapy (patients with mild disease): Symbicort Turbuhaler 160/4.5 mcg is taken as needed for the relief of asthma symptoms when they occur, and as a preventive treatment of symptoms in those circumstances recognised by the patient to precipitate an asthma attack. Patients should be advised to always have Symbicort Turbuhaler 160/4.5 mcg available for relief of symptoms.
Preventive use of Symbicort Turbuhaler 160/4.5 mcg for allergen- or exercise-induced bronchoconstriction (AIB/EIB) should be discussed between physician and patient; the recommended dose frequency should take into consideration both allergen exposure and exercise patterns.
Recommended doses: Adults and adolescents (12 years and older): Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 mcg 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 normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences a three-day period of deteriorating symptoms after taking additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
B. Symbicort anti-inflammatory reliever plus maintenance therapy: When maintenance treatment with a combination of inhaled corticosteroid (ICS) and long-acting β₂ agonist (LABA) is required, patient take Symbicort anti-inflammatory reliever therapy and in addition take a daily maintenance dose of Symbicort Turbuhaler. The as-needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to have Symbicort Turbuhaler available for relief of symptoms at all times.
Preventative use of Symbicort Turbuhaler 160/4.5 mcg for AIB/EIB should be discussed between physician and patient; the recommended dose frequency should take into consideration both allergen exposure and exercise patterns.
Recommended doses: Adults and adolescents (12 years and older): Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 mcg as needed in response to symptoms to control asthma. If symptoms persist after a few minutes, another inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
Patients also take the recommended maintenance dose of Symbicort Turbuhaler 160/4.5 mcg, which is two inhalations per day, given as either one inhalation in the morning and evening or as two inhalations in either the morning or evening. For some patients, a maintenance dose of Symbicort Turbuhaler 160/4.5 mcg two inhalations twice daily may be appropriate. The maintenance dose should be titrated to the lowest dose at which effective control of asthma is maintained.
A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences a three-day period of deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
Children (6 years and older): A lower strength is available for children 6-11 years.
C. Symbicort maintenance therapy (fixed dose): When maintenance treatment with a combination of ICS and LABA is required, Symbicort Turbuhaler is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator available for relief of symptoms at all times.
Increasing use of short-acting bronchodilators indicates a worsening of the underlying condition and warrants reassessment of the asthma therapy. The dosage of Symbicort Turbuhaler should be individualised according to disease severity. When control of asthma has been achieved, the maintenance dose should be titrated to the lowest dose at which effective asthma control is maintained.
Recommended doses: Adults and adolescents (12 years and older): 1-2 inhalations of Symbicort Turbuhaler 160/4.5 mcg twice daily. The maximum recommended daily maintenance dose is 4 inhalations (2 inhalations twice daily corresponding to 800 mcg metered dose (640 mcg delivered dose) budesonide/24 mcg metered dose (18 mcg delivered dose) formoterol).
COPD: Adults: 2 inhalations twice daily.
320/9 mcg: Recommended doses: Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily.
Adolescents (12-17 years): 1 inhalation twice daily.
Patients should be regularly reassessed by a doctor, so that the dosage of Symbicort remains optimal. 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 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 Symbicort Forte Turbuhaler given once daily, when in the opinion of the prescriber, a long acting bronchodilator would be required to maintain control.
Children (6 years and older): A lower strength (80/4.5 μg/inhalation) is available for children 6-11 years. Symbicort Forte Turbuhaler is not recommended for children under 12 years old.
COPD: Adults: 1 inhalation twice daily.
General Information: 160/4.5 mcg: If patients take Symbicort Turbuhaler as an anti-inflammatory reliever (either alone or in combination with maintenance therapy) physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency for asthma treatment.
If patients take Symbicort Turbuhaler as a maintenance therapy, they should be instructed to take the maintenance dose of Symbicort Turbuhaler even when asymptomatic for optimal benefit.
Special patient groups: There are no special dosing requirements for elderly patients.
There are no data available for use of Symbicort Turbuhaler 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 Symbicort 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 check the expiry date.
To carefully read the instructions for use/handling at the end of this monograph.
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 the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Symbicort Turbuhaler due to the small amount of drug dispensed.