Symbicort Turbuhaler

Symbicort Turbuhaler Dosage/Direction for Use

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Route of administration: For inhalation use.
Posology: Asthma: Symbicort Turbuhaler can be used according to different treatment approaches: Symbicort anti-inflammatory reliever therapy (patients with mild disease).
Symbicort anti-inflammatory reliever plus maintenance therapy.
Symbicort maintenance therapy (fixed dose).
Symbicort anti-inflammatory reliever therapy (patients with mild disease): Symbicort Turbuhaler 160/4.5 μg/inhalation is taken as needed for the relief of asthma symptoms when they occur and as a preventative 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 μg/inhalation available for relief of symptoms.
Preventative use of Symbicort Turbuhaler 160/4.5 μg/inhalation 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.
Adults and adolescents (12 years and older): Patient should take 1 inhalation of Symbicort Turbuhaler 160/4.5 μg/inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. No 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 inhalation, the patient should be reassessed for alternative explanations of persisting symptoms.
Symbicort Turbuhaler 80/4.5 μg/inhalation should NOT be used as Symbicort Anti-inflammatory Reliever Therapy.
Children under 12 years: Symbicort anti-inflammatory reliever therapy is not recommended for children.
Symbicort anti-inflammatory reliever plus maintenance 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 anti-inflammatory reliever plus maintenance 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.
Preventative use of Symbicort Turbuhaler 160/4.5 μg/inhalation 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): Anti-inflammatory Reliever Therapy (in addition to Maintenance Therapy): Patients should take 1 additional inhalation of Symbicort Turbuhaler 80/4.5 μg/inhalation or 160/4.5 μg/inhalation as needed in response to symptoms to control asthma. 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.
Maintenance Therapy: Patients also take the recommended maintenance dose of Symbicort Turbuhaler 80/4.5 μg/inhalation or 160/4.5 μg/inhalation, which 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 Symbicort Turbuhaler 160/4.5 μg/inhalation 2 inhalations twice daily may be appropriate. The maintenance dose should be titrated to the lowest dose at which effective control of asthma is maintained.
Maximum Daily Symbicort Dose: 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. If the patient experiences a three-day period of deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalation, the patient should be reassessed for alternative explanations of persisting symptoms.
Children under 12 years: Symbicort anti-inflammatory reliever plus maintenance therapy is not recommended for children.
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 for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief use at all times.
Recommended doses: Adults (18 years and older): Symbicort Turbuhaler 80/4.5 μg/inhalation or 160/4.5 μg/inhalation: 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Adolescents (12-17 years): Symbicort Turbuhaler 80/4.5 μg/inhalation or 160/4.5 μg/inhalation: 1-2 inhalations twice daily.
Children (6 years and older): Symbicort Turbuhaler 80/4.5 μg/inhalation: 2 inhalations twice daily.
Children under 6 years: Symbicort Turbuhaler 80/4.5 and 160/4.5 μg/inhalation: As only limited data are available, Symbicort Turbuhaler is not recommended for children under 6 years old.
Patients should be regularly reassessed by their prescriber/health care provider, 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 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.
COPD: Recommended doses: Adults (18 years and older): Symbicort Turbuhaler 160/4.5 μg/inhalation: 2 inhalations twice daily.
General information: If patients take Symbicort Turbuhaler as 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.
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 diseases.
Method of administration: 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/handling under Patient Counselling Information; 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 Turbuhaler due to the small amount of drug dispensed.
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