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Asthma: SYMBICORT is not intended for the initial management of asthma. The dosage of the components of SYMBICORT is individualized 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 beta-agonist 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 80/4.5 mcg/dose turbuhaler there are two alternative therapies and for SYMBICORT 160/4.5 mcg/dose turbuhaler there are 3 alternative therapies.
SYMBICORT maintenance and reliever therapy: SYMBICORT is taken as both regular maintenance treatment and also as needed in response to symptoms. The as needed inhalations provide both rapid relief and improved asthma control. Patients should be advised to have SYMBICORT available for rescue use at all times. A separate inhaler for rescue use is not necessary. Clinical studies have demonstrated that SYMBICORT maintenance and reliever therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to SYMBICORT maintenance therapy with a separate rapid-acting bronchodilator (see Pharmacology: Pharmacodynamics under Actions).
Recommended doses: Adult 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 of Symbicort 160/4.5 mcg 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 re-assessment of asthma therapy should be considered in patients using an increasing number of SYMBICORT inhalations for symptom relief without achieving improved asthma control within 2 weeks.
Turbuhaler & Rapihaler 80/4.5 mcg/dose: A total daily dose of more than 8 inhalations for adults and adolescents and 4 inhalations for children is not normally needed, however a total daily dose of up to 12 inhalations for adults and adolescents and 8 inhalations for children could be used temporarily.
Turbuhaler & Rapihaler 160/4.5 mcg/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 temporarily.
Children (6 years and older): Turbuhaler & Rapihaler 80/4.5 mcg/dose: The usual maintenance dose is 1 inhalation once daily. 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 4 inhalations should be taken on any single occasion.
Turbuhaler & Rapihaler 160/4.5 mcg/dose: A lower strength is available for children 6-11 years.
SYMBICORT maintenance therapy: Symbicort taken as regular maintenance treatment, with a separate rapid-acting bronchodilator as rescue. Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses: Adults and 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 SYMBICORT Turbuhaler/Rapihaler 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): Turbuhaler & Rapihaler 80/4.5 mcg/dose: 2 inhalation twice daily.
Turbuhaler & Rapihaler 160/4.5 mcg/dose: A lower strength is available for children 6-11 years
Children under 6 years: SYMBICORT Turbuhaler/Rapihaler 80/4.5 mcg/dose is not recommended for children under 6 years of age.
Turbuhaler & Rapihaler 160/4.5 mcg/dose: COPD: Adults (18 years and older): 2 inhalations twice daily.
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.
Turbuhaler 160/4.5 mcg/dose: SYMBICORT Anti-Inflammatory Therapy (Patients with Mild Disease): Symbicort is taken as needed for the relief of asthma symptoms when they occur. Patients should be advised to always have Symbicort available for relief of symptoms.
Recommended doses: Adults and adolescents (12 years and older): Patients should take 1 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 asthma therapy should be reconsidered.
Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Symbicort as-needed inhalations.
Children under 12 years: Efficacy and safety of Symbicort anti-inflammatory reliever therapy in children under 12 years have not been studied.
Turbuhaler: 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 mouth with water after inhaling the prescribed maintenance dose to minimize the risk of oropharyngeal thrush. If oropharyngeal thrush occurs, patients should also rinse 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.
Rapihaler: General information: 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.
Hepatic/renal impairment: 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 systemic availability can be expected in patients with severe liver disease.
Instructions for correct use of Symbicort Rapihaler: On actuation of Symbicort Rapihaler, a volume of the suspension is expelled from the canister at high velocity. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways. Check the expiry date.
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 of Symbicort Rapihaler.
Shake the inhaler gently prior to each use to mix its contents properly.
Prime the inhaler by actuating it twice into the air when the inhaler is new, if it has not been used for more than one week or if it has been dropped.
Place the mouthpiece in the mouth. While breathing in slowly and deeply, press the device firmly to release the medication. Continue to breathe in and hold the breath for approximately 10 seconds or as long as is comfortable. Shake the inhaler again and repeat this step for the second inhalation.
Rinse the mouth with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
Clean the mouthpiece of the inhaler regularly, at least once a week with a clean dry cloth. Do not put the inhaler into water.
