Symbicort 80/4.5 mcg/Dose

/ Astra Zeneca

Symbicort Turbuhaler is not intended for the initial management of asthma. The dosage of the components of Symbicort Turbuhaler 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 beta2-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 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.
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 longacting 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: Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.
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 adolescents under 18 years: Symbicort maintenance and reliever therapy is not recommended for children and adolescents.
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.
Method of Administration: 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 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.

Symbicort Turbuhaler is indicated in the regular treatment of asthma
where use of a combination (inhaled corticosteroid and long acting betaagonist) is appropriate:
– patients not adequately controlled with inhaled corticosteroids and “as
needed” inhaled short acting beta2-agonists.
Or
– patients already adequately controlled on both inhaled corticosteroids
and long acting beta2-agonists.
Note: Symbicort 80/4.5 micrograms/inhalation is not appropriate in
patients with severe asthma.

Hypersensitivity to the active substance(s) or to any of the excipients.

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
If patients find the treatment ineffective, or exceed the highest recommended dose of Symbicort, medical attention must be sought. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should undergo urgent medical assessment. In this situation consideration should be given to the need for increased therapy with corticosteroids, e.g., a course of oral corticosteroids, or antibiotic treatment if an infection is present.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Symbicort. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Symbicort should be used.
Patients should not be initiated on Symbicort during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
See prescribing information for full details.

Common: Palpitations, Candida infections in the oropharynx, Headache, Tremor, Mild irritation in the throat, Coughing, Hoarseness.
See prescribing information for full details.

Pharmacokinetic interactions: The metabolic conversion of budesonide is impeded by substances metabolized by CYP P450 3A4 (e.g. itraconazole, ritonavir). The concomitant administration of these potent inhibitors of CYP P450 3A4 may increase plasma levels of budesonide. The concomitant use of these drugs should be avoided unless the benefit outweighs the increased risk of systemic side-effects. In patients using potent CYP3A4 inhibitors, Symbicort maintenance and reliever therapy is not recommended.
Pharmacodynamic interactions: Beta-adrenergic blockers can weaken or inhibit the effect of formoterol.
Symbicort Turbuhaler should therefore not be given together with betaadrenergic blockers (including eye drops) unless there are compelling
reasons.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2-sympathomimetics.
Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.
There is an elevated risk of arrhythmias in patients receiving concomitant
anaesthesia with halogenated hydrocarbons.
Concomitant use of other beta-adrenergic drugs can have a potentially additive effect.
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Budesonide has not been observed to interact with any other drugs used in the treatment of asthma.

Pregnancy: During pregnancy, Symbicort Turbuhaler should only be used when the benefits outweigh the potential risks. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Lactation: Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child are anticipated. It is not known whether formoterol passes into human breast milk. . In rats, small amounts of formoterol have been detected in maternal milk. Administration of Symbicort Turbuhaler to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

An overdose of formoterol would likely lead to effects that are typical for beta2-adrenergic agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
If Symbicort therapy has to be withdrawn due to overdose of the formoterol component of the drug, provision of appropriate inhaled corticosteroid therapy must be considered.