Symbicort 320/9 mcg/Dose

/ Astra Zeneca

Asthma
Symbicort Turbohaler 320/9 mcg/dose is not intended for the initial management of asthma.
The dosage of the components of Symbicort Turbuhaler 320/9 mcg/dose 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.
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 their prescriber/health care provider, so that the dosage of Symbicort Turbuhaler 320/9 mcg/dose remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When longterm 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 320/9 mcg/dose 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 (6 years and older): A lower strength (80 mcg/4.5 mcg/inhalation)
is available for children 6-11 years.
Children under 6 years: As only limited data are available, Symbicort Turbuhaler 320/9 mcg/dose is not recommended for children younger than 6 years.
Symbicort Turbuhaler 320/9 micrograms/dose should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen (160 mcg/4.5 mcg/inhalation and 80 mcg/4.5 mcg/inhalation).
COPD
Recommended doses: Adults: 1 inhalation twice daily.
Special patient groups: There are no special dosing requirements for elderly patients.
There are no data available for use of Symbicort Turbuhaler 320/9 mcg/dose 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: The Inhaler 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 Symbicort Turbohaler 320/9 mcg/dose 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 320/9 mcg/dose Inhaler after use.
– To rinse their 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 320/9 mcg/dose due to the small amount of drug dispensed.

Asthma: Indicated in adults and adolescents, age 12-17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:
– Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.
Or
– Patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptor-agonists.
Chronic Obstructive Pulmonary Disease (COPD): Indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in I second (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

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. Increasing use of rescue
bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma or COPD 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.
Patients should not be initiated on Symbicort during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after use of systemic and topical corticosteroids.
See prescribing information for full details.

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

Pharmacokinetic interactions: Potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided. If this is not possible the time interval between administration of the inhibitor and budesonide should be as long as possible.
The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose of 3 mg) on average six-fold.
When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels. Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four-fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled
budesonide (single dose of 1000 μg).
Pharmacodynamic interactions: Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Symbicort Turbuhaler 320/9 mcg/dose should therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), 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 or anticholinergic drugs can have a potentially additive bronchodilating effect.
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Budesonide and formoterol have not been observed to interact with any other drugs used in the treatment of asthma.

Pregnancy: For Symbicort or the concomitant treatment with formoterol and budesonide, no clinical data on exposed pregnancies are available. During pregnancy, Symbicort 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 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 β2-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.