Symbicort

Per 160/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 80/2.25 mcg rapihaler Budesonide 80 mcg, formoterol fumarate dihydrate 2.25 mcg. Per 160/4.5 mcg rapihaler Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg

Asthma; to achieve overall asthma control including prevention & symptomatic relief, risk reduction of exacerbations where use of inhaled corticosteroids is appropriate. Turbuhaler: Symptomatic treatment of patients w/ COPD [FEV₁ <70% predicted normal (post-bronchodilator)] & history of repeated exacerbations despite regular long-acting bronchodilator therapy. Rapihaler: Regular treatment of patients w/ severe COPD (FEV₁ <50% predicted normal) w/ frequent symptoms & history of exacerbations despite regular bronchodilator therapy.

Asthma [anti-inflammatory reliever therapy (mild disease)] Adult & adolescent ≥12 yr 160/4.5 mcg turbuhaler 1 inhalation as needed in response to symptoms & for prevention of allergen- or exercise-induced bronchoconstriction to control asthma. Additional 1 inhalation should be taken if symptoms persist after a few min. Max: 6 inhalations on any single occasion. Max total daily dose that can be used temporarily: 12 inhalations. 80/2.25 mcg rapihaler 2 actuations as needed in response to symptoms & for prevention of allergen- or exercise-induced bronchoconstriction to control asthma. Additional 2 actuations should be taken if symptoms persist after a few min. Max: 12 actuations on any single occasion. Max total daily dose that can be used temporarily: 24 actuations. Anti-inflammatory reliever plus maintenance therapy Adult & adolescent ≥12 yr 160/4.5 mcg turbuhaler 1 inhalation as needed in response to symptoms & for prevention of allergen- or exercise-induced bronchoconstriction to control asthma. Additional 1 inhalation should be taken if symptoms persist after a few min. Max: 6 inhalations on any single occasion. Maintenance: 2 inhalations daily given either as 1 inhalation in morning & evening or as 2 inhalations either in morning or evening. 2 inhalations bd may be appropriate for some patients. Max total daily dose for a limited period: 12 inhalations. 80/2.25 mcg rapihaler 2 actuations as needed in response to symptoms & for prevention of allergen- or exercise-induced bronchoconstriction to control asthma. Additional 2 actuations should be taken if symptoms persist after a few min. Max: 12 actuations on any single occasion. Maintenance: 4 actuations daily given either as 2 actuations in morning & evening or as 4 actuations either in morning or evening. 4 actuations bd may be appropriate for some patients. Max total daily dose that can be used temporarily: 24 actuations. Maintenance therapy (fixed dose) Adult ≥18 yr 160/4.5 mcg turbuhaler 1-2 inhalations bd. Max: 4 inhalations bd. 80/2.25 mcg rapihaler 2-4 actuations bd. Max: 8 actuations bd. 160/4.5 mcg rapihaler 2 actuations bd. Max: 4 actuations bd. Adolescent 12-17 yr 160/4.5 mcg turbuhaler 1-2 inhalations bd. Max: 4 inhalations bd. 80/2.25 mcg rapihaler 2-4 actuations bd. Max: 8 actuations bd. 160/4.5 mcg rapihaler 2 actuations bd. Max: 4 actuations bd. Childn 6-11 yr 80/2.25 mcg rapihaler 2 actuations bd. Max daily dose: 4 actuations. COPD Adult 160/4.5 mcg turbuhaler 2 inhalations bd. 80/2.25 mcg rapihaler 4 actuations bd. Max daily dose: 8 actuations. 160/4.5 mcg rapihaler 2 actuations bd. Max daily dose: 4 actuations.

Hypersensitivity to budesonide or formoterol. Turbuhaler: Hypersensitivity to lactose.

Taper maintenance dose & do not abruptly stop when treatment is discontinued. Instruct patient to rinse mouth w/ water after inhaling maintenance dose to minimise risk of oropharyngeal Candida infection. Possible serious asthma-related adverse events & exacerbations; advise patient to seek medical advice if asthma symptoms remain uncontrolled or worsen after treatment initiation. Discontinue use if paradoxical bronchospasm occurs. Systemic effects may occur w/ any inhaled corticosteroid particularly at high doses for long periods. Possible adrenal suppression, decreased bone mineral density, cataract, glaucoma; visual disturbance w/ systemic & topical corticosteroid use. Consider referral to an ophthalmologist if patient presents w/ symptoms eg, blurred vision or other visual disturbances for evaluation. Risk of impaired adrenal function for a considerable time in patients transferring from oral steroids & those who require high-dose emergency corticosteroid therapy or prolonged treatment at the highest recommended inhaled corticosteroid dose. Consider additional systemic corticosteroid cover during periods of stress or elective surgery. Patients w/ severe CV disorders (including hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm, ischaemic heart disease, heart rhythm abnormalities or severe heart failure), phaeochromocytoma, DM, untreated hypokalaemia or thyrotoxicosis. Patients w/ QTc interval prolongation. Potentially serious hypokalaemia in high doses; concomitant use w/ hypokalaemia-inducing drugs (eg, xanthine derivatives, steroids, diuretics); monitor serum K levels. Consider additional blood glucose controls in diabetic patients. Re-evaluate the need for & dose of inhaled corticosteroids in patients w/ active or quiescent pulmonary TB, fungal & viral airway infections. Possible development of pneumonia in COPD patients. Concomitant treatment w/ potent CYP3A4 inhibitors. Increased exposure in patients w/ severe liver diseases. Hepatic & renal impairment. Pregnancy & lactation. Growth retardation in childn & adolescents; regularly monitor height of childn receiving prolonged treatment. Not recommended in childn <6 yr. Turbuhaler: Contains lactose which may cause allergic reactions. COPD patients w/ pre-bronchodilator FEV₁ >50% predicted normal & w/ post-bronchodilator FEV₁ <70% predicted normal. Anti-inflammatory reliever plus maintenance therapy is not recommended for childn <12 yr. Rapihaler: Possible psychological/behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn).

Palpitations; oropharyngeal Candida infection, pneumonia (in COPD patients); headache, tremor; mild throat irritation, coughing, hoarseness.

May increase systemic budesonide exposure w/ potent CYP3A4 inhibitors. Weakened or inhibited formoterol effect w/ β-adrenergic blockers (including eye drops). May prolong QTc interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, terfenadine, MAOIs & TCAs. May impair cardiac tolerance towards β₂-sympathomimetics w/ L-dopa, L-thyroxine, oxytocin & alcohol. May precipitate hypertensive reactions when concomitantly used w/ MAOIs including agents w/ similar properties (eg, furazolidone & procarbazine). Elevated risk of arrhythmias in patients receiving concomitant anaesth w/ halogenated hydrocarbons. Potential additive effect when concomitantly used w/ other β-adrenergic drugs. Hypokalaemia may increase disposition towards arrhythmias in patients who are treated w/ digitalis glycosides.

Antiasthmatic & COPD Preparations

R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

POM