Symbicort

Per 80/4.5 mcg turbuhaler Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 160/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 320/9 mcg turbuhaler Budesonide 320 mcg, formoterol fumarate dihydrate 9 mcg. Per 80/2.25 mcg rapihaler Budesonide 80 mcg, formoterol fumarate dihydrate 2.25 mcg. Per 80/4.5 mcg rapihaler Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 160/4.5 mcg rapihaler Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg

Turbuhaler: Regular treatment of asthma using combination of inhaled corticosteroid & long-acting β₂-agonist in patients not adequately controlled w/ inhaled corticosteroids & as needed inhaled short-acting β₂-agonists or patients already adequately controlled on both inhaled corticosteroids & long-acting β₂-agonists. 160/4.5-mcg turbuhaler: Treatment of asthma to achieve overall asthma control, including prevention & symptomatic relief, reduction of exacerbation risks. 160/4.5-mcg & 320/9-mcg turbuhaler: Symptomatic treatment of patients w/ COPD [FEV₁ <70% predicted normal (post-bronchodilator)] & history of repeated exacerbations despite regular long-acting bronchodilator therapy. Rapihaler: Asthma; achieve overall asthma control, including prevention & symptomatic relief, reduction of exacerbation risks; & where the use of inhaled corticosteroids is appropriate. Regular treatment of patients w/ severe COPD (FEV₁ <50% predicted normal) w/ frequent symptoms & history of exacerbations despite regular bronchodilator therapy.

Asthma (maintenance & reliever therapy) Adult & adolescent ≥12 yr 80/4.5-mcg turbuhaler Maintenance dose: 2 inhalations daily, 1 inhalation in the morning & evening or as 2 inhalations either in the morning or evening. Additional inhalations may be taken as needed but not >6 inhalations/occasion. A total daily dose of up to 12 inhalations could be used for a limited period. Maintenance treatment w/ a separate rapid-acting bronchodilator as rescue Adult ≥18 yr 80/4.5 mcg turbuhaler 1-2 inhalations bd. Max: 4 inhalations bd. Adolescent 12-17 yr 80/4.5-mcg turbuhaler 1-2 inhalations bd. Childn ≥6 yr 80/4.5-mcg turbuhaler 2 inhalations bd. Anti-inflammatory reliever therapy (mild disease); 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 inhalations may be taken but not >6 inhalations/occasion. 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 may be taken if symptoms persist after a few min. Max: 12 actuations (on any single occasion); 24 actuations (total daily dose). Patient recommended to take maintenance dose 160/4.5-mcg turbuhaler 2 inhalations daily, 1 inhalation in the morning & evening or as 2 inhalations either in the morning or evening. 80/2.25-mcg rapihaler 4 actuations daily given either as 2 actuations in the morning & evening or as 4 actuations in either morning or evening. 4 actuations bd may be appropriate for some. Max total daily dose: 24 actuations. Maintenance therapy (fixed dose) Adult ≥18 yr & Adolescent 12-17 yr 160/4.5-mcg turbuhaler 1-2 inhalations bd. Max: 4 inhalations bd. 80/2.25-mcg rapihaler 2 or 4 actuations bd. Max: 8 actuations bd. 80/4.5-mcg & 160/4.5-mcg rapihaler 2 actuations bd. Max: 4 actuations bd. Childn 6-11 yr 80/2.25-mcg & 80/4.5-mcg rapihaler 2 actuations bd. Max daily dose: 4 actuations. Asthma Adult ≥18 yr 320/9-mcg turbuhaler 1 inhalation bd. Max: 2 inhalations bd. Adolescent 12-17 yr 1 inhalation bd. COPD Adult 160/4.5-mcg turbuhaler 2 inhalations bd. 320/9-mcg turbuhaler 1 inhalation 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.

Not intended for the initial management of asthma & regular prophylaxis of asthma (except for 160/4.5-mcg turbuhaler & 80/2.25-mcg rapihaler). Maintenance dose should be tapered when the treatment is discontinued & should not be stopped abruptly. Possible serious asthma-related adverse events & exacerbations; 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. 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. Turbuhaler contains lactose which may cause allergic reactions. Concomitant treatment w/ potent CYP3A4 inhibitors. Patients w/ severe CV disorders including hypertrophic obstructive cardiomyopathy, idiopathic subvalvular stenosis, severe HTN, aneurysm, ischaemic heart disease, heart rhythym 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 & dose of inhaled corticosteroids in patients w/ active or quiescent pulmonary TB, fungal & viral airway infections. Pregnancy & lactation. Growth retardation in childn & adolescents; regularly monitor height of childn receiving prolonged treatment. Not recommended in childn <6 yr. 80/4.5-mcg turbuhaler: Not appropriate in patients w/ severe asthma. 160/4.5-mcg & 320/9-mcg turbuhaler, rapihaler: Possible development of pneumonia in patients w/ COPD.

Palpitations; Candida infections in the oropharynx; headache, tremor; mild throat irritation, coughing, hoarseness. 160/4.5-mcg & 320/9-mcg turbuhaler, rapihaler: Pneumonia (in COPD patients).

Systemic budesonide exposure may be increased by potent CYP3A4 inhibitors. Weakened or inhibited formoterol effect by β-adrenergic blockers (including eye drops). Prolonged QTc-interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, terfenadine, MAOIs, TCAs. Cardiac tolerance can be impaired by L-dopa, L-thyroxine, oxytocin & alcohol. Hypertensive reactions may be precipitated when concomitantly use 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 w/ 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