Symbicort

Symbicort

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
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 & Rapihaler: Treatment of asthma to achieve overall asthma control, including prevention & relief of symptoms, 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: Regular treatment of patients w/ severe COPD (FEV1 <50% predicted normal) w/ frequent symptoms & history of exacerbations despite regular bronchodilator therapy.
Dosage/Direction for Use
Asthma (maintenance & reliever therapy) Adult & adolescent ≥12 yr 80/4.5-mcg turbuhaler Maintenance dose: 2 inhalations/day, 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 1 dose (2 actuations) as needed in response to symptoms & for prevention of allergen- or exercise-induced bronchoconstriction to control asthma. 1 additional dose (2 actuations) may be taken but not >6 doses (12 actuations)/occasion. Max daily dose: 12 doses (24 actuations). Patient recommended to take maintenance dose 160/4.5-mcg turbuhaler 2 inhalations/day, 1 inhalation in the morning & evening or as 2 inhalations either in the morning or evening. 80/2.25-mcg rapihaler 2 doses (4 actuations) once daily or bd. Max daily dose: 12 doses (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 1 or 2 doses (2 or 4 actuations) bd. Max: 4 doses (8 actuations) bd. 80/4.5-mcg & 160/4.5-mcg rapihaler 1 dose (2 actuations) bd. Max: 2 doses (4 actuations) bd. Childn 6-11 yr 80/2.25-mcg & 80/4.5-mcg rapihaler 1 dose (2 actuations) bd. Max daily dose: 2 doses (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 320/9-mcg turbuhaler 1 inhalation bd. 160/4.5-mcg turbuhaler 2 inhalations bd. 80/2.25-mcg rapihaler 2 doses (4 actuations) bd. Max daily dose: 4 doses (8 inhalations). 160/4.5-mcg rapihaler 1 dose (2 actuations) bd. Max daily dose: 2 doses (4 actuations).
Contraindications
Hypersensitivity to budesonide or formoterol. Turbuhaler: Hypersensitivity to lactose.
Special Precautions
Not intended for the initial management of asthma & regular prophylaxis of asthma (except for 160/4.5-mcg turbuhaler & 80/2.25-mcg rapihaler). Dose should be tapered when the treatment is discontinued & should not be stopped abruptly. Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Discontinue treatment if paradoxical bronchospasm occur. Systemic effects may occur w/ any inhaled corticosteroid particularly at high doses for long periods. Regularly monitor the growth of childn & adolescent on prolonged treatment. Adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression; visual disturbance may be reported w/ systemic & topical corticosteroid use. Thyrotoxicosis, phaeochromocytoma, DM, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, iodopathic subvalvular aortic stenosis, severe HTN, aneurysm; severe CV disorders eg, ischaemic heart disease, tachyarrhythmias or severe heart failure. Rinse mouth w/ water after each dosing to minimise risk of oropharyngeal candida infection. Patients w/ QTc interval prolongation. Active or quiescent pulmonary TB; fungal & viral infections in the airways; unstable asthma w/ variable use of rescue bronchodilators. Increased risk of pneumonia in patients w/ COPD. Avoid concomitant treatment w/ itraconazole, ritonavir or potent CYP3A4 inhibitors. Pregnancy & lactation. Growth retardation in childn & adolescents. Not recommended in childn <6 yr. 80/4.5 mcg turbuhaler: Not appropriate in patients w/ severe asthma.
Adverse Reactions
Palpitations, Candida infections in the oropharynx; headache, tremor; mild throat irritation, coughing, hoarseness.
Drug Interactions
Potent CYP3A4 inhibitors may increase systemic exposure to budesonide. Weakened or inhibited effect of fometerol w/ β-adrenergic blockers. Prolonged QTc-interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, terfenadine, MAOIs, TCAs. Impaired cardiac tolerance w/ levodopa, L-thyroxine, oxytocin & alcohol. MAOIs including agents w/ similar properties eg, furazolidone & procarbazine may precipitate hypertensive reactions. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Potential additive effect w/ β-adrenergic drugs. Hypokalaemia may increase arrhythmias w/ digitalis glycosides.
ATC Classification
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.
Presentation/Packing
Form
Symbicort 80/2.25 mcg rapihaler
Packing/Price
120 actuation x 1's
Form
Symbicort 160/4.5 mcg turbuhaler
Packing/Price
120 dose x 1's;60 dose x 1's
Form
Symbicort 160/4.5 mcg rapihaler
Packing/Price
120 actuation x 1's
Form
Symbicort 320/9 mcg turbuhaler
Packing/Price
60 dose x 1's
Form
Symbicort 80/4.5 mcg rapihaler
Packing/Price
120 actuation x 1's
Form
Symbicort 80/4.5 mcg turbuhaler
Packing/Price
60 dose x 1's
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