Symbicort

Per dose Symbicort 80/4.5 mcg turbuhaler Budesonide 80 mcg, formoterol fumarate 4.5 mcg. Per dose Symbicort 160/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol fumarate 4.5 mcg. Per dose Symbicort 80/4.5 mcg rapihaler Budesonide 80 mcg, formoterol fumarate 4.5 mcg. Per dose Symbicort 160/4.5 mcg rapihaler Budesonide 160 mcg, formoterol fumarate 4.5 mcg

Turbuhaler: Turbuhaler 160/4.5: Symptomatic treatment & reduce the risk of exacerbations of asthma in adult & adolescents ≥12 yr where the use of inhaled corticosteroids is appropriate. Symptomatic treatment of severe COPD (FEV₁ <50% predicted normal) & history of repeated exacerbations in patients w/ significant symptoms despite regular therapy w/ long-acting bronchodilators. Turbuhaler 80/4.5: Regular treatment of asthma where use of combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate. Rapihaler: Regular treatment of asthma where use of combination (inhaled corticosteroid & long-acting β2-adrenoceptor agonist) is appropriate. Rapihaler 160/4.5: Symptomatic treatment of patients w/ COPD (FEV₁ ≤50% predicted normal) & history of exacerbation despite regular bronchodilator therapy.

Turbuhaler Asthma Individualized dosage. Anti-inflammatory therapy in patient w/ mild disease: Adult & adolescent ≥12 yr 1 inhalation 160/4.5 mcg as needed for symptoms & an additional inhalation if symptoms persist after a few min. Max: 6 inhalations. Maintenance & reliever therapy: Adult & adolescent ≥12 yr 2 inhalations daily of 80/4.5 mcg or 160/4.5 mcg given either as 1 inhalation in the morning & evening or 2 inhalations in either the morning or evening. 1 additional dose as needed for symptoms & 1 more if symptoms persist after a few min. Max: 6 inhalations. Maintenance dose: 1-2 inhalations twice daily of 160/4.5 mcg. Childn ≥6 yr 1 inhalation once daily of 80/4.5 mcg. Max: 4 inhalations. Maintenance therapy: Adult & adolescent ≥12 yr 1-2 inhalations twice daily of 80/4.5 mcg or 160/4.5 mcg. Childn ≥6 yr 2 inhalations daily of 80/4.5 mcg. COPD Adult 2 inhalations twice daily of 160/4.5 mcg. Rapihaler Asthma Maintenance & reliever therapy Adults & adolescent ≥12 yr 2 inhalations once or twice daily of 160/4.5 mcg or 80/4.5 mcg, may be increased to max of 2 inhalations twice daily. 1 additional inhalation as needed for symptoms & 1 more if symptoms after a few min. Max: 6 inhalations. Childn 6-11 yr 80/4.5 mcg 1 inhalation once daily. 1 additional inhalation as needed in response to symptoms. Max: 4 inhalations. Maintenance therapy Adult & adolescent ≥12 yr 1-2 inhalations twice daily of 160/4.5 mcg or 80/4.5 mcg. Childn 6-11 yr 80/4.5 mcg 2 inhalations twice daily. COPD Adult ≥18 yr 160/4.5 mcg 2 inhalations twice daily.

Hypersensitivity to budesonide, formoterol. Turbuhaler: Hypersensitivity to lactose (which contains small amounts of milk proteins).

Not to be discontinued abruptly. Contact physician if patient finds treatment ineffective or max daily dose exceeded & consider need for increased therapy w/ corticosteroids. Rescue inhaler must be available at all times. Not to be initiated to treat severe exacerbations. Systemic effects may occur in high doses & long-term treatment eg, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral density, cataracts, glaucoma. Regularly monitor height of childn receiving prolonged treatment. Initial small but temporary reduction in growth in childn & adolescents during 1st yr of treatment. Patients transferred from oral or systemic steroid therapy; who have required high dose emergency corticosteroid therapy in the past or had prolonged treatment w/ high dose of inhaled corticosteroids. Rinse mouth out after each inhalation to minimize risk of candida infection. Concomitant treatment w/ itraconazole, ritonavir & other potent CYP3A4 inhibitors; β2-agonists & drugs which can induce hypokalaemia eg, xanthine derivatives, steroids, duretics. Patients w/ DM, untreated hypokalaemia, severe HTN, tachyarrhythmia or severe heart failure; prolongation of the QTc interval; active or quiescent pulmonary TB; fungal & viral infections in the airways. Monitor serum K levels. Additional blood glucose controls in diabetic patients. Pregnancy & lactation. Turbuhaler & Rapihaler 160/4.5: Increased risk of pneumonia in COPD patients. Turbuhaler: Patients must take maintenance dose as prescribed, even when asymptomatic. Reliever inhalations are not intended for regular prophylactic use. Discontinue use if paradoxical bronchospasm occurs. Patients w/ thyrotoxicosis, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, idiopathic sub-valvular aortic stenosis, aneurysm or other severe heart disease. Contains lactose (<1 mg/inhalation) which amount does not normally cause problem in lactose intolerant people, but may cause allergic reactions. Rapihaler: Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Monitor HPA axis function; visual disturbances.

Palpitations; oropharyngeal candida infection; headache, tremor; mild throat irritation, coughing, hoarseness. Turbuhaler & Rapihaler 160/4.5: Pneumonia in COPD patient.

Increased budesonide plasma levels w/ potent CYP3A4 inhibitors. Weakened or inhibited formoterol effect w/ β-adrenergic blockers including eye drops. Potentiated hypokalaemia w/ xanthine derivatives, corticosteroids, diuretics. Prolonged QTc interval & increased risk of ventricular arrhythmias w/ TCAs, quinidine, disopyramide, procainamide, phenothiazines, or antihistamines. Additive effects w/ β-adrenergic drugs. Turbuhaler: L-dopa, L-thyroxine, oxytocin & alcohol can impair cardiac tolerance towards β2 sympathomimetics. Concomitant use w/ MAOIs & similar agents eg, furazolidone, procarbazine may precipitate hypertensive reactions. Elevated risk of arrhythmias w/ concomitant anaesth w/ halogenated hydrocarbons. Hypokalaemia may increase disposition towards arrhythmias in patients 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.

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