DuoResp Spiromax

Per 160/4.5 mcg inhalation powd Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 320/9 mcg inhalation powd Budesonide 320 mcg, formoterol fumarate dihydrate 9 mcg

Asthma in combination w/ inhaled corticosteroid & long-acting β₂-adrenoceptor agonist in adults & adolescents ≥12 yr not adequately controlled w/ inhaled corticosteroids & as needed inhaled short-acting β₂-adrenoceptor agonists, or those already adequately controlled on both inhaled corticosteroids & long-acting β₂-adrenoceptor agonists. Symptomatic treatment of COPD w/ forced expiratory vol in 1 sec (FEV₁) <70% predicted normal (post-bronchodilator), & history of repeated exacerbations w/ significant symptoms despite regular therapy w/ long-acting bronchodilators in adults ≥18 yr.

160/4.5 mcg inhalation powd Asthma Maintenance therapy: Adult ≥18 yr 1-2 inhalations bid. Max: 4 inhalations bid. Adolescent ≥12 yr 1-2 inhalations bid. May titrate to lowest effective dose given once daily when control of symptoms is achieved. Maintenance & reliever therapy: Adult & adolescent ≥12 yr Recommended maintenance dose: 2 inhalations daily (as 1 inhalation in the morning & evening, or as 2 inhalations either morning or evening). Alternatively, 2 inhalations bid. Take 1 additional inhalation as needed in response to symptoms, then 1 additional inhalation if symptoms persist after few min. Max: 6 inhalations on any single occasion. COPD Adult ≥18 yr Recommended dose: 2 inhalations bid. 320/9 mcg inhalation powd Maintenance therapy only. Asthma Adult ≥18 yr 1 inhalation bid. Max: 2 inhalations bid. Adolescent ≥12 yr 1 inhalation bid. May titrate to lowest effective dose given once daily. COPD Adult ≥18 yr 1 inhalation bid.

Hypersensitivity.

Discontinue therapy immediately if paradoxical bronchospasm occurs. Not intended for initial management of asthma; regular prophylactic use eg, prior to exercise. Not for treatment in adult or adolescent w/ only mild asthma. Not to be initiated during exacerbation or significantly worsening or acutely deteriorating asthma. Sudden & progressive deterioration in control of asthma or life-threatening COPD. Cushing's syndrome, cushingoid features, adrenal suppression, decrease in bone mineral density, cataract & glaucoma; psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn); blurred vision & other visual disturbances; adrenal suppression. Potential effects on bone density in patients on high doses for prolonged periods w/ co-existing risk factors for osteoporosis. Possible pneumonia development in patients w/ COPD. Unstable asthma w/ variable use of rescue bronchodilators in acute severe asthma augmented by hypoxia & increased hypokalaemia. Patients w/ pre-bronchodilator FEV₁ >50% predicted normal & post-bronchodilator FEV₁ <70% predicted normal; thyrotoxicosis, phaeochromocytoma, DM, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm or other severe CV disorders eg, ischaemic heart disease, tachyarrhythmias or severe heart failure; QTc-interval prolongation; active or quiescent pulmonary TB, fungal & viral airway infections. Taper dose & avoid abrupt discontinuation. Monitor hypothalamic-pituitary adrenocortical axis function regularly; height of childn receiving prolonged treatment; serum K levels. Rinse mouth w/ water after inhalation & if oropharyngeal thrush occurs. Consider additional blood glucose controls in diabetic patients. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Transfer to budenoside/formoterol fumarate fixed-dose combination therapy. Avoid concomitant use w/ itraconazole, ritonavir or other potent CYP3A4 inhibitors. Concomitant use w/ medicinal products inducing hypokalaemia/potentiating hypokalaemic effect eg, xanthine derivatives, steroids & diuretics. Severe liver cirrhosis. Pregnancy & lactation. Growth retardation in childn & adolescents. Not recommended for use in childn <12 yr.

Candida infections in oropharynx, pneumonia (in COPD patients); headache, tremor; palpitations; mild throat irritation, coughing, hoarseness.

Increased budesonide plasma levels w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone & HIV PIs. Increased risk of systemic side effects w/ CYP3A inhibitors including cobicistat-containing drugs. Weakened or inhibited formoterol effect w/ β-adrenergic blockers. Prolonged QTc-interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) & TCAs. Impaired cardiac tolerance w/ L-dopa, L-thyroxine, oxytocin & alcohol. Precipitated hypertensive reactions w/ MAOIs & medicinal products w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Potentially additive bronchodilating effect w/ other β-adrenergic medicinal products & anticholinergics. Increased disposition towards arrhythmias 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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