Foster NEXThaler

Regular treatment of asthma in adult patients where use of a combination product (inhaled corticosteroid & long-acting β₂-agonist) is appropriate; patients inadequately controlled w/ inhaled corticosteroids & as needed inhaled short-acting β₂-agonist or those adequately controlled on both inhaled corticosteroids & long-acting β₂-agonists. Symptomatic treatment of patients w/ severe COPD (FEV₁ <50% predicted normal) & a history of repeated exacerbations who have significant symptoms despite regular therapy w/ long-acting bronchodilators.

Adult ≥18 yr Asthma maintenance therapy 1 or 2 inhalations bid. Max: 4 inhalations daily. Maintenance & reliever therapy 1 inhalation bid (1 inhalation in the morning & 1 inhalation in the evening), may take 1 additional inhalation as needed in response to symptoms. If symptoms persist after few min, an additional inhalation should be taken. Max: 8 inhalations daily. COPD 2 inhalations bid.

Hypersensitivity.

Do not stop treatment abruptly. Do not use for initial management of asthma. Do not initiate during an exacerbation or if asthma is significantly worsening or acutely deteriorating. Immediately discontinue use if paradoxical bronchospasm occurs; assess patient & institute alternative therapy if necessary. Pneumonia in patients w/ COPD. Systemic effects (eg, Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression) of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods. Situations which could potentially trigger acute adrenal crisis including trauma, surgery, infection or any rapid dosage reduction; consider additional systemic corticosteroid cover during periods of stress or elective surgery. Risk of impaired adrenal reserve in patients transferring from oral to inhaled corticosteroids. Patients who have required high dose emergency corticosteroid therapy in the past or have received prolonged treatment w/ high doses of inhaled corticosteroids. Active or quiescent pulmonary TB, fungal & viral airway infections; cardiac arrhythmias especially 3rd degree AV block, tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, severe heart failure, arterial HTN & aneurysm; known or suspected QTc interval prolongation; thyrotoxicosis, DM, phaeochromocytoma, untreated hypokalaemia; unstable asthma. Visual disturbance (eg, blurred vision) w/ systemic & topical corticosteroid use. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Rinse mouth, gargle w/ water or brush teeth after inhalation to minimise risk of oropharyngeal fungal infections & dysphonia. Monitor serum K & blood glucose levels. Not to be administered for at least 12 hr prior to start of anaesth w/ halogenated anaesth. Concomitant use w/ other drugs which can induce hypokalaemia (eg, xanthine derivatives, steroids & diuretics). Not recommended during pregnancy. Discontinue breastfeeding or discontinue/abstain from therapy. Growth retardation in childn & adolescents. Childn <18 yr; not to be used in 5-11 yr.

Pneumonia (in COPD patients); tremor.

Beclometasone dipropionate: Concomitant use w/ strong CYP3A inhibitors (eg, ritonavir, cobicistat). Formoterol: Reduced or abolished effect w/ β-blockers. Potential additive effects w/ theophylline or other β-adrenergic drugs. Increased risk of ventricular arrhythmias & prolonged QTc interval w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines (eg, terfenadine), MAOIs, TCAs. Impaired cardiac tolerance w/ l-dopa, l-thyroxine, oxytocin & alcohol. May precipitate hypertensive reactions w/ MAOIs including agents w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbon-containing anaesth. Possible potentiation of hypokalaemic effect w/ xanthine derivatives, steroids or diuretics. May increase arrhythmic disposition w/ digitalis glycosides.

Antiasthmatic & COPD Preparations

R03AK08 - formoterol and beclometasone ; 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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