Foster NEXThaler

Foster NEXThaler

Manufacturer:

Chiesi

Distributor:

Zuellig Pharma

Marketer:

Orient Europharma
Concise Prescribing Info
Contents
Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg
Indications/Uses
Regular treatment of asthma for patients inadequately controlled w/ inhaled corticosteroids & as needed inhaled short-acting β2-agonist or on both inhaled corticosteroids & long-acting β2-agonists. Symptomatic treatment of patients w/ severe COPD (FEV1 <50%) & history of repeated exacerbations who have significant symptoms despite regular therapy w/ long-acting bronchodilators.
Dosage/Direction for Use
Adult ≥18 yr Asthma maintenance therapy 1 or 2 inhalations bd. Max daily dose: 4 inhalations. Maintenance & reliever therapy 1 inhalation bd, may take 1 additional inhalation as needed in response to symptoms. If symptoms persist after few min, an additional inhalation should be taken. Max daily dose: 8 inhalations. COPD 2 inhalations bd.
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not to be used for initial management of asthma. Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Pneumonia in patients w/ COPD. Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression; blurred vision or central serous chorioretinopathy. 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. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Risk of oropharyngeal fungal infections & dysphonia. Monitor serum K & blood glucose levels. Transferring patients from oral to inhaled corticosteroids. Avoid abrupt w/drawal. High-dose & prolonged use. Not to be administered for at least 12 hr prior to anaesth. Concomitant use w/ xanthine derivatives, steroids, diuretics. Not recommended during pregnancy. Lactation. Growth retardation in childn & adolescents <18 yr.
Adverse Reactions
Drug Interactions
Reduced or abolished effect w/ β-blockers. 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. Precipitated hypertensive reactions w/ furazolidone, procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbon-containing anaesth. Potentiated hypokalaemic effect w/ xanthine derivatives, steroids or diuretics. Increased arrhythmic disposition w/ digitalis glycosides. Caution w/ strong CYP3A inhibitors eg, ritonavir, cobicistat.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
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.
Presentation/Packing
Form
Foster NEXThaler DPI
Packing/Price
120 actuation x 1's
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