Foster Nexthaler

Foster Nexthaler

Manufacturer:

OEP Phils

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per dose Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg
Indications/Uses
Regular treatment of asthma in adult patients where use of a combination product (inhaled corticosteroid & long-acting β2-agonist) is appropriate; patients not adequately controlled w/ inhaled corticosteroids & 'as needed' inhaled short-acting β2-agonist or patients already adequately controlled on both inhaled corticosteroids & long-acting β2-agonists. Symptomatic treatment of patients w/ severe COPD (FEV1 <50% predicted normal) & 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 bid. Max: 4 inhalations daily. Maintenance & reliever therapy 1 inhalations bid (1 inhalation in the morning & 1 inhalation in the evening). Additional 1 inhalation as needed in response to symptoms. If symptoms persist after a few min, an additional inhalation should be taken. Max: 8 inhalations daily. COPD 2 inhalations bid.
Special Precautions
Avoid abrupt w/drawal, taper dose when treatment is discontinued. Do not initiate during an exacerbation or significant worsening or acutely deteriorating asthma. Discontinue use if paradoxical bronchospasm occurs. Not intended for initial management of asthma. Patients should be reminded to take daily as prescribed even when asymptomatic. Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Transferring patients from oral to 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 & severe asthma. Potentially may cause hypokalaemia; concomitant w/ other drugs which can induce hypokalaemia eg, xanthine derivatives, steroids & diuretics. Caution in unstable asthma. Monitor serum K & blood glucose levels. Not to be administered for at least 12 hr prior to anaesth w/ halogenated anaesth. Risk of oropharyngeal fungal infections & dysphonia. High dose & prolonged use. Allergy to lactose; galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Visual disturbance may occur. Pregnancy & lactation. Growth retardation in childn & adolescents <18 yr.
Adverse Reactions
Beclometasone/formoterol fixed combination: Tremor. Formoterol: Tremor, headache, tachycardia, sinus bradycardia, angina pectoris, myocardialischaemia, QT prolongation. Beclometasone: Nasopharyngitis, oral candidiasis, dysphonia, throat irritation, irritability, decreased cortisol-free urine & blood cortisol, increased blood glucose.
Drug Interactions
Formoterol: Reduced or abolished effect w/ β-blockers (including eye drops). Additive effects w/ theophylline or other β-adrenergic drugs. Prolonged QTc-interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines (eg, terfenadine), MAOIs & TCAs. Impaired cardiac tolerance w/ levodopa, l-thyroxine, oxytocin & alcohol. May precipitate hypertensive reactions w/ furazolidone & procarbazine. Elevated risk of arrhythmias in patients receiving concomitant anaesth w/ halogenated hydrocarbons. Possible potentiation of hypokalaemic effect w/ xanthine derivatives, steroids or diuretics. Increased arrhythmic disposition w/ digitalis glycosides.
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 powd for inhalation
Packing/Price
120 dose x 1's
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