Innovair/Innovair NEXThaler

Innovair/Innovair NEXThaler

Manufacturer:

Zambon
Concise Prescribing Info
Contents
Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg
Indications/Uses
Regular treatment of asthma in patients not adequately controlled by using inhaled corticosteroids & 'as needed' short-acting bronchodilators or asthma is responding well to treatment w/ both corticosteroids & long-acting bronchodilators. Innovair NEXThaler Regular treatment of asthma 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.
Dosage/Direction for Use
Adult ≥18 yr Asthma 1 or 2 inhalations twice daily. Max daily dose: 4 inhalations. Innovair NEXThaler 1 or 2 inhalations twice daily (1 in the morning & 1 in the evening). Max: 4 inhalations daily. Maintenance therapy Take as regular maintenance w/ a separate as needed rapid-acting bronchodilator. Maintenance & reliever therapy Take as regular maintenance & as needed in response to asthma symptoms.
Special Precautions
Discontinue if paradoxical bronchospasm occurs. Not to be initiated during exacerbation or if patients have significantly worsening or acutely deteriorating asthma. Not intended for initial management of asthma. Not for use in acute asthma attacks. Risk of oropharyngeal fungal infections & dysphonia. Patients w/ active or quiescent pulmonary TB, fungal & viral infections in the airways; cardiac arrhythmias especially 3rd degree AV block & tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute MI, ischaemic heart disease, CHF, occlusive vascular diseases particularly arteriosclerosis, arterial HTN & aneurysm; thyrotoxicosis, DM, phaeochromocytoma & untreated hypokalaemia. Monitor serum K levels in severe & unstable asthma; blood glucose levels regularly. Avoid abrupt discontinuation of treatment. Transferring patients from oral to inhaled corticosteroids. Prolonged treatment w/ high doses may result in adrenal suppression & acute adrenal crisis. Not to be administered for at least 12 hr prior to anaesth. Not to be taken by patient w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Hepatic or renal impairment. Not recommended during pregnancy. Lactation. Not recommended in childn & adolescent <18 yr. Innovair Known or suspected congenital or drug-induced prolongation of QTc interval. Innovair NEXThaler Pneumonia in patients w/ COPD. Systemic effects may occur eg, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation (in childn & adolescents), decreased bone mineral density, cataract, glaucoma & more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Visual disturbance. Always have Innovair NEXThaler available for rescue use.
Adverse Reactions
Innovair Headache, hoarseness, sore throat. Innovair NEXThaler Pneumonia (in COPD patients); tremor.
Drug Interactions
Effect of formoterol may be reduced w/ β-blockers. β-adrenergic drugs may increase the effects of formoterol. Quinidine, disopyramide, procainamide, antihistamines, phenelzine & isocarboxazid, amitryptiline & imipramine, phenothiazines can cause some changes in the ECG, heart trace & may also increase the risk of disturbances of heart rhythm. Levodopa, L-thyroxine, medicines containing oxytocin & alcohol can lower heart’s tolerance to formoterol. MAOIs, including drugs w/ similar properties eg, furazolidone & procarbazine can cause a rise in BP. Digoxin can cause a fall in blood K level. Theophylline, aminophylline or steroids & diuretics may cause a fall in K level. Some anaesth can increase the risk of abnormal heart rhythms.
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
Innovair inhalation soln
Packing/Price
120 actuation x 1's (Rp504,000/kontainer)
Form
Innovair NEXThaler inhalation powd
Packing/Price
((DPI) 120 actuations) 1's (Rp586,000/inhaler)
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