DuoResp Spiromax

DuoResp Spiromax

budesonide + formoterol

Manufacturer:

Norton Healthcare

Distributor:

DKLL

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
Asthma in combination w/ inhaled corticosteroid & long-acting β2-adrenoceptor agonist in adult ≥18 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 adults ≥18 yr w/ COPD w/ forced expiratory vol in 1 sec (FEV1) <70% predicted normal (post-bronchodilator), & a history of repeated exacerbations who have significant symptoms despite regular therapy w/ long-acting bronchodilators.
Dosage/Direction for Use
Adult ≥18 yr Asthma 160/4.5 mcg inhalation powd Individualized dosage. Recommended maintenance dose: 2 inhalations daily (as 1 inhalation in the morning & evening, or as 2 inhalations bid). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few min, an additional inhalation should be taken. Not >6 inhalations should be taken on any single occasion. Maintenance therapy: 1-2 inhalations bid. Max: 4 inhalations bid. 320/9 mcg inhalation powd 1 inhalation bid up to a max of 2 inhalation bid. Should be used as maintenance therapy only. COPD Recommended dose: 160/4.5 mcg inhalation powd 2 inhalations bid. 320/9 mcg inhalation powd 1 inhalation bid.
Special Precautions
Do not stop treatment abruptly & taper dose upon discontinuation. Consider increasing therapy w/ corticosteroids or antibiotic treatment if infection is present. Not intended for regular prophylactic use eg, before exercise. Regularly assess patients w/ asthma. Do not initiate treatment during an exacerbation or if they have significantly worsening or acutely deteriorating asthma. COPD patients w/ pre-bronchodilator FEV1 >50% predicted normal & w/ a post-bronchodilator FEV1 <70% predicted normal. Discontinue treatment if paradoxical bronchospasms occur & assess patient; institute alternative therapy if necessary. Systemic effects may occur especially in long periods. Visual disturbance. Consider potential effects on bone density particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Risk of impaired adrenal reserve in patients transferring to a budesonide/formoterol fumarate fixed-dose combination therapy; regularly monitor hypothalamic pituitary adrenocortical axis. Consider additional systemic corticosteroid cover during periods of stress eg, severe infections or elective surgery in prolonged treatment. Oral infections. Increased risk of pneumonia in patients w/ COPD. Avoid concomitant use w/ itraconazole, ritonavir or other potent CYP3A4 inhibitors. Patients w/ 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;  prolonged QTc-interval. Re-evaluate treatment in patients w/ active or quiescent pulmonary TB, fungal & viral infections in the airways. Consider additional blood glucose controls in diabetic patients. Concomitant treatment w/ drugs that can induce hypokalaemia or potentiate a hypokalaemic effect eg, xanthine-derivatives, steroids & diuretics. Unstable asthma w/ variable use of rescue bronchodilators in acute severe asthma; monitor serum K. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactaction. Regularly monitor height in childn receiving prolonged treatment.
Adverse Reactions
Candida infections in the oropharynx, pneumonia (in COPD patients); headache, tremor; palpitations; mild irritation in the throat, coughing, hoarseness.
Drug Interactions
Increased plasma levels w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone & HIV PIs). Increased risk of systemic side effects in co-treatment w/ CYP3A inhibitors including cobicistat-containing drugs. May weaken or inhibit effect w/ β-adrenergic blockers. May prolong QTc-interval & increase risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) & TCAs. May impair cardiac tolerance w/ L-Dopa, L-thyroxine, oxytocin & alcohol. May precipitate hypertensive reactions w/ MAOIs & drugs w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Potentially additive bronchodilating effect w/ other β-adrenergic drugs & anticholinergics. Increase disposition toward arrhythmias w/ digitalis glycosides.
ATC Classification
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.
Presentation/Packing
Form
DuoResp Spiromax inhalation powd 320/9 mcg
Packing/Price
1's
Form
DuoResp Spiromax inhalation powd 160/4.5 mcg
Packing/Price
1's
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