Manufacturer
ASTRAZENECA AB
Contents
Per 80/4.5 mcg inhalation Budesonide 80 mcg, formoterol 4.5 mcg. Per 160/4.5 mcg inhalation Budesonide 160 mcg, formoterol 4.5 mcg. Per 320/9 mcg inhalation Budesonide 320 mcg, formoterol 9 mcg
Indication
Regular treatment of asthma where use of combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate. Symptomatic treatment of patients w/ COPD (FEV1 <70% predicted normal) & history of exacerbation despite regular bronchodilator therapy.
Instruction
Asthma Maintenance therapy Adult ≥18 yr 1-2 inhalations bd, may be increased up to max: 4 inhalations bd. Adolescent 12-17 yr 1-2 inhalations bd. Childn ≥6 yr 80/4.5 mcg 2 inhalations bd. Adult & adolescent ≥12 yr Maintenance therapy 2 inhalations daily either as 1 inhalation in the morning & evening or 2 inhalations either morning or evening. Reliever therapy 1 additional inhalation as needed in response to symptoms. Not >6 inhalations on any single occasion. Max: >8 inhalations daily is not normally needed, but may use up to 12 inhalations daily for limited period. COPD Adult ≥18 yr 2 inhalations bd. 320/9 mcg 1 inhalation bd.
Drug interaction
Increased plasma levels of budesonide w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, HIV PIs. Weakened or inhibited effect of formoterol w/ β-adrenergic blockers including eye drops. Prolonged QTc interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines, TCAs. Impaired cardiac tolerance by L-dopa, L-thyroxine, oxytocin, alcohol. Precipitated hypertensive reactions w/ MAOIs including agents w/ similar properties eg, furazolidone, procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbons. Additive bronchodilating effect w/ other β-adrenergic drugs. Hypokalaemia w/ digitalis glycosides.
Malaysia
