budesonide + formoterol




Four Star
Concise Prescribing Info
Per 80/4.5 mcg Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 160/4.5 mcg Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg
Regular treatment of asthma where use of a combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate in adults & adolescents who are symptomatic on inhaled corticosteroid therapy; or who are established on regular long-acting β2-agonist & inhaled corticosteroid therapy. Symptomatic treatment of moderate to severe COPD in adults w/ frequent symptoms despite long-acting bronchodilator use, &/or history of recurrent exacerbations.
Dosage/Direction for Use
Asthma Adult & adolescent ≥12 yr 2 inhalations bd. Max: 4 inhalations daily. COPD Adult 160/4.5 mcg 2 inhalations bd. Max: 4 inhalations daily.
Special Precautions
Should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. Use for the shortest time required to achieve control of asthma symptoms. Consider discontinuation & a test of inhaled corticosteroid alone when long-term control of asthma is maintained w/ lowest dose. Not intended to treat severe exacerbation. Not to be used to initiate treatment w/ inhaled steroids in patients transferred from oral steroids. Potential systemic effects of inhaled corticosteroids. Monitor signs of adrenal dysfunction particularly in patients switched from oral corticosteroids & patients concomitantly taking CYP3A4 substrates. Closely follow the growth of childn & adolescents taking long-term corticosteroids. May mask signs of infection & new infections may appear w/ high doses of glucocorticosteroids. Patients w/ active or quiescent pulmonary TB or fungal, bacterial, or viral infections of the resp system; increased susceptibility to sympathomimetic amines; severe CV disorders; diabetes; severe liver disease. Risk of hypokalaemia. Reports of pneumonia. Pregnancy & lactation. Not recommended in childn <12 yr.
Adverse Reactions
Palpitations; candida infections in the oropharynx; headache, tremor; mild throat irritation, coughing, hoarseness.
Drug Interactions
Increased systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole. β-blockers may partially or totally inhibit effect of β2-agonists. Cumulative effect w/ other β-adrenergic stimulants or sympathomimetic amines (eg, ephedrine). Potentiated hypokalaemia w/ xanthine derivatives, mineralocorticosteroids, & diuretics. Exacerbated CV effects w/ MAOIs, TCAs, quinidine, disopyramide, procainamide, phenothiazines, or antihistamines (eg, terfenadine, astemizole).
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.
Vannair 160/4.5 mcg MDI
120 dose x 1's
Vannair 80/4.5 mcg MDI
120 dose x 1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in