Interactions : אינטראקציות

4.5 Interaction with other medicinal products and other forms of interaction


COPD medicinal products
Co-administration of Duaklir Genuair with other anticholinergic and/or long-acting β2- adrenergic agonist containing medicinal products has not been studied and is not recommended.
Although no formal in vivo drug interaction studies have been performed with Duaklir Genuair, it has been used concomitantly with other COPD medicinal products including short- acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.


Hypokalaemic treatment
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of β2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).


β-adrenergic blockers
β -adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists. If β-adrenergic blockers are required (including eye drops), cardioselective beta-adrenergic blockers are preferred, although they should also be administered with caution.


Other pharmacodynamic interactions
Duaklir Genuair should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides because the action of formoterol, a component of Duaklir Genuair, on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.


Metabolic interactions
In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases. Formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations (see section 5.2).