Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction
Although no formal in vivo drug interaction studies have been performed between Spiolto Respimat and other drugs, inhaled Spiolto Respimat has been used concomitantly with other COPD medicinal products, including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.


Anticholinergic agents
The co-administration of tiotropium bromide, one component of Spiolto Respimat, with other anticholinergic containing drugs has not been studied and therefore is not recommended.

Adrenergic agents
Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of Spiolto Respimat.

Xanthine derivatives, steroids or diuretics
Concomitant treatment with xanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate any hypokalemic effect of adrenergic agonists (see section 4.4).

Beta-blockers
Beta-adrenergic blockers may weaken or antagonise the effect of olodaterol. Cardioselective beta- blockers could be considered, although they should be administered with caution.

MAO inhibitors and tricyclic antidepressants, QTc Prolonging drugs

Spiolto Respimat                                       Approved prescribing information Inhalation solution                                    May 2019
Monamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of Spiolto Respimat on the cardiovascular system.

Pharmacokinetic Drug Drug interactions
No relevant effect on systemic exposure to olodaterol has been observed in drug-drug interaction studies with co-administration of fluconazole, used as model inhibitor of CYP2C9.

Co-administration of ketoconazole as potent P-gp and CYP3A4 inhibitor increased systemic exposure to olodaterol by approximately 70%. No dose adjustment of Spiolto Respimat is necessary.

In vitro investigations have shown that olodaterol does not inhibit CYP enzymes or drug transporters at the plasma concentrations achieved in clinical practice.