Indacaterol maleate

This product is a compound preparation. Its active ingredients are indacaterol maleate and glycopyrrolate. Excipients are: lactose monohydrate, magnesium stearate, and hydroxypropyl methylcellulose capsule shell.

Indacaterol and glycopyrronium are administered by oral inhalation at the same time. The two active ingredients do not affect each other's mechanics at steady state. No specific drug interaction studies have been conducted for this product. Information on potential drug interactions is derived from information on the possible interactions of each. In vitro studies have shown that at exposure levels of clinical doses, indacaterol has almost no potential for near-acting metabolically related drugs. (See [Pharmacokinetics]). In vitro studies have shown that glycopyrronium is unlikely to inhibit or induce the metabolism of other drugs, nor does it affect processes involving transporters. In the clearance of glycopyrronium, multiple enzymes are involved in metabolism and play a minor role. Inhibition or induction of glycopyrronium metabolism is unlikely to result in a meaningful 1-year change in the systemic exposure of the drug. (See [Pharmacokinetics]). Drugs not recommended for concomitant use β-adrenergic blockers β-adrenergic blockers have a weakening or antagonistic effect on β2-adrenergic agonists, so Chuankangpin should not be used in combination with β-adrenergic blockers (including eye drops) unless there is a reason for its use. If necessary, cardiovascular selective beta-adrenergic blockers may be preferred. However, they should be used with caution. Anticholinergic drugs There are no studies on the combined use of this product with other anticholinergic drugs, so it is not recommended to use this product with other anticholinergic drugs. (See [Precautions]). Sympathomimetics and other sympathomimetics (used alone or as part of a combination preparation) may have the potential to increase the risk of adverse events of indacaterol. (See [Precautions]) Drugs that should be used with caution Hypokalemia treatment The potential for hypokalemia of beta2-adrenergic agonists may be increased when combined with methylxanthine derivatives, steroids or non-potassium sparing diuretics. Therefore, they should be used with caution. (See [Precautions]) Drugs known to prolong the QTc interval, like other drugs containing beta2-adrenergic agonists, should be used with caution in patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or drugs known to prolong the QT interval. This is because the effect on the QT interval may be enhanced. Drugs known to prolong the QT interval may increase the risk of ventricular arrhythmias. (See [Precautions] Factors to consider when co-administering drugs. Drug interactions based on metabolism and transporters. Inhibition of CYP3A4 and P-glycoprotein (P-gp), which play a major role in the clearance of indacaterol, can increase the systemic exposure of indacaterol by up to 2 times. Clinical safety data for 1 year of administration of indacaterol at twice the maximum recommended dose of indacaterol have been available. Therefore, it is believed that the increase in exposure caused by the interaction will not increase any safety risk. In addition, cimetidine and other organic cation transport inhibitors. In clinical studies with healthy volunteers, cimetidine (organic cation transport inhibitor) can affect the excretion of glycopyrronium, increasing the total exposure (AUC) of glycopyrronium by 22% and reducing renal excretion by 23%. Based on the extent of this exposure change, it is expected that there will be no clinically significant drug interactions when glycopyrronium is used in combination with cimetidine or other organic cation transport inhibitors.