Glycopyrrolate

This product is a compound preparation, the active ingredients of which are budesonide, glycopyrrolate and formoterol fumarate.

No formal drug interaction studies have been conducted for this product. COPD-related drug interactions No clinical studies have been conducted on the combined use of this product with other anticholinergic drugs and/or drugs containing long-acting β2-adrenergic receptor agonists, so combined use is not recommended. Pharmacokinetic interactions. Budesonide is mainly metabolized by CYP3A4. The combined use of budesonide and CYP3A inhibitors (such as itraconazole, ketoconazole, HIV protease preparations, and preparations containing cobicistat) may increase the risk of systemic side effects. The clinical importance of these research information for short-term (1-2 weeks) treatment is limited, but the combination of drugs should be carefully considered during long-term treatment with strong CYP3A4 inhibitors. Since glycopyrrolate is mainly excreted through the kidneys, potential drug interactions may occur when used with drugs that affect the renal excretion mechanism. In vitro studies have shown that glycopyrrolate is a substrate for the renal transporters OCT2 and MATE1/2K. The effect of cimetidine (a probe inhibitor of OCT2 and MATE1) on the distribution of inhaled glycopyrronium showed that after co-administration with cimetidine, the total systemic exposure (AUC0-t) of glycopyrronium was limited to 22%, and the renal elimination rate was slightly reduced by 23%. At therapeutically relevant concentrations, formoterol has no inhibitory effect on CYP450 enzymes, and at therapeutically relevant concentrations, budesonide and glycopyrronium have no inhibitory or inductive effect on CYP450 enzymes. Hypokalemia caused by drug interactions For patients who may or already have hypokalemia, the use of this product in combination with certain drugs (such as potassium-sparing diuretics, xanthine drugs, systemic hormone drugs, etc.) may aggravate their hypokalemia. Interaction with beta-adrenergic receptor blockers Beta-adrenergic receptor blockers (including eye drops) can weaken or inhibit the efficacy of formoterol. Other biodynamic interactions: This product should be used with caution in patients receiving drugs known to prolong the QTc interval.

This product is a compound preparation, and its active ingredients are glycopyrrolate and formoterol fumarate. Active ingredient: glycopyrrolate Chemical name: 3-hydroxy-1,1-dimethylpyrrolidinyl-α-cyclopentyl mandelate bromide. Molecular formula: C19H28BrNO3 Molecular weight: 398.34 Active ingredient: Formoterol fumarate Chemical name: (±)-N-[2-hydroxy-5-[(1RS)-1-hydroxy-2[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide fumarate dihydrate. Molecular formula: (C19H24N204)2▪C4H404▪2H2O Molecular weight: 840.91 Excipients: The excipients of this product include loose particles and propellant HFA134a. The loose particles are composed of 1,2-distearoylphosphatidylcholine (DSPC) and calcium chloride.

Drug interaction studies have not been conducted for this product. Adrenaline drugs should be used with caution when additional adrenomimetics are administered by any route, as formoterol, a component of this product, may enhance its sympathetic effects (see [Precautions]). Xanthine derivatives, steroids, or diuretics Concomitant treatment with xanthine derivatives, steroids, or diuretics may enhance the hypokalemic effect of β2 adrenergic receptor agonists (e.g., formoterol, a component of this product). Non-potassium sparing diuretics β2-agonists can cause ECG changes and/or acute exacerbation of hypokalemia that may be caused by the administration of non-potassium sparing diuretics (e.g., loop diuretics or thiazide diuretics), especially when the dose exceeds the recommended dose of the β2 receptor agonist. During two 24-week placebo-controlled studies, approximately 17% of CO PD subjects have taken non-potassium sparing diuretics. The incidence of adverse events was similar between subjects treated with this product and those treated with placebo who took non-potassium sparing diuretics. In addition, no evidence was found that this product had a therapeutic effect on serum potassium compared with placebo in subjects who took non-potassium sparing diuretics during the two 24-week studies. However, caution is recommended when using this product in combination with non-potassium sparing diuretics. Monoamine oxidase inhibitors, tricyclic antidepressants, QTc interval prolonging drugs. This product should be administered to patients who are receiving monoamine oxidase inhibitors or tricyclic antidepressants, just like other 2 receptor agonists. Particular caution should be exercised when using this product with patients who are taking medications known to prolong the QTc interval, such as beta-blockers, beta-adrenergic receptor antagonists, and other medications known to prolong the QTc interval, as these medications may enhance the effects of adrenergic receptor agonists on the cardiovascular system. Drugs known to prolong the QTc interval may lead to an increased risk of ventricular arrhythmias. Beta-blockers may cause drug interactions when used in combination with this product. Beta-blockers not only block the therapeutic effects of beta2 receptor agonists, but can also cause severe bronchospasm in patients with COPD. Therefore, Under normal circumstances, COPD patients should not be treated with beta-blockers. However, in some cases, for example, there is no alternative treatment for beta-blockers for COPD patients who need preventive treatment after myocardial infarction. In this case, the use of cardioselective beta-blockers can be considered, but it should be used with caution. Anticholinergics When this product is used in combination with anticholinergic drugs, additive interactions may occur. Therefore, the combination of this product with other anticholinergic drugs should be avoided, otherwise it may lead to an increase in the adverse reactions of anticholinergic drugs (see [Precautions] and [Adverse Reactions]).

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.