indacaterol, inhaled/glycopyrrolate inhaled (Rx)

Brand and Other Names:Utibron Neohaler
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

indacaterol/glycopyrrolate

inhalation powder

  • (27.5mcg/15.6mcg)/capsule

Chronic Obstructive Pulmonary Disease (COPD)

Combination inhalant containing long-acting muscarinic antagonist (LAMA) plus a long-acting beta2-agonist (LABA) indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Orally inhale contents of 1 capsule PO q12hr using the Neohaler device

Dosage Modifications

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild-to-moderate renal impairment

Severe renal or hepatic impairment: Not studied

Dosing Considerations

Limitations of use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma

Safety and efficacy not established

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Interactions

Interaction Checker

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            Contraindicated (2)

            • umeclidinium bromide/vilanterol inhaled

              indacaterol, inhaled, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.

              glycopyrrolate inhaled, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Duplicate therapy.

            • vilanterol/fluticasone furoate inhaled

              indacaterol, inhaled, vilanterol/fluticasone furoate inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.

            Serious - Use Alternative (20)

            • amisulpride

              amisulpride and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.

            • arformoterol

              arformoterol and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • crizotinib

              crizotinib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              indacaterol, inhaled and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

            • glasdegib

              indacaterol, inhaled and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • glucagon

              glucagon increases toxicity of glycopyrrolate inhaled by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • glucagon intranasal

              glucagon intranasal increases toxicity of glycopyrrolate inhaled by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • inotuzumab

              inotuzumab and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • lefamulin

              lefamulin and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • mobocertinib

              mobocertinib and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • ondansetron

              indacaterol, inhaled, ondansetron. QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • panobinostat

              indacaterol, inhaled and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • pitolisant

              indacaterol, inhaled and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • pramlintide

              pramlintide, glycopyrrolate inhaled. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.

            • revefenacin

              revefenacin and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.

            • ribociclib

              ribociclib increases toxicity of indacaterol, inhaled by QTc interval. Avoid or Use Alternate Drug.

            Monitor Closely (227)

            • abiraterone

              indacaterol, inhaled, abiraterone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • abobotulinumtoxinA

              abobotulinumtoxinA increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .

            • acebutolol

              indacaterol, inhaled, acebutolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • aclidinium

              glycopyrrolate inhaled and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • alfuzosin

              indacaterol, inhaled and alfuzosin both increase QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              alfuzosin and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • amantadine

              glycopyrrolate inhaled increases levels of amantadine by unknown mechanism. Use Caution/Monitor.

              glycopyrrolate inhaled, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

            • amiodarone

              indacaterol, inhaled, amiodarone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • amitriptyline

              indacaterol, inhaled, amitriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              amitriptyline increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              glycopyrrolate inhaled and amitriptyline both decrease cholinergic effects/transmission. Modify Therapy/Monitor Closely.

            • amoxapine

              glycopyrrolate inhaled and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              amoxapine increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, amoxapine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • anticholinergic/sedative combos

              anticholinergic/sedative combos and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • apomorphine

              indacaterol, inhaled, apomorphine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • aripiprazole

              glycopyrrolate inhaled decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of aripiprazole by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              aripiprazole increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              aripiprazole and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • arsenic trioxide

              indacaterol, inhaled, arsenic trioxide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • atenolol

              glycopyrrolate inhaled increases levels of atenolol by unknown mechanism. Use Caution/Monitor.

            • artemether

              artemether and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • artemether/lumefantrine

              indacaterol, inhaled, artemether/lumefantrine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • asenapine

              indacaterol, inhaled, asenapine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • atenolol

              indacaterol, inhaled, atenolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • atomoxetine

              atomoxetine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • atracurium

              atracurium and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine

              atropine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine IV/IM

              atropine IV/IM and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • azithromycin

              indacaterol, inhaled, azithromycin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • belladonna alkaloids

              belladonna alkaloids and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna and opium

              glycopyrrolate inhaled and belladonna and opium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • benperidol

              glycopyrrolate inhaled decreases levels of benperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              benperidol increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • benztropine

              benztropine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • betamethasone

              betamethasone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • betaxolol

              indacaterol, inhaled, betaxolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • bethanechol

              bethanechol increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • bisoprolol

              indacaterol, inhaled, bisoprolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • bumetanide

              bumetanide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, bumetanide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • carbachol

              carbachol increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ceritinib

              ceritinib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • cevimeline

              cevimeline increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • chlorothiazide

              chlorothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, chlorothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • chlorpromazine

              glycopyrrolate inhaled decreases levels of chlorpromazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              chlorpromazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              chlorpromazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, chlorpromazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              glycopyrrolate inhaled decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.

            • chlorthalidone

              chlorthalidone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, chlorthalidone. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • cisatracurium

              cisatracurium and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ciprofloxacin

              indacaterol, inhaled, ciprofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • citalopram

              indacaterol, inhaled, citalopram. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • clarithromycin

              clarithromycin increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, clarithromycin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • clomipramine

              indacaterol, inhaled, clomipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              clomipramine increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              glycopyrrolate inhaled and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clozapine

              glycopyrrolate inhaled decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of clozapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              clozapine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

              clozapine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cortisone

              cortisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • cyclizine

              cyclizine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

              indacaterol, inhaled, cyclobenzaprine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • darifenacin

              darifenacin and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • dasatinib

              indacaterol, inhaled, dasatinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • degarelix

              indacaterol, inhaled, degarelix. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • desipramine

              desipramine increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, desipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • deutetrabenazine

              deutetrabenazine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • dicyclomine

              dicyclomine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • dexamethasone

              dexamethasone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • dichlorphenamide

              dichlorphenamide and indacaterol, inhaled both decrease serum potassium. Use Caution/Monitor.

            • digoxin

              glycopyrrolate inhaled increases levels of digoxin by unknown mechanism. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • disopyramide

              indacaterol, inhaled, disopyramide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • dobutamine

              dobutamine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • dofetilide

              dofetilide increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.

            • dolasetron

              indacaterol, inhaled, dolasetron. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • donepezil

              donepezil and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

              donepezil increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dopamine

              dopamine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • dosulepin

              glycopyrrolate inhaled and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • doxepin

              glycopyrrolate inhaled and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              indacaterol, inhaled, doxepin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              doxepin increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

            • dronedarone

              indacaterol, inhaled, dronedarone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • droperidol

              glycopyrrolate inhaled decreases levels of droperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              droperidol increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • droperidol

              indacaterol, inhaled, droperidol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • echothiophate iodide

              echothiophate iodide increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • efavirenz

              efavirenz and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • encorafenib

              encorafenib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • ephedrine

              ephedrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • epinephrine

              epinephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • eribulin

              eribulin and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • erythromycin base

              indacaterol, inhaled, erythromycin base. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              erythromycin base increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, erythromycin ethylsuccinate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • erythromycin lactobionate

              erythromycin lactobionate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, erythromycin lactobionate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • erythromycin stearate

              erythromycin stearate increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, erythromycin stearate. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • escitalopram

              indacaterol, inhaled, escitalopram. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              escitalopram increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.

            • esmolol

              indacaterol, inhaled, esmolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • ethacrynic acid

              ethacrynic acid, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, ethacrynic acid. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • fesoterodine

              fesoterodine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • fingolimod

              fingolimod and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • flavoxate

              flavoxate and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • flecainide

              indacaterol, inhaled, flecainide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • fluconazole

              indacaterol, inhaled, fluconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • fluoxetine

              indacaterol, inhaled and fluoxetine both increase QTc interval. Modify Therapy/Monitor Closely. Fluoxetine prolongs the QT interval; the prescribing information for fluoxetine recommends avoiding concurrent use of other drugs that may prolong the QT interval; risk may be increased with higher doses and/or when associated with hypokalemia; drugs that prolong the QTc interval may potentiate the effects of beta2 agonists on the cardiovascular system

            • fluphenazine

              fluphenazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, fluphenazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              fluphenazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of fluphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • foscarnet

              indacaterol, inhaled, foscarnet. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • galantamine

              galantamine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fostemsavir

              indacaterol, inhaled and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • furosemide

              furosemide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, furosemide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • gemifloxacin

              indacaterol, inhaled, gemifloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • gemtuzumab

              indacaterol, inhaled and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, glycopyrrolate inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • goserelin

              goserelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • haloperidol

              indacaterol, inhaled, haloperidol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              haloperidol increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of haloperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • hawthorn

              indacaterol, inhaled, hawthorn. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • henbane

              glycopyrrolate inhaled and henbane both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • histrelin

              histrelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • homatropine

              glycopyrrolate inhaled and homatropine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • huperzine A

              huperzine A increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • hydrochlorothiazide

              hydrochlorothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, hydrochlorothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • hydrocortisone

              hydrocortisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • hyoscyamine

              glycopyrrolate inhaled and hyoscyamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • hyoscyamine spray

              glycopyrrolate inhaled and hyoscyamine spray both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ibutilide

              indacaterol, inhaled, ibutilide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • iloperidone

              glycopyrrolate inhaled decreases levels of iloperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              iloperidone increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              indacaterol, inhaled, iloperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • imipramine

              glycopyrrolate inhaled and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              imipramine increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, imipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • indapamide

              indapamide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, indapamide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

              indacaterol, inhaled, indapamide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • ipratropium

              glycopyrrolate inhaled and ipratropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • isocarboxazid

              indacaterol, inhaled, isocarboxazid. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • isoproterenol

              isoproterenol increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • ketoconazole

              ketoconazole increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

            • lapatinib

              lapatinib increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, lapatinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • lenvatinib

              indacaterol, inhaled and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • leuprolide

              leuprolide increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levodopa

              glycopyrrolate inhaled, levodopa. Other (see comment). Use Caution/Monitor. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .

            • levofloxacin

              indacaterol, inhaled, levofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • lofepramine

              glycopyrrolate inhaled and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • lopinavir

              indacaterol, inhaled, lopinavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • loxapine

              glycopyrrolate inhaled decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.

              loxapine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • loxapine inhaled

              glycopyrrolate inhaled decreases levels of loxapine inhaled by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

              loxapine inhaled increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • lumefantrine

              indacaterol, inhaled, lumefantrine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • maprotiline

              glycopyrrolate inhaled and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              maprotiline increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, maprotiline. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • meclizine

              glycopyrrolate inhaled and meclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • mefloquine

              indacaterol, inhaled, mefloquine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • methadone

              indacaterol, inhaled, methadone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • methscopolamine

              glycopyrrolate inhaled and methscopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • methyclothiazide

              methyclothiazide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, methyclothiazide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • methylprednisolone

              methylprednisolone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • metolazone

              metolazone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, metolazone. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • metoprolol

              indacaterol, inhaled, metoprolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • moxifloxacin

              indacaterol, inhaled, moxifloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • nadolol

              indacaterol, inhaled, nadolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • nebivolol

              indacaterol, inhaled, nebivolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • nelfinavir

              nelfinavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

            • neostigmine

              neostigmine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nilotinib

              indacaterol, inhaled, nilotinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • norepinephrine

              norepinephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • nortriptyline

              glycopyrrolate inhaled and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              nortriptyline increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              indacaterol, inhaled, nortriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • octreotide

              indacaterol, inhaled, octreotide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • olanzapine

              glycopyrrolate inhaled decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.

              olanzapine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • ofloxacin

              indacaterol, inhaled, ofloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • olodaterol inhaled

              indacaterol, inhaled and olodaterol inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Caution with coadministration of adrenergic drugs by any route because of additive sympathetic effects

            • onabotulinumtoxinA

              onabotulinumtoxinA and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • orphenadrine

              glycopyrrolate inhaled and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • osilodrostat

              osilodrostat and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxaliplatin

              oxaliplatin will increase the level or effect of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • oxybutynin

              glycopyrrolate inhaled and oxybutynin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin topical

              glycopyrrolate inhaled and oxybutynin topical both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin transdermal

              glycopyrrolate inhaled and oxybutynin transdermal both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ozanimod

              ozanimod and indacaterol, inhaled both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • paliperidone

              paliperidone increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              indacaterol, inhaled, paliperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • pancuronium

              glycopyrrolate inhaled and pancuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • pazopanib

              indacaterol, inhaled, pazopanib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • penbutolol

              indacaterol, inhaled, penbutolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • pentamidine

              indacaterol, inhaled, pentamidine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • perphenazine

              perphenazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              perphenazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of perphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              indacaterol, inhaled, perphenazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • phenelzine

              indacaterol, inhaled, phenelzine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • physostigmine

              physostigmine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenylephrine

              phenylephrine increases effects of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol may be potentiated.

            • pilocarpine

              pilocarpine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pimozide

              glycopyrrolate inhaled decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.

              pimozide increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of pimozide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              indacaterol, inhaled, pimozide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • pindolol

              indacaterol, inhaled, pindolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • pralidoxime

              glycopyrrolate inhaled and pralidoxime both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • posaconazole

              indacaterol, inhaled, posaconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • prednisolone

              prednisolone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • prednisone

              prednisone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • procainamide

              indacaterol, inhaled, procainamide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • prochlorperazine

              glycopyrrolate inhaled decreases levels of prochlorperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              prochlorperazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • promethazine

              glycopyrrolate inhaled decreases levels of promethazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.

              promethazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • propafenone

              indacaterol, inhaled, propafenone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • propantheline

              glycopyrrolate inhaled and propantheline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • propranolol

              indacaterol, inhaled, propranolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • protriptyline

              indacaterol, inhaled, protriptyline. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              glycopyrrolate inhaled and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              protriptyline increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

            • pyridostigmine

              pyridostigmine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • quetiapine

              indacaterol, inhaled, quetiapine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • quetiapine

              glycopyrrolate inhaled decreases levels of quetiapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.

              quetiapine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • quinidine

              indacaterol, inhaled, quinidine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • quinine

              indacaterol, inhaled, quinine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • ranolazine

              indacaterol, inhaled, ranolazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • rapacuronium

              glycopyrrolate inhaled and rapacuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • rimantadine

              glycopyrrolate inhaled, rimantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced CNS side effects.

            • risperidone

              risperidone increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of risperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              indacaterol, inhaled, risperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • ritonavir

              ritonavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, ritonavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • rivastigmine

              rivastigmine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • rocuronium

              glycopyrrolate inhaled and rocuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • romidepsin

              indacaterol, inhaled, romidepsin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • saquinavir

              saquinavir increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

              indacaterol, inhaled, saquinavir. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • scopolamine

              glycopyrrolate inhaled and scopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • selpercatinib

              selpercatinib increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor.

            • solifenacin

              glycopyrrolate inhaled and solifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • solriamfetol

              indacaterol, inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • sotalol

              indacaterol, inhaled, sotalol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

              indacaterol, inhaled, sotalol. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • succinylcholine

              succinylcholine increases and glycopyrrolate inhaled decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • sunitinib

              indacaterol, inhaled, sunitinib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • tacrolimus

              indacaterol, inhaled, tacrolimus. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • telavancin

              indacaterol, inhaled, telavancin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • theophylline

              theophylline, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • thioridazine

              indacaterol, inhaled, thioridazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              glycopyrrolate inhaled decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of thioridazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              thioridazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • thiothixene

              indacaterol, inhaled, thiothixene. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              glycopyrrolate inhaled decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of thiothixene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              thiothixene increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • timolol

              indacaterol, inhaled, timolol. Other (see comment). Use Caution/Monitor. Comment: Beta-blockers and indacaterol may interfere with the effect of each other when administered concurrently. Beta-blockers may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

            • tiotropium

              glycopyrrolate inhaled and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • tolterodine

              glycopyrrolate inhaled and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • toremifene

              indacaterol, inhaled, toremifene. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • torsemide

              torsemide, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              indacaterol, inhaled, torsemide. Other (see comment). Use Caution/Monitor. Comment: Caution is advised in the coadministration of indacaterol neohaler with non-potassium-sparing diuretics.

            • tranylcypromine

              indacaterol, inhaled, tranylcypromine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with MAO inhibitors. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

            • triclabendazole

              triclabendazole and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • trifluoperazine

              indacaterol, inhaled, trifluoperazine. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              glycopyrrolate inhaled decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              trifluoperazine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of trifluoperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • trihexyphenidyl

              glycopyrrolate inhaled and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.

            • trimipramine

              indacaterol, inhaled, trimipramine. QTc interval. Use Caution/Monitor. Indacaterol should be administered with extreme caution to patients treated with TCAs. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • trimipramine

              glycopyrrolate inhaled and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              trimipramine increases levels of glycopyrrolate inhaled by unknown mechanism. Use Caution/Monitor.

            • triptorelin

              triptorelin increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • trospium chloride

              glycopyrrolate inhaled and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • umeclidinium bromide

              umeclidinium bromide and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

            • vandetanib

              indacaterol, inhaled, vandetanib. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • vardenafil

              indacaterol, inhaled, vardenafil. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • vecuronium

              glycopyrrolate inhaled and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • verapamil

              verapamil increases levels of indacaterol, inhaled by Other (see comment). Use Caution/Monitor. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

            • voclosporin

              voclosporin, indacaterol, inhaled. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              indacaterol, inhaled, voriconazole. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • vorinostat

              indacaterol, inhaled, vorinostat. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • ziprasidone

              glycopyrrolate inhaled decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.

              ziprasidone increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              glycopyrrolate inhaled decreases levels of ziprasidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              indacaterol, inhaled, ziprasidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • zotepine

              glycopyrrolate inhaled decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.

            Minor (7)

            • chloroquine

              chloroquine increases toxicity of indacaterol, inhaled by QTc interval. Minor/Significance Unknown.

            • desipramine

              glycopyrrolate inhaled and desipramine both decrease cholinergic effects/transmission. Minor/Significance Unknown.

            • dimenhydrinate

              dimenhydrinate increases toxicity of glycopyrrolate inhaled by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.

            • donepezil

              donepezil decreases effects of glycopyrrolate inhaled by pharmacodynamic antagonism. Minor/Significance Unknown.

            • galantamine

              galantamine decreases effects of glycopyrrolate inhaled by pharmacodynamic antagonism. Minor/Significance Unknown.

            • itraconazole

              itraconazole increases levels of indacaterol, inhaled by Other (see comment). Minor/Significance Unknown. Comment: Data suggests that systemic clearance is influenced by modulation of both P-gp and CYP3A4 activities. No dose adjustment is warranted at the 75 mcg dose.

            • lofepramine

              lofepramine increases levels of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

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            Adverse Effects

            1-10%

            Nasopharyngitis (4.1%)

            Hypertension (2%)

            Back pain (1.8%)

            Oropharyngeal pain (1.6%)

            Postmarketing Reports

            Angioedema

            Dysphonia

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            Warnings

            Black Box Warnings

            Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death

            Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol

            This finding with salmeterol is considered a class effect of all LABAs, including indacaterol

            Safety and efficacy of indacaterol/glycopyrrolate in patients with asthma have not been established

            Not indicated for the treatment of asthma

            Contraindications

            Hypersensitivity

            All LABAs are contraindicated in patients with asthma without use of an inhaled corticosteroid; indacaterol/glycopyrrolate is not indicated for the treatment of asthma

            Cautions

            Safety and efficacy in patients with asthma not established; not indicated for asthma; monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death (see Black Box Warnings)

            Available data do not suggest an increased risk of death with use of LABA in patients with COPD

            Should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD; also do not use for the relief of acute symptoms (ie, as rescue therapy) for treating acute episodes of bronchospasm

            Do not use more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients receiving therapy should not use another medicine containing a LABA for any reason

            Can produce paradoxical bronchospasm that may be life-threatening Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrrolate; if signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips, and face), anaphylaxis, urticaria, or skin rash, therapy should be discontinued immediately and alternative therapy instituted; drug should be used with caution in patients with severe hypersensitivity to milk proteins

            LABAs can produce clinically significant cardiovascular effects, including increases in pulse rate or systolic or diastolic blood pressure

            Caution with convulsive disorders, thyrotoxicosis, patients who are unusually responsive to sympathomimetic amines, narrow-angle glaucoma (may worsen), or urinary retention (eg, prostatic hyperplasia, bladder-neck obstruction); instruct patients to contact their physician immediately with worsening disease symptoms

            Doses of the related beta2-agonist albuterol, when administered IV, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis

            LABAs may produce significant hypokalemia, which has the potential to produce adverse cardiovascular effect; in patients with severe COPD, hypokalemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility for cardiac arrhythmias

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            Pregnancy

            Pregnancy

            There are no adequate and well-controlled studies with drug combination or its individual components, indacaterol and glycopyrrolate, in pregnant women; women should be advised to contact their healthcare provider if they become pregnant while receiving therapy

            There are no adequate and well-controlled human trials that have investigated effects of therapy during labor and delivery; because beta-agonists may potentially interfere with uterine contractility, drug should be used during labor only if potential benefit justifies potential risk

            Animal data

            • Animal reproduction studies were conducted with individual components, indacaterol and glycopyrrolate.
            • Indacaterol: In animal reproduction studies, there was no evidence of fetal harm or structural abnormalities following subcutaneous administration of indacaterol maleate to pregnant Wistar rats and New Zealand White rabbits during the period of organogenesis at exposures approximately 340 and 770 times, respectively, the maximum recommended human dose (MRHD of 55 mcg) on an exposure (AUC) basis
            • Glycopyrrolate: In animal reproduction studies, there was no evidence of fetal harm or structural abnormalities in Wistar rats or New Zealand White rabbits at inhaled doses approximately 1400 and 530 times, respectively, the MRHD (31.2 mcg) on an AUC basis

            Lactation

            There is no data on presence of indacaterol or glycopyrrolate or their metabolites in human milk, effects on breastfed infant, or on milk production

            Studies of lactating rats, indacaterol and glycopyrrolate were present in the milk; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condi

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Glycopyrronium: Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle

            Indacaterol: Long-acting beta2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

            Absorption

            Absolute bioavailability: 43-45% (indacaterol)

            Peak plasma time: 5 minutes (glycopyrrolate); 15 minutes (indacaterol)

            Distribution

            Protein bound: 38-41% (glycopyrrolate); ~95% (indacaterol)

            Vd: 83-376 L (glycopyrrolate); 2361-2557 L (indacaterol)

            Metabolism

            Indacaterol

            • Metabolized by UGT1A to the phenolic O-glucuronide
            • Also undergoes hydroxylation (predominantly by CYP3A4)

            Glycopyrrolate

            • Hydroxylation of results in a variety of mono-and bishydroxylated metabolites and direct hydrolysis results in the formation of a carboxylic acid derivative (M9)
            • M9 is hydrolyzed by multiple CYP isoenzymes

            Elimination

            Half-life: 40-56 hr (indacaterol oral); 33-53 hr (glycopyrrolate inhaled)

            Renal clearance: 0.46-1.2 L/hr (indacaterol)

            Systemic clearance: 18.8-23.3 L/hr (indacaterol)

            Excretion

            • Indacaterol: 54% (unchanged) and 23% (metabolites) in feces
            • Glycopyrrolate: 60-70% urine; 30-40% nonrenal (mostly by metabolism; also biliary)

            Pharmacogenomics

            Indacaterol

            • The pharmacokinetics of indacaterol were prospectively investigated in subjects with the UGT1A1 (TA)7/(TA)7 genotype (low UGT1A1 expression; also referred to as *28) and the (TA)6, (TA)6 genotype
            • Steady-state AUC and Cmax were 1.2-fold higher in the [(TA)7, (TA)7] genotype, suggesting no relevant effect of UGT1A1 genotype of indacaterol exposure
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            Administration

            Instructions

            For oral inhalation only

            Do not swallow the capsules, as the intended effects on the lungs will not be obtained

            Capsules should only be used with the Neohaler device

            Should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day

            More frequent administration or a greater number of inhalations (>1 capsule BID) is not recommended

            Storage

            Store in a dry place at controlled room temperature (77°F [25°C]); excursions permitted to 59-86°F (15-30°C)

            Store capsules in the blister package that they are packaged in, and only remove immediately before use with the Neohaler device

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            Images

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.