Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (22)
- adagrasib
adagrasib, indacaterol, inhaled. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- 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.
- itraconazole
itraconazole and indacaterol, inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- 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 (233)
- 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.
- asenapine transdermal
asenapine transdermal and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- 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. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- 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. - donepezil transdermal
donepezil transdermal, glycopyrrolate inhaled. Either decreases effects of the other by pharmacodynamic antagonism. 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.
- gilteritinib
gilteritinib and indacaterol, inhaled 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.
- levoketoconazole
levoketoconazole 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.
- 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.
- quizartinib
quizartinib, indacaterol, inhaled. Either increases effects of the other by QTc interval. Modify Therapy/Monitor Closely. Monitor patients more frequently with ECG if coadministered with QT prolonging drugs.
- 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
- valbenazine
valbenazine and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.
- 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.
Adverse Effects
1-10%
Nasopharyngitis (4.1%)
Hypertension (2%)
Back pain (1.8%)
Oropharyngeal pain (1.6%)
Postmarketing Reports
Angioedema
Dysphonia
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
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.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
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
Images
Formulary
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