indacaterol, inhaled (Rx)

Brand and Other Names:Arcapta Neohaler
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule, powder for inhalation

  • 75mcg/capsule

COPD

Long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

75 mcg inhaled orally qDay; not to exceed once daily

Limitations of use

  • Not indicated for acute deteriorations of COPD
  • Not indicated for asthma

Administration

For oral inhalation only

Do not swallow the capsules for inhalation; if swallowed, intended effects on the lungs will not be obtained

For use with Neohaler inhaler device only

Administer qDay at the same time of the day by the oral inhalation route only

If a dose is missed, the next dose should be taken as soon as it is remembered

Not to exceed once daily administration

Store capsule in the blister pack it comes in until immediately before use

Safety and efficacy not established

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

Data are not available for severe hepatic impairment

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Interactions

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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.

            • 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 (12)

            • 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.

            • 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.

            • 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.

            • ribociclib

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

            Monitor Closely (144)

            • 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.

            • 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.

            • 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.

            • 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.

            • amoxapine

              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.

            • 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.

            • 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.

            • 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.

            • 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.

            • 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.

            • 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.

            • 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

              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.

            • 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.

            • 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.

            • cortisone

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

            • cyclobenzaprine

              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.

            • 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

              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.

            • 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.

            • 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.

            • 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.

            • doxepin

              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.

            • 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

              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.

            • 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.

            • 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.

            • 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

              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.

            • 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.

            • 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.

            • 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.

            • 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.

            • histrelin

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

            • 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.

            • 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

              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

              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.

            • 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.

            • 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.

            • 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.

            • 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

              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.

            • 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.

            • 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.

            • 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

              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.

            • 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

            • 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.

            • 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

              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.

            • 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

              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.

            • 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.

            • pimozide

              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.

            • 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.

            • 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.

            • 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.

            • 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.

            • 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.

            • risperidone

              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.

            • 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.

            • selpercatinib

              selpercatinib increases toxicity of indacaterol, inhaled by QTc interval. 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.

            • 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.

            • 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.

            • 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.

            • 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.

            • 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.

            • triptorelin

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

            • 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.

            • 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.

            • 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

              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.

            Minor (2)

            • chloroquine

              chloroquine increases toxicity of indacaterol, inhaled by QTc interval. 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.

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            Adverse Effects

            >10%

            Post-inhalation cough (24% compared with 7% on placebo)

            1-10%

            Cough (6.5%)

            Nasopharyngitis (5.3%)

            Headache (5.1%)

            Nausea (2.4%)

            Oropharyngeal pain (2.2%)

            Postmarketing Reports

            Hypersensitivity reactions

            Paradoxical bronchospasm

            Tachycardia/heart rate increase/palpitations

            Pruritus/rash

            Dizziness

            Pruritus

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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 long-acting beta2-adrenergic agonist (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 LABA, including indacaterol

            The safety and efficacy of indacaterol in patients with asthma have not been established

            Indacaterol is NOT indicated for the treatment of asthma

            Contraindications

            Hypersensitivity

            Use of a long-acting beta2-adrenergic agonists (LABAs) without an inhaled corticosteroid in patients with asthma

            Cautions

            Do not initiate in acutely deteriorating COPD patients

            Do not use for relief of acute symptoms; prescribe concomitant short-acting beta2-agonists for acute exacerbations

            Do not exceed recommended daily dose; excessive doses may result in cardiovascular effects and may be fatal

            Life-threatening paradoxical bronchospasm can occur; discontinue use immediately

            Immediate hypersensitivity reactions reported; discontinue immediately and initiate alternate therapy

            Safety and efficacy in patients with asthma not established; not indicated for asthma

            Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see Black Box Warnings)

            Caution with CV disease, epilepsy, thyrotoxicosis, or sensitivity to sympathomimetics

            Contains trace levels of milk protein

            Tolerance to the effects of inhaled beta-agonists can occur with regularly-scheduled, chronic use

            Increased sympathomimetic effects may occur if coadministered with other adrenergic drugs

            May cause hypokalemia; this effect may be potentiated if coadministered with xanthine derivatives, corticosteroids, or diuretics

            ECG changes or hypokalemia that may result from non-potassium sparing diuretics (eg, thiazides or loop diuretics) can be acutely worsened by beta-agonists, especially with high doses; use caution

            Caution with coadministration of MOAIs, TCAs, and drugs that prolong QTc interval

            Beta blockers may antagonize the effect of indacaterol

            Strong dual inhibitors of CYP3A4 and P-gp (ie, ketoconazole, erythromycin, verapamil, ritonavir) may delay systemic clearance of indacaterol (AUC increased 1.9-fold); no dose adjustment is warranted with 75 mcg/day

            Beta2 agonists may increase serum glucose; use caution in patients with diabetes mellitus

            Use caution in patients with seizure disorders

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            Pregnancy & Lactation

            Pregnancy Category: C

            Beta-agonists are known to inhibit uterine contractility

            Lactation: Unknown whether distributed in human breast milk; use caution

            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

            Long-acting beta2-adrenergic agonist; when inhaled, acts locally in the lung as a bronchodilator

            Stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

            In vitro studies have shown that indacaterol has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors (selectivity profile is similar to formoterol)

            Absorption

            Bioavailability: 43-45% following inhalation (composite of pulmonary and intestinal absorption)

            Peak Plasma Time: 15 min

            Distribution

            Protein Bound: 95% (after IV administration)

            Vd: 2361-2557 L (after IV administration)

            Metabolism

            Metabolized by UGT1A1, CYP3A4 (predominant for hydroxylation), CYP1A1, CYP2D6

            Low affinity for efflux pump P-gp

            In vitro investigations indicated that indacaterol has negligible potential to cause metabolic interactions with medications (by inhibition or induction of cytochrome P450 enzymes, or induction of UGT1A1)

            Elimination

            Half-life (terminal): 45.5-126 hr, multiphasic half-life

            Half-life (effective): 40-56 hr, calculated from accumulation after repeated dosing

            Renal clearance: 0.46-1.2 L/hr

            Total body clearance: 18.8-23.3 L/hr

            Excretion: feces (54% unchanged, 23% hydroxylated metabolites), urine (<2%)

            Pharmacogenomics

            Pharmacokinetics were prospectively investigated in individuals 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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            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.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.