glycopyrrolate inhaled/formoterol (Rx)

Brand and Other Names:Bevespi Aerosphere
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Dosing & Uses

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Dosage Forms & Strengths

glycopyrrolate/formoterol fumarate

inhalation aerosol

  • (9mcg/4.8mcg)/inhalation

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 with COPD, including chronic bronchitis and/or emphysema

2 inhalations (ie, 18 mcg/9.6 mcg) PO BID (morning and evening)

Do not exceed 2 inhalations BID

Dosage Modifications

Renal impairment

  • Studies not conducted
  • Severe (CrCl ≤30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis: Use only if expected benefit outweighs the potential risk

Hepatic impairment

  • Studies not conducted
  • Since formoterol fumarate is predominantly cleared by hepatic metabolism, impairment may lead to plasma formoterol accumulation; monitor closely

Dosing Considerations

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

Safety and efficacy not established

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Interactions

Interaction Checker

and glycopyrrolate inhaled/formoterol

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            Contraindicated (1)

            • umeclidinium bromide/vilanterol inhaled

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

            Serious - Use Alternative (4)

            • 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. .

            • 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.

            Monitor Closely (97)

            • 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. .

            • aclidinium

              glycopyrrolate inhaled and aclidinium both decrease cholinergic effects/transmission. 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.

            • amitriptyline

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

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

            • 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.

            • anticholinergic/sedative combos

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

            • aripiprazole

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

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

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

            • atenolol

              glycopyrrolate inhaled increases levels of atenolol by unknown mechanism. 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.

            • 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.

            • bethanechol

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

            • carbachol

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

            • cevimeline

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

            • chlorpromazine

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

              glycopyrrolate inhaled decreases levels of chlorpromazine by pharmacodynamic antagonism. 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.

            • cisatracurium

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

            • clomipramine

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

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

            • clozapine

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

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

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

            • 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.

            • darifenacin

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

            • desipramine

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

            • dicyclomine

              dicyclomine and glycopyrrolate inhaled both decrease cholinergic effects/transmission. 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.

            • donepezil

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

            • 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.

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

            • 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.

            • echothiophate iodide

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

            • fesoterodine

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

            • flavoxate

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

            • fluphenazine

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

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

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

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

            • galantamine

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

            • haloperidol

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

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

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

            • henbane

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

            • 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.

            • 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.

            • 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.

            • 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.

            • ipratropium

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

            • 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. .

            • lofepramine

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

            • 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.

            • 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.

            • meclizine

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

            • methscopolamine

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

            • neostigmine

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

            • 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.

            • 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.

            • 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.

            • 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.

            • paliperidone

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

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

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

            • pancuronium

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

            • perphenazine

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

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

            • physostigmine

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

            • pilocarpine

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

            • pilocarpine ophthalmic

              pilocarpine ophthalmic 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 inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              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.

            • pralidoxime

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

            • 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.

            • propantheline

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

            • protriptyline

              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

              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.

            • 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

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

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

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

            • 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.

            • scopolamine

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

            • solifenacin

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

            • succinylcholine

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

            • thioridazine

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

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

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

            • thiothixene

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

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

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

            • 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.

            • trifluoperazine

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

              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.

            • trihexyphenidyl

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

            • 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.

            • 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

            • vecuronium

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

            • ziprasidone

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

              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.

            • 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 (12)

            • 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.

            • lofepramine

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

            • prochlorperazine

              prochlorperazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

            • promazine

              promazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

            • promethazine

              promethazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

            • rimantadine

              rimantadine increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Minor/Significance Unknown.

            • thioridazine

              thioridazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

            • trazodone

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

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

            • trifluoperazine

              trifluoperazine increases toxicity of glycopyrrolate inhaled by unknown mechanism. Minor/Significance Unknown.

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            Adverse Effects

            1-10%

            Cough (4%)

            Urinary tract infection (2.6%)

            Arthralgia (<2%)

            Chest pain (<2%)

            Tooth abscess (<2%)

            Muscle spasms (<2%)

            Headache (<2%)

            Oropharyngeal pain (<2%)

            Vomiting (<2%)

            Pain in extremity (<2%)

            Dizziness (<2%)

            Anxiety (<2%)

            Dry mouth (<2%)

            Fall (<2%)

            Influenza (<2%)

            Fatigue (<2%)

            Acute sinusitis (<2%)

            Contusion (<2%)

            Frequency Not Defined

            Formoterol

            • Hypersensitivity reactions
            • Hyperglycemia
            • Sleep disturbance
            • Agitation
            • Restlessness
            • Tremor
            • Nausea
            • Tachycardia
            • Palpitations
            • Cardiac arrhythmias
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            Warnings

            Black Box Warnings

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

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

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

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

            Not indicated for the treatment of asthma

            Contraindications

            Hypersensitivity

            All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication; not indicated for the treatment of asthma

            Cautions

            Data from a large placebo-controlled US study in asthma patients showed that LABAs may increase the risk of asthma-related death (see Black Box Warnings)

            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 combination with additional therapy containing a LABA because of risk of overdose; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic medicines; patients using drug should not use another medicine containing a LABA for any reason

            Can produce paradoxical bronchospasm that may be life-threatening; treat immediately with an inhaled, short-acting bronchodilator, discontinue therapy, and institute alternative therapy

            Immediate hypersensitivity reactions have been reported after administration of formoterol or glycopyrrolate

            LABAs can produce clinically significant cardiovascular effects, including increases in pulse rate or systolic or diastolic blood pressure; if such effects occur, discontinue therapy

            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 owing to transient hyperglycemia; use caution

            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; the decrease in serum potassium is usually transient, not requiring supplementation

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            Pregnancy & Lactation

            Pregnancy

            There are no well-controlled human trials that have investigated the effects on preterm labor or labor at term; because beta 2 agonists may potentially interfere with uterine contractility, drug should be used during labor only if potential benefit justifies potential risk

            Single-dose studies in humans found that a very small amount of glycopyrrolate passed the placental barrier

            Animal studies

            • Glycopyrrolate
              • Administered by the subcutaneous route in rats and rabbits, there were no structural abnormalities or a decrease in fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (MRHDID), respectively; it had no effects on physical, functional, and behavioral development of rat pups with exposures up to 2700 times the MRHDID
            • Formoterol fumarate
              • Formoterol fumarate alone, administered by the oral route in rats and rabbits, caused structural abnormalities at 1500 and 61,000 times the MRHDID, respectively
              • Formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 110 times the MRHDID
              • The adverse effects generally occurred at large multiples of the MRHDID when formoterol fumarate was administered by oral route to achieve high systemic exposures
              • No structural abnormalities, embryocidal, or developmental effects were seen in rats that received inhalation doses up to 350 times the MRHDID

            Lactation

            There are no available data on effects of glycopyrrolate, or formoterol fumarate on breastfed child or milk production

            There are no available data on presence of glycopyrrolate or formoterol fumarate in human milk

            Formoterol fumarate and glycopyrrolate have been detected in plasma of undosed rat pups suckling from exposed dams; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breast-fed child from drug or from underlying maternal condition

            Pregnancy Categories

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

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

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

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

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

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

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

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

            Absorption

            Peak plasma concentration: 5 min (glycopyrrolate); 20-60 min (formoterol)

            Steady-state achieved: 2-3 days

            Extent of systemic exposure increases at steady state compared to first dose; 2.3 x higher (glycopyrrolate) and 1.5 x higher (formoterol)

            Distribution

            Protein bound: 46-58% (formoterol)

            Vd (central compartment): 951 L (glycopyrrolate); 948 L (formoterol)

            Vd (peripheral compartment): 2019 L (glycopyrrolate); 434 L (formoterol)

            Metabolism

            Glycopyrrolate: metabolism plays a minor role in the overall elimination of glycopyrrolate

            Formoterol

            • Primary metabolism of formoterol is by direct glucuronidation and by O-demethylation followed by conjugation to inactive metabolites
            • Secondary metabolic pathways include deformylation and sulfate conjugation
            • CYP2D6 and CYP2C have been identified as being primarily responsible for O-demethylation

            Elimination

            Half-life: 11.8 hr (glycopyrrolate); 11.8 hr (formoterol)

            Elimination

            • Glycopyrrolate: 85% urine; small amount in bile
            • Formoterol: 62% in urine; 24% in feces
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            Administration

            Orally Inhaled Administration

            Shake well before each use

            Do not exceed 2 inhalations twice daily

            Canister contains 120 inhalations and has an attached dose indicator, which indicates how many inhalations remain

            The dose indicator display will move after every tenth actuation

            When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red

            Discarded when the dose indicator display window shows zero

            Prime device

            • Prime the inhaler to ensure appropriate drug content in each actuation
            • Prime before using for the first time
            • To prime, release 4 sprays into the air away from the face, shaking well before each spray
            • Must be reprimed when the inhaler has not been used for >7 days; to reprime, release 2 sprays into the air away from the face; shake canister well before each spray

            Storage

            Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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            Images

            No images available for this drug.
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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
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.