glycopyrrolate (Rx)

Brand and Other Names:Cuvposa, Dartisla ODT, more...glycopyrronium, Robinul, Robinul Forte

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 1mg (generic, Robinul)
  • 1.5mg (generic)
  • 2mg (generic, Robinul Forte)

tablet, oral disintegrating

  • 1.7mg (Dartisla ODT)

oral solution

  • 1mg/5mL (Cuvposa)

injectable solution

  • 0.2mg/mL

Surgery

Preoperative reduction of saliva or intraoperative reduction of cholinergic effects

Preoperative: 4mcg/kg IM 30-60 min before surgery  

Intraoperative: 0.1 mg IV; may repeat q2-3min

Neuromuscular Blockade Reversal

Prevention of muscarinic adverse effects

0.2 mg IV per 1 mg of neostigmine or 5 mg of pyridostigmine administered

Adjunct to Treatment of Peptic Ulcer

Indicated in adults to reduce symptoms of peptic ulcer as an adjunct to treatment of peptic ulcer1.7 mg PO BID/TID; not to exceed 6.8 mg/day

Use lowest effective dose to control symptoms

Switching from other oral glycopyrrolate

  • Patients receiving 2 mg of another oral tablet dosage form of glycopyrrolate may be switched to 1.7 mg

Drooling (Off-label)

0.1 mg/kg PO q8-12hr; not to exceed 8 mg/day

Frey Syndrome (Orphan)

Orphan indication sponsor

  • Wellesley Therapeutics, Inc; 200 Gerrard St., East Toronto, Ontario M5A 2E6; Canada

Dosing Considerations

Dartisla ODT

  • Not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established
  • Not recommended for patients in whom a lower dosage strength of another oral glycopyrrolate product (eg, 1-mg tablet) is appropriate for initial or maintenance treatment

Dosage Forms & Strengths

tablets

  • 1mg (generic, Robinul)
  • 2mg (generic, Robinul Forte)

injectable solution

  • 0.2mg/mL (Cuvposa)

oral solution

  • 1mg/5mL

Surgery

Preoperative reduction of saliva or intraoperative reduction of cholinergic effects

1 month to 2 years (preoperative): 4-9 mcg/kg IM 30-60 min before anesthesia or when preanesthetic opioid and/or sedative administered  

>2 years: 4 mcg/kg IM

Preoperative: 30-60 min before surgery

Intraoperative: May repeat q2-3min; not to exceed 0.1 mg

Drooling

FDA-approved for children with chronic, severe drooling associated with neurologic conditions (eg, cerebral palsy)

<3 years: Safety and efficacy not established

3-16 years: 0.02 mg/kg PO q8hr initially; may increase by 0.02 mg/kg q5-7days if warranted, up to 0.1 mg/kg q8hr  

Not to exceed 1.5-3 mg/dose (based on weight; see Mfr info)

Control of Secretions (Off-label)

0.004-0.01 mg/kg IV/IM q6hr  

0.04-0.1 mg/kg PO q6hr

Neuromuscular Blockade Reversal

0.2 mg IV per 1 mg of neostigmine or 5 mg of pyridostigmine administered

Next:

Interactions

Interaction Checker

and glycopyrrolate

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      Serious - Use Alternative

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            Contraindicated (1)

            • umeclidinium bromide/vilanterol inhaled

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

            Serious - Use Alternative (7)

            • glucagon

              glucagon increases toxicity of glycopyrrolate 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 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. .

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, glycopyrrolate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • macimorelin

              glycopyrrolate, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.

            • pramlintide

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

            • revefenacin

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

            • secretin

              glycopyrrolate decreases effects of secretin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Concomitant use of anticholinergic drugs may cause a hyporesponse to stimulation testing with secretin. Discontinue anticholinergic drugs at least 5 half-lives before administering secretin.

            Monitor Closely (95)

            • abobotulinumtoxinA

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

            • aclidinium

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

            • amantadine

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

            • amitriptyline

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

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

            • amoxapine

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

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

            • aripiprazole

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

            • atenolol

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

            • atropine

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

            • atropine IV/IM

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

            • belladonna alkaloids

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

            • belladonna and opium

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

            • benperidol

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

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

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

            • bethanechol

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

            • buprenorphine, long-acting injection

              buprenorphine, long-acting injection increases effects of glycopyrrolate by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of buprenorphine with anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

            • carbachol

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

            • cevimeline

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

            • chlorpromazine

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

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

            • clomipramine

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

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

            • clozapine

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

            • cyclizine

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

            • cyclobenzaprine

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

            • darifenacin

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

            • desipramine

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

            • dicyclomine

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

            • digoxin

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

            • diphenhydramine

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

            • donepezil

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

            • donepezil transdermal

              donepezil transdermal, glycopyrrolate. Either decreases effects of the other by pharmacodynamic antagonism. Use Caution/Monitor.

            • dosulepin

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

            • doxepin

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

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

            • droperidol

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

            • echothiophate iodide

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

            • fesoterodine

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

            • flavoxate

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

            • fluphenazine

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

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

            • galantamine

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

            • haloperidol

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

            • henbane

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

            • homatropine

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

            • huperzine A

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

            • hyoscyamine

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

            • hyoscyamine spray

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

            • iloperidone

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

            • imipramine

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

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

            • ipratropium

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

            • levodopa

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

            • loxapine

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

            • loxapine inhaled

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

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

            • maprotiline

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

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

            • meclizine

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

            • metformin

              glycopyrrolate increases toxicity of metformin by unspecified interaction mechanism. Use Caution/Monitor. May require a dose reduction.

            • methscopolamine

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

            • metoclopramide intranasal

              glycopyrrolate will decrease the level or effect of metoclopramide intranasal by Other (see comment). Use Caution/Monitor. Coadministration of metoclopramide intranasal with drugs that impair GI motility may decrease systemic absorption of metoclopramide. Monitor for reduced therapeutic effect.

            • neostigmine

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

            • nortriptyline

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

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

            • olanzapine

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

            • oliceridine

              glycopyrrolate increases toxicity of oliceridine by Other (see comment). Use Caution/Monitor. Comment: Anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility if oliceridine is coadministered with anticholinergics.

            • onabotulinumtoxinA

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

            • orphenadrine

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

            • oxybutynin

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

            • oxybutynin topical

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

            • oxybutynin transdermal

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

            • paliperidone

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

            • pancuronium

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

            • perphenazine

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

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

            • physostigmine

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

            • pilocarpine

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

            • pimozide

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

            • prabotulinumtoxinA

              glycopyrrolate, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.

            • pralidoxime

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

            • prochlorperazine

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

            • promethazine

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

            • propantheline

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

            • protriptyline

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

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

            • pyridostigmine

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

            • quetiapine

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

            • rapacuronium

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

            • risperidone

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

            • rocuronium

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

            • scopolamine

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

            • solifenacin

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

            • succinylcholine

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

            • thioridazine

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

            • thiothixene

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

            • tiotropium

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

            • tolterodine

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

            • trifluoperazine

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

            • trihexyphenidyl

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

            • trimipramine

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

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

            • trospium chloride

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

            • umeclidinium bromide

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

            • vecuronium

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

            • ziprasidone

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

            • zotepine

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

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

            Minor (12)

            • desipramine

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

            • dimenhydrinate

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

            • donepezil

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

            • galantamine

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

            • lofepramine

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

            • prochlorperazine

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

            • promazine

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

            • promethazine

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

            • rimantadine

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

            • thioridazine

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

            • trazodone

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

            • trifluoperazine

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

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            Adverse Effects

            Frequency Not Defined

            Anticholinergic symptoms (mydriasis, hyperthermia, tachycardia, cardiac arrhythmia)

            Dry mouth

            Dry skin

            Anhidrosis

            Flushing

            Blurred vision

            Cycloplegia

            Photophobia

            Palpitation

            Xerophthalmia

            Constipation

            Urinary retention

            Postmarketing Reports

            Angioedema

            Paradoxical bronchospasm

            Dysphonia

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            Warnings

            Contraindications

            Hypersensitivity to drug or components

            Glaucoma

            Obstructive uropathies, including prostatic hypertrophyMechanical obstructive diseases of gastrointestinal tract (eg, pyloroduodenalstenosis, strictures)

            Gastrointestinal motility disorders (eg, achalasia, paralytic ileus, intestinal atony)Bleeding gastrointestinal ulcer

            Active inflammatory or infectious colitis which can lead to toxic megacolon

            History of or current toxic megacolon

            Myasthenia gravis

            Cautions

            Use caution in patients with hepatic impairment

            May cause urinary retention and further complicate existing renal impairment; dose adjustment may be necessary

            Use caution in patients with hiatal hernia with reflux esophagitis

            May worsen symptoms of prostatic hyperplasia and/or bladder neck destruction (may increase urinary retention); use with caution

            Use caution in patients with autonomic neuropathy

            Use caution in patients with hyperthyroidism

            May cause increased intraocular pressure in patients with glaucoma and reduce effects of antiglaucoma agents; instruct patients to discontinue therapy and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils)

            In ulcerative colitis, large doses may suppress intestinal motility and exacerbate an ileus or toxic magacolon; use is contraindicated in patients with ulcerative colitis

            Incomplete mechanical intestinal obstruction may present as diarrhea, especially in patients with an ileostomy or colostomy; discontinue treatment if incomplete mechanical intestinal obstruction is suspected or if diarrhea occurs

            In presence of high environmental temperature, heat prostration resulting in fever and heatstroke can occur due to decreased sweating, particularly in geriatric patients; advise patients to avoid exposure to hot or very warm environmental temperatures when receiving therapy; therapy not recommended in geriatric patients

            May impair mental abilities to perform tasks that require mental alertness, including operating heavy machinery

            Parenteral product contains benzyl alcohol; generally avoid in neonates

            Pediatric patients with spastic paralysis may experience increased response to anticholinergics, increasing the potential for adverse effects; a paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses; use caution

            May increase risk for anticholinergic effects, confusion, and hallucinations; use caution

            Not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (eg, autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and inpatients taking other anticholinergic medications

            Geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therapy is not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions

            Decreased gastrointestinal motility

            • Reduces gastrointestinal motility and may result in delayed gastric emptying constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon
            • The risk of gastrointestinal adverse reactions is further increased with use of other anticholinergics and other medications that decrease gastrointestinal peristalsis
            • Monitor patients for symptoms of decreased gastrointestinal motility; concomitant use of drugs and other anticholinergics or other medications that decrease GI peristalsis is not recommended

            Cognitive and visual adverse reactions

            • Glycopyrrolate may produce drowsiness and blurred vision and impair mental and/or physical abilities required for performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work
            • Concomitant use of other drugs that have anticholinergic properties may increase these effects; inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that therapy does not affect them adversely; discontinue therapy if signs or symptoms of cognitive or visual impairment develop
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            Pregnancy & Lactation

            Pregnancy

            Over decades of use, there is absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

            Animal data

            • In animal studies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits; a pre-and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed

            Lactation

            There are no data on the presence of glycopyrrolate in either human or animal milk, effects on breastfed infants, or milk production; as with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on the breastfed infant from therapy

            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

            Competitively inhibits action of ACh on autonomic effectors innervated by postganglionic nerves

            Inhibits salivation, tracheobronchial secretions, bradycardia, and hypotension

            Absorption

            Onset: 1 min (IV); 15-30 min (IM, SC)

            Duration: 2-3 hr (parenteral, vagal block); 7 hr (parenteral, inhibition of salivation); 8-12 hr (PO; anticholinergic effects)

            Peak plasma time: 30-45 min

            Incompletely absorbed from GI tract since completely ionized

            Distribution

            Vd: 1.3-1.8 L/kg (children); 0.2-0.62 L/kg (adults)

            Metabolism

            Several metabolites

            Elimination

            Excretion: Mainly as unchanged drug in feces via biliary elimination and in urine

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            Administration

            IV Incompatibilities

            Additive: Methylprednisolone sodium succinate

            Syringe: Chloramphenicol, dexamethasone sodium phosphate, diazepam, dimenhydrinate, methohexital, pentazocine, pentobarbital, secobarbital, sodium bicarbonate, thiopental

            Unstable at pH >6

            IV Compatibilities

            Syringe: Atropine, hydroxyzine, lidocaine, meperidine, morphine

            IV Administration

            Inspect product visually to ensure there is no particulate matter

            Administer at a rate of 0.2 mg over 1-2 min

            For IV administration, glycopyrrolate may be administered by IM or IV without dilution

            May also be administered via tubing of a running IV infusion of a compatible solution

            Oral Administration

            Administer 1 hr ac or 2 hr pc

            High fat food reduces PO bioavailability

            Oral disintegrating tablet (ODT): Using dry hands, place ODT on top of tongue; allow tablet to disintegrate and swallow without water; do not break or cut tablet

            Storage

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

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            Images

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            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Select a drug:
            Patient Education
            glycopyrrolate oral

            GLYCOPYRROLATE DISINTEGRATING TABLET - ORAL

            (GLYE-koe-PIR-oh-late)

            COMMON BRAND NAME(S): Dartisla

            USES: Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

            HOW TO USE: Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after food) as directed by your doctor, usually 2 to 3 times a day. Do not remove the tablet from the blister pack until just before taking. Dry your hands before peeling back the foil on the blister pack to carefully remove a tablet. Do not push the tablet through the foil. The tablet should not be cut or broken before using. Place the tablet on your tongue, allow it to dissolve, then swallow it with saliva. Do not swallow the tablet with water.The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Tell your doctor if your condition does not get better or if it gets worse.

            SIDE EFFECTS: Drowsiness, dizziness, blurred vision, dry eyes/mouth, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, ask your pharmacist about artificial tears or other eye lubricants.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stomach/abdominal bloating or pain, diarrhea, vomiting, decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), difficulty urinating/inability to urinate.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, problems with urination (such as due to a blockage, enlarged prostate), other stomach/intestinal problems (such as chronic constipation, slow gut, intestinal blockage/infection, ulcerative colitis), myasthenia gravis, kidney problems.This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, constipation, and urination problems.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: potassium tablets/capsules, drugs that are affected by slowed gut movement (such as pramlintide).Tell your doctor or pharmacist if you are using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or a fast heartbeat. Ask your pharmacist about using those products safely.This medication may interfere with certain lab tests (such as gastric secretion tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: flushing, hot/dry skin, fever, severe dizziness, mental/mood changes (such as confusion, agitation), fast/irregular heartbeat, seizures.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as stomach/intestinal exams) should be done while you are taking this medication. Keep all medical and lab appointments.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised October 2022. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            OR Other Restrictions
            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.