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glycopyrrolate (Rx)Brand and Other Names:Cuvposa, glycopyrronium, more...Robinul

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 1mg
  • 1.5mg
  • 2mg

oral solution

  • 1mg/5mL

injectable solution

  • 0.2mg/mL
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Surgery

Preoperative reduction of saliva or intraoperative reduction of cholinergic effects

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

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

Neuromuscular Blockade Reversal

Prevention of muscarinic AEs

0.2 mg IV per1 mg of neostigmine or 5 mg of pyridostigmine administered

Administration

  • Concurrently in same syringe or a few minutes before cholinergic agent

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

Dosage Forms & Strengths

tablets

  • 1mg
  • 2mg

injectable solution

  • 0.2mg/mL

oral solution

  • 1mg/5mL
more...

Surgery

Preoperative reduction of saliva or intraoperative reduction of cholinergic effects

1 month to 2 years (preoperative): 4 mcg/kg IM; may increase to 8 mcg/kg 

>2 years: 4 mcg/kg IM

Administration

  • 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)

Administration

  • Administer 1 hr ac or 2 hr pc
  • High fat food reduces PO bioavailability

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

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Interactions

Interaction Checker

glycopyrrolate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

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            Warnings

            Contraindications

            Hypersensitivity to glycopyrrolate or other ingredients

            Medical conditions that preclude anticholinergic therapy (eg, angle-closure glaucoma, obstructive uropathy, GI obstruction, paralytic ileus, intestinal atony of elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis, toxic megacolon, myasthenia gravis, reflux esophagitis, hiatal hernia, mitral stenosis)

            Concomitant use of solid oral dosage forms of potassium chloride

            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

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

            May decrease GI motility, which can result in constipation or intestinal pseudo-obstruction; intestinal pseudo-obstruction can result in abdominal distention, pain, nausea, or vomiting; if obstruction suspected, discontinue and evaluate

            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

            May cause heat prostration in the presence of fever, high ambient temperature, physical exercise; to avoid heat postration; use caution in hot weather and/or exercise

            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

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Excretion in milk unknown; use with 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

            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

            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

            Storage

            Unstable at pH >6

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            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.
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            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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