Glycopyrrolate

Glycopyrrolate is a prescription medication used during Surgery for preoperative reduction of saliva, intraoperative reduction of cholinergic effects, Reversal of Neuromuscular Blockade and as an Adjunct to Treatment of Peptic Ulcer. 

• Glycopyrrolate is available under the following different brand names: Cuvposa, Dartisla ODT, Glycopyrronium, Robinul, Robinul Forte.

Common side effects of Glycopyrrolate include:

• constipation, 
• nausea, 
• vomiting, 
• bloating, 
• drowsiness, 
• dizziness, 
• weakness, 
• nervousness, 
• slow heartbeats, 
• sleep problems (insomnia), 
• blurred vision, 
• sensitivity to light, 
• dry mouth, 
• decreased sense of taste, 
• decreased sweating, 
• decreased urination, 
• impotence, 
• sexual problems, 
• headache, and 
• rash

Serious side effects of Glycopyrrolate include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe constipation, 
• severe stomach pain, 
• bloating, 
• diarrhea, 
• painful or difficult urination, 
• fast or pounding heartbeats, 
• fluttering in the chest, 
• confusion, 
• severe drowsiness, 
• eye pain, 
• seeing halos around lights, 
• fever, 
• shallow breathing, 
• weak pulse, and
• hot and red skin

Specific to children:  

• dry diapers, 
• fussiness, and
• excessive crying

Rare side effects of Glycopyrrolate include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablets

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

Tablet, oral disintegrating 

Adult dosage only

• 1.7 mg (Dartista ODT)

Oral solution

• 1 mg/5mL (Cuvposa)

Injectable solution

• 0.2 mg/mL

Surgery

Adult dosage

• Preoperative: 4 mcg/kg IM 30-60 minutes before surgery
• Intraoperative: 0.1 mg IV; may repeat every 2-3 minutes

Pediatric dosage

• Children 1 month to 2 years of age (preoperative): 4-9 mcg/kg IM 30-60 minutes before anesthesia or when preanesthetic opioid and/or sedative administered
• Children older than 2 years of age: 4 mcg/kg IM
• Preoperative: 30-60 minutes before surgery
• Intraoperative: May repeat every 2-3 minutes; not to exceed 0.1 mg 

Neuromuscular Blockade Reversal

Adult dosage

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

Pediatric dosage

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

Adjunct to Treatment of Peptic Ulcer

Adult dosage

• 1.7 mg orally twice or three times daily; not to exceed 6.8 mg per day

Drooling

Pediatric dosage

• Children younger than 3 years of age: Safety and efficacy not established
• Children 3-16 years: 0.02 mg/kg orally every 8 hours initially; may increase by 0.02 mg/kg every 5-7 days if warranted, up to 0.1 mg/kg every 8 hours
• Not to exceed 1.5-3 mg/dose (based on weight; see manufacturer instruction)

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Glycopyrrolate has severe interactions with the following drug:
  • umeclidinium bromide/vilanterol inhaled
• Glycopyrrolate has serious interactions with the following drugs:
  • glucagon
  • glucagon intranasal
  • glycopyrronium tosylate topical
  • macimorelin
  • pramlintide
  • revefenacin
  • secretin
• Glycopyrrolate has moderate interactions with at least 94 other drugs.
• Glycopyrrolate has minor interactions with at least 12 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to glycopyrrolate or other ingredients.
• Medical conditions that preclude anticholinergic therapy (e.g., 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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Glycopyrrolate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Glycopyrrolate?”

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 megacolon; 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 an obstruction is suspected, discontinue and evaluate
• Incomplete mechanical intestinal obstruction may present as diarrhea, especially in patients with an ileostomy or colostomy; discontinue treatment if an incomplete mechanical intestinal obstruction is suspected or if diarrhea occurs
• May cause heat prostration in the presence of fever, high ambient temperature, or physical exercise; to avoid heat prostration; 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 an 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 the risk for anticholinergic effects, confusion, and hallucinations; use caution

Pregnancy and Lactation

• May be acceptable during pregnancy. 
• Lactation: Excretion in milk unknown; use with caution.