Indications
Glycopyrrolate are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
(1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)
Contraindications
Glycopyrrolate are contraindicated in:
- Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: o Glaucoma [ see Warnings and Precautions (5.1) ] o Obstructive uropathies, including prostatic hypertrophy o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see Warnings and Precautions (5.2) ] o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see Warnings and Precautions (5.3) ] o Bleeding gastrointestinal ulcer o Active inflammatory or infectious colitis which can lead to toxic megacolon o History of or current toxic megacolon o Myasthenia gravis
- Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in glycopyrrolate [ see Adverse Reactions (6) and Description (11) ].
- Patients at risk for anticholinergic toxicity due to various underlying medical conditions. ( 4 , 5.1 , 5.2 , 5.3 )
- Hypersensitivity to glycopyrrolate or the inactive ingredients. (4)
Warnings and precautions
- Precipitation of Acute Glaucoma : May increase intraocular pressure; if symptoms occur, discontinue use and promptly seek medical care. ( 4 , 5.1 )
- Partial or Complete Mechanical Intestinal Obstruction : Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If the obstruction is suspected, discontinue use and evaluate the patient for obstruction. ( 4 , 5.2 )
- GI Adverse Reactions Due to Decreased GI Motility : Delayed gastric emptying, constipation, and intestinal pseudo-obstruction may occur and precipitate or aggravate paralytic ileus and toxic megacolon; not recommended for use with anticholinergics or other medications that decrease GI peristalsis. ( 4 , 5.3 , 7.1 )
At a glance
- Brand name
- Robinul
- Active substance
- glycopyrrolate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Casper Pharma LLC
- Status
- Prescription
- FDA approval
- 11 Aug 1961
- Application
- NDA012827-001



