Glycopyrrolate - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Glycopyrrolate. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting.
Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase.
Incomplete mechanical intestinal obstruction: May present as diarrhea.
If obstruction is suspected, discontinue Glycopyrrolate oral solution and evaluate.
High ambient temperature: To reduce the risk of heat prostration, avoid high temperatures.
5.1 Constipation or Intestinal Pseudo-obstruction Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see Adverse Reactions ].
Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase.
Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.
5.2 Incomplete Mechanical Intestinal Obstruction Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy.
If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with Glycopyrrolate oral solution and evaluate for intestinal obstruction.
5.3 High Ambient Temperatures In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Glycopyrrolate oral solution.
Advise patients/ caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.
5.4 Operating Machinery or an Automobile Glycopyrrolate oral solution may produce drowsiness or blurred vision.
As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking Glycopyrrolate oral solution.
5.5 Anticholinergic Drug Effects Use Glycopyrrolate oral solution with caution in patients with conditions that are exacerbated by anticholinergic drug effects including: Autonomic neuropathy Renal disease Ulcerative colitis – Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate "toxic megacolon", a serious complication of the disease Hyperthyroidism Coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition
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