Glycopyrrolate

5 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 ) • Cognitive and Visual Adverse Reactions : May impair mental and/or physical function. Inform patients not to operate motor vehicles or perform other hazardous tasks until reasonably certain they are not adversely affected; discontinue use if signs or symptoms develop. ( 5.4 , 7.1 ) • Heat Prostration at High Environmental Temperatures : Heat prostration resulting in fever and heatstroke can occur, especially in geriatric patients. Avoid exposure to hot or very warm environmental temperatures. ( 5.5 , 5.7 ) • Other Conditions Exacerbated by Anticholinergic Adverse Reactions : Use is not recommended in patients with autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia, etc. ( 5.6 , 7.1 ) • Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients : Complications include urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. Not recommended in geriatric patients and may be contraindicated in some patients with underlying medical conditions. ( 4 , 5.7 , 8.5 ) 5.1 Precipitation of Acute Glaucoma Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. Instruct patients to discontinue glycopyrrolate and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [ see Contraindications (4) ]. 5.2 Partial or Complete Mechanical Intestinal Obstruction Glycopyrrolate may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. If partial or complete intestinal obstruction is suspected, discontinue the use of glycopyrrolate and evaluate for potential intestinal obstruction [ see Contraindications (4) ]. 5.3 Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility Glycopyrrolate 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 [ see Contraindications (4) ]. The risk of gastrointestinal adverse reactions is further increased with the use of other anticholinergics and other medications that decrease gastrointestinal peristalsis. Monitor patients for symptoms of decreased gastrointestinal motility. Concomitant use of glycopyrrolate and other anticholinergics or other medications that decrease GI peristalsis is not recommended [ see Drug Interactions (7.2) ]. 5.4 Cognitive and Visual Adverse Reactions Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work [ see Adverse Reactions (6) ]. Concomitant use of other drugs that have anticholinergic properties may increase these effects [ see Drug Interactions (7.1) ]. Inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that glycopyrrolate does not affect them adversely. Discontinue glycopyrrolate if signs or symptoms of cognitive or visual impairment develop. 5.5 Heat Prostration at High Environmental Temperatures In the presence of a high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of glycopyrrolate due to decreased sweating, particularly in geriatric patients [ see Adverse Reactions (6) ]. Advise patients to avoid exposure to hot or very warm environmental temperatures when taking glycopyrrolate. Glycopyrrolate are not recommended in geriatric patients [ see Warnings and Precautions (5.7) ] . 5.6 Other Conditions Exacerbated by Anticholinergic Adverse Reactions Glycopyrrolate are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications [ see Drug Interactions (7.1) ]. 5.7 Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients 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. Glycopyrrolate are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [ see Contraindications (4), Warnings and Precautions (5.2 , 5.5 ), Adverse Reactions (6 ) and Use in Specific Populations (8.5) ].