ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.Glycopyrrolate is chemically quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis,etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate Tablets are contraindicated in those patients with hypersensitivity to glycopyrrolate.

DESCRIPTION SECTION.

Description. Glycopyrrolate Tablets, USP contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1, di-methyl bromide.Glycopyrrolate Tablets, USP mg are white to off-white, round, flat beveled edge tablet debossed with MCR 117 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg. Glycopyrrolate Tablets, USP mg are white to off white, round, flat beveled edge tablet debossed with AC 108 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate. ACTIONSGlycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The dosage of Gylcopyrrolate Tablets, USP mg and mg should be adjusted to the needs of the individual patient to assure symptomatic control with minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is mg.Glycopyrrolate Tablets, USP mg: The recommended initial dosage of Glycopyrrolate Tablets, USP mg for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, dosage of one tablet twice day is frequently adequate. Glycopyrrolate Tablets, USP mg: The recommended dosage of Glycopyrrolate Tablets, USP mg for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate Tablets are not recommended for use in pediatric patients under the age of 12 years.

DRUG INTERACTIONS SECTION.

DRUG INTERACTIONS. There are no known drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Glycopyrrolate Tablets, USP mg are white to off-white, round, flat beveled edge tablet debossed with MCR 117 separated by break line on one side and plain on other side. Packaged in bottles of 100.Glycopyrrolate Tablets, USP mg tablets in bottles of 100 (NDC 23155-606-01).Glycopyrrolate Tablets, USP mg are white to off white, round, flat beveled edge tablet debossed with AC 108 separated by break line on one side and plain on other side. Packaged in bottles of 100.Glycopyrrolate Tablets, USP mg tablets in bottles of 100 (NDC 23155-607-01).Store at 20C to 25C (68F to 77F); excursions permitted between 15 to 30C (59- 86F) [see USP Controlled Room Temperature].Keep out of reach of children.Dispense in tight container.Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 200146Rev: 12/2019. logo.

INDICATIONS & USAGE SECTION.

INDICATIONS. For use as adjunctive therapy in the treatment of peptic ulcer.

OVERDOSAGE SECTION.

OVERDOSAGE. The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.To guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas.To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.To combat respiratory depression-administer oxygen; utilize respiratory stimulant such as Dopram(R) i.v.; artificial respiration.. To guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas.. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.. To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.. To combat respiratory depression-administer oxygen; utilize respiratory stimulant such as Dopram(R) i.v.; artificial respiration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

mg Tablet. mg tablet.

PRECAUTIONS SECTION.

PRECAUTIONS. Use Glycopyrrolate Tablets with caution in the elderly and in all patientswith:Autonomic neuropathy.Hepatic or renal disease.Ulcerative colitis-large doses may suppress intestinal motility to the point of producing paralytic ileus and for this reason may precipitate or aggravate toxic megacolon, serious complication of the disease.Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy.Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.. Autonomic neuropathy.. Hepatic or renal disease.. Ulcerative colitis-large doses may suppress intestinal motility to the point of producing paralytic ileus and for this reason may precipitate or aggravate toxic megacolon, serious complication of the disease.. Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy.. Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.. DRUG INTERACTIONS. There are no known drug interactions.

WARNINGS SECTION.

WARNINGS. In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrrolate Tablets.Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.Glycopyrrolate may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating motor vehicle or other machinery, or performing hazardous work while taking this drug. Theoretically, with overdosage, curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.PregnancyThe safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed. Nursing MothersIt is not known whether this drug is excreted in human milk. As general rule, nursing should not be undertaken while patient is on drug since many drugs are excreted in human milk.Pediatric UseSince there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

SPL UNCLASSIFIED SECTION.

2.1Important Dosing Information. Glycopyrrolate tablets mg are not recommended for patients in whom lower dosage strength of oral glycopyrrolate (e.g., mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of glycopyrrolate tablets mg may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets.. Glycopyrrolate tablets mg are not recommended for patients in whom lower dosage strength of oral glycopyrrolate (e.g., mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of glycopyrrolate tablets mg may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Reproduction studies in rats resulted in diminished rates of conception in dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.. 12.2 Pharmacodynamics. No formal pharmacodynamic studies have been conducted with glycopyrrolate.. 12.3 Pharmacokinetics. Patients with Renal Impairment In the published literature, glycopyrrolate mcg/kg was administered intravenously (glycopyrrolate tablets are not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. The mean AUC (10.6 mcg.h/L) and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcg.h/L, and 65%, respectively) [see Use in Specific Populations (8.6)].

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Tablets: Glycopyrrolate Tablets USP, mg are white to off-white, round, flat beveled edge tablet debossed with MCR 117 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg.Glycopyrrolate Tablets USP, mg are white to off white, round, flat beveled edge tablet debossed with AC 108 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg.. Glycopyrrolate Tablets USP, mg are white to off-white, round, flat beveled edge tablet debossed with MCR 117 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg.. Glycopyrrolate Tablets USP, mg are white to off white, round, flat beveled edge tablet debossed with AC 108 separated by break line on one side and plain on other side. Each tablet contains: Glycopyrrolate, USP mg.. Tablets: mg (functionally scored) and mg (functionally scored) (3). Tablets: mg (functionally scored) and mg (functionally scored) (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therefore, glycopyrrolate tablets are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [see Contraindications (4) and Warnings and Precautions (5) ].

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Precipitation of Acute Glaucoma Advise patients to discontinue glycopyrrolate tablets 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 Warnings and Precautions (5.1)]. Partial or Complete Mechanical Intestinal Obstruction Advise patients to contact their healthcare provider if diarrhea occurs, especially in patients with ileostomy or colostomy [see Warnings and Precautions (5.2)]. Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility Inform patients that glycopyrrolate tablets may cause adverse reactions related to decreased gastrointestinal motility and report to their healthcare provider if they experience symptoms such as vomiting, early satiety, abdominal distention, and constipation [see Warnings and Precautions (5.3)]. Cognitive and Visual Adverse Reactions Inform patients that glycopyrrolate tablets may cause cognitive or visual impairment and not operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that glycopyrrolate tablets do not affect them adversely. Advise patients to discontinue glycopyrrolate tablets immediately and contact their healthcare provider if symptoms develop (e.g., drowsiness or blurred vision) [see Warnings and Precautions (5.4)]. Heat Prostration at High Environmental Temperatures Inform patients that glycopyrrolate tablets can reduce sweating, leading to the possibility of heat exhaustion or heat stroke. Advise patients to avoid exposure to hot or very warm environmental temperatures [see Warnings and Precautions (5.5)].Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784)200146 Revised: 10/2022. avet-logo-spl.

LABOR & DELIVERY SECTION.

8.2 Lactation. Risk Summary There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for glycopyrrolate tablets and any potential adverse effects on the breastfed infant from glycopyrrolate tablets.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Reproduction studies in rats resulted in diminished rates of conception in dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. No formal pharmacodynamic studies have been conducted with glycopyrrolate.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. Patients with Renal Impairment In the published literature, glycopyrrolate mcg/kg was administered intravenously (glycopyrrolate tablets are not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. The mean AUC (10.6 mcg.h/L) and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcg.h/L, and 65%, respectively) [see Use in Specific Populations (8.6)].

PREGNANCY SECTION.

8.1 Pregnancy. Risk Summary Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits. pre- and post-natal development study of oral glycopyrrolate in rats showed decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data At non-maternally toxic doses of oral glycopyrrolate, there were no effects on embryo-fetal development or toxicity in rats or rabbits. pre- and post-natal development study of oral glycopyrrolate in rats showed decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed. In published reproductive and developmental study, male and female rats were administered glycopyrrolate in the diet at mg/kg/day, 32.5 mg/kg/day, 63 mg/kg/day, and 130 mg/kg/day for weeks to weeks and through up to three consecutive litters. There was no indication of abnormalities in the pups of treated dams. There was decreased rate of conception and in survival rate at weaning for all treated animals in dose-related manner. Diminished rates of conception may be due to diminished seminal secretion [see NonclinicalToxicology (13.1)].

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. Renal Impairment: Monitor patients with renal impairment; if anticholinergic adverse reactions occur, discontinue use. (8.6). Renal Impairment: Monitor patients with renal impairment; if anticholinergic adverse reactions occur, discontinue use. (8.6). 8.1 Pregnancy. Risk Summary Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits. pre- and post-natal development study of oral glycopyrrolate in rats showed decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data At non-maternally toxic doses of oral glycopyrrolate, there were no effects on embryo-fetal development or toxicity in rats or rabbits. pre- and post-natal development study of oral glycopyrrolate in rats showed decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed. In published reproductive and developmental study, male and female rats were administered glycopyrrolate in the diet at mg/kg/day, 32.5 mg/kg/day, 63 mg/kg/day, and 130 mg/kg/day for weeks to weeks and through up to three consecutive litters. There was no indication of abnormalities in the pups of treated dams. There was decreased rate of conception and in survival rate at weaning for all treated animals in dose-related manner. Diminished rates of conception may be due to diminished seminal secretion [see NonclinicalToxicology (13.1)].. 8.2 Lactation. Risk Summary There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for glycopyrrolate tablets and any potential adverse effects on the breastfed infant from glycopyrrolate tablets.. 8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. 8.5 Geriatric Use. Geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therefore, glycopyrrolate tablets are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [see Contraindications (4) and Warnings and Precautions (5) ].. 8.6Renal Impairment. Glycopyrrolate is substantially excreted by the kidney [see Clinical Pharmacology (12.3)]. Monitor patients with renal impairment for anticholinergic adverse reactions [see Adverse Reactions (6)]. If anticholinergic adverse reactions occur, discontinue glycopyrrolate tablets.

WARNINGS AND PRECAUTIONS SECTION.

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). 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). 5.1Precipitation 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 tablets 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)].. 5.2Partial 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 tablets and evaluate for potential intestinal obstruction [see Contraindications (4)].. 5.3Gastrointestinal 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 tablets and other anticholinergics or other medications that decrease GI peristalsis is not recommended [see Drug Interactions (7.2)].. 5.4Cognitive 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 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 tablets does not affect them adversely.Discontinue glycopyrrolate tablets if signs or symptoms of cognitive or visual impairment develop.. 5.5Heat Prostration at High Environmental Temperatures. In the presence of high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of glycopyrrolate tablets 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 tablets. Glycopyrrolate tablets are not recommended in geriatric patients [see Warnings and Precautions (5.7)].. 5.6Other Conditions Exacerbated by Anticholinergic Adverse Reactions. Glycopyrrolate tablets 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)].. 5.7Increased 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 tablets 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) ].