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, 1-dimethylpyrrolidinium bromide .Each mg tablet contains:Glycopyrrolate, USP......... mg Each mg tablet contains: Glycopyrrolate, USP..........2 mg Inactive Ingredients: dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium Stearate, povidone, and sodium starch glycolate.. glycopyrrolatefig1.

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.

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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Glycopyrrolate, 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 glycopyrrolate tablets 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 mg. The recommended initial dosage of glycopyrrolate tablets 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 mg. The recommended dosage of glycopyrrolate tablets 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 There are no known drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Glycopyrrolate Tablets USP, mg are white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 08 on the other side. Bottles of 10 NDC 13107-014-11 Bottles of 100 NDC 13107-014-01 Bottles of 1000 NDC 13107-014-99 10 10 Unit-dose Tablets NDC 13107-014-10 Glycopyrrolate Tablets USP, mg are white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 51 on the other side. Bottles of 10 NDC 13107-015-11 Bottles of 100 NDC 13107-015-01 Bottles of 1000 NDC 13107-015-99 10 10 Unit-dose Tablets NDC 13107-015-10 Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature]. Keep this and all medication out of the reach of children. Dispense in tight container. Trademarks are the property of their respective owners. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 04/2018.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. 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.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 1 mg (100 Tablet Bottle). NDC 13107-014-01Glycopyrrolate Tablets, USP mg WHITE DYE-FREE Rx only 100 Tablets AUROBINDO glycopyrrolatefig2.

PRECAUTIONS SECTION.

PRECAUTIONS. Use glycopyrrolate tablets with caution in the elderly and in all patients with: 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.

WARNINGS SECTION.

WARNINGS. In the presence of high environmental temperature, heatprostration (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 tablets 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.Pregnancy The 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 Mothers It 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 Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, 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.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Tablets: mg, white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 08 on the other side.2 mg, white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 51 on the other side.. mg, white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 08 on the other side.. mg, white to off-white, round, beveled edge uncoated tablets, debossed with and break line on one side and 51 on the other side.. Tablets: mg (functionally scored) and mg (functionally scored) (3). Tablets: mg (functionally scored) and mg (functionally scored) (3).

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS. Other Anticholinergic Drugs: Concomitant use is not recommended. (5.3, 5.4, 5.6, 7.1)Drugs with Altered Absorption due to Decreased GI Motility: Concomitant use is not recommended. (7.2)GI Toxicity with Solid Oral Dosage Forms of Potassium Chloride: Concomitant use is not recommended. (7.3). Other Anticholinergic Drugs: Concomitant use is not recommended. (5.3, 5.4, 5.6, 7.1). Drugs with Altered Absorption due to Decreased GI Motility: Concomitant use is not recommended. (7.2). GI Toxicity with Solid Oral Dosage Forms of Potassium Chloride: Concomitant use is not recommended. (7.3). 7.1 Other Anticholinergic Drugs. There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e.g., tricyclic antidepressants, anti-epileptics, class antiarrhythmics, anti-spasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Coadministration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. Glycopyrrolate is not recommended in patients taking other anticholinergic drugs [see Warnings and Precautions (5.3, 5.4, 5.6)]. 7.2 Drugs with Altered Absorption due to Decreased Gastrointestinal Motility and Increased Transit Time. Decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading toincreased or decreased drug exposure. Glycopyrrolate is not recommended in patients taking other drugs that are affected by altered gastrointestinal motility [see Warnings and Precautions (5.3)]. 7.3 Gastrointestinal Toxicity with Solid Dosage Forms of Potassium Chloride. Oral glycopyrrolate may worsen gastrointestinal mucosal injury reported with solid oral dosage forms of potassium chloride due to decreased gastric motility and increased transit time, leading to prolonged contact with the gastrointestinal mucosa. Glycopyrrolate is not recommended in patients taking solid oral dosage forms of potassium chloride.

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 is 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 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 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 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 do not affect them adversely. Advise patients to discontinue glycopyrrolate 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 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)]. Trademarks are the property of their respective owners. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 05/2023.

LABOR & DELIVERY SECTION.

8.2 Lactation. Risk SummaryThere 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 and any potential adverse effects on the breastfed infant from glycopyrrolate.

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. 13.1 Carcinogenesis, 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.DataAnimal 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 Nonclinical Toxicology (13.1)].

SPL UNCLASSIFIED SECTION.

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

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.DataAnimal 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 Nonclinical Toxicology (13.1)]. 8.2 Lactation. Risk SummaryThere 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 and any potential adverse effects on the breastfed infant from glycopyrrolate.. 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 is 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)].. 8.6 Renal 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.

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). 5.1 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 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 hazardoustasks 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 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 is not recommended in geriatric patients [see Warnings and Precautions (5.7)]. 5.6 Other Conditions Exacerbated by Anticholinergic Adverse Reactions. Glycopyrrolate is 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 is 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)].