GLYCOPYRROLATE

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 tablets does not affect them adversely. Discontinue Glycopyrrolate tablets 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 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) ].

5.6 Other 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) ].

5.7 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 tablet 1 mg and Glycopyrrolate tablet 2 mg 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) ].

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Precipitation of Acute Glaucoma [ see Warnings and Precautions (5.1) ] • Partial or Complete Mechanical Intestinal Obstruction [ see Warnings and Precautions (5.2) ] • Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility [ see Warnings and Precautions (5.3) ] • Cognitive and Visual Adverse Reactions [ see Warnings and Precautions (5.4) ] • Heat Prostration at High Environmental Temperatures [ see Warnings and Precautions (5.5) ] • Other Conditions Exacerbated by Anticholinergic Adverse Reactions [ see Warnings and Precautions (5.6) ] • Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients [ see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or postmarketing reports. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: chest pain, hypertension, tachycardia Endocrine Disorders: decreased sweating Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting Immune System Disorders : anaphylaxis [ see Contraindications (4) ] Nervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness Respiratory Disorders: respiratory depression, throat irritation Renal and Urinary Disorders: urinary hesitancy, urinary retention Reproductive System and Breast Disorders: impotence, suppression of lactation Vascular Disorders: flushing Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. (6) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharma LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .