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Important Dosing Information (2.1) • Glycopyrrolate is not recommended for patients initiating treatment or receiving maintenance treatment with glycopyrrolate or another 1 mg dosage strength of oral glycopyrrolate tablets. Recommended Dosage (2.2) • The recommended initial dosage of glycopyrrolate is 1 mg three times daily (in the morning, early afternoon, and at bedtime). Some patients may require 2 mg at bedtime to assure overnight control of symptoms. For maintenance, a dosage of 1 mg twice a day is frequently adequate. • The recommended dosage of glycopyrrolate for adults is 2 mg two or three times daily at equally spaced intervals. • The maximum recommended daily dosage is 8 mg. • Use the lowest effective dosage of glycopyrrolate to control symptoms. If patients can be titrated to a lower dose, switch from glycopyrrolate or another 1 mg oral tablet of glycopyrrolate. 2.1 Important Dosing Information • Glycopyrrolate is not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., glycopyrrolate or another 1 mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of glycopyrrolate may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets. 2.2 Recommended Dosage • The recommended initial dosage of glycopyrrolate for adults is 1 mg three times daily (in the morning, early…

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…

Glycopyrrolate are contraindicated in: • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: o Glaucoma [ see Warnings and Precautions (5.1) ] o Obstructive uropathies, including prostatic hypertrophy o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see Warnings and Precautions (5.2) ] o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see Warnings and Precautions (5.3) ] o Bleeding gastrointestinal ulcer o Active inflammatory or infectious colitis which can lead to toxic megacolon o History of or current toxic megacolon o Myasthenia gravis • Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in glycopyrrolate [ see Adverse Reactions (6) and Description (11) ]. • Patients at risk for anticholinergic toxicity due to various underlying medical conditions. ( 4 , 5.1 , 5.2 , 5.3 ) • Hypersensitivity to glycopyrrolate or the inactive ingredients. (4)

Signs and symptoms of glycopyrrolate overdosage are related to excessive anti-muscarinic anticholinergic activity and are generally peripheral (e.g., flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation, and light sensitivity due to mydriasis), but central nervous system toxicity (agitation, seizures, hyperthermia) may also occur. If over-exposure occurs, call the Poison Control Center at 1-800-222-1222 for current information on the management of glycopyrrolate poisoning and overdosage. Management of glycopyrrolate overdosage is based upon presenting signs and symptoms, including close observation for severe or life-threatening complications which may require respiratory and cardiovascular monitoring and support. Consider administration of activated charcoal and/or use of a reversible anticholinesterase as appropriate or recommended by Poison Control.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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 I antiarrhythmics, anti­-spasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Co-administration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. Glycopyrrolate are 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 to increased or decreased drug exposure. Glycopyrrolate are 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 Oral 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 are not recommended in patients taking solid oral dosage forms of potassium chloride.