Glycopyrrolate

Glycopyrrolate are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

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.

Important Dosing Information. • 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. • 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.

Glycopyrrolate are contraindicated in: • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including: o Glaucoma o Obstructive uropathies, including prostatic hypertrophy o Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) o Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) 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.

• Precipitation of Acute Glaucoma: May increase intraocular pressure, if symptoms occur, discontinue use and promptly seek medical care. • 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. • 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. • Cognitive and Visual Adverse Reactions: May impair mental and/or physical function.

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Precipitation of Acute Glaucoma • Partial or Complete Mechanical Intestinal Obstruction • Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility • Cognitive and Visual Adverse Reactions • Heat Prostration at High Environmental Temperatures • Other Conditions Exacerbated by Anticholinergic Adverse Reactions • Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients 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.

• Other Anticholinergic Drugs: Concomitant use is not recommended. • Drugs with Altered Absorption due to Decreased GI Motility: Concomitant use is not recommended. • GI Toxicity with Solid Oral Dosage Forms of Potassium Chloride: Concomitant use is not recommended.

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).