Antihidrotics

Glycopyrrolate

Approved 21 Sept 2012OralTablet

The FDA lists this product in 60 strengths and forms.

Indications

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

(1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)

Contraindications

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

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.

Indications

(1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)

Contraindications

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)

Warnings and precautions

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 post marketing 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 Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Glycopyrrolate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Glycopyrrolate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Precipitation of Acute Glaucoma

5.2Partial or Complete Mechanical Intestinal Obstruction

5.3Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

5.4Cognitive and Visual Adverse Reactions

5.6Other Conditions Exacerbated by Anticholinergic Adverse Reactions

5.7Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

Interactions

7.1Other Anticholinergic Drugs

7.2Drugs with Altered

7.3Gastrointestinal Toxicity with Solid Oral Dosage Forms of Potassium Chloride

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance