Glycopyrrolate
Generic Name: glycopyrrolate
Brand Names:
Glycopyrrolate
11 DESCRIPTION Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C 19 H 28 BrNO 3 , the molecular weight is 398.3 g/mol, and the structural formula is: Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient.
Overview
11 DESCRIPTION Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C 19 H 28 BrNO 3 , the molecular weight is 398.3 g/mol, and the structural formula is: Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient.
Uses
1 INDICATIONS AND USAGE 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 )
Dosage
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) Glycopyrrolate tablets 2 mg are not recommended for patients initiating treatment or receiving maintenance treatment with glycopyrrolate tablets 1 mg or another 1 mg dosage strength of oral glycopyrrolate tablets. Recommended Dosage ( 2.2 ) The recommended initial dosage of glycopyrrolate tablets 1 mg 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 tablets 2 mg for adults is 2 mg two or three times daily at equally spaced intervals. The maximum recommended daily dosage is 8 mg.
Side Effects
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 a...
Interactions
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 ) 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. Coadministration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia.
Warnings
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 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 Precautio...
Pregnancy
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 a 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Glycopyrrolate tablets USP, 1 mg are white to off-white, round, beveled edge uncoated tablets, debossed with ‘Y’ and break line on one side and ‘08’ on the other side.
Frequently Asked Questions
What is Glycopyrrolate used for?▼
1 INDICATIONS AND USAGE 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 )
What are the side effects of Glycopyrrolate?▼
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 a...
Can I take Glycopyrrolate during pregnancy?▼
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 a 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.
What are the important warnings for Glycopyrrolate?▼
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 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 Precautio...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.