Glycopyrronium bromide

Glycopyrronium bromide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Glycopyrronium bromide is an anticholinergic that is FDA approved for the treatment of for use as adjunctive therapy in the treatment of peptic ulcer.. Common adverse reactions include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• For use as adjunctive therapy in the treatment of peptic ulcer.
• The dosage of Glycopyrrolate tablets 1 and 2 mg should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of Glycopyrrolate is 8 mg.
• Glycopyrrolate, 1 mg Tablets. The recommended initial dosage of Glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.
• Glycopyrrolate, 2 mg Tablets. The recommended dosage of Glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals.
• Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Glycopyrronium bromide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycopyrronium bromide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Glycopyrronium bromide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Glycopyrronium bromide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycopyrronium bromide in pediatric patients.

Contraindications

• Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

Warnings

• In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrrolate tablets.
• Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
• Glycopyrrolate tablets may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug.
• Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.

Pregnancy

• The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience.
• Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed.

Nursing Mothers

• It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

• Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Glycopyrronium bromide Clinical Trials Experience in the drug label.

Postmarketing Experience

• Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions.
• Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.
• Glycopyrrolate tablets is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

Drug Interactions

• There are no known drug interactions.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child.
• Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.
• Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glycopyrronium bromide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glycopyrronium bromide during labor and delivery.

Nursing Mothers

• It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

• Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Glycopyrronium bromide in geriatric settings.

Gender

There is no FDA guidance on the use of Glycopyrronium bromide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glycopyrronium bromide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glycopyrronium bromide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glycopyrronium bromide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Glycopyrronium bromide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Glycopyrronium bromide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Glycopyrronium bromide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Glycopyrronium bromide and IV administrations.

Overdosage

• The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
• To guard against further absorption of the drug--use gastric lavage, cathartics and/or enemas.

To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.

• To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.
• To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram® i.v.; artificial respiration.

Pharmacology

Mechanism of Action

• Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.
• Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.

Structure

There is limited information regarding Glycopyrronium bromide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Glycopyrronium bromide Pharmacodynamics in the drug label.

Pharmacokinetics

• The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

Nonclinical Toxicology

There is limited information regarding Glycopyrronium bromide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Glycopyrronium bromide Clinical Studies in the drug label.

How Supplied

• Glycopyrrolate Tablets, USP
• Glycopyrrolatetablets, USP 1 mg are scored, compressed white tablets engraved ‘I 21’.
• Glycopyrrolate Tablets, USP 2 mg are scored, compressed white tablets engraved ‘I 22’.
• Glycopyrrolate Tablets, USP 1 mg, supplied as follows:

• NDC (55111-648-01) bottles of 100’s and
• NDC (55111-648-05) bottles of 500’s

• Glycopyrrolate Tablets, USP 2 mg, supplied as follows:

• NDC (55111-649-01) bottles of 100’s and
• NDC (55111-649-05) bottles of 500’s

Storage

• Store at 20° to 25°C (68° to 77°F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Glycopyrronium bromide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Glycopyrronium bromide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• GLYCOPYRROLATE®

Look-Alike Drug Names

There is limited information regarding Glycopyrronium bromide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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