m (Protected "Glycopyrrolate (tablet)": Bot: Protecting all pages from category Drug ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite)))
*For use as adjunctive therapy in the treatment of [[peptic ulcer]].
*For use as adjunctive therapy in the treatment of peptic ulcer.
=====Dosing Information=====
=====Dosing Information=====
*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.
*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.
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<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
<!--Contraindications-->
|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]].
|contraindications=
*Glycopyrrolate tablets are contraindicated in those patients with a [[hypersensitivity]] to glycopyrrolate.
* 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-->
<!--Warnings-->
|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.
|warnings=
*[[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.
* 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.
*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]].
*Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.
====Precautions====
====Precautions====
*Use Glycopyrrolate tablets with caution in the elderly and in all patients with:
*Use Glycopyrrolate tablets with caution in the elderly and in all patients with:
:*Autonomic neuropathy.
:*[[Autonomic neuropathy]].
:*Hepatic or renal disease.
:*Hepatic or [[renal disease]].
:*Ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate "toxic megacolon," a serious complication of the disease.
:*[[Ulcerative colitis]]-large doses may suppress intestinal motility to the point of producing a [[paralytic ileus]] and for this reason may precipitate or aggravate "[[toxic megacolon]]," a serious complication of the disease.
:*Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.
:*[[Hiatal hernia]] associated with [[reflux esophagitis]], since [[anticholinergic drugs]] may aggravate this condition.
<!--Adverse Reactions-->
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=
|clinicalTrials=*[[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]]; [[mydriasis|dilatation of the pupil]]; [[cycloplegia]]; increased ocular tension; loss of taste; [[headaches]]; [[nervousness]]; mentalconfusion; [[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.
*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.
*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.
<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* There are no known drug interactions.
|drugInteractions=
* There are no known drug interactions.
<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=*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.
|useInPregnancyFDA=
*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.
|useInPregnancyAUS=
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=
|useInNursing=*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.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInPed=*Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInNursing=
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
*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.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment]].
|useInPed=
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment.]]
*Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]].
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=*Oral
*Intravenous
*Inhalation
*Intramuscular
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|administration=
* Oral
* Intravenous
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
<!--Overdosage-->
|overdose=*The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
|overdose=
*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.
*The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.
* lycopyrrolate, 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.
}}
<!--Mechanism of Action-->
|mechAction=* lycopyrrolate, 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.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., [[bronchorrhea]], [[bronchospasm]], [[bradycardia]], and intestinal [[hypermotility]]) induced by cholinergic drugs such as the [[anticholinesterases]].
*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.
*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.
<!--Structure-->
<!--Structure-->
|structure=* Glycopyrrolate tablets contain the synthetic [[anticholinergic]], glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.
|structure=
* Glycopyrrolate tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.
: [[File:{{PAGENAME}}03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
<!--Clinical Studies-->
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
<!--How Supplied-->
|howSupplied=* Glycopyrrolate Tablets, USP
|howSupplied=
* Glycopyrrolate Tablets, USP
*Glycopyrrolatetablets, USP 1 mg are scored, compressed white tablets engraved ‘I 21’.
*Glycopyrrolatetablets, USP 1 mg are scored, compressed white tablets engraved ‘I 21’.
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*Dispense in tight container.
*Dispense in tight container.
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
<!--Brand Names-->
|brandNames=*Robinul
|brandNames=
*Robinul Forte
*Cuvposa
* ®<ref>{{Cite web | title = | url = }}</ref>
*Glycate
<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=
|lookAlike=
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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For use as adjunctive therapy in the treatment of peptic ulcer.
Dosing Information
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 Glycopyrrolate (tablet) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycopyrrolate (tablet) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Glycopyrrolate (tablet) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Glycopyrrolate (tablet) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Glycopyrrolate (tablet) in pediatric patients.
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.
Precautions
Use Glycopyrrolate tablets with caution in the elderly and in all patients with:
Ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate "toxic megacolon," a serious complication of the disease.
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.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Glycopyrrolate (tablet) in the drug label.
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 Glycopyrrolate (tablet) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Glycopyrrolate (tablet) 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 Glycopyrrolate (tablet) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Glycopyrrolate (tablet) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Glycopyrrolate (tablet) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Glycopyrrolate (tablet) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Glycopyrrolate (tablet) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Glycopyrrolate (tablet) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Glycopyrrolate (tablet) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Inhalation
Intramuscular
Monitoring
There is limited information regarding Monitoring of Glycopyrrolate (tablet) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Glycopyrrolate (tablet) in the drug label.
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.
lycopyrrolate, 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.
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.
Structure
Glycopyrrolate tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.
03.png){kind=link}