GLYCOPYRROLATE SUMMARY
Glycopyrrolate Injection, USP
Rx only
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q. s. Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.
In Anesthesia
Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
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NEWS HIGHLIGHTS
Published Studies Related to Glycopyrrolate
Prophylactic glycopyrrolate prevents bradycardia after spinal anesthesia for Cesarean section: a randomized, double-blinded, placebo-controlled prospective trial with heart rate variability correlation. [2011.08]
STUDY OBJECTIVE: To determine if prophylactic glycopyrrolate prevents bradycardia after spinal anesthesia... CONCLUSION: Bradycardia after spinal anesthesia occurs commonly. Prophylactic glycopyrrolate may prevent the bradycardia, but not necessarily the hypotension. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Comparison of the efficacy and impact on cognition of glycopyrrolate and biperiden for clozapine-induced sialorrhea in schizophrenic patients: a randomized, double-blind, crossover study. [2010.06]
BACKGROUND: Clozapine-induced sialorrhea (CIS) is a subjective distressing adverse effect and occurs in 31%-57% of schizophrenic patients receiving clozapine therapy. Current pharmacotherapy on CIS has focused on anticholinergic agents, even though they may impair cognitive function. Previous case reports have suggested the benefit of glycopyrrolate or biperiden in treating this condition, but no randomized controlled trial has provided evidence. The objective of our study was to evaluate the efficacy and impact on cognition of glycopyrrolate and biperiden treatments for schizophrenic patients suffering from CIS... CONCLUSION: We provide evidence, for the first time, of the efficacy of glycopyrrolate and biperiden in the treatment of CIS. Furthermore, glycopyrrolate displays less impact on cognitive function. Consequently, glycopyrrolate can become a valid option for treating CIS. Observations from our study serve as a springboard for additional large-scale prospective trials. Copyright (c) 2010 Elsevier B.V. All rights reserved.
Glycopyrrolate for sialorrhea in Parkinson disease: a randomized, double-blind, crossover trial. [2010.04.13]
BACKGROUND: Sialorrhea affects approximately 75% of patients with Parkinson disease (PD). Sialorrhea is often treated with anticholinergics, but central side effects limit their usefulness. Glycopyrrolate (glycopyrronium bromide) is an anticholinergic drug with a quaternary ammonium structure not able to cross the blood-brain barrier in considerable amounts. Therefore, glycopyrrolate exhibits minimal central side effects, which may be an advantage in patients with PD, of whom a significant portion already experience cognitive deficits. OBJECTIVE: To determine the efficacy and safety of glycopyrrolate in the treatment of sialorrhea in patients with PD... CONCLUSIONS: Oral glycopyrrolate 1 mg 3 times daily is an effective and safe therapy for sialorrhea in Parkinson disease. Classification of evidence: This study provides Class I evidence that glycopyrrolate 1 mg 3 times daily is more effective than placebo in reducing sialorrhea in patients with Parkinson disease during a 4-week study.
Glycopyrrolate for sialorrhea in Parkinson disease: a randomized, double-blind,
crossover trial. [2010]
treatment of sialorrhea in patients with PD... CONCLUSIONS: Oral glycopyrrolate 1 mg 3 times daily is an effective and safe
Comparison of the efficacy and impact on cognition of glycopyrrolate and
biperiden for clozapine-induced sialorrhea in schizophrenic patients: a
randomized, double-blind, crossover study. [2010]
CIS... CONCLUSION: We provide evidence, for the first time, of the efficacy of
Clinical Trials Related to Glycopyrrolate
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation [Recruiting]
The purpose of this study is to determine if the antisialogogues (anti-salivary agents),
Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating
patients with Ketamine for procedural sedation in the emergency department or abscess
clinic. The investigators will measure salivary flow rate by collecting oral secretions by
oral suctioning over a 30 minute time period starting with the administration of Ketamine.
The investigators hypothesize that patients who receive either atropine or glycopyrrolate
will have fewer oral secretions than patients who receive placebo.
Intranasal Administration of Neostigmine and Glycopyrrolate for Bowel Evacuation [Recruiting]
DWE (difficulty with evacuation) is a common and an important quality of life issue after
spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the
results are often suboptimal in terms of complications such as incontinence and impaction.
Bowel care regimens after spinal cord injury have not changed in any significant fashion in
many years. The usual strategies for attaining bowel evacuation involve dietary
manipulation (e. g., high fiber diets and hydration), thrice weekly laxative administration
(senna and cascara) and thrice weekly anorectal instillation of cathartics (enemas and
suppositories). Bowel care can be quite time consuming (greater than 2 hours in many
instances) and may also require extensive nursing care. Finally, incomplete evacuation
could contribute to fecal incontinence that has significant morbidity in these patients.
In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of
neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote
bowel evacuation in the SCI population. In an effort to provide a more realistic
administration of this procedure, we propose to test the intranasal spray injection of
neostigmine and glycopyrrolate for safety and efficacy.
Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease [Not yet recruiting]
This is an investigation of the beneficial effects, tolerability and safety of a range of
single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female
patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a
long term and progressive disease of the lungs, generally caused by cigarette smoking, but
other factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful
in dilating the constricted airways of such patients, with a duration of action variously
described as being between 12 and 24 hours.
This study will investigate how well tolerated and safe this medication is at a range of
doses. It will also help in the selection of a suitable dose for larger and repeat dose
studies, based on measures of lung response. It will also help to determine how often the
medication should be given; twice daily, or once daily.
Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of
age. Patients will be medically assessed before participation to ensure their suitability.
The study will take place in one centre in the UK over five sessions; at each session one
dose (2 puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple
inhaler device. Neither staff nor patients will know which dose, or if placebo, is being
taken. Lung function will be measured for up to 26 hours after the administration of each
dose using standard spirometry equipment. Blood samples will be taken over a 24-hour period
to check the blood levels of GB. There will be a period of about a week between each dosing
session. Patients will be medically reviewed after the study to confirm that no untoward
effects are present.
Efficacy and Safety Study of Oral Glycopyrrolate Liquid to Manage Problem Drooling Associated With Cerebral Palsy or Other Neurologic Conditions in Children [Completed]
This multi-center randomized, double blind, eight-week study is designed to assess the safety
and efficacy of oral Glycopyrrolate Liquid in the management of problem drooling associated
with cerebral palsy or other neurologic conditions in children. In addition, the
effectiveness of a training tool to help educate parents and caregivers in dose titration and
the identification of adverse events associated with glycopyrrolate will also be assessed.
This is a clinical research study of an experimental oral liquid for the treatment of
profuse, severe drooling in patients with cerebral palsy or other neurological conditions.
Patients participating in the study may receive an active drug (Oral Glycopyrrolate Liquid),
or an inactive drug (placebo). What treatment a patient will receive is determined by chance
(like drawing a number from a hat). Dosing amounts will be based on patient's weight and
will be increased for possibly 4 weeks until optimal dose is achieved. All patients, no
matter which treatment is assigned will receive very close attention by the study staff,
during the time of participation.
Participation in the study can be up to 8 weeks.
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers [Recruiting]
Reports of Suspected Glycopyrrolate Side Effects
Drug Interaction (6),
Atrioventricular Dissociation (5),
Medication Error (2),
Circumstance or Information Capable of Leading TO Medication Error (2),
Autonomic Nervous System Imbalance (2),
Supraventricular Tachycardia (2),
Atrial Fibrillation (2),
Product Substitution Issue (1),
Anaphylactic Reaction (1),
Tachycardia (1), more >>
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Page last updated: 2013-02-10
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