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
Anticholinergic premedication for flexible bronchoscopy: a randomized, double-blind, placebo-controlled study of atropine and glycopyrrolate. [2009.08]
BACKGROUND: Anticholinergic premedication is commonly used during flexible bronchoscopy, although the benefits are unproven and potential risks exist... CONCLUSIONS: Anticholinergic premedication may reduce airway secretions during flexible bronchoscopy but is not associated with any significant reduction in cough, patient discomfort, oxygen desaturation, or procedure time and is associated with greater hemodynamic fluctuations. Routine anticholinergic premedication may be unnecessary or even harmful during flexible bronchoscopy.
The cardiorespiratory effects of a fentanyl infusion following acepromazine and glycopyrrolate in dogs. [2008.11.01]
We investigated whether the analgesic mu-opioid fentanyl can be used safely in dogs in everyday clinical veterinary practice, with limited and non-invasive monitoring. To this end, the cardiorespiratory effects of fentanyl, administered in doses reported to be adequate for inducing opiate analgesia in spontaneously breathing canine patients, were evaluated by measuring the respiration rate, oxygen saturation (SpO2), heart rate, respiratory sinus arrhythmia (RSA), and rectal body temperature...
Intramuscular neostigmine and glycopyrrolate safely accelerated bowel evacuation in patients with spinal cord injury and defecatory disorders. [2008.10]
Difficulty with evacuation after spinal cord injury (SCI) may be due to a lack of parasympathetic stimulation of the colon. Prior studies in persons with spinal cord injury have suggested that intravenous administration of neostigmine stimulates colonic motility while glycopyrrolate attenuates some of the cholinergic side effects of neostigmine...
Sugammadex reversal of rocuronium-induced neuromuscular blockade: a comparison with neostigmine-glycopyrrolate and edrophonium-atropine. [2007.03]
BACKGROUND: Sugammadex is a modified [gamma] cyclodextrin compound, which encapsulates rocuronium to provide for a rapid reversal of residual neuromuscular blockade. We tested the hypothesis that sugammadex would provide for a more rapid reversal of a moderately profound residual rocuronium-induced blockade than the commonly used cholinesterase inhibitors, edrophonium and neostigmine... CONCLUSION: Sugammadex, 4 mg/kg IV, more rapidly and effectively reversed residual neuromuscular blockade when compared with neostigmine (70 microg/kg IV) and edrophonium (1 mg/kg IV). Use of sugammadex was associated with less frequent dry mouth than that with the currently used reversal drug combinations.
Glycopyrrolate during sevoflurane-remifentanil-based anaesthesia for cardiac catheterization of children with congenital heart disease. [2005.11]
BACKGROUND: Remifentanil is recommended for use in procedures with painful intraoperative stimuli but minimal postoperative pain. However, bradycardia and hypotension are known side-effects. We evaluated haemodynamic effects of i.v. glycopyrrolate during remifentanil-sevoflurane anaesthesia for cardiac catheterization of children with congenital heart disease... CONCLUSION: I.V. glycopyrrolate 6 microg kg(-1) prevents bradycardia during general anaesthesia with remifentanil and sevoflurane for cardiac catheterization in children with congenital heart disease. Administering 12 microg kg(-1) of glycopyrrolate temporarily induces tachycardia and offers no additional advantage.
Clinical Trials Related to Glycopyrrolate
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.
Safety Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Condition [Active, not recruiting]
This is an open-label clinical research study of an experimental glycopyrrolate oral liquid
for the treatment of chronic to severe drooling in patients with cerebral palsy or other
neurological conditions.
Patients participating in the study will receive oral glycopyrrolate three times a day for
study duration of 24 weeks. Dosing amounts will be based on patient's weight and will be
increased for possibly 4 weeks until optimal individual response is achieved or a maximum of
0. 1mg/kg or 3 mg TID is attained, whichever is lesser. Optimal dose for each patient is
defined as the dose at which he/she is receiving the maximum benefit from the study drug
(greatest improvement in drooling) while experiencing minimum side effects. All patients
will receive close attention by study staff, during the time of participation.
Participation in the study can be up to 24 weeks.
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.
Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children [Recruiting]
Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and
blood pressure in children. To differentiate between contractility and the effect of the
circulating volume, some of the subjects will receive additional fluid. This will be
evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.
Safety and Tolerability of 28 Days Treatment With Glycopyrrolate(NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD [Completed]
This study will assess the safety/tolerability of 28 days of treatment with NVA237 100 and
200µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive
Pulmonary Disease (COPD).
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