Oral Glycopyrrolate Research Articles

Comparing the Efficacy of 3% NaCl With Pressure Dressing and Oral Glycopyrrolate With Pressure Dressing in the Treatment of Parotid Sialocele in Postoperative Oral Squamous Cell Carcinoma Patients: Study Protocol of a Randomized Controlled Trial.

Introduction Parotid sialocele is a common complication following surgery for oral squamous cell carcinoma (OSCC), leading to discomfort and potential complications. Various treatment modalities have been proposed, including 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing, yet evidence comparing their efficacy is limited. This randomized controlled trial aims to compare the efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients undergoing neck dissection. Material and methods Patients diagnosed with OSCC undergoing surgical intervention resulting in parotid sialocele will be randomly assigned to receive either 3% NaCl with pressure dressing or oral glycopyrrolate with pressure dressing. Treatment efficacy will be assessed based on the discharge of any serous collection from the suture line, the length of time required for resolution of salivary sialocele, wound dehiscence, the length of the postoperative stay, the amount of time to resume oral feeds, and the timing of postoperative adjuvant therapy. Results This is an ongoing study protocol, and we are expecting the analysis of the results in 2026. Conclusion This randomized controlledtrial will furnish invaluable insights into the comparative efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients. The findings will inform evidence-based decision-making and optimize treatment strategies for this common complication.

Compounded glycopyrrolate is a compelling choice for drooling children: five years of facility experience

BackgroundDescribe the efficacy of a galenic glycopyrrolate formulation and its impact on patients with sialorrhea Quality of Life (QoL), including costs analysis.MethodsWe performed a retrospective observational study on 21 patients who received a custom-formulated galenic glycopyrrolate syrup for sialorrhea for an average period of 14.3 months. We analyzed the telephone interviews with elaborated and validated questionnaires and the therapy costs comparing the brand marketed drug with the galenic formulation.ResultsOverall, 16 out of 21 patients (76.2%) reported a significant improvement in sialorrhea and QoL. In 14 subjects (66.7%), there was a remarkable decrease in the drooling severity; 10 individuals (47.6%) reported a reduction in drooling frequency. Nine patients experienced at least one adverse effect of glycopyrrolate therapy, and three of them stopped the treatment. No severe side effects were observed. The galenic drug significantly reduced costs for patients.ConclusionsAn oral glycopyrrolate solution easily administered to children with brain injuries is not commercially available in many European countries. This study demonstrates the efficacy of a compounded glycopyrrolate syrup on drooling severity, frequency and ensures a better QoL in patients and their caregivers.

26301 Pharmacokinetic analyses show limited systemic exposure with topical glycopyrronium tosylate

GT is a topical anticholinergic approved (US) for primary axillary hyperhidrosis in patients ≥9 years. In a Phase 1 study, GT was applied by study staff once-daily to axillae of primary axillary hyperhidrosis patients (5 days); oral glycopyrrolate was administered to healthy adults every 8h (15 days; 1.0 mg then increasing by 1.0 mg/5 days). In the Phase 2 studies (NCT02016885, NCT02129660), primary axillary hyperhidrosis patients were randomized to topical glycopyrronium (0.8-3.2%) or vehicle applied to axillae once-daily (4 weeks). Pharmacokinetic parameters were similar between GT-treated adult and pediatric patients, with no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events (AEs) occurred with GT in the Phase 1 study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic AEs occurred in the Phase 2 studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related AEs increased with higher glycopyrronium concentration; however, the mean (0.0985 μg/L [SD 0.213]) and median (0.026 μg/L [min, max [0, 1.67]) Cmax values were low. Mild AEs tended to occur at low concentrations, while the probability of moderate/severe AEs did not become appreciable (over 20%) until Cmax values of approximately 0.2 μg/L; most patients had glycopyrronium Cmax values <0.2 μg/L. No relationship was observed between efficacy and pharmacokinetic measures. These studies indicate limited absorption and low risk of anticholinergic AEs with proper GT administration, which underscores the importance of following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact).

Oral glycopyrrolate for primary focal hyperhidrosis in a pediatric population: A cross-sectional study

Oral glycopyrrolate for primary focal hyperhidrosis in a pediatric population: A cross-sectional study

Axillary Botulinum Toxin Injection for the Treatment of Moderate to Severe Hyperhidrosis

ABSTRACT Primary focal hyperhidrosis can cause lifelong distress in everyday activities. Some patients cannot adequately decrease excessive perspiration with over-the-counter or prescription-strength antiperspirants. Oral glycopyrrolate is an anticholinergic medication that can decrease perspiration but may also lead to intolerable systemic side effects. Botulinum toxin injected into the axilla provides immediate symptomatic relief that lasts for approximately 6 months. Offering patients botulinum toxin as a second-line agent for treatment-resistant axillary hyperhidrosis can markedly improve quality of life with minimal side effects.

Adjusting oral glycopyrrolate medication for hyperhidrosis to reflect seasonal temperature variations.

The condition of most patients with hyperhidrosis (HH) is known to worsen with increased temperature. However, most prior studies of oral glycopyrrolate (OGly) for the treatment of HH have assumed a stable treatment protocol, without taking into account seasonal variations in temperature. The main aim of this study is to evaluate the outcomes derived from performing a seasonal adjustment of the dose of OGly for patients with HH. A prospective study of patients who began OGly for HH, and maintained treatment for at least 1 year, was performed. All patients had experienced treatment failure with oral oxybutynin. All were recommended to vary the dose of medication according to the time of year. Of the 35 patients included in the study, 20 (57.14%) varied the dose. Those with palmar and plantar HH had a greater propensity to do so. The patients who varied the dose according to the time of year were significantly more likely to report an "Excellent" response after 12 months of treatment. The frequency of adverse effects was 71.4% with no significant differences among the study groups. However, there was a significantly higher proportion of adverse effects other than oral xerosis in the group that did not vary the dose.

Survival study of treatment adherence by patients given oral glycopyrrolate for hyperhidrosis following treatment failure with oral oxybutynin.

Oral anticholinergics such as oxybutynin (OOx) and glycopyrrolate (OGly) are frequently used in the management of hyperhidrosis. Although OOx is considered currently the anticholinergic drug of first choice, OGly is a safe and effective alternative if OOx fails. The aim of this study was to identify the main variables associated with treatment adherence by patients receiving OGly, for whom previous treatment with OOx had failed. A prospective study was conducted of patients with hyperhidrosis receiving treatment with OGly in the period 2012 to 2019. Epidemiological variables, treatment details, effectiveness and adverse effects were recorded. A total of 58 patients (41 women), with a mean age of 35.9 years, were included in the study. The median follow-up period was 32 months. At 3 months, 70.7% of the patients had responded to treatment (excellent response: 75.6%), and adverse effects were reported by 70.7%. At 12 months, 53.4% had responded (excellent response: 74.2%), with adverse effects in 70.9%. The variables associated with poorer adherence were affected areas: palms of the hands, soles of the feet and armpits. The only variable associated with greater adherence was the generalized presence of hyperhidrosis. Our results provide valuable insights into the outcomes achieved when OGly is used to treat hyperhidrosis.

Stepwise treatment of primary focal hyperhidrosis with aluminum chloride hexahydrate lotion (20%) and oral glycopyrrolate: a retrospective study from a tertiary care center.

Primary focal hyperhidrosis is a common reason for dermatology outpatient visit and has significant impact on patient's social and professional activities. The study describes the clinical profile of those patients and response with aluminum chloride hexahydrate lotion (ACH 20%) and oral glycopyrrolate (OGP). A retrospective study was carried out at a tertiary care center between the year 2016 and 2018. Details of history, baseline assessment, treatment response recorded in specially designed proformas were analyzed. Initially, the patients received topical ACH daily at night. Non-responders were advised OGP 1 mg BD and increased to 2 mg BD if they did not respond. Response was measured according to patient global assessment and objective evaluation of sweating. Among total 69 patients 57 had onset <10 years of age. There was male preponderance and most common trigger was situations causing anxiety (n = 15). Around 15.3% patients got adequate response with ACH lotion. The cumulative response increased to 45.8% by addition of OGP 1 mg BD and to 55.9% by increasing the dose to 2 mg BD. Addition of OGP to topical ACH increases the treatment efficacy in patients with primary focal hyperhidrosis. Increasing the glycopyrrolate dose augments the response further. However, the current medical treatment options are able to give moderate response.

Clonidine is effective for the treatment of primary idiopathic hyperhidrosis and hot flushes: a case report

BackgroundWhile primary hyperhidrosis can be seen in men, accompanying hot flushes is rarely seen in men. Primary hyperhidrosis is thought to be related to overactivity of the sympathetic nervous system while hot flushes are believed to be related to altered peripheral vascular reactivity and a narrowed thermoregulatory zone.Case presentationI report the case of a 29-year-old man of Arab origin who presented to a dermatology clinic with a complaint of generalized sweating, with heavier involvement of his inguinal region, axilla, and lower back. His complaint was associated with a transient hot sensation and erythema over the affected areas. He did not respond to topical antiperspirants containing aluminum chloride, topical aluminum chloride, or to botulinum toxin A injected in both inguinal areas. He was then referred to an endocrinology clinic to rule out secondary causes of hyperhidrosis and hot flushes; a primary diagnosis was confirmed. He did not respond to oral glycopyrrolate and additionally was complaining of its anticholinergic side effects. The glycopyrrolate was then replaced with oral clonidine 0.15 mg twice a day. Clonidine was well tolerated without remarkable side effects and he quickly started to feel marked improvement which was maintained for 2 years.ConclusionsI report an atypical presentation of primary hyperhidrosis and hot flushes that was effectively controlled by clonidine without remarkable side effects. Further research on a large number of patients may be required before recommending clonidine in similar conditions.

Glycopyrrolate-induced craniofacial compensatory hyperhidrosis successfully treated with oxybutynin: report of a novel adverse effect and subsequent successful treatment

Hyperhidrosis, or abnormally increased sweating, is a condition that may have a primary or secondary cause. Usually medication- induced secondary hyperhidrosis manifests with generalized, rather than focal sweating. We report a 32-year-old woman with a history of palmoplantar hyperhidrosis for 15 years who presented for treatment and was prescribed oral glycopyrrolate. One month later, the palmoplantar hyperhidrosis had resolved, but she developed new persistent craniofacial sweating. After an unsuccessful trial of clonidine, oxybutynin resolved the craniofacial hyperhidrosis. To our knowledge, this is the first case of compensatory hyperhidrosis secondary to glycopyrrolate reported in the literature. The case highlights the importance of reviewing medication changes that correlate with new onset or changing hyperhidrosis. It also demonstrates a rare drug adverse effect with successful treatment.

Oral Glycopyrrolate for Refractory Pediatric and Adolescent Hyperhidrosis

Primary hyperhidrosis is a common disorder affecting children and adolescents, and it can have a significant negative psychosocial effect. Treatment for pediatric hyperhidrosis tends to be limited by low efficacy, low adherence, and poor tolerance. Oral glycopyrrolate is emerging as a potential second-line treatment option, but experience with safety, efficacy, and dosing is especially limited in children. We present an institutional review of 12 children with severe, refractory hyperhidrosis treated with oral glycopyrrolate; 11 (92%) noted improvement and 9 (75%) would recommend oral glycopyrrolate to their friends. No significant side effects were noted. Our retrospective analysis suggests that oral glycopyrrolate is safe and effective in children with hyperhidrosis.

Glycopyrrolate and Theophylline for the Treatment of Severe Pallid Breath-holding Spells

Severe pallid breath-holding spells (BHSs) are based on parasympathetic hyperactivity, leading to cardiac asystole, pallor, brain ischemia, loss of consciousness, and reflex anoxic seizures. In recent years, an increasing number of patients with severe pallid BHSs have been successfully treated with pacemaker implantation. We present the case of a 13-month-old girl suffering from repeated severe pallid BHSs, causing asystole, loss of consciousness, and generalized anoxic seizures. She underwent treatment with oral glycopyrrolate, an anticholinergic drug, and an oral retard preparation of theophylline. The aim of the treatment was to decrease cardiac inhibition with glycopyrrolate and to bring about a positive chronotropic effect with theophylline. In our case, the combined therapy was effective in suppressing syncope and reflex anoxic seizures associated with BHSs This avoided the need for ventricular pacemaker implantation.

Effectiveness of Oral Glycopyrrolate Use in Compensatory Hyperhidrosis Patients

Compensatory hyperhidrosis or reflex hyperhidrosis is the increase in sweating in the postoperative stage of thoracic sympathectomy or lumbar sympathectomy. It shares several features with anxiety disorders and has a negative impact on a patient's quality of life. Oralglycopyrrolate is one of the treatment options available. This study reviewed case notes in a series of 19 patients with compensatory hyperhidrosis. We made a comparison between the Milanez de Campos score of a pre-glycopyrrolate medication group and the Milanez de Campos score of a post-glycopyrrolate medication group. The Beck Depression Inventory (BDI) score, Beck Anxiety Inventory (BAI) score, and autonomic nervous system (ANS) scale score were also compared between the pre-medication and post-medication groups. In the post-glycopyrrolate medication group, there was decrease in the Milanez de Campos score, BAI score, and BDI score (P < 0.05). But no meaningful change was seen in the ANS score in the post-glycopyrrolate medication group (P > 0.05). Glycopyrrolate is an effective medication in the treatment of compensatory hyperhidrosis that, can alleviate anxiety and improve patients' quality of life.

Oral glycopyrrolate as second-line treatment for primary pediatric hyperhidrosis

Primary focal hyperhidrosis not uncommonly begins during the first two decades of life, and can have a profound effect on quality of life. Few treatment options have been studied in children. We sought to evaluate the response to oral glycopyrrolate in pediatric patients. Records of pediatric patients with hyperhidrosis seen at a pediatric hospital in a 10-year period were reviewed retrospectively and, if possible, parents and patients were also interviewed. The efficacy and adverse effects of oral glycopyrrolate were assessed. In all, 31 children took at least one dose of oral glycopyrrolate. All had daily hyperhidrosis that affected their quality of life and were resistant or intolerant of aluminum salts. The mean age of hyperhidrosis onset was 10.3 years, and mean age of initiation of glycopyrrolate was 14.8 years. At a mean dosage of 2 mg daily, 90% of patients experienced improvement, which was major in 71% of responders. Improvement occurred within hours of administration and disappeared within a day of discontinuation. Duration of treatment averaged 2.1 years (range to 10 years). Side effects were noted by 29% of children, most commonly dry mouth (26%) and eyes (10%), and were dose-related. One patient developed blurred vision, which resolved with dosing below 5 mg/d; one patient experienced palpitations and discontinued the medication. This was a retrospective analysis of a limited number of pediatric patients. Oral glycopyrrolate is a cost-effective, painless second-line therapy for children and adolescents with primary focal hyperhidrosis that impacts their quality of life.

Efficacy of Glycopyrrolate in Primary Hyperhidrosis Patients

BackgroundPrimary hyperhidrosis is a disorder of excessive sweating, which shares several features with anxiety disorders and has a negative impact on a patient's quality of life. Oral glycopyrrolate is one of the treatments available. There are a few published studies on the use of glycopyrrolate given orally in the treatment of hyperhidrosis.MethodsThies is study was a review of case notes in a series of 36 patients with primary hyperhidrosis. We made a comparison between the Keller's scale score of a pre-glycopyrrolate medication group and the Keller's scale score f a post-glycopyrrolate medication group. The Milanez de Campos score, Short Form_36 (SF-36) score, Beck Depression Inventory (BDI) score, Beck Anxiety Inventory (BAI) score, and autonomic nervous system (ANS) scale score were also compared between the two groups.ResultsIn the post-glycopyrrolate medication group, there were declines in Keller's scale, and Milanez de Campos scale score and BAI score (P < 0.001). In addition, there were increases in SF_36 score in the post-glycopyrrolate medication group (P = 0.03) However, no changes were seen in, BDI score and ANS score in the post-glycopyrrolate medication group (P < 0.001).ConclusionsGlycopyrrolate is an effective initial method of treating primary hyperhidrosis that, reduces anxiety and improve patients' quality of life.

Safety and efficacy of glycopyrrolate oral solution for management of pathologic drooling in pediatric patients with cerebral palsy and other neurologic conditions

BackgroundThe purpose of this study was to assess the safety and efficacy of oral glycopyrrolate solution 1 mg/5 mL for 24 weeks in pediatric patients with chronic moderate-to- severe drooling associated with cerebral palsy and other neurologic conditions.MethodsIn this multicenter, open-label, 24-week study, males and females aged 3–18 years weighing at least 27 lb received oral glycopyrrolate solution, starting at 0.02 mg/kg three times daily and titrated in increments of 0.02 mg/kg every 5–7 days for 4 weeks to an optimal maintenance dose or a maximum dose of 0.1 mg/kg, but not exceeding 3 mg three times daily. Safety was assessed by description and tabulation of all adverse events. The primary efficacy endpoint was response, defined as at least a three-point change from baseline to week 24 on the modified Teacher’s Drooling Scale.ResultsOf 137 intent-to-treat participants, 10 (7.3%) received the maximum dose of 0.1 mg/kg three times daily; 122 (89%) had at least one treatment-emergent adverse event, 47% related to oral glycopyrrolate solution, with most being mild-to-moderate in intensity. The most commonly reported treatment-emergent adverse events were constipation (20.4%), vomiting (17.5%), diarrhea (17.5%), pyrexia (14.6%), dry mouth (10.9%), flushing (10.9%), and nasal congestion (10.9%). Nineteen patients (13.9%) discontinued treatment due to an adverse event, but no adverse event was specifically associated with discontinuation. Two patients had clinically significant toxicity grade shifts, one each in platelet count and calcium concentration. No deaths occurred on treatment; deaths of three patients (multisystem organ failure, anoxic encephalopathy, and aspiration pneumonia) within 30 days of their last dose were not considered to be treatment-related. At 24 weeks, 52.3% (95% confidence interval 43.7–60.9) of patients were responders, with at least a three-point decrease in modified Teacher’s Drooling Scale from baseline, with 83.5% of parents/caregivers and 85.8% of investigators rating oral glycopyrrolate solution as being worthwhile.ConclusionOral glycopyrrolate solution 1 mg/5 mL for chronic moderate-to-severe drooling associated with cerebral palsy or other neurologic conditions was well tolerated over 24 weeks by pediatric patients aged 3–18 years.

Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children

Excessive drooling may complicate the care of children with chronic neurological conditions by socially isolating both patients and families and by causing secondary dermatitis and infection. Normal control of saliva requires normal integrity of oral structures, normal oropharyngeal sensation, and motor functioning, as well as normal cognitive awareness and rate of salivary production. Glycopyrrolate is an anticholinergic medication with a quaternary structure that recently received Food and Drug Administration approval to treat sialorrhea due to neurological problems in children ages 3–16 years. This review summarizes the few published studies of safety and efficacy of glycopyrrolate for drooling in children with chronic neurological conditions.

Glycopyrrolate for sialorrhea in Parkinson disease

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. To determine the efficacy and safety of glycopyrrolate in the treatment of sialorrhea in patients with PD. We conducted a 4-week, randomized, double-blind, placebo-controlled, crossover trial with oral glycopyrrolate 1 mg 3 times daily in 23 patients with PD. The severity of the sialorrhea was scored on a daily basis by the patients or a caregiver with a sialorrhea scoring scale ranging from 1 (no sialorrhea) to 9 (profuse sialorrhea). The mean (SD) sialorrhea score improved from 4.6 (1.7) with placebo to 3.8 (1.6) with glycopyrrolate (p = 0.011). Nine patients (39.1%) with glycopyrrolate had a clinically relevant improvement of at least 30% vs 1 patient (4.3%) with placebo (p = 0.021). There were no significant differences in adverse events between glycopyrrolate and placebo treatment. Oral glycopyrrolate 1 mg 3 times daily is an effective and safe therapy for sialorrhea in Parkinson disease. 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.

Use of oral glycopyrronium bromide in hyperhidrosis

Idiopathic hyperhidrosis may be a disabling condition causing emotional stress and negative impact on a patient's quality of life. Oral anticholinergics are one of the treatments available. There are few published data on the use of the anticholinergic drug glycopyrronium bromide (glycopyrrolate) given orally in the treatment of hyperhidrosis. To report a retrospective analysis describing the treatment responses, doses and side-effects of oral glycopyrrolate in the treatment of idiopathic hyperhidrosis. Review of case notes in a series of 24 patients, nine with generalized and 15 with localized hyperhidrosis. Fifteen of 19 evaluable patients (79%) responded to oral glycopyrrolate. However, treatment was limited by side-effects in around one third of patients. A prospective clinical study to compare the efficacy and side-effects of oral anticholinergics is warranted.

Oral glycopyrrolate for the treatment of diabetic gustatory sweating

Oral glycopyrrolate for the treatment of diabetic gustatory sweating