glycopyrronium
Regulatory sources consulted
Approved indications
- Topical treatment of severe primary axillary hyperhidrosis in adults.
Contraindications
Absolute
- Hypersensitivity; glaucoma, paralytic ileus, cardiovascular instability in acute hemorrhage, severe ulcerative colitis or toxic megacolon, myasthenia gravis, or Sjögren syndrome.
Clinical warnings
- Major warning · Stop and seek advice for urinary retention. Use cautiously in urinary obstruction, coronary disease, heart failure, arrhythmia, or hypertension. — CIMA/AEMPS, ficha técnica 88077
- Avoid the eyes, nose, mouth, inflamed or damaged skin, and skin-to-skin contact with others; it may cause mydriasis, blurred vision, dry mouth, and anticholinergic effects. — CIMA/AEMPS, ficha técnica 88077
- Major warning · Hypersensitivity and angioedema have been reported with unknown frequency; discontinue and assess immediately if they occur. — CIMA/AEMPS, ficha técnica 88077
- Major warning · It has not been studied in people with blood-brain barrier dysfunction, such as recent brain injury, chemotherapy, cranial radiotherapy, cranial or brain surgery, or intravenous drug use. Use only if other options are not sufficiently effective. — CIMA/AEMPS, ficha técnica 88077
- Dry mouth and reduced salivation may increase the risk of dental caries; maintain careful dental hygiene and regular dental check-ups. — CIMA/AEMPS, ficha técnica 88077
Drug interactions
- HighOther anticholinergic medicines
Mechanism: Anticholinergic effects may increase.
Recommendation: Avoid or combine only cautiously; this includes topiramate, sedating antihistamines, tricyclics, MAO inhibitors, neuroleptics, antipsychotics, and opioids.
CIMA/AEMPS, ficha técnica 88077https://cima.aemps.es/cima/dochtml/ft/88077/FT_88077.html
Adverse events
Common (≥1%)
Application-site reactions · Dry mouth · Dry eyes · Nasal dryness · Headache · Constipation · Blurred vision
Rare but serious
Uncommon: thrombocytopenia, tachycardia, QT prolongation, and increased liver enzymes or bilirubin
Pregnancy and lactation
It may be considered during pregnancy if needed. During breastfeeding, decide whether to stop breastfeeding or treatment and prevent infant contact with the cream or treated skin.
Recent literature (PubMed)
Hyperhidrosis is a dermatosis presenting as pathologically excessive focal or generalized sweating. The stigmatizing nature of hyperhidrosis may cause patients to feel embarrassment and apprehension about their symptoms and experience a significant decrease in well-being. Severe cases of hyperhidrosis can also increase the risk of developing psychiatric and somatic comorbidities. Conventional non-surgical treatments of hyperhidrosis include aluminum salts, iontophoresis, botulinum toxin injections, and oral glycopyrronium. In recent years, new topical anticholinergic medications and devices have emerged that may improve the patients' symptoms and even prevent the development of comorbidities. The treatment of hyperhidrosis can be a complex matter and may require the combination of several therapies. The purpose of this paper was to firstly review the literature on existing non-surgical treatment options for hyperhidrosis, and secondly provide a stepwise approach to investigating and treating patients with hyperhidrosis. No information is available on the use of glycopyrrolate during breastfeeding. Because glycopyrrolate is a quaternary ammonium compound, it is not likely to be absorbed and reach the bloodstream of the infant, especially when given by inhalation or topically on the skin.[1-3] Long-term oral use of glycopyrrolate might reduce milk production or milk letdown, but a single dose is unlikely to interfere with breastfeeding. During long-term use, observe for signs of decreased lactation such as poor weight gain. The inhaled form of glycopyrrolate has not been studied, but is unlikely to cause effects in the breastfed infant or on milk production.
Long-acting muscarinic antagonists (LAMA) can be added to inhaled corticosteroid- (ICS)-long-acting β2-agonist (LABA) therapy for inadequately controlled asthma. We aimed to evaluate the efficacy and safety of budesonide-glycopyrronium-formoterol fumarate dihydrate (BGF) versus budesonide-formoterol fumarate dihydrate using Aerosphere co-suspension delivery technology (BFFA) and the current suspension formulation (Symbicort, BFFS). Two multicentre, randomised, double-blind, double-dummy, phase 3 studies (KALOS and LOGOS) recruited participants aged 12-80 years with inadequately-controlled asthma despite daily medium-dose or high-dose ICS-LABA use from across 378 sites in 20 countries (KALOS), and 324 sites in 15 countries (LOGOS). Participants were randomly assigned (1:1:1:1) to BGF 320 μg, 28·8 μg, 10 μg (BGF 28·8); BGF 320 μg, 14·4 μg, 10 μg (BGF 14·4); BFFA 320 μg, 10 μg; or BFFS 320 μg, 9 μg, twice a day via pressurised metered-dose inhaler for 24-52 weeks. Primary lung function endpoints were change from baseline in FEV1 area under the curve from 0 h to 3 h (AUC0-3) and in morning pre-dose trough FEV1 from day 1 to week 24 (over 24 weeks; depending on regional health authority guidance). The primary pooled analysis across both studies was annualised severe exacerbations. The efficacy analysis set and safety set included all randomly assigned participants receiving any amount of study treatment but were analysed according to randomly assigned treatment and received treatment, respectively. The KALOS and LOGOS studies are registered with ClinicalTrials.gov (NCT04609878 and NCT04609904, respectively) and are complete. Between Dec 15, 2020, and March 21, 2025 (KALOS), and between March 1, 2021, and March 20, 2025 (LOGOS), 8820 participants were recruited and 4311 received treatment (1179 received BGF 28·8, 726 received BGF 14·4, 1210 received BFFA, and 1196 received BFFS). In each study, the pre-specified multiplicity-adjusted primary endpoints for all regulatory c
Randomized controlled trials (RCTs) comparing triple therapies (inhaled corticosteroid [ICS], long-acting β2-agonist [LABA], and long-acting muscarinic antagonist [LAMA]) for the treatment of chronic obstructive pulmonary disease (COPD) are limited. This network meta-analysis (NMA) investigated the comparative efficacy of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus any triple (ICS/LABA/LAMA) combinations and dual therapies in patients with COPD. This NMA was conducted on the basis of a systematic literature review (SLR), which identified RCTs in adults aged at least 40 years with COPD. The RCTs compared different ICS/LABA/LAMA combinations or an ICS/LABA/LAMA combination with any dual therapy (ICS/LABA or LAMA/LABA). Outcomes of interest included forced expiratory volume in 1 s (FEV1), annualized rate of combined moderate and severe exacerbations, St George's Respiratory Questionnaire (SGRQ) total score and SGRQ responders, transition dyspnea index focal score, and rescue medication use (RMU). Analyses were conducted at 24 weeks (primary endpoint), and 12 and 52 weeks (if feasible). The NMA was informed by five trials reporting FEV1 at 24 weeks. FF/UMEC/VI was statistically significantly more effective at increasing trough FEV1 (based on change from baseline) than all triple comparators in the network apart from UMEC + FF/VI. The NMA was informed by 17 trials reporting moderate or severe exacerbation endpoints. FF/UMEC/VI demonstrated statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus single-inhaler budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR). At 24 weeks, the NMA was informed by five trials. FF/UMEC/VI showed statistically significant improvements in annualized rate of combined moderate or severe exacerbations versus UMEC + FF/VI and BUD/GLY/FOR. FF/UMEC/VI also demonstrated improvements in mean SGRQ score versus other triple therapy comparators at
Hyperhidrosis (HH), a condition characterized by excessive sweating beyond thermoregulation, significantly impairs quality of life. Conventional medications to treat HH include aluminum chloride hexahydrate, systemic anticholinergics, and botulinum toxin injections. New treatments have emerged including glycopyrronium bromide, sofpironium bromide, targeted alkali thermolysis, and microwave devices. This paper reviews the mechanism of action, efficacy, safety, and practical considerations associated with these treatments.