Hyperhidrosis: oral glycopyrronium bromide

Summary

There is weak evidence from case series that oral glycopyrronium bromide tablets reduce sweating in people with hyperhidrosis. The most commonly reported adverse effects are antimuscarinic, particularly dry mouth. There is no randomised controlled trial evidence of the use of oral glycopyrronium bromide for hyperhidrosis.

Regulatory status: unlicensed

Key points

Glycopyrronium bromide is an antimuscarinic drug that prevents the stimulation of sweat glands. This evidence summary reviews the use of oral glycopyrronium bromide for treating hyperhidrosis, or excessive sweating.

Oral preparations of glycopyrronium bromide (tablets and solution or suspension) are not licensed or available in the UK for treating hyperhidrosis. Such preparations must be either imported or prepared by 'specials' manufacturers. Use for this indication would be unlicensed.

Glycopyrronium bromide powder for solution (Robinul powder) is currently licensed for the iontophoretic treatment (electromotive drug administration) of primary (idiopathic) hyperhidrosis of the palms of hands and soles of feet in children and adults.

No randomised controlled trials were identified. Five case series reported the use of oral glycopyrronium bromide tablets in people with hyperhidrosis: 3 in a total 100 adults with focal or generalised primary hyperhidrosis (Bajaj and Langtry 2007; Lee et al. 2012; Walling 2012); 1 case series in 31 children or young people with focal primary hyperhidrosis (Paller et al. 2012); and 1 case series in 19 adults or young people with compensatory hyperhidrosis following sympathectomy for focal primary hyperhidrosis (Gong and Kim 2013).

Dosages of oral glycopyrronium bromide in these case series ranged from 1 mg to a maximum 8 mg (in divided doses) daily, and treatment duration was variable or unreported. In all but 1 study, participants had tried previous treatments and either the condition had not responded, or they had been intolerant to the treatment.

Across these case series, hyperhidrosis responded to treatment in 67 to 90% of participants. These response rates were based on absolute responses to therapy as recorded in patient records, or on patient questionnaires, which could be subjective and do not appear to be validated.

Adverse effects affected between 29 and 79% of participants, the most frequent being dry mouth (affecting 16–63%). Two studies (Bajaj and Langtry 2007; Walling 2012) reported that, respectively, 26% and 20% of participants stopped treatment because of adverse effects. Paller et al. (2012) reported that 1 child (3%) stopped because of palpitations. The other 2 studies reported no withdrawals because of adverse effects.

Additional safety information is included in the labelling of the oral glycopyrronium bromide products available in the USA but not licensed for hyperhidrosis (glycopyrrolate tablets, USP, Robinul and Robinul Forte; glycopyrrolate oral solution, Cuvposa). The tablets are contraindicated in medical conditions that preclude antimuscarinic therapy. There are also warnings about fever and heat stroke as a result of decreased sweating in high environmental temperatures, and diarrhoea, which may be an early symptom of incomplete intestinal obstruction. Listed adverse effects include dry mouth, urinary retention, blurred vision, palpitations, drowsiness, vomiting and constipation.

Overall, the 5 case series provide weak evidence of the efficacy and safety of oral glycopyrronium bromide for treating hyperhidrosis.