Glycopyrrolate is NOT Contraindicated in 9-Year-Olds for Hyperhidrosis
Glycopyrrolate is specifically FDA-approved for primary axillary hyperhidrosis in patients ≥9 years of age and represents the only topical anticholinergic treatment option approved for pediatric patients with this condition. 1
FDA-Approved Indication and Safety Profile
Topical glycopyrronium tosylate (2.4% cloth) received FDA approval for primary axillary hyperhidrosis in patients aged ≥9 years and older, making it explicitly appropriate for your 9-year-old patient 1
The approval was based on two phase 3 randomized controlled trials (ATMOS-1 and ATMOS-2) that included pediatric patients as young as 9 years, demonstrating both efficacy and safety in this age group 2
Long-term safety data extending up to 48 weeks confirms that pediatric patients (≥9 to ≤16 years) tolerate glycopyrrolate well, with most adverse events being mild to moderate and related to expected anticholinergic activity 3
Efficacy in Pediatric Patients
In the pivotal trials, 44 patients aged 9-16 years were treated, with 25 receiving glycopyrronium tosylate 2
Pediatric patients demonstrated comparable improvements to older patients in sweating severity, disease severity scores (HDSS), sweat production, and quality of life measures 2
Response rates and magnitude of improvement were similar between children and adults, with no age-related differences in treatment effect 2
Safety Considerations Specific to Pediatrics
The most common adverse events in pediatric patients were anticholinergic in nature (dry mouth 26%, dry eyes 10%), were dose-related, and rarely led to discontinuation 4
In the 44-week open-label extension study, only 1 of 38 pediatric patients (2.6%) discontinued due to adverse events 3
No serious treatment-emergent adverse events occurred in pediatric patients during the long-term study 3
Most anticholinergic adverse events resolved within 7 days and did not require dose modification 3
Systemic absorption of topical glycopyrronium is limited compared to oral formulations, reducing the risk of systemic anticholinergic effects 5
Alternative Oral Formulation
Oral glycopyrrolate has been used off-label as second-line therapy in pediatric hyperhidrosis with good results: in a retrospective study of 31 children (mean age 14.8 years at treatment initiation), 90% experienced improvement at a mean dose of 2 mg daily 4
Treatment duration averaged 2.1 years (range up to 10 years) with sustained benefit 4
Side effects occurred in 29% of children, predominantly dry mouth and eyes, and were dose-related 4
Clinical Caveats
Ensure proper application technique with topical formulation: wipe each underarm once with the same cloth, wash hands immediately after, and avoid ocular contact to minimize systemic absorption and local adverse effects 5
Start with the FDA-approved topical formulation (2.4% cloth) applied once daily rather than oral glycopyrrolate, as it provides targeted delivery with lower systemic exposure 1, 5
Monitor for anticholinergic side effects (dry mouth, dry eyes, blurred vision, urinary retention, constipation), though these are typically mild and transient 3, 4
The frequency and severity of anticholinergic adverse events increase with higher glycopyrronium concentrations, so adherence to proper dosing is essential 5