of breastfeeding should be considered along with the mother’s clinical need for Qbrexza andany potential adverse effects on the breastfed infant from Qbrexza or from the underlying

maternal condition.

8.4 Pediatric Use

The safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatricpatients age 9 years and older for topical treatment of primary axillary hyperhidrosis [see

Clinical Pharmacology (12.3)]. Use of Qbrexza in this age group is supported by evidence fromtwo multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which

included 34 pediatric subjects 9 years and older [see Adverse Reactions (6.1) and ClinicalStudies (14)]. The safety and effectiveness of Qbrexza have not been established in pediatric

patients under 9 years of age.

8.5 Geriatric Use

Clinical trials of Qbrexza did not include sufficient numbers of subjects age 65 years and olderto determine whether they respond differently from younger subjects.

8.6 Renal Impairment

The elimination of glycopyrronium is severely impaired in patients with renal failure [see ClinicalPharmacology (12.3)].

10 OVERDOSAGE

Because glycopyrronium is a quaternary amine which does not easily cross the blood-brainbarrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather

than central compared to other anticholinergic agents. Associated signs and symptoms relatedto excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus,urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis.

In the case of overdose when symptoms are severe or life threatening, therapy may include:

• Managing per standard of care any acute conditions such as hyperthermia, coma, and/orseizures, as applicable, and managing any myoclonic or choreoathetoid movements which

may lead to rhabdomyolysis in some cases of anticholinergic overdosage

• Managing severe urinary retention with catheterization if not spontaneously reversedwithin several hours

• Providing cardiovascular support and/or controlling arrhythmias

• Maintaining an open airway, providing ventilation as necessary

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• Administering a quaternary ammonium anticholinesterase such as neostigmine to helpalleviate severe and/or life threatening peripheral anticholinergic effects.

Topical overdosing of Qbrexza could result in an increased incidence or severity of local skinreactions. Administration of Qbrexza under occlusive conditions may result in an increase inanticholinergic effects, including dry mouth and urinary hesitation.

11 DESCRIPTION

Qbrexza (glycopyrronium) cloth, 2.4% is an anticholinergic drug available as a clear, colorless topale yellow solution on a single-use pre-moistened cloth (an absorbent polypropylene pad)

packaged in a pouch for topical administration. Each pouch contains 105 mg glycopyrroniumtosylate, equivalent to 66 mg of glycopyrronium. The inactive ingredients are citric acid,

dehydrated alcohol, purified water, and sodium citrate.