Qbrexza (glycopyrronium tosylate)

Concentration of glycopyrronium tosylate is expressed in terms of glycopyrronium.

For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older, one cloth premoistened with glycopyrronium 2.4% solution should be wiped once across both axillae once daily. Glycopyrronium topical solution should not be applied more frequently than once every 24 hours.

Glycopyrronium tosylate is applied topically using an absorbent polypropylene pad (cloth) that has been premoistened with a solution containing 2.4% glycopyrronium. The solution is for topical external use only and should be applied to clean, dry skin in the axillary area only. The solution should not be applied to other body areas or to broken skin; treated sites should not be covered by occlusive dressings.

Because glycopyrronium may cause temporary mydriasis and blurred vision if contact with the eyes occurs, care should be taken to avoid transfer of the solution to the periocular area.

Prior to topical application, a pouch containing a single cloth premoistened with glycopyrronium 2.4% solution should be torn open, and the cloth should be pulled out, unfolded, and wiped once across one entire axilla and then across the other axilla. The cloth should then be discarded and the hands should be washed immediately with soap and water. The cloths should not be reused.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Medical conditions that can be exacerbated by increased anticholinergic activity (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in patients with acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren's syndrome).

• Glaucoma
• Hemorrhagic shock
• Paralytic ileus
• Pyloroduodenal obstruction
• Severe ulcerative colitis
• Sjogren's syndrome
• Toxic megacolon

• Autonomic dysreflexia
• Benign prostatic hyperplasia
• Bladder outflow obstruction
• Gastric ulcer
• Gastrointestinal obstruction
• Myasthenia gravis
• Toxin-mediated diarrhea
• Ulcerative colitis
• Urinary retention
• Urinary tract obstructive uropathy

• Chronic heart failure
• Coronary artery disease

Adverse effects occurring in 2% or more of patients receiving glycopyrronium 2.4% topical solution include dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, nasal dryness, dry throat, dry eye, dry skin, and constipation. Adverse local effects (e.g., erythema, burning/stinging, pruritus) have been reported in more than 5% of patients receiving the drug.

There are no severe adverse reactions for this drug.

More Frequent

• Erythema
• Mydriasis
• Pain in oropharynx
• Stinging of skin
• Xerostomia

Less Frequent

• Blurred vision
• Constipation
• Dry eye
• Dry nose
• Dry skin
• Dry throat
• Headache disorder
• Pharyngitis
• Pruritus of skin
• Skin inflammation
• Skin rash
• Treatment site sequelae
• Urinary hesitancy

No enhanced messaging available.

Safety and efficacy of glycopyrronium topical solution have not been established in pediatric patients younger than 9 years of age. Safety, efficacy, and pharmacokinetics of the drug have been established in pediatric patients 9 years of age and older for the topical treatment of primary axillary hyperhidrosis. Use in this age group is supported by evidence from 2 clinical trials that included 34 pediatric patients 9 years of age or older. (See Primary Axillary Hyperhidrosis under Uses.)

No data are available regarding topical use of glycopyrronium in pregnant women by which to establish a drug-associated risk for adverse developmental outcomes. No adverse embryofetal developmental effects were observed with IV glycopyrrolate (glycopyrronium bromide) in rabbits. No increase in the incidence of gross external or visceral defects was observed with oral glycopyrrolate in rats, although reduced maternal and fetal weight gain, fetal resorption, and minor skeletal effects (likely secondary to maternal toxicity) were observed. Available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of glycopyrronium 2.4% solution.

It is not known whether topically administered glycopyrronium or its metabolites are distributed into milk, affect breast-fed infants, or affect milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for topical glycopyrronium and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

There is insufficient experience in patients 65 years of age and older to determine whether geriatric patients respond differently than younger individuals.