Glycopyrronium
Brand names: Qbrexza
Drug class:
Antineoplastic Agents , Antineoplastic Agents
Usage of Glycopyrronium
Primary Axillary Hyperhidrosis
Treatment of primary axillary hyperhidrosis.
May be considered for first-line therapy or for use in patients who have had an unsatisfactory response to antiperspirants containing aluminum or zirconium salts. Other second-line treatment options include botulinum toxin injections and microwave thermolysis. An adequate trial of such therapy usually is recommended before systemic oral drug therapy, local sweat gland ablation, or sympathectomy is considered.
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How to use Glycopyrronium
Administration
Topical Administration
Apply topically using an absorbent polypropylene pad (cloth) that has been premoistened with a solution containing 2.4% glycopyrronium.
For topical external use only. Apply to clean dry skin in the axillary area only. Do not apply to other body areas or to broken skin. Do not cover treated areas with occlusive dressings.
May cause temporary mydriasis and blurred vision if contact with the eyes occurs; take care to avoid transferring solution to the periocular area.
Prior to application, tear open a pouch containing a single cloth premoistened with glycopyrronium 2.4% solution, pull out and unfold the cloth, then wipe it once across one entire axilla and then across the other axilla. Do not reuse the cloth.
Wash hands with soap and water immediately after applying solution and discarding the cloth.
Dosage
Available as glycopyrronium tosylate; concentration expressed in terms of glycopyrronium.
Pediatric Patients
Primary Axillary Hyperhidrosis TopicalPediatric patients ≥9 years of age: Wipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.
Adults
Primary Axillary Hyperhidrosis TopicalWipe one cloth premoistened with glycopyrronium 2.4% solution across both axillae one time once daily.
Prescribing Limits
Pediatric Patients
Primary Axillary Hyperhidrosis TopicalPediatric patients ≥9 years of age: Do not apply more frequently than once every 24 hours.
Adults
Primary Axillary Hyperhidrosis TopicalDo not apply more frequently than once every 24 hours.
Special Populations
No special population dosage recommendations.
Warnings
Contraindications
Warnings/Precautions
GU Disorders
Use with caution in patients with current or prior documented urinary retention. Be alert for manifestations of urinary retention (e.g., difficulty passing urine, distended bladder), especially in individuals with prostatic hyperplasia or bladder neck obstruction, and discontinue use immediately if such manifestations develop. Clinical trials did not include patients with a history of urinary retention.
Thermoregulatory Effects
At hot or very warm environmental temperatures, heat illness (e.g., hyperpyrexia, heat stroke) due to decreased sweating reported with use of anticholinergic drugs. Be alert for a generalized lack of sweating when exposed to such conditions. Advise patients to avoid use if not sweating in hot or very warm temperatures.
Ocular Effects
Transient blurred vision reported following topical application. Performance of activities requiring visual acuity (e.g., operating machinery, driving a motor vehicle, performing hazardous work) may be impaired. If blurred vision occurs, discontinue use until symptoms resolve.
Flammability
Qbrexza cloths premoistened with glycopyrronium tosylate solution are flammable; do not expose to excessive heat or flames.
Specific Populations
PregnancyNo available data regarding topical glycopyrronium use in pregnant women by which to establish a drug-associated risk for adverse developmental outcomes.
No adverse embryofetal developmental effects observed with IV glycopyrrolate (glycopyrronium bromide) in rabbits. No increase in incidence of gross external or visceral defects observed with oral glycopyrrolate in rats. 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.
LactationNot known whether topically administered glycopyrronium or its metabolites distribute into milk, affect breast-fed infants, or affect milk production.
Consider developmental and health benefits of breast-feeding along with the mother's clinical need for topical glycopyrronium and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.
Pediatric UseSafety and efficacy not established in pediatric patients <9 years of age. Use for topical treatment of primary axillary hyperhidrosis in pediatric patients ≥9 years of age supported by evidence from 2 clinical trials that included 34 pediatric patients ≥9 years of age.
Geriatric UseInsufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger individuals.
Renal ImpairmentElimination of IV glycopyrronium in patients with renal failure is severely impaired. Pharmacokinetics of topical glycopyrronium in patients with renal impairment not determined.
Common Adverse Effects
Topical therapy of primary axillary hyperhidrosis (≥2%): Dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, nasal dryness, dry throat, dry eye, dry skin, constipation. Adverse local effects (e.g., erythema, burning/stinging, pruritus) reported in >5% of patients.
What other drugs will affect Glycopyrronium
Topical glycopyrronium not expected to induce CYP isoenzymes 1A2, 2B6, or 3A4 or inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4.
Specific Drugs
Drug
Interaction
Comments
Anticholinergic agents
Possible additive anticholinergic effects
Avoid concomitant use
Disclaimer
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