Hyperhidrosis, primary, axillary: Topical: Apply to each underarm not more frequently than once every 24 hours
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); following IV administration of glycopyrronium, elimination is severely impaired in renal failure.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied)
Refer to adult dosing; use with caution (has not been studied in sufficient numbers of patients)
(For additional information see "Glycopyrrolate (glycopyrronium) (topical): Pediatric drug information")
Hyperhidrosis, primary, axillary: Children ≥9 years and Adolescents: Topical: Apply to clean dry skin on the underarm areas only, no more frequently than once every 24 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, glycopyrronium elimination is severely impaired in renal failure.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Erythema (17%), burning sensation of skin (≤14%), stinging of the skin (≤14%)
Gastrointestinal: Xerostomia (24%)
1% to 10%:
Central nervous system: Headache (5%)
Dermatologic: Pruritus (8%), xeroderma (2%)
Gastrointestinal: Constipation (2%)
Genitourinary: Urinary hesitancy (4%)
Ophthalmic: Mydriasis (7%), blurred vision (4%), xerophthalmia (2%)
Respiratory: Oropharyngeal pain (6%), dry nose (3%), dry throat (3%)
Medical conditions that can be exacerbated by the anticholinergic effect of glycopyrronium (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren disease).
Concerns related to adverse effects:
• Heat illness: May occur in the presence of increased environmental temperature; advise patients to avoid use if not sweating in hot or very warm environmental temperatures.
• Urinary retention: Signs and symptoms of new or worsening urinary retention (eg, difficulty passing urine, distended bladder) may occur with use and may require discontinuation of therapy.
• Visual disturbances: May cause transient blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns:
• Prostatic hypertrophy/bladder neck obstruction: Use with caution in patients with prostatic hypertrophy or bladder neck obstruction.
Other warnings/precautions:
• Accidental exposure: Proper storage and disposal of cloths, as well as recommended handwashing, is essential to prevent accidental exposures, especially in children; accidental exposure may result in anisocoria, blurred vision, and mydriasis, which typically resolved within 1 week of exposure.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pad, External, as tosylate:
Qbrexza: 2.4% (1 ea, 30 ea)
No
Pads (Qbrexza External)
2.4% (per each): $25.84
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Topical: Administer to clean dry skin on the underarm areas only; do not apply to broken skin and avoid use with occlusive dressings. After opening pouch, remove and unfold the single-use premoistened cloth and wipe across the entire underarm of each arm once using the same cloth. Dispose of cloth in household trash out of the reach of children and others. Wash hands immediately with soap and water after application and disposal of cloth. Avoid contact with the eyes. Flammable; avoid use near heat or flame.
Topical: For topical use; apply to clean dry skin on the underarm area only; not for use in other body areas. Do not apply to broken skin and avoid use with occlusive dressings. After opening pouch, remove and unfold the single-use premoistened cloth and wipe across the entire underarm of each arm once using the same cloth. After applying, immediately discard cloth and wash hands with soap and water. Dispose of cloth in household trash out of the reach of children and others. Avoid contact with the eyes. Flammable; avoid use near heat or flame.
Primary axillary hyperhidrosis: For topical treatment of primary axillary hyperhidrosis in adult and pediatric patients ≥9 years.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Aclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Acrivastine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Agents with Clinically Relevant Anticholinergic Effects: Glycopyrronium (Topical) may increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Amantadine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Benperidol: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Benperidol. Risk C: Monitor
Botulinum Toxin-Containing Products: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Bromperidol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bromperidol. Risk C: Monitor
Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of Cannabinoid-Containing Products. Risk C: Monitor
Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Chlorprothixene. Risk C: Monitor
Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Cimetropium. Risk X: Avoid
DroNABinol: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of DroNABinol. Risk X: Avoid
Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Eluxadoline. Risk X: Avoid
Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor
Gepotidacin: May decrease anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Glucagon: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor
Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
Ipratropium (Nasal): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ipratropium (Oral Inhalation): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Itopride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Itopride. Risk C: Monitor
Levosulpiride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Levosulpiride. Risk X: Avoid
Melperone: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Mirabegron: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Mirabegron. Risk C: Monitor
Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor
Opioid Agonists: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor
Oxatomide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Perazine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid
Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid
Pramlintide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid
QuiNIDine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Ramosetron. Risk C: Monitor
Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Revefenacin. Risk X: Avoid
Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Rivastigmine. Rivastigmine may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider Therapy Modification
Secretin: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider Therapy Modification
Sofpironium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Sofpironium. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Tiapride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Tiapride. Risk C: Monitor
Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tiotropium. Risk X: Avoid
Topiramate: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Topiramate. Risk C: Monitor
Trimethobenzamide: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trimethobenzamide. Risk C: Monitor
Umeclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Adverse events were not observed in animal reproduction studies using systemic glycopyrronium bromide (glycopyrrolate). Pharmacokinetic studies using topical glycopyrronium tosylate have not been conducted in pregnant patients.
Also refer to the glycopyrrolate systemic monograph for additional information.
It is not known if glycopyrronium is present in breast milk following topical application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Also refer to the Glycopyrrolate Systemic monograph for additional information.
Anticholinergic effects, including urinary retention.
Competitive inhibitor of acetylcholine receptors located on certain peripheral tissues, including sweat glands; reduces sweating by inhibiting the action of acetylcholine on sweat glands.
Absorption: Topical: No evidence of accumulation after repeated daily dosing for 5 days.
Time to peak: Topical: 1 to 1.5 hours
Excretion: IV: Urine: ~85% (>80% as unchanged drug); bile: <5% (>80% as unchanged drug)