Primary axillary hyperhidrosis: 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)
(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.
Refer to adult dosing; use with caution (has not been studied in sufficient numbers of patients)
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
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.
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's syndrome)
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.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Anticholinergic Agents: Glycopyrronium (Topical) may enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect 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 combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Secretin: Anticholinergic Agents may diminish the therapeutic effect 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
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
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)
Pads (Qbrexza External)
2.4% (per each): $25.84
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