Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pad, External, as tosylate:
Qbrexza: 2.4% (1 ea, 30 ea)
Pharmacology
Mechanism of Action
Competitive inhibitor of acetylcholine receptors located on certain peripheral tissues, including sweat glands; reduces sweating by inhibiting the action of acetylcholine on sweat glands.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: No evidence of accumulation after repeated daily dosing for 5 days.
Excretion
IV: Urine: ~85% (>80% as unchanged drug); bile: <5% (>80% as unchanged drug)
Time to Peak
Topical: 1 to 1.5 hours
Use: Labeled Indications
Primary axillary hyperhidrosis: For topical treatment of primary axillary hyperhidrosis in adult and pediatric patients ≥9 years.
Contraindications
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)
Dosage and Administration
Dosing: Adult
Primary axillary hyperhidrosis: Topical: Apply to each underarm not more frequently than once every 24 hours
Dosing: Geriatric
Refer to adult dosing; use with caution (has not been studied in sufficient numbers of patients)
Dosing: Pediatric
Hyperhidrosis, primary axillary: Children ≥9 years and Adolescents: Topical: Apply once daily to clean dry skin on the underarm areas only; do not use more often than every 24 hours
Administration
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. 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.
Storage
Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), Protect from heat or flame.
Drug Interactions
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Anticholinergic Agents: Glycopyrronium (Topical) may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. 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. 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. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. 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. Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. 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. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Adverse Reactions
>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%)
Warnings/Precautions
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.
- 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:
- Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction; discontinue therapy if indicated.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Monitoring Parameters
Anticholinergic effects
Pregnancy
Pregnancy Considerations
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.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry mouth, sore throat, dry nose, dry skin, headache, redness, burning, stinging, itching, or constipation. Have patient report immediately to prescriber unable to pass urine, passing a lot of urine, difficult urination, enlarged pupils, blurred vision, fast heartbeat, abnormal heartbeat, fast breathing, shallow breathing, hot or red skin, change in alertness, passing out, or lack of sweat (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
