Dosing & Uses
Dosage Forms & Strengths
topical cloth
- 2.4% (packaged in single-use individual pouch)
Hyperhidrosis
Indicated for topical treatment of primary axillary hyperhidrosis
For topical use in the underarm area only and not for use in other body areas
Apply using premoistened cloth topically to clean dry skin on the underarm areas only, apply no more frequently than once q24hr
Also see Administration
Dosage Modifications
Renal impairment
- Elimination of glycopyrronium is severely impaired in patients with renal failure
- Pharmacokinetics in patients with renal impairment have not been studied
Hepatic impairment
- Pharmacokinetics were not evaluated in patients with hepatic impairment
Dosage Forms & Strengths
topical cloth
- 2.4% (packaged in single-use individual pouch)
Hyperhidrosis
Indicated for topical treatment of primary axillary hyperhidrosis
<9 years: Safety and efficacy not established
≥9 years
- For topical use in the underarm area only and not for use in other body areas
- Apply using premoistened cloth to clean dry skin on the underarm areas only, apply no more frequently than once q24hr
- Also see Administration
Dosage Modifications
Renal impairment
- Elimination of glycopyrronium is severely impaired in patients with renal failure
- Pharmacokinetics in subjects with renal impairment have not been studied
Hepatic impairment
- Pharmacokinetics were not evaluated in patients with hepatic impairment
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (17)
- atropine
glycopyrronium tosylate topical, atropine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- atropine IV/IM
glycopyrronium tosylate topical, atropine IV/IM. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- benztropine
glycopyrronium tosylate topical, benztropine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- darifenacin
glycopyrronium tosylate topical, darifenacin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- dicyclomine
glycopyrronium tosylate topical, dicyclomine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- fesoterodine
glycopyrronium tosylate topical, fesoterodine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- glycopyrrolate
glycopyrronium tosylate topical, glycopyrrolate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- hyoscyamine
glycopyrronium tosylate topical, hyoscyamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- hyoscyamine spray
glycopyrronium tosylate topical, hyoscyamine spray. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- incobotulinumtoxinA
glycopyrronium tosylate topical, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- methscopolamine
glycopyrronium tosylate topical, methscopolamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- onabotulinumtoxinA
glycopyrronium tosylate topical, onabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- propantheline
glycopyrronium tosylate topical, propantheline. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- solifenacin
glycopyrronium tosylate topical, solifenacin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- tolterodine
glycopyrronium tosylate topical, tolterodine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- trihexyphenidyl
glycopyrronium tosylate topical, trihexyphenidyl. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- trospium chloride
glycopyrronium tosylate topical, trospium chloride. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
Monitor Closely (40)
- aclidinium
glycopyrronium tosylate topical, aclidinium. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- amitriptyline
glycopyrronium tosylate topical, amitriptyline. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- amoxapine
glycopyrronium tosylate topical, amoxapine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- brompheniramine
glycopyrronium tosylate topical, brompheniramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- carbinoxamine
glycopyrronium tosylate topical, carbinoxamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- chlorpheniramine
glycopyrronium tosylate topical, chlorpheniramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- chlorpromazine
glycopyrronium tosylate topical, chlorpromazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- clemastine
glycopyrronium tosylate topical, clemastine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- clomipramine
glycopyrronium tosylate topical, clomipramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- cyproheptadine
glycopyrronium tosylate topical, cyproheptadine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- desipramine
glycopyrronium tosylate topical, desipramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- dexchlorpheniramine
glycopyrronium tosylate topical, dexchlorpheniramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- dimenhydrinate
glycopyrronium tosylate topical, dimenhydrinate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- diphenhydramine
glycopyrronium tosylate topical, diphenhydramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- donepezil transdermal
donepezil transdermal, glycopyrronium tosylate topical. Either decreases effects of the other by pharmacodynamic antagonism. Use Caution/Monitor.
- doxepin
glycopyrronium tosylate topical, doxepin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- fluphenazine
glycopyrronium tosylate topical, fluphenazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- glycopyrrolate inhaled
glycopyrronium tosylate topical, glycopyrrolate inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- haloperidol
glycopyrronium tosylate topical, haloperidol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- hydroxyzine
glycopyrronium tosylate topical, hydroxyzine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- imipramine
glycopyrronium tosylate topical, imipramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- ipratropium
glycopyrronium tosylate topical, ipratropium. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- loxapine
glycopyrronium tosylate topical, loxapine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- loxapine inhaled
glycopyrronium tosylate topical, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- molindone
glycopyrronium tosylate topical, molindone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- nortriptyline
glycopyrronium tosylate topical, nortriptyline. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- perphenazine
glycopyrronium tosylate topical, perphenazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- pimozide
glycopyrronium tosylate topical, pimozide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- prochlorperazine
glycopyrronium tosylate topical, prochlorperazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- promethazine
glycopyrronium tosylate topical, promethazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- protriptyline
glycopyrronium tosylate topical, protriptyline. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- rimabotulinumtoxinB
glycopyrronium tosylate topical, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- thioridazine
glycopyrronium tosylate topical, thioridazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- thiothixene
glycopyrronium tosylate topical, thiothixene. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- tiotropium
glycopyrronium tosylate topical, tiotropium. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- trifluoperazine
glycopyrronium tosylate topical, trifluoperazine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- trimipramine
glycopyrronium tosylate topical, trimipramine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- triprolidine
glycopyrronium tosylate topical, triprolidine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- umeclidinium bromide
glycopyrronium tosylate topical, umeclidinium bromide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- umeclidinium bromide/vilanterol inhaled
glycopyrronium tosylate topical, umeclidinium bromide/vilanterol inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
Minor (0)
Adverse Effects
>10%
Dry mouth (16.9-24.2%)
Erythema (17%)
Burning/stinging (14.1%)
1-10%
Pruritus (8.1%) Mydriasis (5.3-6.8%)
Blurred vision (3.5-6.7%)
Pain, application site reactions (6.4%)
Nasopharyngitis (5.8%)
Oropharyngeal pain (5.7%)
Headache (5%)
Urinary hesitation (4.2%)
Dermatitis (3.8%)
Pruritus, application site reactions (3.8%)
Rash, application site reactions (3.8%)
Nasal dryness (2.6-3.6%)
Urinary hesitation (3.5%)
Dry throat (2.6%)
Dry eye (2.4%)
Erythema, application site reactions (2.4-17%)
Pharyngitis (2.2%)
Dry skin (2.2%)
Constipation (2%)
Postmarketing Reports
Genitourinary system disorders: New onset of urinary retention
Warnings
Contraindications
Patients with conditions that may be exacerbated by glycopyrronium's anticholinergic effects (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, SjÖgren syndrome)
Cautions
Caution with history or presence of documented urinary retention, especially with prostatic hypertrophy or bladder-neck obstruction; monitor for signs and symptoms of urinary retention include difficulty passing urine and distended bladder; new or worsening signs and symptoms of urinary retention (eg, difficulty passing urine, distended bladder) have occurred in patients taking this medication with or without a history of documented urinary retention; if signs and symptoms develop, discontinue use immediately and consult a physician
In the presence of high ambient temperature, heat illness (eg, hyperpyrexia, heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs; monitor for generalized lack of sweating when in hot or very warm environmental temperatures and avoid use if not sweating under these conditions
Transient blurred vision may occur; if blurred vision occurs, the patient should discontinue use until symptoms resolve; avoid engaging in activities that require clear vision such as operating a motor vehicle or other machinery, performing hazardous work, until the symptoms have resolved
Risk of accidental exposure
- Cases of accidental exposure resulting in mydriasis, anisocoria, and blurred vision reported in postmarketing surveillance
- The exposures occurred when children accessed glycopyrronium tosylate wipes discarded in trash or when patients touched the periocular area after using the drug; in most cases, the mydriasis, anisocoria, and blurred vision were temporary and resolved within one week following exposure
- The risk of accidental exposure was increased in these cases by not adhering to recommendations for appropriate use of the drug
- Strict adherence to the recommended hand washing after use and disposal instructions is of the utmost importance to prevent accidental exposure
Drug interaction overview
- Coadministration with other anticholinergic medications may enhance anticholinergic adverse effects
- Avoid use with other anticholinergic-containing medications
Pregnancy
Pregnancy
No available data on use in pregnant women to inform a drug-associated risk for adverse developmental outcomes
Lactation
There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Competitively inhibits acetylcholine receptors that are located on certain peripheral tissues, including sweat glands
In hyperhidrosis, glycopyrronium inhibits the action of acetylcholine on sweat glands, reducing sweating
Absorption
Peak plasma concentration: 0.08 ng/mL (adults); 0.07 ng/mL (children)
Peak plasma time: 1 hr
AUC: 0.2 ng·hr/mL (0-6hr); 0.88 ng·hr/mL (AUC 0-24hr)
Distribution
Vd (IV): 1.3-1.8 L/kg (aged 1-14 years); 0.42 L/kg (aged 60-75 years)
Metabolism
A small proportion of glycopyrronium is metabolized following IV administration; metabolic pathway for glycopyrronium is not characterized
Elimination
Excretion: Urine (~85%); bile (<5%)
Greater than 80% in both urine and bile was unchanged drug
Administration
Topical Administration
For topical use only
For use in the underarm area only and not for use in other body areas
Apply using single-use, premoistened cloth to clean dry skin on the underarm areas only; not be used more frequently than once q24hr
Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once
Using the same cloth, wipe the other underarm once; apply to both underarms
Wash hands immediately with soap and water after applying; discard cloth after use
Avoid transferring the cloths to the periocular area; may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes
Do not apply to broken skin
Avoid use with occlusive dressings
Storage
Store at room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Cloth is flammable; keep away from heat or flame
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Qbrexza topical - | 2.4 % miscellaneous |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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