glycopyrronium tosylate topical (Rx)

Brand and Other Names:Qbrexza
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

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              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 (39)

              • 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.

              • 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)

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                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%)

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                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; 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

                Drug interaction overview

                • Coadministration with other anticholinergic medications may enhance anticholinergic adverse effects
                • Avoid use with other anticholinergic-containing medications
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                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.

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                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

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                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

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Qbrexza topical
                -
                2.4 % miscellaneous

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.