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

and glycopyrronium tosylate topical

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    Contraindicated

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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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            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.
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            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.