Glycopyrronium tosylate topical

Indications

Glycopyrronium tosylate topical is used for: Hyperhidrosis

Adult Dose

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

Child Dose

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

Renal Dose

Renal impairment Elimination of glycopyrronium is severely impaired in patients with renal failure Pharmacokinetics in patients with renal impairment have not been studied

Administration

Contra Indications

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)

Precautions

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

Pregnancy-Lactation

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

Interactions

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

Adverse Effects

Side effects of Glycopyrronium tosylate topical : >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%)

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