sofpironium
Sofdra
Pharmaceutical company: Botanix Pharmaceuticals
Pharmacologic classification: Anticholinergic
Therapeutic classification: Dermatologic agent
AVAILABLE FORMS
Gel: 12.45%
INDICATIONS AND DOSAGES
Primary axillary hyperhidrosis
Adults and children ages 9 and older: Apply one pump actuation to each underarm once daily at bedtime.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with conditions exacerbated by anticholinergic effects, such as glaucoma, paralytic ileus, unstable CV status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, and Sjőgrens syndrome.
- Use cautiously in patients with a history of, or current, urinary retention.
- Transient blurred vision may occur, impairing the ability to perform activities that require clear vision.
- Safety and effectiveness in patients with kidney or liver impairment, or in children younger than 9 years haven't been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Studies during human pregnancy are inadequate to inform risk. Adverse events were observed in some animal reproduction studies.
- This drug was found in animal milk during studies. It isn't known if the drug appears in human milk or how the drug affects milk production or infants who are breastfed. Weigh the benefits to the patient against the risk to the infant before use.
INTERACTIONS
Drug-drug. Anticholinergic agents (atropine, scopolamine, diphenhydramine):May increase anticholinergic adverse effects. Avoid use together.
Strong CYP2D6 inhibitors (fluoxetine, bupropion): May increase sofpironium level and risk of anticholinergic adverse effects. Avoid use together.
Drug-lifestyle. High environmental temperatures: May increase risk of heat-related illness. Avoid use if not sweating in hot or very warm environments.
ADVERSE REACTIONS
CNS: headache.
CV: hypertension.
EENT: dry mouth, blurred vision, mydriasis, dry eyes.
GU: urinary retention.
Respiratory: upper respiratory infection, viral upper respiratory infection.
Skin: application site erythema, dermatitis, pruritus, irritation, exfoliation, rash, folliculitis, dryness, or pain.
Other: flulike symptoms.
Reactions in bold italics are life-threatening.
Released: November 2024
Nursing Drug Handbook
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