Sofpironium Application Scope

Sofdra is approved for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and pediatric patients aged 9 years and older.

Sofpironium Characteristics

Ingredients:
- Active Ingredient: Sofpironium bromide 12.45%
- Inactive Ingredients: Citric acid, dehydrated alcohol, hexylene glycol, hydroxypropyl cellulose, isopropyl myristate.
Properties: Sofpironium bromide is a competitive inhibitor of acetylcholine receptors located on peripheral tissues, including sweat glands. By preventing the stimulation of these receptors, it reduces the rate of sweating.
Packaging Specification: Supplied in a 50 mL metered-dose pump bottle
Storage: Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F)
Expiry Date: 36 months from the date of manufacture
Executive Standard: As per FDA-approved prescribing information.
Approval Number: NDA 217347
Date of Revision: June 2024
Manufacturer: Botanix Pharmaceuticals Ltd.

Guidelines for the Use of Sofpironium

Dosage and Administration:
- Apply once daily at bedtime to clean, dry underarm skin.
- Use one pump per underarm.
- Do not shave underarms at least 8 hours before application.
- Do not shower at least 30 minutes before application.
- Allow the gel to dry completely (approximately 5 minutes) before dressing.
Adverse Reactions:
- Local skin reactions: Erythema (7–8%), irritation (2–6%), rash (4%), folliculitis (3%), exfoliation (2–3%), dryness (2%)
- Systemic effects: Mydriasis (5–7%), dry eye (4%), urinary retention (2–4%), hypertension (3%), upper respiratory tract infection (4%)
Contraindications:

Patients with conditions exacerbated by anticholinergic effects, such as:
- Glaucoma
- Paralytic ileus
- Unstable cardiovascular status in acute hemorrhage
- Severe ulcerative colitis
- Toxic megacolon complicating ulcerative colitis
- Myasthenia gravis
- Sjögren’s syndrome
Precautions:
- Avoid contact with eyes and mucous membranes.
- Wash hands immediately after application.
- Monitor for signs of urinary retention.
- Be cautious in hot environments due to reduced sweating, which may increase the risk of heat-related illnesses.

Sofpironium Interactions

Drug Interactions:
Anticholinergic Medications: Concurrent use may enhance anticholinergic side effects; avoid coadministration.
Strong CYP2D6 Inhibitors: Avoid coadministration as they may increase systemic exposure to sofpironium.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.