SOFDRA (sofpironium) Topical Gel, 12.45% Approved for the treatment of Axillary Hyperhidrosis

Author: Dr. Ahmed Farhan     Published: 5 months ago 0 Replies

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SOFDRA (sofpironium) Topical Gel, 12.45% Approved for the treatment of Axillary Hyperhidrosis

INDICATIONS AND USAGE

SOFDRA is an anticholinergic medication used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children aged 9 and older.

DOSAGE AND ADMINISTRATION

Apply one pump of SOFDRA to each underarm once daily at bedtime. This medication is for topical use only.

It is available as a topical gel containing 12.45% sofpironium.

CONTRAINDICATIONS:

Do not use SOFDRA if you have medical conditions that could worsen due to its anticholinergic effects, such as:

• Glaucoma
• Paralytic ileus
• Unstable cardiovascular status during acute hemorrhage
• Severe ulcerative colitis
• Toxic megacolon complicating ulcerative colitis
• Myasthenia gravis
• Sjögren’s syndrome

WARNINGS AND PRECAUTIONS

• Urinary Retention:

Use cautiously if you have a history of urinary retention.

Stop using SOFDRA and consult a healthcare provider if symptoms develop.

• Control of Body Temperature:

Avoid using SOFDRA in hot environments if you experience reduced sweating.

• Operating Machinery or Driving:

SOFDRA may cause temporary blurred vision.

Discontinue use and avoid driving or operating machinery if this occurs until the symptoms resolve.

ADVERSE REACTIONS

Common side effects (occurring in 2% or more of patients) include dry mouth, blurred vision, pain or redness at the application site, pupil dilation, dermatitis at the application site, itching at the application site, urinary retention, and irritation at the application site.

DRUG INTERACTIONS

• Anticholinergics:

Avoid using SOFDRA with other anticholinergic drugs as it may increase anticholinergic side effects.

• Strong Inhibitors of CYP2D6:

Avoid using SOFDRA with strong CYP2D6 inhibitors.