SOFDRA
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh
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Overview
SOFDRA is an {{{drugClass}}} that is FDA approved for the treatment of SOFDRA is an anticholinergic FDA approved for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.. Common adverse reactions include • Most common adverse reactions (incidence ≥2%) are:
dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, application site irritation..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
SOFDRA is indicated for the:
treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
• Do not shave armpits at least 8 hours before applying SOFDRA.
• Do not shower at least 30 minutes before applying SOFDRA.
• Apply SOFDRA to clean, dry skin once a day at bedtime.
• Apply a single pump actuation to the top of the supplied applicator. Spread the entire amount to cover 1 underarm. Apply a separate, single pump actuation to the top of the supplied applicator. Apply the entire amount to the second underarm. Allow to dry completely (5 minutes) before putting on clothing.
• Wash hands immediately with soap.
• For topical use only.
• Avoid fire, flame, and smoking during and immediately following application.
• Do not shower or wash underarms for at least 8 hours after application.
• Do not touch underarms after applying SOFDRA.
• Do not use more than once daily.
• Avoid transfer of SOFDRA to the periocular area.
• Do not apply SOFDRA to broken skin.
• Avoid using SOFDRA with occlusive dressings.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of SOFDRA in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of SOFDRA in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in pediatric patients 9 years of age and older.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of SOFDRA in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of SOFDRA in pediatric patients.
Contraindications
SOFDRA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium bromide: • glaucoma, • paralytic ileus, • unstable cardiovascular status in acute hemorrhage, • severe ulcerative colitis, • toxic megacolon complicating ulcerative colitis, • myasthenia gravis, Sjögren's syndrome.
Warnings
There is limited information regarding SOFDRA Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding SOFDRA Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding SOFDRA Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding SOFDRA Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of SOFDRA in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of SOFDRA in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of SOFDRA during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of SOFDRA in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of SOFDRA in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of SOFDRA in geriatric settings.
Gender
There is no FDA guidance on the use of SOFDRA with respect to specific gender populations.
Race
There is no FDA guidance on the use of SOFDRA with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of SOFDRA in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of SOFDRA in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of SOFDRA in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of SOFDRA in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding SOFDRA Administration in the drug label.
Monitoring
There is limited information regarding SOFDRA Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of SOFDRA and IV administrations.
Overdosage
There is limited information regarding SOFDRA overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding SOFDRA Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding SOFDRA Mechanism of Action in the drug label.
Structure
There is limited information regarding SOFDRA Structure in the drug label.
Pharmacodynamics
There is limited information regarding SOFDRA Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding SOFDRA Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding SOFDRA Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding SOFDRA Clinical Studies in the drug label.
How Supplied
There is limited information regarding SOFDRA How Supplied in the drug label.
Storage
There is limited information regarding SOFDRA Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding SOFDRA Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-SOFDRA interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding SOFDRA Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding SOFDRA Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.