Sofpironium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh
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Overview
Sofpironium is an {{{drugClass}}} that is FDA approved for the treatment of SOFDRA is an anticholinergic approved for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Sofpironium FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sofpironium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sofpironium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sofpironium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sofpironium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sofpironium in pediatric patients.
Contraindications
There is limited information regarding Sofpironium Contraindications in the drug label.
Warnings
There is limited information regarding Sofpironium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
• Most common adverse reactions (incidence ≥2%) are:
o dry mouth, o vision blurred, o application site pain, o application site erythema, o mydriasis, o application site dermatitis, o application site pruritus, o urinary retention, o application site irritation.
Postmarketing Experience
There is limited information regarding Sofpironium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Sofpironium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sofpironium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sofpironium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sofpironium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sofpironium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sofpironium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sofpironium in geriatric settings.
Gender
There is no FDA guidance on the use of Sofpironium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sofpironium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sofpironium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sofpironium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sofpironium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sofpironium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Sofpironium Administration in the drug label.
Monitoring
There is limited information regarding Sofpironium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Sofpironium and IV administrations.
Overdosage
There is limited information regarding Sofpironium 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 Sofpironium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sofpironium Mechanism of Action in the drug label.
Structure
There is limited information regarding Sofpironium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sofpironium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sofpironium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sofpironium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sofpironium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Sofpironium How Supplied in the drug label.
Storage
There is limited information regarding Sofpironium 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 Sofpironium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sofpironium 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 Sofpironium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sofpironium 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.