Sofdra gel

Pronunciation: sof-drah
Generic name: sofpironium
Brand name: Sofdra
Dosage form: topical gel

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 15, 2024.

What is Sofdra gel?

Sofdra topical gel (sofpironium 12.45%) is applied directly to the underarm area to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.

Sofdra made by Botanix is an anticholinergic that works by blocking acetylcholine receptors found on the sweat glands located in the armpit. Acetylcholine stimulates sweat production, so Sofdra's mechanism of action is to prevent the stimulation of these receptors and reduce sweating.

Sofdra was FDA-approved on 18 June 2024.

Sofdra gel side effects

The most common side effects of Sofdra gel include:

dry mouth
blurred vision
pain, redness, swelling, itching, and irritation in the underarm area
dilation of the pupils of your eyes (mydriasis)
problems with urination.

Sofdra can cause serious side effects, including:

Urinary retention. Symptoms may include difficulty urinating, urinating frequently, experiencing a weak stream or dripping when urinating, or difficulty emptying your bladder (distended bladder). If you develop these symptoms, stop using Sofdra gel and call your healthcare provider right away.

Problems with body temperature control. Sofdra can cause you to have decreased sweating in areas of your body other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for a lack of sweating on your body, and stop using Sofdra gel if you are unable to sweat normally. Also, stop Sofdra and call your healthcare provider right away if you develop any of these symptoms of heat illness or heatstroke, such as:

hot, red skin
decreased alertness or passing out (unconsciousness)
fast, weak pulse
fast, shallow breathing
increased body temperature (fever).

Blurred vision. Sofdra may cause you to have temporarily blurred vision. If you develop blurred vision, call your healthcare provider, stop using Sofdra, and do not drive, operate machinery, or do hazardous work until your vision is clear.

It is not known if Sofdra is safe and effective in children under 9 years of age.

These are not all of the possible side effects of Sofdra gel. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Do not use Sofdra if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as:

glaucoma
severe ulcerative colitis or certain other serious bowel problems
myasthenia gravis
Sjogren’s syndrome.

Talk to your healthcare provider if you are not sure if you have a medical condition that can be made worse by taking an anticholinergic medicine.

Before using Sofdra, tell your healthcare provider about all of your medical conditions, including if you:

have prostate or bladder problems, or problems passing urine
have kidney problems
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

There is no data about using Sofdra gel in pregnant women. It is not known if Sofdra will harm your unborn baby. Talk to your healthcare provider about the risks and benefits of using Sofdra during pregnancy.

Breastfeeding

It is not known if Sofdra gel passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How do I apply Sofdra topical gel?

Use Sofdra gel exactly as your healthcare provider tells you to use it. Refer to the detailed Instructions for Use in the Sofdra Package insert by Botanix.

The usual dosage for Sofdra gel is 1 pump per underarm 1 time a day at bedtime.
This dosage of Sofdra topical gel is the same for adults and children 9 years of age and older.
Apply to clean, dry, intact skin of your underarm areas only.
Use 1 pump for each underarm. Apply to both underarm areas.
Wash your hands right away after applying Sofdra.

Do not:

shower or wash underarms for at least 8 hours after applying Sofdra
use it more than 1 time a day
apply to broken skin
cover the treated area with a plastic (occlusive) dressing
apply Sofdra if you have shaved your underarms or applied deodorant within the last 8 hours
apply Sofdra if you have exercised, showered, or washed your underarms within the last 30 minutes
allow clothing to contact Sofdra for 5 minutes after applying
touch your underarms after applying Sofdra.

Wash your hands with soap and water right away after you apply Sofdra. You must wash your hands because the Sofdra still on your hands can cause blurred vision if you touch your eyes.

What happens if I miss a dose?

If you miss a dose and have already woken up, do not apply a dose of Sofdra topical gel. Skip that dose then go back to your regular schedule of applying a dose at bedtime.

What happens if I overdose?

If you use too much Sofdra topical gel, remove the gel with soap and water, and call your healthcare provider or Poison Help line at 1-800-222-1222.

What should I avoid while using Sofdra gel?

Sofdra gel is flammable. Avoid fire, flame, and smoking during and right after applying it to your skin.

If you develop blurred vision, stop using Sofdra geland do not drive, operate machinery, or do hazardous work until your vision is clear.

Use on the skin in the underarm area only. Do not apply Sofdra gel to other parts of your body.

What other drugs will affect Sofdra gel?

Tell your healthcare provider about all your medicines, including prescription, over-the-counter, vitamins, and herbal supplements. Sofdra gel may affect the way other medicines work causing side effects. Especially tell your healthcare provider if you take:

Anticholinergics, such as atropine, cyclopentolate, or benztropine. Using Sofra gel with these oral anticholinergic medicines may increase anticholinergic side effects, su, dry eyes, blurred vision, a fast heart rate, and urinary retention
Strong inhibitors of CYP2D6, such as bupropion, fluoxetine, and orphenadine. This may prevent the breakdown of Sofdra gel and are not recommended to be taken together.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.