Description
Sofpironium topical gel is used to treat excessive underarm sweating (primary axillary hyperhidrosis).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Gel/Jelly
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sofpironium topical gel in children younger than 9 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sofpironium topical gel in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aclidinium
- Amantadine
- Amitriptyline
- Amoxapine
- Atropine
- Belladonna
- Benztropine
- Biperiden
- Brompheniramine
- Bupropion
- Carbinoxamine
- Carisoprodol
- Chlorpheniramine
- Chlorpromazine
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Cyclobenzaprine
- Cyclopentolate
- Cyproheptadine
- Darifenacin
- Desipramine
- Dicyclomine
- Dimenhydrinate
- Diphenhydramine
- Doxepin
- Fesoterodine
- Flavoxate
- Fluoxetine
- Fluphenazine
- Glycopyrrolate
- Glycopyrronium Tosylate
- Homatropine
- Hydroxyzine
- Hyoscyamine
- Imipramine
- Ipratropium
- Loxapine
- Meclizine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bladder problems (eg, distended bladder, bladder-neck obstruction) or
- Enlarged prostate or
- Kidney disease or
- Trouble passing urine—Use with caution. May make these conditions worse.
- Blood or vessel disease in acute bleeding, unstable or
- Glaucoma or
- Myasthenia gravis (nerve or muscle disease) or
- Sjogren's syndrome (immune system disorder) or
- Stomach or bowel problems (eg, paralytic ileus, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis)—Should not be used in patients with these conditions.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is for use on the underarms only. Do not get it in your eyes or any other part of the body.
To use the gel:
- Wash your hands with soap and water before and after you use this medicine.
- Apply the medicine to clean, dry, intact skin on your underarm areas only.
- Do not shower or wash your underarms for at least 8 hours after applying this medicine. Do not apply to broken skin. Do not cover the treated area with a bandage unless your doctor has told you to.
- Do not apply this medicine if you have shaved or applied deodorant within the last 8 hours. Do not apply this medicine if you have exercised, showered, or washed your underarm within the last 30 minutes.
- Do not allow your clothes to touch your underarm for 5 minutes after applying it. Do not touch your underarms after applying the medicine.
- This medicine is flammable. Do not smoke or go near an open flame until the gel is dry.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage form (gel):
- For excessive sweating of the underarms:
- Adults and children 9 years of age and older—Apply to both underarm areas using 1 pump for each underarm once a day at bedtime.
- Children younger than 9 years of age—Use and dose must be determined by your doctor.
- For excessive sweating of the underarms:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
This medicine may cause urinary retention (trouble passing urine or not fully emptying the bladder), especially if you have bladder blockage. Check with your doctor right away if you or your child has a decrease in urine volume, a decrease in the frequency of urination, difficulty in passing urine, feeling of full bladder, or painful urination.
This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
This medicine may cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bigger, dilated, or enlarged pupils (black part of the eye)
- blistering, crusting, irritation, itching, pain, swelling, or reddening of skin at the application site
- blurred vision
- increased sensitivity of eyes to light
- swelling
Less common
- Body aches or pain
- cough
- decrease in frequency of urination
- decrease in urine volume
- diarrhea
- difficulty in passing urine (dribbling)
- dizziness
- dryness at the application site
- fever or chills
- general feeling of discomfort or illness
- headache
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- nausea or vomiting
- nervousness
- new loss of taste or smell
- painful urination
- pounding in the ears
- shivering
- slow or fast heartbeat
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dry mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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