Hydrocortisone; Pramoxine Topical Foam

What is this medication?

HYDROCORTISONE; PRAMOXINE (hye droe KOR ti sone; pra MOX een) reduces swelling, redness, itching, or rashes caused by skin conditions, such as eczema. It works by decreasing pain and inflammation. It is a combination of a local anesthetic and a topical steroid.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Epifoam, ProctoFoam HC

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Large areas of burned or damaged skin
• Liver disease
• Skin infection
• An unusual or allergic reaction to hydrocortisone, pramoxine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label. Shake the container for 5 to 10 seconds before each use. Gently cleanse the affected area prior to use. While holding the container upright prime the container by pressing down several times on container cap until foam appears. Dispense foam onto a cleansing tissue or pad and gently rub into the affected area. The container and cap should be disassembled and rinsed with warm water after each use. Do not use on healthy skin or over large areas of skin.  Do not use your medication more often than directed. Do not use for more than 14 days.

Apply to the affected area. Do not use an airtight bandage to cover the affected area unless your care team tells you to.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

If applying this medication to the diaper area of a child, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medication that passes through the skin and increase the risk of serious side effects.

People 65 year and older may be more likely to have damaged skin through aging, and this may increase side effects. This medication should only be used for brief periods and infrequently in older patients.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Call your care team if you are around anyone with measles, chickenpox, or if you develop sores or blisters that do not heal properly.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Cushing syndrome—increased fat around the midsection, upper back, neck, or face, pink or purple stretch marks on the skin, thinning, fragile skin that easily bruises, unexpected hair growth
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in skin color
• Fragile or thinning skin that bruises easily
• Mild skin irritation, redness, or dryness
• Small, red, pus-filled bumps on skin around hair follicles
• Unexpected hair growth at application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not refrigerate. Do not freeze. Get rid of any unused medication after the expiration date.

This medication is flammable. Avoid exposure to heat, fire, flame, and smoking.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.