Hydrocortisone; Pramoxine Suppository

What is this medication?

HYDROCORTISONE; PRAMOXINE (hye dro KOR ti sone; pra MOX een) treats hemorrhoids or inflammatory bowel diseases. 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.

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

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

• Diabetes
• Immune system problems
• Infection
• Rectal blockage
• Rectal tear
• 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 rectal use only. Do not take it by mouth. Take it as directed on the prescription label. Do not use it more often than directed. Wash your hands before and after use. Take off the foil wrapping. Wet the tip of the suppository with cold water to make it easier to use. Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Lift upper buttock to expose the rectal area. Apply gentle pressure to insert the suppository completely into the rectum, pointed end first. Hold buttocks together for a few seconds. Remain lying down for about 15 minutes to avoid having the suppository come out.

Talk to your care team about the use of this medication in children. Special care may be needed. Do not use 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.

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

What may interact with this medication?

Interactions are not expected. Do not use any other rectal products 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.

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 these 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 C (68 and 77 F). Get rid of any unused medication after the expiration date.

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.