Hydrocortisone/pramoxine (Rectal)

Brand Name(s)

Zypram, Z-Pram, Proctofoam-HC

When This Medicine Should Not Be Used

How to Use This Medicine

Cream, Foam

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• This medicine is for use only on your skin in your anus or around your anus. Do not get any medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after using this medicine.
• Apply the foam medicine with the applicator provided. Do not put any part of the aerosol container into your anus.
• Put the cap on the aerosol foam container, and then shake the container for 5 to 10 seconds just before using. Do not take the cap off the container. Wash the foam applicator with warm, soapy water after you use it.
• Do not inhale the foam or use it near heat, open flame, or while smoking. Do not puncture, break, or burn the aerosol can.
• To use this medicine on the skin around your anus, spread the medicine on a tissue or piece of cotton and gently wipe your skin.
• Do not cover the treated area with a bandage unless your doctor has told you to.If you are using this medicine on a baby, put a loose diaper on over the medicine. Do not dress the baby in tight diapers or plastic pants.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the creamor lotion medicine at room temperature in a closed container, away from heat and direct light. Store the foam medicine upright, at room temperature, away from heat or fire.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine applicators, containers, and any leftover medicine after finishing your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Introduction

Hydrocortisone Acetate (hye-droe-KOR-ti-sone AS-e-tate), Pramoxine Hydrochloride (pram-OX-een hye-droe-KLOR-ide)

Treats skin itching, swelling, or pain in and around the anus. This medicine is a combination of a steroid and an anesthetic.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Headache or trouble seeing in a child, or a bulging "soft spot" on a baby's head
• Increase in how much or how often you urinate, increased thirst
• Skin rash, itching, or peeling
• Unusual bleeding or bruising
• Unusually round, enlarged face

If you notice these less serious side effects, talk with your doctor:

• Mild burning or itching when you apply the medicine
• Mild skin dryness or irritation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding.
• If your symptoms do not improve or if they get worse, call your doctor.
• This medicine can cause side effects, even though you use it only on the skin. A child is more likely than an adult to have side effects. Tell your child's doctor if you think your child is not growing properly while using this medicine.
• Using this medicine for long time can increase the chance of side effects. Your doctor may need to check your progress at regular visits. Be sure to keep all appointments.
• Tell your doctor if you get any kind of skin infection while you are using this medicine.
• Do not use this medicine for a skin problem that has not been checked by your doctor.