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

Treats inflammation of the rectum and anus. This medicine contains a corticosteroid.

Brand Name(s):

Proctofoam-HC, Zypram

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream, Foam

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine is for use only on your skin in or around your anus. Do not get any medicine in your eyes, nose, or mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after you use this medicine.
• Foam
  • Do not use the aerosol container to put the medicine directly into your rectum. Always use the applicator that came with the medicine.
  • Connect the applicator to the cap of the aerosol container. Shake the container for 5 to 10 seconds just before using.
  • After you fill the applicator, gently insert it into the anus. Push the plunger to release the medicine.
  • To use this medicine on the skin around your anus, place a small amount on a tissue and gently wipe your skin.
  • Do not use near heat or open flame, or while smoking. Do not puncture, break, or burn the aerosol can.
  • Wash the applicator with warm, soapy water after use.
  • Store the medicine upright, at room temperature, away from heat and direct light. Do not refrigerate.
• Cream
  • Attach the applicator to the tube of medicine. Squeeze the tube to fill it with the cream.
  • After you fill the applicator, gently insert it into the anus. Push the plunger to release the medicine.
  • If you have a reusable applicator, wash it with warm, soapy water after use. If you have a disposable applicator, throw it away after use.
• Do not cover the treated skin with tight-fitting diapers or plastic pants if you are using this medicine on a child's diaper area.
• Missed dose:Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

Drugs and Foods to Avoid:

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

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• This medicine may cause adrenal gland problems. It may also cause you to get infections more easily, so tell your doctor if you have any type of infection.
• This medicine may delay growth in children. If you think your child is not growing properly while using this medicine, talk with your doctor.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Call your doctor if your symptoms do not improve or if they get worse.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

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

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Weight gain around your neck, upper back, face, or waist

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

• Rectal irritation, burning, or itching

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