Proctofoam HC (Hydrocortisone / Pramoxine Hydrochloride)

(hye droe kor' ti sone)

Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Hydrocortisone rectal comes as a cream, an enema, suppositories, and a foam to use in the rectum. Follow the directions on your prescription or your product label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use rectal hydrocortisone exactly as directed. Do not use it more or less of it or use it more often than prescribed by your doctor. For proctitis, hydrocortisone rectal foam usually is used one or two times a day for 2 to 3 weeks, then if necessary, every other day until your condition improves. Hydrocortisone rectal suppositories usually are used two or three times daily for 2 weeks; may require treatment for up to 6 to 8 weeks in severe cases. Proctitis symptoms may improve within 5 to 7 days. For hemorrhoids, hydrocortisone rectal cream usually is used in adults and children 12 years and older up to 3 or 4 times daily. If you obtained hydrocortisone without a prescription (over the counter) and your condition does not improve within 7 days, stop using it and call your doctor. Do not put the cream into your rectum with your fingers. For ulcerative colitis, hydrocortisone rectal enema usually is used every night for 21 days. Although colitis symptoms may improve within 3 to 5 days, 2 to 3 months of regular enema use may be required. Call your doctor if your colitis symptoms do not improve within 2 or 3 weeks. Your doctor may change your dose of rectal hydrocortisone during your treatment to be sure that you are always using the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment. Hydrocortisone rectal suppositories may stain clothing and other fabrics. Take precautions to prevent staining when you use this medication. Before using hydrocortisone rectal foam the first time, carefully read the written instructions that come with it. Ask your doctor or pharmacist to explain any part you do not understand. If using a hydrocortisone rectal enema, follow these steps:

• Try to have a bowel movement. The medication will work best if your bowels are empty.
• Shake the enema bottle well to make sure the medication is mixed.
• Remove the protective cover from the applicator tip. Be careful to hold the bottle by the neck so that the medication will not leak out of the bottle.
• Lie down on your left side with your lower (left) leg straight and your right leg bent toward your chest for balance. You can also kneel on a bed, resting your upper chest and one arm on the bed.
• Gently insert the applicator tip into your rectum, pointing it slightly toward your navel (belly button).
• Hold the bottle firmly and tilt it slightly so that the nozzle is aimed toward your back. Squeeze the bottle slowly and steadily to release the medicine.
• Withdraw the applicator. Remain in the same position for at least 30 minutes. Try to keep the medicine inside of your body all night (while you sleep).
• Wash your hands thoroughly. Throw away the bottle in a trash can that is out of the reach of children and pets. Each bottle contains only one dose and should not be reused.

Before using rectal hydrocortisone,
• tell your doctor and pharmacist if you are allergic to hydrocortisone, any other medications, or any of the ingredients in rectal hydrocortisone products. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amphotericin B (Abelcet, Ambisome, Fungizone); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); barbiturates; carbamazepine (Carbatrol, Epitol, Tegretol, others); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); hormonal contraceptives (birth control pills, patches, rings, implants, and injections); isoniazid (in Rifamate, in Rifater); ketoconazole (Extina, Nizoral, Xolegel); macrolide antibiotics such as clarithromycin (Biaxin, in Prevpac) or erythromycin (E.E.S., Eryc, Eryped, others); medications for diabetes; phenytoin (Dilantin, Phenytek); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with hydrocortisone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have a fungal infection (other than on your skin or nails), peritonitis (inflammation of the lining of the stomach area), intestinal obstruction, a fistula (abnormal connection between two organs inside your body or between an organ and the outside of your body) or a tear in the wall of your stomach or intestine. Your doctor may tell you not use rectal hydrocortisone.
• tell your doctor if you have or have ever had threadworms (a type of worm that can live inside the body); diabetes; diverticulitis (inflamed bulges in the lining of the large intestine); heart failure; high blood pressure; a recent heart attack; osteoporosis (condition in which the bones become weak and fragile and can break easily); myasthenia gravis (a condition in which the muscles become weak); emotional problems, depression or other types of mental illness; tuberculosis (TB: a type of lung infection); ulcers; cirrhosis; or liver, kidney, or thyroid disease. Also tell your doctor if you have any type of untreated bacterial, parasitic, or viral infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using rectal hydrocortisone, call your doctor.
• do not have any vaccinations (shots to prevent diseases) without talking to your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using rectal hydrocortisone.
• you should know that rectal hydrocortisone may decrease your ability to fight infection and may prevent you from developing symptoms if you get an infection. Stay away from people who are sick and wash your hands often while you are using this medication. Be sure to avoid people who have chicken pox or measles. Call your doctor immediately if you think you may have been around someone who had chicken pox or measles.

Your doctor may instruct you to follow a low-salt, high potassium, or high calcium diet. Your doctor may also prescribe or recommend a calcium or potassium supplement. Follow these directions carefully.

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Rectal hydrocortisone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• local pain or burning
• muscle weakness
• extreme changes in mood changes in personality
• inappropriate happiness
• difficulty falling asleep or staying asleep
• slowed healing of cuts and bruises
• irregular or absent menstrual periods
• thin, fragile, or dry skin
• acne
• increased sweating
• changes in the way fat is spread around the body

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• bleeding
• vision changes
• depression
• rash
• itching
• swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
• hives
• difficulty breathing or swallowing

Children who use rectal hydrocortisone may have an increased risk of side effects including slowed growth and delayed weight gain. Talk to your child's doctor about the risks of using this medication. People who use rectal hydrocortisone for a long time may develop glaucoma or cataracts. Talk to your doctor about the risks of using rectal hydrocortisone and how often you should have your eyes examined during your treatment. Rectal hydrocortisone may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication. Rectal hydrocortisone may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it according to the package instructions. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze or refrigerate rectal hydrocortisone products. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to rectal hydrocortisone. Before having any laboratory test, tell your doctor and the laboratory personnel that you are using rectal hydrocortisone. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.