Cortenema (foam or enema) is a steroid medicine that is used with other medicines to treat ulcerative colitis and its effects on the lower intestines and rectal area.

Cortenema may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Use this medicine in the smallest amount and for the shortest time needed to treat your condition.

Do not take by mouth. Rectal medicine is for use only on your rectum.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Try to empty your bowel and bladder before using rectal medicine.

Wash your hands before and after using this medicine.

Use only the applicator provided with this medicine to insert it into your rectum.

Do not insert the applicator tip too deeply or you could damage your rectum.

Call your doctor if your symptoms do not improve or if they get worse.

Your dose needs may change during times of illness or unusual stress. Do not change your dose or stop using Cortenema without your doctor's instructions.

Store at room temperature away from moisture and heat. Do not refrigerate.

The rectal foam is flammable. Keep away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty foam canister.

You should not use Cortenema if you are allergic to hydrocortisone, or if you have:

• a fungal infection;

• an intestinal infection;

• a fistula (abnormal opening) or perforation (a hole or tear) in your intestines;

• a bowel obstruction or severe constipation;

• if you need certain vaccinations;

• if you recently had surgery on your intestines; or

• if you are allergic to propylene glycol, parabens or other ingredients in the rectal foam or enema.

Tell your doctor if you have ever had:

• any type of infection, including tuberculosis or a parasite infection that causes diarrhea (such as threadworms);

• a stomach ulcer, diverticulitis, ulcerative colitis, or intestinal surgery;

• unexplained diarrhea;

• heart problems, high blood pressure, or a heart attack;

• problems with your adrenal gland;

• vision problems such as cataracts, glaucoma, or herpes simplex of the eyes;

• diabetes, or a thyroid disorder;

• osteoporosis or low bone mineral density;

• myasthenia gravis;

• kidney disease; or

• cirrhosis.

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Do not receive a "live" vaccine while using Cortenema. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cortenema may cause serious side effects. Call your doctor at once if you have:

• severe rectal pain or burning, bleeding from your rectum;

• fever or other signs of infection;

• vision changes;

• muscle weakness, joint pain, bone pain;

• unusual changes in mood or behavior;

• severe headaches, ringing in your ears, pain behind your eyes;

• a seizure;

• heart problems--chest pain, irregular heartbeats, swelling, rapid weight gain;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes); or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Cortenema may include:

• stomach pain, bloating;

• acne, rash, redness, dryness;

• changes in your menstrual periods;

• increased sweating; or

• changes in the shape or location of body fat (especially in your face, neck and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Cortenema. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.