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Cortifoam Foam is used for:

Treating inflammation of the rectum.

Cortifoam Foam is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Do NOT use Cortifoam Foam if:

• you are allergic to any ingredient in Cortifoam Foam
• you have a rectal obstruction, abscess, or perforation; irritation of the of peritoneum (lining of the abdomen); or fistulas
• you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortifoam Foam:

Some medical conditions may interact with Cortifoam Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a parasitic, bacterial, fungal, or viral infection; diabetes; diarrhea; swelling of the esophagus; stomach problems; blockage or the intestine or other intestinal problems; measles; tuberculosis (TB); a positive TB skin test; chicken pox; shingles; herpes infection of the eye; ulcers; kidney problems; high blood pressure; thyroid problems; or you have received a recent vaccination
• if you have a history of heart failure or heart attack

Some MEDICINES MAY INTERACT with Cortifoam Foam. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, cholestyramine, colestipol, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Cortifoam Foam's effectiveness
• Aprepitant, clarithromycin, estrogens (eg, estradiol), macrolide immunosuppressants (eg, tacrolimus), nefazodone, or steroidal contraceptives (eg, birth control pills) because side effects such as adrenal gland or central nervous system problems may occur
• Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), live vaccines, macrolide immunosuppressants (eg, tacrolimus), nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, or theophylline because their actions and the risk of their side effects may be increased by Cortifoam Foam
• Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, mifepristone , or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Cortifoam Foam

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cortifoam Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortifoam Foam:

Use Cortifoam Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• Do not insert any part of the aerosol container directly into the anus. Apply to anus only with the applicator.
• If you miss a dose of Cortifoam Foam, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cortifoam Foam.

Important safety information:

• If your symptoms do not get better within 2 to 3 weeks or if they get worse, check with your doctor.
• Do not use Cortifoam Foam for other rectal conditions at a later time.
• Check with your doctor or pharmacist concerning the use of a stool softener or bulk laxative to help improve your symptoms.
• Check with your doctor before having vaccinations while you are using Cortifoam Foam.
• If you get Cortifoam Foam in your eyes, immediately flush them with cool tap water.
• Cortifoam Foam may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortifoam Foam while you are pregnant. It is not known if Cortifoam Foam is found in breast milk. If you are or will be breast-feeding while you use Cortifoam Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortifoam Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Rectal pain or burning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; rectal pain, burning, itching, bleeding, or irritation not present before using Cortifoam Foam.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Cortifoam Foam may be harmful if swallowed.

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 20 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120 degrees F (49 degrees C). Do not store in the bathroom. Keep Cortifoam Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Cortifoam Foam, please talk with your doctor, pharmacist, or other health care provider.
• Cortifoam Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cortifoam Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.