Generic Name: budesonide
Date of Approval: January 14, 2013
Company: Santarus, Inc.

Treatment for: Ulcerative Colitis

FDA Approves Uceris

The U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended release tablets, a prescription corticosteroid for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Uceris is taken once daily in the morning with or without food for up to 8 weeks.

Uceris Patient Information

What is Uceris?

Uceris is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission).

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

It is not known if Uceris is safe and effective in children.

Who should not take Uceris?

Do not take Uceris if:

  • you are allergic to budesonide or any of the ingredients in Uceris. See the end of this leaflet for a complete list of ingredients in Uceris.

What should I tell my healthcare provider before taking Uceris?

Before you take Uceris tell your healthcare provider if you:

  • have liver problems
  • are planning to have surgery
  • have chicken pox or measles or have recently been near anyone with chicken pox or measles
  • have an infection
  • have or had a family history of diabetes, cataracts or glaucoma
  • have or had tuberculosis
  • have high blood pressure (hypertension)
  • have decreased bone mineral density (osteoporosis)
  • stomach ulcers
  • any other medical condition
  • are pregnant or plan to become pregnant. It is not known if Uceris will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Uceris can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Uceris or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. Uceris and other medicines may affect each other causing side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Uceris?

  • Take Uceris exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how many Uceris to take.
  • Take Uceris in the morning.
  • Take Uceris capsules whole with water. Do not chew, crush, or break Uceris before swallowing.
  • If you take too much of Uceris, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid?

  • Do not eat grapefruit or drink grapefruit juice while taking Uceris. Eating grapefruit or drinking grapefruit juice can increase the level of Uceris in your blood.

Uceris side effects

Uceris can cause some serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of Uceris can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
    • acne
    • bruise easily
    • rounding of your face (moon face)
    • ankle swelling
    • thicker or more hair on your body and face
    • a fatty pad or hump between your shoulders (buffalo hump)
    • pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
  • Adrenal suppression. When Uceris is taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with Uceris including:
    • tiredness
    • vomiting
    • weakness
    • low blood pressure
    • nausea
  • Immune system effects and a higher chance of infections. Uceris weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chicken pox or measles, while taking Uceris.

    Tell your healthcare provider about any signs or symptoms of infection during treatment with Uceris, including:
    • fever
    • pain
    • aches
    • chills
    • feeling tired
    • nausea and vomiting
  • Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to Uceris may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking Uceris.

The most common side effects of Uceris include:

  • headache
  • nausea
  • decreased blood cortisol levels
  • stomach-area pain
  • tiredness
  • stomach or intestinal gas
  • bloating
  • acne
  • urinary tract infection
  • joint pain
  • constipation

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Uceris. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Uceris?

  • Store Uceris at room temperature, between 68°F to 77 F (20°C to 25 C)
  • Keep the bottle tightly closed to protect Uceris from light and moisture.

Keep Uceris and all medicines out of the reach of children.

General Information about Uceris

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Uceris for a condition for which it was not prescribed. Do not give Uceris to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Uceris that is written for health professionals.

For more information go to www.Uceris.com or call (1-888-778-0887).

What are the ingredients in Uceris?

Active Ingredients: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropylcellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethylcitrate, and titanium dioxide.