Ulcerative colitis medications and treatments

Bringing medications for the treatment of UC to life

While there is currently no cure for ulcerative colitis (UC), medications are available to help reduce the inflammation and relieve symptoms, allowing the colon to heal.

Medications used to treat UC include

  • Aminosalicylates (5-ASAs): This class of antiinflammatory drugs is typically used to treat mild to moderate UC symptoms and help prevent relapses. They include sulfasalazine and oral formulations of mesalamine. APRISO is an aminosalicylate indicated for the maintenance of UC remission
  • Corticosteroids: Also known as steroids, drugs such as prednisone, methylprednisolone, and hydrocortisone also reduce inflammation and are used to treat moderate to severely active UC. Corticosteroids suppress the immune system and are not recommended for long-term use because of significant side effects
  • Immune modifiers: Immune modifiers are sometimes called immunomodulators. These drugs are used to help decrease corticosteroid usage. They lessen the inflammatory response caused by UC by working on the body's immune system
  • Biologic therapies: Biologic therapies are the newest class of drugs used for people with moderate to severe ulcerative colitis. These drugs are made from antibodies that bind with certain molecules to block a particular action. Biologic drugs are administered by injection or infusion

Indication for APRISO

APRISO® is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.

The use of APRISO for treating ulcerative colitis beyond 6 months has not been evaluated in controlled clinical trials.

Important Safety Information about APRISO

You should not take APRISO® (mesalamine) extended-release capsules if you experience an allergic reaction to salicylates or aminosalicylates (sulfasalazine), or to any of the components of APRISO capsules.

It is recommended that you have an evaluation of kidney function prior to treatment with APRISO therapy and periodically while on therapy. Talk to your doctor if you have any kidney or renal problems before taking APRISO.

Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.

If you have liver disease, talk to your doctor before taking APRISO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.

You should not take APRISO while taking antacids because the dissolving of APRISO granules depends on pH. If you are 65 years old or older, talk to your doctor before taking APRISO. Blood cell count must be monitored closely if you are 65 or older and on mesalamine therapy. Additionally, if you have phenylketonuria (PKU), please be aware that APRISO contains 2.24 mg of phenylalanine per day.

In the clinical studies, the most common side effects occurring in at least 3% of adult patients taking APRISO were headache, diarrhea, upper abdominal (stomach) pain, nausea, nasopharyngitis (inflammation of the nasal passages), flu and flu-like illness, and inflammation of the sinuses.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for APRISO.PDF