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
Please see complete Prescribing Information for APRISO.