Generic Name and Formulations:
Mesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap.
Valeant Pharmaceuticals, Inc
Indications for APRISO:
Maintenance of remission of ulcerative colitis (UC) in adults.
≥18yrs: 1.5g once daily in the AM.
<18yrs: not established.
Sulfasalazine allergy. Renal dysfunction or history of renal disease; assess renal function at the beginning and periodically during treatment. Hepatic impairment. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers.
Do not co-administer with antacids.
Headache, nausea, diarrhea, upper abdominal pain, nasopharyngitis, flu-like symptoms, sinusitis; renal impairment, mesalamine-induced acute intolerance syndrome (eg, cramping, abdominal pain, bloody diarrhea, fever, headache, rash); discontinue if occurs.