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Drug Name:


Generic Name and Formulations:
Mesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap.

Valeant Pharmaceuticals, Inc

Therapeutic Use:

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.

Pharmacological Class:


Adverse Reactions:

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.

Generic Availability:


How Supplied:


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