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Gastrointestinal agent
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Mesalamine
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To induce remission in active, mild-to-moderate ulcerative colitis; and to maintain remission of ulcerative colitis
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1. Adults: กร18yrs: Swallow whole with a meal. 2.4-4.8g once daily for up to 8 weeks. Maintenance: 2.4g once daily. 2. Children: <18yrs: Not recommended.
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Category B
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Ulcerative colitis, headache, flatulence, abnormal liver function test; acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) (discontinue if suspected), renal impairment, cardiac hypersensitivity reactions, pancreatitis (rare).
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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