#特殊劑型：不建議磨粉、管灌藥品

Mild to moderate ulcerative colitis, Active

Mesalamine (5-aminosalicylic acid) is the active component of sulfasalazine; the specific mechanism of action is unknown; however, it is thought that mesalamine modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF); action appears topical rather than systemic.

Absorption:
Bioavailability: 20% to 30%
Distribution:
Vd: 0.2 L/kg
Metabolism:
Liver: Acetylated via N-acetyltransferase activity
Excretion:
Renal: 13% to 30% as metabolite (2% to 8% unchanged)
Elimination Half Life:
7 to 12 hours .

Hypersensitivity to mesalamine, other salicylates (including aspirin) or aminosalicylates, or to any product component.

Fetal risk cannot be ruled out. (TH)

Drugs that have been associated with significant effects on some nursing infants and should be given to nursing mothers with caution. (AAP)
Infant risk cannot be ruled out.(MDX)

Common:
Dermatologic: Rash (Up to 6% ; pediatrics, 5% )
Gastrointestinal: Abdominal pain (Adult, 2.2% to 18% ; pediatrics, 10% ), Burping (16% ), Diarrhea (Adults, up to 8% ; pediatrics, 5% ), Nausea (Up to 4% ), Vomiting (less than 1% to 5% )
Musculoskeletal: Arthralgia (less than 3% to greater than 5% )
Neurologic: Asthenia (less than 1% to greater than 5% ), Headache (Adults, 2.9% to 14% ; pediatrics, 10% )
Respiratory: Nasopharyngitis (Adults, 1.4% to 4% ; pediatrics, 15% ), Rhinitis (5% or more )
Other: Pain (up to 14% )
Serious:
Cardiovascular: Myocarditis, Pericarditis
Gastrointestinal: Exacerbation of ulcerative colitis (Pediatrics, 12% ), Gastrointestinal hemorrhage (2% or greater ), Pancreatitis (Less than 1% ), Rectal hemorrhage (less than 3% to 2% or greater.)
Hematologic: Agranulocytosis, Aplastic anemia, Leukopenia, Neutropenia, Pancytopenia, Thrombocytopenia
Hepatic: Cholestatic hepatitis (Less than 3% ), Hepatotoxicity, Liver failure, Sclerosing cholangitis
Immunologic: Hypersensitivity reaction
Renal: Renal impairment
Other: Drug intolerance, Syndrome, Infectious disease

Crohn disease, mild to moderate (treatment):
Initial: 1 g 4 times daily
Crohn disease, mild to moderate (maintenance of remission):
1 g 3 times daily
Ulcerative colitis (maintenance of remission):
Pentasa: 1 g 4 times daily.

Ulcerative colitis (treatment): Children ?5 years and Adolescents:
17 to 32 kg: 800 mg in the morning and 400 mg in the evening for 6 weeks; maximum dose: 1,200 mg/day
33 to 53 kg: 1,200 mg in the morning and 800 mg in the evening for 6 weeks; maximum dose: 2,000 mg/day
54 to 90 kg: 1,200 mg in the morning and 1,200 mg in the evening for 6 weeks; maximum dose: 2,400 mg/day.(UTD)

GFR ?30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
GFR <30 mL/minute/1.73 m2: Use is contraindicated.(UTD)

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Severe impairment: Use is contraindicated.(UTD)