Ulcerative colitis

5-Aminosalicylic Acid Derivative

■ Absorption:~20% to 28%.■ Protein binding: Mesalamine (5-ASA): ~43%; N-acetyl-5-ASA: ~78%.■ Metabolism: Hepatic and via GI tract to N-acetyl-5-aminosalicylic acid.■ Half-life elimination: 5-ASA and N-acetyl-5-ASA: Variable; ~ 25 hours (range: 2 to 296 hours).■ Time to peak, serum: 1~6 hours.■ Excretion:Urine (primarily as N-acetyl-5-ASA, ?12% as unchanged drug); feces (unabsorbed mesalamine).

Hypersensitivity to mesalamine, aminosalicylates, salicylates, or any component of the formulation; Severe renal impairment (GFR <30 mL/minute/1.73 m ㎡); severe hepatic impairment.

B

No controlled studies have been conducted on the use of PENTASAR during breastfeeding. The possibility that this drug may cause allergic reactions in newborns (such as diarrhea) cannot be excluded. If diarrhea occurs in the newborn, breastfeeding should be discontinued.【文字內容來自仿單】

Abdominal pain (1% to 21%), constipation (?11%), eructation (?26%),Headache (3% to 14%),Nasopharyngitis (children and adolescents: 15%; adults: 1% to 4%)

■ 疾病發作期（Treatment dose during disease onset）Maximum daily dose: 4 g, may be administered as a single dose or in divided doses■ 緩解期維持治療（Stable-period maintenance dose）Recommended daily dose: 2 g, may be administered as a single dose or in divided doses【文字內容由仿單翻譯而來】

Children (6-18 years old)1.During Disease Onset (Treatment Dose)Initial dose: 30–50 mg/kg/day, in divided dosesMaximum dose: 75 mg/kg/day, in divided dosesTotal daily dose must not exceed 4 g2.Maintenance Therapy (Stable Period)Initial dose: 15–30 mg/kg/day, in divided dosesTotal daily dose must not exceed 2 g3.Weight-Based Adjustment< 40 kg body weight: recommended to use half of the adult dose? 40 kg body weight: recommended to use the same dosage as adults【文字由仿單翻譯而來】

No dosage adjustment necessary but use with caution and with frequent monitoring

Use with caution in patients with hepatic impairment. Liver function tests (e.g., ALT, AST) should be performed prior to and during treatment, as clinically indicated.

Store in the original package at temperatures below 30°C. Protect from light. Do not freeze.