Mesalamine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Ulcerative Colitis - Active

ORAL:
Asacol(R), Delzicol(TM): 800 mg orally 3 times a day
Asacol(R) HD: 1600 mg orally 3 times a day
Lialda(R): 2.4 to 4.8 g orally once a day
Pentasa(R): 1 g orally 4 times a day

Duration of therapy:
-Asacol(R), Asacol(R) HD, Delzicol(TM): 6 weeks
-Lialda(R), Pentasa(R): Up to 8 weeks in controlled trials

Comments:
-Asacol(R) HD: Safety and efficacy have not been established beyond 6 weeks.

Approved indications:
-Asacol(R), Delzicol(TM): For the treatment of mildly to moderately active ulcerative colitis
-Asacol(R) HD: For the treatment of moderately active ulcerative colitis
-Lialda(R): For the induction of remission of active mild to moderate ulcerative colitis
-Pentasa(R): For the induction of remission and for the treatment of mildly to moderately active ulcerative colitis

RECTAL:
Rectal suspension enema: 4 g rectally once a day at bedtime
Duration of therapy: Generally from 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings; effect may be seen within 3 to 21 days

Comments:
-Best results are achieved if used soon after the bowel is emptied.
-Rectal suspension enemas should be retained for approximately 8 hours.

Approved indications: For the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis

Usual Adult Dose for Ulcerative Colitis - Maintenance

Apriso(R): 1.5 g orally once a day in the morning
Asacol(R), Delzicol(TM): 1.6 g orally per day in divided doses
Lialda(R): 2.4 g orally once a day
Pentasa(R): 1 g orally 4 times a day

Approved indication: For the maintenance of remission of ulcerative colitis; Pentasa(R) has not been explicitly approved for this indication.

Usual Adult Dose for Ulcerative Proctitis

Rectal suppository: 1 g rectally once a day at bedtime
Duration of therapy: Generally from 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings

Comments:
-Rectal suppositories should be retained for 1 to 3 hours or longer, if possible.
-Safety and efficacy have not been established beyond 6 weeks.

Approved indication: For the treatment of mild to moderately active ulcerative proctitis

Usual Pediatric Dose for Ulcerative Colitis - Active

Asacol(R):
5 years or older:
17 to less than 33 kg: 36 to 71 mg/kg/day orally in 2 divided doses
Maximum dose: 1.2 g/day

33 to less than 54 kg: 37 to 61 mg/kg/day orally in 2 divided doses
Maximum dose: 2 g/day

54 to 90 kg: 27 to 44 mg/kg/day orally in 2 divided doses
Maximum dose: 2.4 g/day

Duration of therapy: 6 weeks

Comments:
-Tablets should be swallowed whole without cutting, breaking, or chewing.

Approved indication: For the treatment of mildly to moderately active ulcerative colitis

Renal Dose Adjustments

Patients with known renal dysfunction or history of renal disease: Caution recommended.

Liver Dose Adjustments

Patients with liver dysfunction/disease: Caution recommended.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Apriso(R): Capsules may be taken without regard to meals; should not be coadministered with antacids (coating of granules depends on pH for dissolution).
-Asacol(R), Asacol(R) HD, Delzicol(R): Tablets/capsules should be swallowed whole without cutting, breaking, or chewing (coating is important part of delayed-release formulation).
-Asacol(R) HD: Tablets may be taken without regard to meals.
-Delzicol(R): Capsules should be taken at least 1 hour before or 2 hours after a meal.
-Lialda(R): Tablets should be taken with a meal; should be swallowed whole, keeping the outer coating intact.
-Rectal suppositories: If a dose is missed, it should be administered as soon as possible, unless it is almost time for the next dose; patients should not use 2 suppositories to make up for a missed dose.
-Rectal suspension enemas: The manufacturer's product information should be consulted.

Storage requirements:
-Asacol(R) HD, Delzicol(R): Protect from moisture; close container tightly and keep desiccant in bottle.
-Rectal suppositories: Store below 25 degrees Celsius (77 degrees Fahrenheit), may refrigerate. Keep away from direct heat, light, or humidity.

General:
-Apriso(R) capsules contain aspartame; usual adult dose provides equivalent of 2.24 mg of phenylalanine per day.
-Asacol(R), Asacol(R) HD, Delzicol(TM), Lialda(R): The release of mesalamine in the colon may be delayed in patients with pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract due to prolonged gastric retention of mesalamine tablets/capsules.
-One Asacol(R) HD 800 mg tablet is not bioequivalent to two Asacol(R) 400 mg tablets or to two Delzicol(TM) 400 mg capsules; should not use interchangeably.
-Asacol(R), Asacol(R) HD, Delzicol(TM): Intact, partially intact, and/or tablet/capsule shells reported in the stool; patients should contact physician if this occurs repeatedly.
-Rectal suppositories and rectal suspension enemas cause staining of direct contact surfaces (including fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel).

Monitoring:
-Gastrointestinal: For worsening colitis symptoms (during therapy)
-Hematologic: Blood cell counts in elderly patients (during therapy)
-Renal: Renal function in all patients (before starting and periodically during therapy)

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