Usual Adult Dose for Ulcerative Colitis - Active

ORAL:
250 and 500 mg capsules: 1 g orally 4 times a day
Duration of therapy: Up to 8 weeks

400 mg tablets: 800 mg orally 3 times a day
Duration of therapy: 6 weeks

400 mg delayed release capsules: 800 mg orally 3 times a day
Duration of therapy: 6 weeks

800 mg delayed release tablets: 1600 mg orally 3 times a day
Duration of therapy: 6 weeks

1200 mg tablets: 2.4 to 4.8 g orally once a day with food

Uses: Treatment of mildly to moderately active ulcerative colitis and induction of remission of ulcerative colitis.
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RECTAL:
Enema: 1 rectal installation (4 gm), once a day, preferably at bedtime

Duration of therapy: 6 weeks

Comments:

• Shake well before use.
• Retain for approximately 8 hours.
• Effects may be seen in 3 to 21 days.
• Therapy usually lasts 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings.

Usual Adult Dose for Ulcerative Colitis - Maintenance

375 mg extended release capsules: 1.5 g (4 capsules) orally once a day in the morning
400 and 800 mg tablets and capsules: 1.6 g orally daily in divided doses
1200 mg tablets: 2.4 g (2 tablets) orally once a day with food

Comments:

• Do not co-administer 375 mg extended release capsules with antacids.

Usual Adult Dose for Ulcerative Proctitis

Suppository:
1 suppository (1000 mg) rectally once a day at bedtime

Duration of therapy: 6 weeks

Comments:

• Retain suppository for 1 to 3 hours or longer, if possible.
• Therapy usually lasts 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings.

• Retain for approximately 8 hours.
• Effects may be seen in 3 to 21 days.
• Therapy usually lasts 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings.
• Shake well before use.

Usual Pediatric Dose for Ulcerative Colitis - Active

400 mg tablets or capsules, dosing is weight based:

17 to less than 33 kg: 36 to 71 mg/kg/day, orally, divided into 2 doses a day
Maximum dose: 1.2 g/day

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

54 to 90 kg: 27 to 44 mg/kg/day, orally, divided into 2 doses a day
Maximum dose: 2.4 gm/day

Duration of therapy: 6 weeks

Use: Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age or older (tablets) or 12 years of age and older (capsules).

Renal Dose Adjustments

Use with caution.

Liver Dose Adjustments

Use with caution.

Precautions

Safety and efficacy of oral formulations have not been established in patients younger than 5 years.

Safety and efficacy of rectal formulations have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not crush, split, chew, or open tablets or capsules.
• Oral product may be taken with or without food.
• Two 400 mg capsules should not be substituted for on 800 mg delayed release capsule/tablet.
• Before prescribing, assess the patient's ability to swallow the capsules or tablets.
• If a dose of the suppository is missed, give as soon as possible unless it is almost time for the next dose. Do not double the dose.
• The manufacturer product information should be consulted for complete instructions.