Usual Adult Dose for Ulcerative Colitis - Active

3 to 4 g/day orally in evenly divided doses

Comments:

• To reduce possible GI intolerance, a lower starting dose (e.g., 1 to 2 g/day) may be considered.
• If GI intolerance occurs after the first few doses, symptoms may be reduced by halving the daily dose and then increasing it gradually over several days; if intolerance continues, the drug should be stopped for 5 to 7 days then restarted at a lower daily dose.
• Increased toxicity risk should be considered if more than 4 g/day is needed to reach desired therapeutic effect.
• Clinical criteria, sigmoidoscopy, and biopsy samples should be evaluated to determine response of acute ulcerative colitis to drug therapy.
• When adequate improvement is confirmed by endoscopy, dose should be reduced to maintenance level; if diarrhea recurs, dose should be increased to previously effective levels.

Uses: In the treatment of mild to moderate ulcerative colitis; as adjunctive therapy in severe ulcerative colitis

Usual Adult Dose for Ulcerative Colitis - Maintenance

2 g/day orally in evenly divided doses

Comments:

• Drug therapy often needs to be continued, even when clinical symptoms are controlled.

Use: To prolong the remission period between acute attacks of ulcerative colitis

Usual Adult Dose for Rheumatoid Arthritis

Delayed-release tablets: 1000 mg orally twice a day

Suggested dosing regimen:
Week 1: 500 mg orally once a day in the evening
Week 2: 500 mg orally twice a day (morning and evening)
Week 3: 500 mg orally in the morning and 1000 mg in the evening
Week 4: 1000 mg orally twice a day (morning and evening)

Comments:

• To reduce possible GI intolerance, a lower starting dose (e.g., 0.5 to 1 g/day) is recommended; a suggested dosing regimen is provided above.
• Degree of improvement in number and extent of actively inflamed joints can be evaluated to determine efficacy of drug therapy.
• This drug does not produce an immediate response. Concomitant analgesics and/or NSAIDs are recommended (at least until the effect of this drug is evident).
• Therapeutic response has been seen 4 weeks after starting therapy; 12 weeks of therapy may be needed before clinical benefit is noticed.
• Increasing the daily dose to 3 g/day may be considered if clinical response is inadequate after 12 weeks; careful monitoring suggested for doses over 2 g/day.

Use: In the treatment of patients with rheumatoid arthritis who responded inadequately to salicylates or other NSAIDs (e.g., insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of 1 or more NSAIDs)

Usual Adult Dose for Crohn's Disease - Acute

3 to 6 g/day orally in divided doses

Comments:

• This dose has been recommended for mild to moderate active ileocolonic or colonic disease; not approved by US FDA.
• Maintenance benefits have not been consistent after medical inductive therapy.

Usual Adult Dose for Uveitis

Study (n=10) - Acute anterior recurrent uveitis
Initial dose: 500 mg/day, then increased by 500 mg/week
Maintenance dose: 1 g twice a day for 1 year; in cases of new flare, dose was increased by 500 mg/week up to 3 g/day

Usual Pediatric Dose for Ulcerative Colitis

6 years or older:
Initial therapy: 40 to 60 mg/kg/day orally divided into 3 to 6 doses
Maintenance therapy: 30 mg/kg/day orally divided into 4 doses

Comments:

• If GI intolerance occurs after the first few doses, symptoms may be reduced by halving the daily dose and then increasing it gradually over several days; if intolerance continues, the drug should be stopped for 5 to 7 days then restarted at a lower daily dose.
• Clinical criteria, sigmoidoscopy, and biopsy samples should be evaluated to determine response of acute ulcerative colitis to drug therapy.
• When adequate improvement is confirmed by endoscopy, dose should be reduced to maintenance level; if diarrhea recurs, dose should be increased to previously effective levels.
• Drug therapy often needs to be continued, even when clinical symptoms are controlled.

Uses: In the treatment of mild to moderate ulcerative colitis; as adjunctive therapy in severe ulcerative colitis; to prolong the remission period between acute attacks of ulcerative colitis

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Delayed-release tablets:
6 years or older: 30 to 50 mg/kg/day orally in 2 equally divided doses
Maximum dose: 2 g/day (normally)

Comments:

• To reduce possible GI intolerance, dosing should be started at 1/4 to 1/3 the planned maintenance dose and increased weekly until maintenance dose is reached at 1 month.

Use: In the treatment of patients with polyarticular-course juvenile rheumatoid arthritis who responded inadequately to salicylates or other NSAIDs

Renal Dose Adjustments

Critical assessment prior to use recommended.

Liver Dose Adjustments

Critical assessment prior to use recommended.

Precautions

Safety and efficacy have not been established in ulcerative colitis patients younger than 2 years. Safety and efficacy have not been established in polyarticular-course juvenile rheumatoid arthritis patients younger than 6 years. This drug is not recommended for the treatment of systemic-course juvenile rheumatoid arthritis.

Consult WARNINGS section for additional precautions.

Dialysis

Critical assessment prior to use recommended for patients with renal dysfunction.

Other Comments

Administration advice:

• Adjust dose to each patient's response and tolerance.
• Administer daily dose in evenly divided doses preferably after meals; dose intervals should not exceed 8 hours.
• Swallow delayed-release tablets whole.
• The manufacturer product information should be consulted for desensitization information.

General:

• Delayed-release tablets are primarily for patients who cannot use uncoated tablets due to GI intolerance.
• Ulcerative colitis rarely remits completely; risk of relapse can be greatly reduced by continued use of this drug at maintenance dose.
• Rheumatoid arthritis rarely remits; continued use of this drug is suggested.

Monitoring:

• General: For toxicity; serum sulfapyridine levels
• Hematologic: CBC including differential white cell count (before starting, every second week during first 3 months, monthly during second 3 months, once every 3 months thereafter, and as indicated)
• Hepatic: Liver function tests (before starting, every second week during first 3 months, monthly during second 3 months, once every 3 months thereafter, and as indicated)
• Renal: Renal function including urinalysis (initially, at least monthly for first 3 months, periodically thereafter as indicated)

Patient advice:

• Maintain adequate fluid intake in order to prevent crystalluria and stone formation.
• An orange-yellow discoloration of urine or skin may occur.
• If delayed-release tablets pass undisintegrated, discontinue the product at once.
• If using for rheumatoid arthritis, follow up with physician to determine the need for continued use.