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SULFASALAZINE Delayed Release Tablets (GREENSTONE LLC) Dosage and Administration

DOSAGE AND ADMINISTRATION

The dosage of sulfasalazine delayed release tablets should be adjusted to each individual's response and tolerance.

Patients should be instructed to take sulfasalazine delayed release tablets in evenly divided doses, preferably after meals, and to swallow the tablets whole.

Ulcerative Colitis

Initial Therapy

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.

Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.

Maintenance Therapy

Adults: 2 g daily.

Children, six years of age and older: 30 mg/kg of body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to sulfasalazine delayed release tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, dosage of sulfasalazine delayed release tablets should be reduced to a maintenance level. If diarrhea recurs, dosage should be increased to previously effective levels.

Sulfasalazine delayed release tablets are particularly indicated in patients who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance (e.g., anorexia, nausea). If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine delayed release tablets, they are probably due to increased serum levels of total sulfapyridine, and may be alleviated by halving the daily dose of sulfasalazine delayed release tablets and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.

Adult Rheumatoid Arthritis

2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage of sulfasalazine delayed release tablets, e.g., 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given below.

In rheumatoid arthritis, the effect of sulfasalazine delayed release tablets can be assessed by the degree of improvement in the number and extent of actively inflamed joints. A therapeutic response has been observed as early as 4 weeks after starting treatment with sulfasalazine delayed release tablets, but treatment for 12 weeks may be required in some patients before clinical benefit is noted. Consideration can be given to increasing the daily dose of sulfasalazine delayed release tablets to 3 g if the clinical response after 12 weeks is inadequate. Careful monitoring is recommended for doses over 2 g per day.

Suggested Dosing Schedule for Adult Rheumatoid Arthritis:

Week ofNumber of sulfasalazine delayed release tablets
TreatmentMorningEvening
1-One
2OneOne
3OneTwo
4TwoTwo
Juvenile Rheumatoid Arthritis - polyarticular course

Children, six years of age and older: 30 to 50 mg/kg of body weight daily in two evenly divided doses. Typically, the maximum dose is 2 g per day. To reduce possible gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until reaching the maintenance dose at one month.

Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,8 7 of 8 patients,9 and 19 of 20 patients.10 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine delayed release tablets should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.

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