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Azulfidine (Sulfasalazine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AZULFIDINE Tablets are indicated:

  • a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
  • b)for the prolongation of the remission period between acute attacks of ulcerative colitis.

DOSAGE AND ADMINISTRATION

The dosage of AZULFIDINE Tablets should be adjusted to each individual's response and tolerance.

Initial Therapy

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind.

Children, six years of age and older: 40 to 60 mg/kg 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 body weight in each 24-hour period, divided into 4 doses.

The response of acute ulcerative colitis to AZULFIDINE 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, the dosage of AZULFIDINE should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of AZULFIDINE, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of AZULFIDINE 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.

Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,4 7 of 8 patients,5 and 19 of 20 patients.6 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, AZULFIDINE 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.

HOW SUPPLIED

AZULFIDINE Tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "101" on one side and "KPh" on the other. They are available in the following package sizes:

  Bottles of 100            NDC 0013-0101-01
  Bottles of 300            NDC 0013-0101-20
  

Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].

Sulfasalazine is also available as AZULFIDINE EN-tabs® brand of sulfasalazine delayed release tablets, USP, 500 mg, in the following package sizes:

  Bottles of 100            NDC 0013-0102-01
  Bottles of 300            NDC 0013-0102-20

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