Azulfidine (sulfasalazine) - 3 indications

Scroll down for more information on each indication:

• mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis and for the prolongation of the remission period between acute attacks of ulcerative colitis;
• for the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs
• for the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs

General Information

Azulfidine (sulfasalazine) is an anti-inflammatory.

Azulfidine is specifically indicated for the following:

• for the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis and for the prolongation of the remission period between acute attacks of ulcerative colitis;
• for the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs
• for the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs

Azulfidine is supplied as regular tablets and delayed release tablets for oral administration. The dosing is as follows:

Regular Tablets:

• 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.

Delayed-Release Tablets: dosing and administration differs for each indication. Scroll down for more information.

Mechanism of Action

Azulfidine (sulfasalazine) is an anti-inflammatory. The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety.

Side Effects

Adverse effects associated with the use of Azulfidine may include, but are not limited to, the following:

• anorexia
• headache
• nausea
• vomiting
• gastric distress
• apparently reversible oligospermia

Indication 1 - mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis and for the prolongation of the remission period between acute attacks of ulcerative colitis

Delayed Release Dosing/Administration

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. 

Clinical Trial Results

N/A

Indication 2 - adult patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs

Delayed Release Dosing/Administration

2 g daily in two evenly divided doses 

Clinical Trial Results

N/A

Indication 3 - pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs

Delayed Release Dosing/Administration

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.

Clinical Trial Results

N/A