Sulfasalazine is indicated in the following conditions:

• Rheumatoid arthritis & Juvenile arthritis: For the treatment of patients with rheumatoid arthritis and pediatric patients with polyarticular juvenile rheumatoid arthritis who have shown inadequate response to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Ulcerative colitis and Crohn’s disease: Used as an adjunct in the treatment of ulcerative colitis along with standard supportive and dietary measures. It is also used in active Crohn’s disease, particularly when there is colonic involvement.

The exact mechanism of action of Sulfasalazine is not fully understood. It may be related to its anti-inflammatory and immunomodulatory effects observed in animal and in vitro studies, its affinity for connective tissues, and its relatively high concentration in serous fluids, liver, and intestinal walls as shown in animal autoradiographic studies. In ulcerative colitis, clinical studies using rectal administration of Sulfasalazine, sulfapyridine, and 5-aminosalicylic acid suggest that the primary therapeutic effect is due to the 5-aminosalicylic acid (5-ASA) component. The relative contribution of the parent drug and its metabolites in rheumatoid arthritis remains unclear.

The dosage of Sulfasalazine tablets should be individually adjusted according to the patient's tolerance and response to the treatment and taken in evenly divided doses preferably after meals.

Adult dose for Crohn’s disease: 500 mg orally 2 to 4 times a day with food.

Pediatric use (6 years or older) for Ulcerative Colitis: The initial dose 40 to 60 mg/kg/day orally divided into 3 to 6 doses.

Adult dose for rheumatoid arthritis: 2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage e.g. 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given below:

• First week: One tablet in the evening
• Second week: One tablet in the morning & One tablet in the evening
• Third week: One tablet in the morning & two tablet in the evening
• Fourth week: Two tablet in the morning & two tablet in the evening

In case of rheumatoid arthritis 6 years or older: initial dose 10 mg/kg/day orally in 2 equally divided doses.

Juvenile rheumatoid arthritis-polyarticular course: Children 6 years of age and older: 30 to 50 mg/kg/day in two evenly divided doses. Typically the maximum dose is 2 g per day.

For other indications:

Initial therapy:

• Adults: 3 to 4 g daily in 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.
• Children 6 years of age and older: 40 to 60 mg/kg/day in to 3 to 6 divided doses.

Maintenance therapy:

• Adults: 2 g daily.
• Children 6 years of age and older: 30 mg/kg/day in 4 divided doses.

Reduced absorption of folic acid and digoxin has been reported when these agents are used concomitantly with sulfasalazine.

Sulfasalazine is contraindicated in patients with hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates, as well as in patients with intestinal or urinary obstruction and porphyria.

Common adverse reactions include anorexia, headache, nausea, vomiting, gastric discomfort, dyspepsia, abdominal pain, dizziness, and apparently reversible oligospermia.

Use in pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. Use in lactation: Caution should be exercised when sulfasalazine is administered to a nursing mother.

Use with caution in patients with hepatic or renal impairment, G6PD deficiency, allergic bronchial asthma, and during lactation.

Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis

Store in a cool and dry place, protected from light.