Description

The mode of action of sulfasalazine is still under investigation. The action may be related to the anti-inflammatory and /or immunomodulatory properties, to its affinity for conncetive tissue, and / or to the relatively high concentration in serous fluids, the liver and intestinal walls.

Presentation

    Reumazin Tablet: Each enteric coated tablet contains sulfasalazine USP 500 mg.

Indications

    Sulfasalazine is indicated in -
    a) Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
    b) Ulcerative colitis and Crohn's Disease: As adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. In the treatment of active Crohn's disease, especially in patients with colonic involvement.

Dosage & Administration

    The dosage of Reumazin 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 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:

    Number of Reumazin Tablet 

    Week Morning Evening
    1 - One
    2 One One
    3 One Two
    4 Two Two


    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.

Contrainidications

    Hypersensitivity to Sulfasalazine, its metabolites, sulfonamides or salicylates, patients with intestinal or urinary obstruction and porphyria.

Warning & Precautions

Side effects

    The common adverse reactions are anorexia, headache, nausea, vomiting, gastric distress, dyspepsia, abdominal pain, dizziness, apparently reversible oligospermia etc.

Drug interaction

    Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with sulfasalazine.

Use in special groups

    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.

Packing

    Reumazin Tablet: Each box contains 50's tablets in Alu-Alu blister.