Composition:

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

Pharmacology:

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.

Indications:

Sulfasalazine is indicated in -

1. 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).
2. 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 and 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 bellow:

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.

Contraindications:

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

Side effects:

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

High risk group:

Pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.

Lactation: Caution should be exercised when sulfasalazine is administered to a nursing mother.

Drug interactions:

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

Benefits:

• Reumazin is the drug of choice for the treatment of rheumatoid arthritis when salicylates or NSAIDs responded inadequately.
• Reumazin is formulated as enteric coated tablet which reduces GI effects unlike non-coated sulfasalazine tablet.
• Reumazin can be given to both adult and juvenile rheumatoid arthritis.
• Reumazin is also effective in ulcerative colitis and Crohn's disease.

Packing:

Reumazin Tablet: Each box contains 5x10's tablets in Alu-Alu blister.