Sulfazin Tablet

Indication
Sulfasalazine is indicated in: 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). 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.

Pharmacology
The mode of action of Sulfasalazine is still under investigation, but 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 Sulfasalazine, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.

Dosage
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 crohnƒ??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.?ÿAdult?ÿdose 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 bellow: First week: One tablet in the?ÿevening Second?ÿweek: One tablet?ÿin the morning &?ÿOne tablet?ÿin the evening Third?ÿweek:?ÿOne tablet?ÿin the morning & two tablet?ÿin the evening Forth?ÿweek: Two tablet?ÿin the morning &?ÿtwo tablet?ÿin 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.

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

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

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

Pregnancy
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.

Precaution
Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.

Overdose

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