Indication

Ulcerative Colitis and Crohn's Disease: Adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. For the management of severe, acute attacks of ulcerative colitis and maintenance therapy. In the treatment of active Crohn's disease, especially in patients with colonic involvement. Rheumatoid Arthritis: Sulfasalazine tablets are indicated for rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (NSAIDs).


Dosage & Administration

he dosage of sulfasalazine should be individually adjusted according to the patient's tolerance and response to the treatment. Inflammatory Bowel Disease: Sulfasalazine tablets should be given preferably after meals in evenly divided doses over a 24 hour period with no more than 8 hours between overnight doses. The enteric coated tablets should not be crushed or broken. Initial dosage: Adults: 1 to 2g four times daily. Children: 40 to 60mg/kg bodyweight daily in three to six divided doses. Maintenance dosage: Adults: 2g daily in four divided doses. Children: 40mg/kg bodyweight daily in four divided doses. The daily maintenance dose should be continued unless contraindicated by side effects.Sulfasalazine tablets may be used to minimise gastrointestinal intolerance to the drug. Rheumatoid Arthritis: Oral: Two Sulfasalazine tablets, two or three times a day, i.e. 2 to 3g daily.. For adults starting therapy, it is advisable to raise the daily dose according to the following schedule: * etc. to 3g/day maximum.

Dose 1st Week 2nd Week 3rd Week 4th Week
Morning 1 tablet 1 tablet 1 tablet 2 tablet
Morning 1 tablet 1 tablet 1 tablet 2 tablet
Evening 1 tablet 1 tablet 1 tablet 2 tablet*


At present no dosage recommendation regarding treatment with Sulfasalazine tablets in rheumatoid arthritis in children can be given.


Precautions

Potential Toxicity: Deaths associated with the administration of sulfasalazine have been reported resulting from hypersensitivity reactions, agranulocytosis, aplastic anaemia, renal and liver damage, irreversible neuromuscular and CNS changes, and fibrosingalveolitis. Sulfasalazine should be administered under constant medical supervision. Reversible Male Infertility: Several recent reports have suggested that sulfasalazine may cause reversible infertility in males. Sulfasalazine therapy has been associated with a reduction in sperm counts, reduced sperm motility, morphologically abnormal sperm and an increased proportion of immature sperm. Patients with a deficiency of erythrocytic glucose-6-phosphate dehydrogenase (G-6-PD) have been noted to develop haemolyticanaemia during treatment with sulfasalazine and should be closely observed. Adequate fluid intake must be maintained in order to reduce the risk of crystalluria and stone formation.Use in children: Use of sulfasalazine in children with systemic onset juvenile rheumatoid arthritis may result in a serum sickness-like reaction. Therefore, sulfasalazine is not recommended in these patients.Use in Pregnancy: Category A.Use in lactation: Caution should be used, particularly if breastfeeding premature infants. Sulfasalazine should not be given to nursing mothers unless the expected benefits to the mother outweigh the potential risk to the infant.


Product Details


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