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PMS-SULFASALAZINE-E.C. TAB is a brand name for Sulfasalazine, supplied as a tablet (enteric-coated). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
C. should be adjusted according to the response to the treatment and the patient's tolerance to the drug. The tablets / delayed-release tablets should be taken at regular and even intervals over the 24-hour period. C. tablets should preferably be taken with a meal.
For intestinal inflammatory diseases, the night-time doses interval should not exceed 8 hours. Patients not previously treated with sulfasalazine should increase the dose gradually during the first few weeks. The incidence of adverse reactions tends to increase with daily dosages of 4 g or more; patients receiving these doses should be advised of this possibility and should be carefully observed for the appearance of adverse reactions.
Recommended Dose and Dosage Adjustment Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease 1.
Acute attacks:
Adults: Severe attacks: 2–4 tablets, 3–4 times daily Moderate and mild attacks: 2 tablets, 3–4 times daily. Children: 25–35 kg body weight: 1 tablet, 3 times daily 35–50 kg body weight: 2 tablets, 2-3 times daily 2.
Prophylaxis:
Adults: In the state of remission in ulcerative colitis the maintenance dose recommended for keeping the patient free from symptoms is 2 tablets 2–3 times a day. Treatment with this dosage should continue indefinitely, unless adverse effects are observed.
In case of deterioration, raise the dosage to 2–4 tablets, 3–4 times a day. C. tablets or a lower dose. C. Product Monograph Page 15 of 30 Rheumatoid Arthritis 1. Adults: 2 delayed-release tablets, 2 times daily. When starting therapy, it is suggested to increase the daily dose as follows: 1st Week 2nd Week 3rd Week 4th Week and after Morning 1 Delayed-release tablet 1 Delayed-release tablet 2 Delayed-release tablets Evening 1 Delayed-release tablet 1 Delayed-release tablet 2 Delayed-release tablets 2 Delayed-release tablets If no response has been seen after two months treatment, dose may be increased to 3 g/day.
5 g/day. A clinical effect generally appears 1–2 months after initiation of treatment. C. tablets is apparent. C. tablets are effective and well-tolerated in long-term treatment. 2.
Children:
The use of sulfasalazine in Juvenile Rheumatoid Arthritis is not recommended since its efficacy / safety has not been established. Special Population 1.
Elderly patients:
Based on pharmacokinetic studies, no special dosage instructions are required for elderly patients. 2. C. should be used with caution in patients with renal deficiency. C. 05% Structural Formula: Physicochemical Properties: Description: Minute, brownish-yellow crystals Melting Point: Decomposes at 240–245°C.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sulfasalazine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Solubility:
Slightly soluble in ale. Practically insoluble in water, benzene, chloroform, and ether. UV max: 237 and 359 nm. C. Product Monograph Page 17 of 30 STORAGE AND STABILITY Store between 15-30°C. Avoid freezing. C. are available in the following dosage forms: pms-SULFASALAZINE 500 mg: Each dark-yellow, round, biconvex tablet scored on one side, identified PMS on other side contains: 500 mg Sulfasalazine.
Available in bottles of 100 and 500. C. 500 mg: Each dark-yellow, oval enteric-coated tablet, contains: 500 mg Sulfasalazine. Available in bottles of 100 and 500. C. are: pms-SULFASALAZINE 500 mg: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Povidone.
C. 500 mg: Acrylic Resin, Croscarmellose Sodium, Iron Oxide Red, Iron Oxide Yellow, Macrogol, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Sodium Carboxy- methylcellulose, Sodium Citrate Dihydrate, Talc, Titanium Dioxide.
DETAILED PHARMACOLOGY As the etiology of ulcerative colitis and Crohn’s disease is unclear, it is difficult to establish the significance of the different pharmacological actions of sulfasalazine. Sulfasalazine has been used for more than four decades in the treatment of inflammatory bowel disease.
Like other azo compounds, sulfasalazine exhibits an affinity for connective tissue. It also has an antibacterial as well as anti-inflammatory effect. An effect on prostaglandin synthetase and metabolism has also been suggested. Significant changes in immunological variables proved the immunosuppressive effect of sulfasalazine.
The absence of etiologic treatment for ulcerative colitis and Crohn's disease is evidenced throughout all studies. The success of the therapy depends on the site of the inflammation. C. Product Monograph Page 18 of 30 when it was tolerated with minimal side effects (13%).
From the data of Goldstein et al, it was suggested that sulfasalazine alone was an effective drug treatment for Crohn's disease. A dosage of 2 g […]