Salazodine-EC (500mg) 10 Tablets

Sulfasalazine is a prodrug that, upon metabolism in the colon, breaks down into sulfapyridine and 5-aminosalicylic acid (5-ASA). Its mechanism of action involves both anti-inflammatory and immunomodulatory effects. The 5-ASA component reduces inflammation by inhibiting the production of pro-inflammatory cytokines and blocking the cyclooxygenase (COX) and lipoxygenase pathways, which decreases the synthesis of prostaglandins and leukotrienes. Additionally, it scavenges free radicals that contribute to inflammation.

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Disease-Modifying Anti-Rheumatic Drug (DMARD)

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Tablet

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Sulfasalazine is used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in patients with ulcerative colitis, a condition in which the bowel is inflamed.

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Sulfasalazine Dosage Recommendations:

• For ulcerative colitis (adults) – The typical starting dose is 1 to 2 grams per day, divided into several doses. It may be gradually increased to a maintenance dose of 2 to 4 grams per day, depending on the patient's response and tolerance.
• For rheumatoid arthritis (adults) – The usual starting dose is 500 mg per day, which can be gradually increased to 2 to 3 grams per day, divided into two to three doses, depending on tolerance and effectiveness.
• For children (over 2 years old) – In ulcerative colitis, the dose is typically 40 to 60 mg/kg per day, divided into smaller doses. For juvenile rheumatoid arthritis, the usual starting dose is 30 to 50 mg/kg per day, also divided into smaller doses.

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There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. There are no documented reports of deaths due to ingestion of large single doses of sulfasalazine.

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If you miss a dose, continue with the next dose as scheduled. Do not take extra to make up for a missed dose.

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You will probably be given sulfasalazine as a tablet, which you should swallow whole with a glass of water. Do not break, crush or chew it. You can take sulfasalazine with or without food. But try to space your doses evenly throughout the day. Your doctor will tell you the correct dose to take. You’ll usually start on a low dose which is slowly increased each week. Follow your doctor’s advice carefully. The usual dose is two tablets (500 mg each) twice a day but this can vary, depending on the reason you are taking sulfasalazine and how well it works for you.

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Do not use Sulfasalazine if you:

• Are allergic (hypersensitive) to any of the ingredients
• Are allergic (hypersensitive) to salicylates (e.g., aspirin) or sulfonamides (e.g., certain antibiotics)
• Have porphyria (a rare blood pigment disorder)
• Have jaundice (yellowing of the skin or eyes)
• Are under 2 years of age

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Potential side effects associated with Sulfasalazine-EC include:

• Gastrointestinal discomfort
• Headache
• Allergic reactions
• Dizziness

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Patients should consider these precautions and warnings before using sulfasalazine:

• Hypersensitivity reactions may occur, presenting as rash, fever, or joint pain. Immediate consultation with a healthcare provider is advised if these symptoms arise.
• Gastrointestinal disturbances such as nausea or vomiting may occur. If these symptoms persist, it is important to inform a healthcare provider.
• Regular blood tests are recommended to detect potential hematological abnormalities, including leukopenia or thrombocytopenia.
• Sulfasalazine may cause yellow-orange discoloration of urine and skin, which is generally harmless but should be noted by the patient.
• Caution is advised for individuals with known allergies to sulfonamides or salicylates, as these may increase the risk of adverse reactions.
• The use of sulfasalazine may be contraindicated in patients with severe renal impairment or hepatic disease. Always follow the prescribed dosage and consult a healthcare provider before making any adjustments to the medication.

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Drug interactions with sulfasalazine include:

• Methotrexate (may increase the risk of bone marrow suppression and hepatotoxicity)
• Warfarin (may enhance the anticoagulant effect)
• Iron supplements (may reduce the absorption of sulfasalazine)
• Antibiotics (e.g., ciprofloxacin) (may affect the intestinal flora and efficacy of sulfasalazine)
• Other DMARDs (e.g., leflunomide) (may have additive effects on immune suppression)

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Store at room temperature, away from moisture and heat. Keep in its original packaging. Dispose of any unused medication through a pharmacy take-back program or follow local disposal instructions for pharmaceutical products.

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