Colosalazine Ec 500 Mg Tablets

Colosalazine Ec 500 Mg Tablets

Description:

Colosalazine Ec 500 mg tablets are a prescription anti-inflammatory medicine containing sulfasalazine, formulated as enteric-coated (ec) tablets to act locally in the intestine. They are primarily used in the management of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and in some cases for rheumatoid arthritis. The enteric coating helps the tablet pass through the stomach and dissolve in the intestine, where sulfasalazine is converted to its active components to reduce inflammation in the bowel wall and joints.

Indications:

• Treatment and maintenance of remission of mild to moderate ulcerative colitis (inflammatory bowel disease affecting the colon and rectum).
• Adjunctive treatment of Crohn's disease, especially when the colon is involved.
• Management of rheumatoid arthritis, usually as a disease-modifying antirheumatic drug (DMARD), as prescribed by a rheumatologist.
• Helps relieve symptoms such as abdominal pain, diarrhea, rectal bleeding, and urgency associated with inflammatory bowel disease.
• May be used in certain cases of chronic inflammatory diarrhea as directed by a physician.

Active Ingredients / Key Components:

• Sulfasalazine – 500 mg per enteric-coated tablet.
• Sulfasalazine is a prodrug composed of 5-aminosalicylic acid (5-ASA) and sulfapyridine, which are released in the colon.
• Excipients and coating agents: full excipient list and concentrations , please check the product leaflet or the manufacturer’s official website.

Dosage & Administration / How to Use:

• Use exactly as prescribed by your doctor. Do not exceed the recommended dose.
• For ulcerative colitis and Crohn's disease (typical adult dosing – may vary by physician):
  • Initial doses are often gradually increased to improve tolerance. A common total daily dose ranges from 2 g to 4 g of sulfasalazine, divided into several doses per day. This corresponds to 4–8 tablets of 500 mg daily, taken in divided doses.
  • Maintenance doses are usually lower than induction doses and are individualized by the physician.
• For rheumatoid arthritis (typical adult dosing – may vary):
  • Therapy is usually started at a low dose and gradually increased to a usual maintenance dose of about 2 g per day (4 tablets of 500 mg), in divided doses, as directed by a rheumatologist.
• Swallow the tablets whole with a glass of water. Do not crush, break, or chew the tablets, as this will damage the enteric coating.
• Take with food or after meals to help reduce gastrointestinal side effects, unless your doctor advises otherwise.
• Take the doses at evenly spaced intervals throughout the day for best effect.
• Drink plenty of fluids during treatment, unless otherwise directed by your doctor.
• If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. Do not double the dose to make up for a missed one.
• Duration of treatment depends on the condition and your doctor’s evaluation; do not stop treatment abruptly without medical advice, especially in chronic inflammatory bowel disease or rheumatoid arthritis.

Clinical Benefits:

• Reduces inflammation in the intestinal wall by inhibiting lipoxygenase and decreasing production of pro-inflammatory leukotrienes and 5-hydroxyeicosatetraenoic acids (hete).
• Helps decrease inflammatory mediators such as interleukin-1 and tumor necrosis factor-alpha (tnf-α), contributing to symptom relief in inflammatory bowel disease and rheumatoid arthritis.
• Improves symptoms of ulcerative colitis and Crohn's disease, including diarrhea, rectal bleeding, abdominal pain, and urgency.
• Acts as a disease-modifying antirheumatic drug (DMARD) in rheumatoid arthritis, helping to reduce joint pain, swelling, and long-term joint damage when used as part of a comprehensive treatment plan.
• Enteric-coated formulation enhances delivery to the intestine, improving local anti-inflammatory action and potentially improving tolerability.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to sulfasalazine, sulfonamides, salicylates, or any component of the formulation.
• Contraindicated in patients with intestinal or urinary obstruction, and in those with porphyria (risk of acute attack).
• Use with caution in patients with liver impairment, kidney impairment, blood dyscrasias, or severe allergies or asthma.
• May cause folic acid deficiency; your doctor may recommend folic acid supplementation and regular blood tests.
• May reduce the efficacy of digoxin; patients on digoxin should be monitored and dosing adjusted as necessary.
• Regular monitoring of complete blood count (cbc), liver function tests, and kidney function is recommended during long-term therapy.
• Discontinue and contact your doctor immediately if you develop signs of blood disorders (unusual bruising, bleeding, sore throat, fever), severe skin reactions, yellowing of the skin or eyes, or persistent abdominal pain.
• Consult your doctor before use if pregnant or planning pregnancy; sulfasalazine may affect folate metabolism and folic acid supplementation is usually recommended.
• Consult your doctor before use if breastfeeding; sulfasalazine and its metabolites may pass into breast milk and could affect the infant.
• Use with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to risk of hemolysis.
• May cause photosensitivity; avoid excessive sun exposure and use sun protection.
• Consult your doctor before use if you are taking other medications, including methotrexate, azathioprine, warfarin, digoxin, or other DMARDs, due to potential interactions.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects: nausea, vomiting, loss of appetite, abdominal discomfort, diarrhea, headache, dizziness, and mild rash.
• Other possible effects: orange-yellow discoloration of urine or skin, reversible sperm count reduction in men, and mild hair thinning.
• Serious side effects (seek immediate medical attention): severe skin reactions (Stevens–Johnson syndrome, toxic epidermal necrolysis), severe rash or blistering, difficulty breathing, facial or tongue swelling, high fever, persistent sore throat, unusual bruising or bleeding, pallor, severe fatigue, jaundice (yellowing of skin or eyes), dark urine, severe abdominal pain, or blood in stools.
• If you experience any unexpected or persistent side effects, contact your doctor or pharmacist promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the package. Store at or below the temperature specified on the product packaging (exact temperature range is not available in the provided information).

Specifications:

• Product type: Prescription medicine – anti-inflammatory / disease-modifying agent for inflammatory bowel disease and rheumatoid arthritis.
• Active ingredient strength: sulfasalazine 500 mg per enteric-coated tablet.
• Form: enteric-coated tablet.
• Pack size: 20 enteric-coated tablets per pack (20 e.c. tabs).
• Route of administration: oral.
• Suitable for: adults and adolescents as prescribed by a physician; not recommended for children unless specifically directed by a pediatric specialist.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.