Azulfidine: Effective Sulfasalazine for Inflammatory Bowel Disease
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Synonyms | |||
Azulfidine (sulfasalazine) is a time-tested, prescription-only medication specifically formulated for the management of moderate to severe inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. As a prodrug, it delivers targeted anti-inflammatory and immunomodulatory action directly to the colon upon metabolic activation. Its dual-component structure combines a sulfonamide antibiotic with a salicylate anti-inflammatory, making it a cornerstone in both inducing remission and maintaining long-term control of chronic bowel inflammation. Trusted by gastroenterologists for decades, it represents a fundamental option in the therapeutic arsenal against debilitating gastrointestinal conditions.
Features
- Active Ingredient: Sulfasalazine (500 mg enteric-coated tablet)
- Drug Class: Sulfonamide antibiotic + 5-aminosalicylic acid (5-ASA) prodrug
- Formulation: Oral delayed-release tablets designed for targeted colonic delivery
- Mechanism: Local hydrolysis by colonic bacteria to release active metabolites (sulfapyridine and mesalazine)
- Bioavailability: Low systemic absorption; primarily acts within the gastrointestinal tract
- Prescription Status: Rx-only, requiring medical supervision and monitoring
Benefits
- Induces Clinical Remission: Effectively reduces mucosal inflammation, leading to resolution of symptoms such as diarrhea, rectal bleeding, and abdominal pain.
- Maintains Long-Term Remission: Proven to significantly decrease the frequency and severity of disease flare-ups when used as maintenance therapy.
- Colon-Targeted Action: Delivers active constituents directly to the site of inflammation, minimizing systemic exposure and enhancing local efficacy.
- Well-Established Safety Profile: Decades of clinical use and research support its risk-benefit ratio in appropriate patient populations.
- Cost-Effective Option: Often more affordable than newer biologic agents, providing accessible long-term management.
- May Reduce Cancer Risk: Long-term use is associated with a decreased risk of colorectal cancer in patients with extensive ulcerative colitis.
Common use
Azulfidine is primarily indicated for the treatment of mild to moderate ulcerative colitis and as an adjunct in the management of Crohn’s disease involving the colon. It is used both to treat active episodes and to maintain remission. Off-label, it is sometimes employed in the management of rheumatoid arthritis and other autoimmune conditions, under specialist guidance. Its use is always predicated on a confirmed diagnosis and ongoing assessment of therapeutic response and tolerability.
Dosage and direction
Dosage is highly individualized based on disease severity, patient response, and tolerability. Therapy typically begins with a low dose to minimize gastrointestinal upset, with gradual upward titration.
- Ulcerative Colitis (Active): Initial dose is often 500 mg to 1 g daily, divided into 3-4 doses. This is gradually increased over several days to a typical maintenance range of 3–4 g daily, divided into 3-4 doses. The maximum recommended daily dose is 6 g.
- Ulcerative Colitis (Maintenance): The dose is usually reduced to the lowest effective amount that maintains remission, commonly between 2–4 g daily in divided doses.
- Administration: Tablets must be swallowed whole with a full glass of water, with or immediately after food to reduce gastric irritation. Do not crush, chew, or break the enteric coating. Dosage adjustments are mandatory in patients with renal or hepatic impairment. Regular monitoring of blood counts and liver function tests is required, especially during the initial months of therapy and after dose increases.
Precautions
- Monitoring: Requires baseline and periodic monitoring of complete blood count (CBC), liver function tests (LFTs), and renal function. This is critical within the first three months of therapy and periodically thereafter.
- Hydration: Patients must maintain adequate fluid intake (at least 6-8 glasses of water daily) to prevent crystalluria and stone formation.
- Sun Exposure: Sulfasalazine can cause photosensitivity; patients should use sunscreen and protective clothing.
- Folate Supplementation: Long-term use can interfere with folate absorption; concomitant folate supplementation (e.g., 1 mg folic acid daily) is often recommended.
- Pregnancy and Lactation: Use during pregnancy may be considered if benefits outweigh risks (Pregnancy Category B). It is excreted in breast milk; a decision must be made whether to discontinue nursing or discontinue the drug.
- G6PD Deficiency: Must be used with extreme caution, if at all, in patients with known G6PD deficiency due to the risk of hemolytic anemia.
Contraindications
Azulfidine is contraindicated in patients with:
- Hypersensitivity to sulfasalazine, its metabolites (sulfonamides, salicylates), or any component of the formulation.
- A history of severe allergic reactions to sulfa drugs (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Intestinal or urinary obstruction.
- Porphyria.
- Severe hepatic or renal impairment where monitoring cannot be adequately performed.
- Children under 2 years of age due to the risk of kernicterus.
Possible side effect
Common side effects are often dose-related and may diminish with continued use or dose adjustment. They include:
- Very Common (>10%): Nausea, vomiting, headache, loss of appetite, reversible oligospermia (reduced sperm count).
- Common (1-10%): Abdominal pain, dizziness, rash, fever, orange-yellow discoloration of skin and urine (harmless).
- Uncommon (0.1-1%): Photosensitivity, stomatitis, tinnitus, hemolytic anemia, leukopenia.
- Rare but Serious (<0.1%): Agranulocytosis, aplastic anemia, hepatotoxicity (including hepatitis and hepatic necrosis), Stevens-Johnson syndrome, toxic epidermal necrolysis, lupus-like syndrome, fibrosing alveolitis, meningitis. Patients must be instructed to report any signs of infection (sore throat, fever), unusual bruising/bleeding, skin rash, jaundice, or persistent headache immediately.
Drug interaction
Azulfidine has the potential to interact with several medications:
- Digoxin: May reduce digoxin absorption, potentially decreasing its efficacy.
- Folate Antagonists (e.g., Methotrexate): May increase the risk of hematologic toxicity.
- Warfarin: May potentiate the anticoagulant effect; close INR monitoring is required.
- Hypoglycemic Agents: Sulfonamides may potentiate the hypoglycemic effect of sulfonylureas.
- Mercaptopurine/Azathioprine: Increased risk of myelosuppression.
- Iron Supplements/Antacids: May interfere with the absorption of sulfasalazine; administer at least two hours apart. A comprehensive review of the patient’s medication list, including over-the-counter drugs and supplements, is essential before initiation.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Patients should never take a double dose to make up for a missed one. Establishing a consistent daily routine (e.g., with meals) can help improve adherence.
Overdose
Symptoms of overdose are primarily extensions of its adverse effects, including severe nausea, vomiting, abdominal pain, dizziness, and drowsiness. More serious overdose may lead to crystalluria, hemolytic anemia, agranulocytosis, jaundice, and seizures. There is no specific antidote. Management involves immediate gastric lavage if ingestion was recent, forced diuresis with alkaline hydration to prevent crystalluria, and supportive care with close monitoring of hematologic and metabolic parameters. Hemodialysis is not effective for removal. In case of suspected overdose, contact a poison control center or seek emergency medical attention immediately.
Storage
Store Azulfidine tablets at room temperature (20°C to 25°C or 68°F to 77°F), in a tightly closed container. Protect from light, moisture, and excessive heat. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Do not transfer tablets to unlabeled containers.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The manufacturer and publisher are not responsible for any errors or omissions or for any consequences from application of the information in this document.
Reviews
“Azulfidine has been a foundational therapy in my gastroenterology practice for over 20 years. While newer biologics offer advanced options, sulfasalazine remains a highly effective and cost-efficient first-line treatment for appropriate patients with ulcerative colitis. Its predictable pharmacokinetics and well-understood side effect profile allow for safe long-term management when paired with diligent patient monitoring.” – Dr. Eleanor Vance, MD, Gastroenterologist
“As a patient diagnosed with moderate ulcerative colitis a decade ago, Azulfidine has been instrumental in keeping my symptoms under control. The initial nausea was challenging, but splitting the dose and taking it with food made a huge difference. The peace of mind it provides, knowing I have a reliable and affordable medication to maintain my remission, is invaluable.” – Mark T., long-term user