Azulfidine: Targeted Relief for Inflammatory Bowel Disease
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Synonyms | |||
Azulfidine (sulfasalazine) is a time-tested, disease-modifying anti-rheumatic drug (DMARD) and aminosalicylate specifically engineered for the management of chronic inflammatory conditions. It is a cornerstone therapy in gastroenterology and rheumatology, offering a dual mechanism of action that combines anti-inflammatory and immunomodulatory effects. This medication is primarily indicated for the treatment of moderately to severely active ulcerative colitis and rheumatoid arthritis, providing both symptomatic control and long-term disease modification. Its unique prodrug design allows for targeted delivery to the colon, maximizing therapeutic efficacy while minimizing systemic exposure.
Features
- Active Ingredient: Sulfasalazine 500 mg enteric-coated tablets.
- Mechanism: A prodrug metabolized into 5-aminosalicylic acid (5-ASA) and sulfapyridine, providing both local anti-inflammatory and systemic immunomodulatory effects.
- Formulation: Delayed-release tablets designed to minimize gastric irritation and ensure targeted release in the colon.
- Prescription Status: Available by prescription only, requiring medical supervision for initiation and monitoring.
Benefits
- Induces and maintains clinical remission in patients with active ulcerative colitis, reducing the frequency and severity of flare-ups.
- Modifies the disease course in rheumatoid arthritis by reducing joint pain, swelling, and progression of structural damage.
- Provides a well-established safety profile with decades of clinical use and extensive post-marketing surveillance data.
- Offers a cost-effective therapeutic option compared to many biologic agents, improving accessibility for long-term management.
- Reduces systemic corticosteroid dependence by providing effective disease control, thereby minimizing steroid-related adverse effects.
- Improves quality of life by enabling better disease control, reduced hospitalization rates, and improved physical function.
Common use
Azulfidine is primarily prescribed for the management of chronic inflammatory conditions. Its most common applications include the treatment of moderately to severely active ulcerative colitis, where it is used both to induce remission during acute episodes and as maintenance therapy to prevent relapse. In rheumatology, it is indicated for the management of rheumatoid arthritis in patients who have had an inadequate response to other non-biologic DMARDs. It may also be used off-label for other inflammatory conditions such as Crohn’s disease (particularly colitis-predominant), ankylosing spondylitis, and psoriatic arthritis, though evidence supporting these uses is more limited. Treatment typically begins after comprehensive diagnostic evaluation confirms an inflammatory etiology.
Dosage and direction
Dosage must be individualized based on the specific condition being treated, disease severity, patient tolerance, and clinical response. For ulcerative colitis in adults: Initial therapy typically begins with 1-2 g daily in divided doses, gradually increasing over several days to a maintenance dose of 2-4 g daily in divided doses. Maximum daily dose should not exceed 4 g. For rheumatoid arthritis in adults: Begin with 500 mg daily, increasing gradually by 500 mg weekly to a maintenance dose of 2-3 g daily in divided doses. Tablets should be swallowed whole with a full glass of water, preferably with food or milk to minimize gastrointestinal upset. Regular monitoring of blood counts and liver function is essential during therapy. Dosage adjustments may be necessary based on clinical response and laboratory parameters.
Precautions
Patients should be thoroughly evaluated before initiating therapy with Azulfidine. Complete blood count, liver function tests, and renal function assessment should be obtained at baseline and regularly during treatment. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency should be monitored closely for hemolysis. Adequate hydration must be maintained to prevent crystalluria and stone formation. The medication may cause orange-yellow discoloration of urine and skin, which is harmless but should be explained to patients to avoid unnecessary concern. Patients should be advised that response may not be immediate, with full therapeutic benefit often taking several weeks to manifest. Regular ophthalmologic examinations are recommended during long-term therapy due to potential ocular effects.
Contraindications
Azulfidine is contraindicated in patients with known hypersensitivity to sulfasalazine, its metabolites, other sulfonamides, or salicylates. It should not be used in patients with intestinal or urinary obstruction due to the potential for crystalline precipitation. Additional contraindications include porphyria, severe liver disease, and severe renal impairment (creatinine clearance <30 mL/min). The medication is contraindicated in children under 2 years of age due to the risk of kernicterus. Patients with a history of agranulocytosis, aplastic anemia, or other serious blood dyscrasias related to sulfonamide use should not receive this medication.
Possible side effect
The most common adverse reactions involve the gastrointestinal system, including nausea (≈20%), vomiting (≈10%), anorexia (≈10%), and abdominal pain (≈5%). Headache (≈15%) and dizziness (≈5%) are frequently reported neurological effects. Reversible oligospermia and male infertility may occur but typically resolve after discontinuation. Skin reactions range from mild rash (≈5%) to serious conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (<0.1%). Hematological effects include leukopenia (≈3%), neutropenia (≈2%), and rarely agranulocytosis or aplastic anemia. Hepatic reactions may include elevated transaminases (≈5%) and rarely hepatitis. Pulmonary complications such as eosinophilic pneumonia and fibrosing alveolitis have been reported. Patients should be instructed to report any fever, sore throat, mouth ulcers, rash, or unusual bleeding promptly.
Drug interaction
Azulfidine may interact with several medication classes. It may enhance the effects of oral anticoagulants, sulfonylureas, and phenytoin by displacing these drugs from protein binding sites. Concurrent use with methotrexate may increase the risk of hematological toxicity. Digoxin absorption may be reduced, necessitating monitoring of digoxin levels. Antibiotics may interfere with the intestinal bacterial metabolism required for sulfasalazine activation. The medication may decrease folic acid absorption, warranting supplementation. Urinary alkalinizers may increase the risk of crystalluria. Live bacterial vaccines may have diminished efficacy during therapy. A comprehensive medication review should be conducted before initiation and during treatment.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed one. Consistent dosing is important for maintaining therapeutic effect, particularly in the management of chronic inflammatory conditions. If multiple doses are missed or uncertainty exists about how to proceed, patients should consult their healthcare provider for guidance rather than attempting to adjust the regimen independently.
Overdose
Sulfasalazine overdose may manifest as nausea, vomiting, abdominal pain, dizziness, headache, drowsiness, and unconsciousness. Hematological effects including hemolysis, methemoglobinemia, and agranulocytosis may occur. In severe cases, renal and hepatic toxicity may develop. There is no specific antidote for sulfasalazine overdose. Management is supportive and symptomatic, including gastric lavage if presented early, activated charcoal, and appropriate fluid and electrolyte management. Hemodialysis may be of limited value due to high protein binding but may be considered in severe cases. Patients should be monitored for methemoglobinemia and treated with methylene blue if necessary. Hospitalization and intensive supportive care are recommended for significant overdoses.
Storage
Azulfidine tablets should be stored at controlled room temperature (20-25°C or 68-77°F) in their original container, protected from light and moisture. The medication should be kept out of reach of children and pets. Tablets should not be removed from their blister packaging until immediately before use to maintain stability. Do not store in bathrooms or other areas with high humidity. Properly discard any medication that has expired or is no longer needed through medication take-back programs or following specific disposal instructions. Do not flush medications down the toilet unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Azulfidine is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual response to medication may vary, and the prescribing physician is the ultimate authority regarding appropriate use, dosage, and duration of therapy. Patients should not initiate, discontinue, or modify their treatment regimen without consulting their healthcare provider. The complete prescribing information should be consulted for comprehensive details about uses, precautions, and adverse effects.
Reviews
Clinical studies spanning decades have established Azulfidine as an effective therapy for inflammatory bowel disease and rheumatoid arthritis. In ulcerative colitis trials, approximately 60-80% of patients achieve clinical improvement, with remission rates of 40-50% at 6 months. Rheumatoid arthritis studies demonstrate significant improvement in tender and swollen joint counts, with 50-60% of patients achieving ACR20 response criteria. Long-term observational studies confirm sustained efficacy with appropriate monitoring. Patient-reported outcomes indicate improved quality of life measures, particularly regarding reduced disease flare frequency and decreased steroid requirements. The safety profile is generally favorable with appropriate monitoring, though the requirement for regular blood tests is noted as a drawback by some patients. Overall, Azulfidine remains a valuable therapeutic option in the management of chronic inflammatory conditions.