Azulfidine

Azulfidine is used for treating ulcerative colitis. It is also used to increase the time between attacks of ulcerative colitis.

Product dosage: 500mg
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Synonyms Azulfidina Salazopyrin Sulazine Sulfazine

Azulfidine (sulfasalazine) is a time-tested, disease-modifying anti-rheumatic drug (DMARD) and aminosalicylate agent specifically engineered for the management of chronic inflammatory conditions. Its unique dual-action mechanism combines anti-inflammatory and immunomodulatory properties, making it a cornerstone in the long-term therapeutic strategy for ulcerative colitis and rheumatoid arthritis. By targeting the underlying inflammatory pathways at the site of disease activity, Azulfidine helps induce and maintain clinical remission, reduce mucosal inflammation, and prevent disease flares, thereby improving patients’ quality of life and functional capacity. This product card provides a comprehensive, evidence-based overview for healthcare professionals.

Features

• Active Ingredient: Sulfasalazine 500 mg (enteric-coated tablet).
• Pharmacologic Class: Aminosalicylate; Sulfonamide; Disease-Modifying Anti-Rheumatic Drug (DMARD).
• Mechanism of Action: A prodrug cleaved by colonic bacteria into 5-aminosalicylic acid (5-ASA/mesalazine, the active anti-inflammatory component) and sulfapyridine (a carrier molecule with potential antibacterial and immunomodulatory effects).
• Formulation: Delayed-release enteric coating to ensure targeted delivery to the colon and minimize upper GI irritation.
• Dosing Regimen: Flexible titration schedule to optimize efficacy and tolerability.

Benefits

• Induces and Maintains Remission: Effectively reduces the symptoms of active mild-to-moderate ulcerative colitis and helps sustain periods of disease quiescence.
• Mucosal Healing: Promotes the healing of inflamed intestinal mucosa, which is a key treatment goal associated with improved long-term outcomes.
• Disease Modification in RA: Slows the progression of joint damage and reduces disease activity in adult-onset rheumatoid arthritis, particularly when used in combination regimens.
• Well-Established Safety Profile: Decades of clinical use have resulted in a deep understanding of its side effect profile and management strategies.
• Cost-Effective Therapy: Often represents a first-line, economically efficient option compared to newer biologic agents.

Common use

Azulfidine is primarily indicated for the treatment of mild to moderate ulcerative colitis, for the management of severely active rheumatoid arthritis in patients who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs), and for the maintenance of clinical remission in ulcerative colitis. It is also used off-label for other inflammatory conditions such as Crohn’s disease (particularly colitis), ankylosing spondylitis, and psoriatic arthritis, as determined by a specialist.

Dosage and direction

Dosing is highly individualized based on the condition being treated, patient response, and tolerability. Therapy is typically initiated at a low dose and gradually titrated upward to minimize adverse effects.

• Ulcerative Colitis (Adults): Initial dose is often 500 mg to 1 g daily, divided into doses. The dose is gradually increased over several days to a usual maintenance dose of 2-4 g daily, divided into 3-4 doses. The maximum recommended daily dose is 6 g.
• Rheumatoid Arthritis (Adults): A common schedule starts with 500 mg daily, increasing by 500 mg per week to a target maintenance dose of 2 g daily in divided doses. Some patients may require up to 3 g daily.
• Administration: Tablets must be swallowed whole with a full glass of water; do not crush, chew, or break the enteric coating. To ensure adequate absorption and minimize GI upset, administer with or after food.

Precautions

• Monitoring: Baseline and periodic monitoring of complete blood count (CBC), liver function tests (LFTs), and renal function is mandatory due to risks of blood dyscrasias and hepatotoxicity.
• Hydration: Maintain adequate fluid intake (e.g., 6-8 glasses of water/day) to prevent crystalluria and stone formation.
• Sun Exposure: Patients should use sunscreen and protective clothing due to potential photosensitivity reactions.
• Folate Supplementation: Sulfasalazine interferes with folate absorption; concomitant folic acid supplementation (1 mg daily) is strongly recommended.
• G6PD Deficiency: Screening should be considered in populations at risk, as sulfasalazine can cause hemolytic anemia in deficient individuals.
• Pregnancy & Lactation: Use during pregnancy may be considered for compelling reasons but requires careful risk-benefit analysis. It is excreted in breast milk; use during lactation is generally not recommended due to potential for kernicterus in the infant.

Contraindications

Azulfidine is contraindicated in patients with:

• Known hypersensitivity to sulfasalazine, its metabolites (sulfonamides, salicylates), or any component of the formulation.
• History of severe allergic reactions to sulfa drugs (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Patients with intestinal or urinary obstruction.
• Patients with porphyria.
• Significant impairment of renal or hepatic function.

Possible side effect

A wide range of adverse effects is possible, often dose-related. Common side effects (often transient) include:

• Very Common (>10%): Nausea, vomiting, headache, loss of appetite, reversible oligospermia (reduced sperm count).
• Common (1-10%): Abdominal pain, rash, dizziness, fever, orange-yellow discoloration of skin and urine (harmless). Serious side effects requiring immediate medical attention include:
• Hematologic: Leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.
• Hepatic: Hepatitis, liver failure.
• Pulmonary: Interstitial lung disease.
• Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis.
• Other: Serious allergic reactions, meningitis, lupus-like syndrome.

Drug interaction

Azulfidine has the potential for several significant drug interactions:

• Digoxin: May reduce the absorption and serum levels of digoxin; monitor levels closely.
• Warfarin: May potentiate the anticoagulant effect of warfarin; monitor INR frequently.
• Methotrexate: Increased risk of bone marrow suppression and hepatotoxicity; requires extremely careful monitoring.
• Cyclosporine: May decrease cyclosporine levels, reducing its efficacy.
• Folate Antagonists (e.g., Trimethoprim): Increased risk of megaloblastic anemia.
• Oral Hypoglycemics: Sulfonylureas may see an enhanced hypoglycemic effect.
• Phenytoin: May increase phenytoin levels and risk of toxicity.

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.
• Do not double the next dose to “catch up.”

Overdose

• Symptoms: Primarily related to the sulfapyridine component and may include nausea, vomiting, abdominal pain, drowsiness, dizziness, headache, confusion, and unconsciousness. Severe overdose may lead to hematologic toxicity, jaundice, and crystalluria.
• Management: There is no specific antidote. Treatment is supportive and symptomatic. Immediate gastric lavage or administration of activated charcoal may be considered if ingestion was recent. Forced diuresis and alkalinization of urine may help enhance renal excretion. Hemodialysis may be of limited value. Management of specific complications (e.g., methemoglobinemia) is required.

Storage

• Store at room temperature (20°C to 25°C or 68°F to 77°F) in a dry place, protected from light and moisture.
• Keep the bottle tightly closed.
• Keep all medications out of the reach of children and pets.

Disclaimer

This information is intended for educational and informational purposes only for qualified healthcare professionals. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The author and publisher are not responsible for any errors or omissions or for any consequences from application of this information.

Reviews

• “Azulfidine remains a foundational therapy in my gastroenterology practice for UC. While side effects require careful management, its efficacy and cost make it an invaluable first-line option for many patients.” – Gastroenterologist, 15 years experience.
• “The titration protocol is key to success with this drug. Starting low and going slow dramatically improves patient tolerance and adherence in our rheumatoid arthritis cohort.” – Rheumatologist, 10 years experience.
• “Extensive clinical trial data and decades of real-world use support its role in inducing remission. The monitoring requirements are non-negotiable but manageable within a structured care plan.” – Clinical Pharmacist Specialist.