• Colorectal disorders

Azulfidine Generic Name & Formulations

General Description

Sulfasalazine 500mg; scored tabs.

Pharmacological Class


How Supplied

Tabs—100, 300


Generic Availability


Azulfidine Indications


Mild to moderate ulcerative colitis. Adjunct in severe ulcerative colitis. To prolong the remission period between acute attacks of ulcerative colitis.

Azulfidine Dosage and Administration


Initially 1–2g daily, increase gradually to 3–4g daily in equally divided doses after meals until symptoms controlled. Maintenance 2g daily; max 4g/day. Minimize gastric intolerance by using EN-tabs, dosing more frequently, reducing dose, or discontinuing for 5–7 days and restarting at lower dose. EN-tabs: swallow whole after meals.


<6yrs: not established. ≥6yrs: initially 40–60mg/kg per day in 3–6 doses. Maintenance: 30mg/kg per day in 4 doses.

Azulfidine Contraindications


Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.

Azulfidine Boxed Warnings

Not Applicable

Azulfidine Warnings/Precautions


Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if renal function deteriorates while on therapy, toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Monitor for signs/symptoms of infection before and after therapy; discontinue if serious infection develops. History of recurring or chronic infections. Underlying conditions or concomitant drugs which may predispose to infections. Severe allergy. Asthma. G6PD deficiency. Monitor CBCs, differential WBC, LFTs before starting, every other week for 1st 3 months, then once monthly for next 3 months, then once every 3 months; urinalysis, renal function, and serum sulfapyridine periodically; discontinue while awaiting blood test results. Maintain adequate hydration. Continue medication after symptoms controlled. See full labeling for desensitizing regimen. Elderly. Pregnancy. Nursing mothers: monitor infants.

Azulfidine Pharmacokinetics


Intestinal bacteria, hepatic. >99.3% plasma protein bound.


Renal (37%).

Azulfidine Interactions


Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.

Azulfidine Adverse Reactions

Adverse Reactions

Anorexia, headache, nausea, vomiting, gastric distress, oligospermia, infertility in men, pruritus, urticaria, rash, fever, hemolytic anemia, other blood dyscrasias, urine or skin discoloration, cyanosis; CNS, renal, hypersensitivity, or severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP), hepatotoxicity.

Azulfidine Clinical Trials

See Literature

Azulfidine Note

Not Applicable

Azulfidine Patient Counseling

See Literature