Label: SULFASALAZINE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated April 8, 2025

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  • DESCRIPTION
    Sulfasalazine tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or ...
  • INDICATIONS AND USAGE
    Sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - b) for the prolongation of the ...
  • CONTRAINDICATIONS
    Sulfasalazine tablets are contraindicated in:   Patients with intestinal or urinary obstruction,   Patients with porphyria as sulfonamides have been reported to precipitate an acute ...
  • WARNINGS
    Hepatic, Renal, and Hematologic Toxicity or Other Conditions - Only after critical appraisal should Sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias ...
  • PRECAUTIONS
    General: Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and ...
  • ADVERSE REACTIONS
    The most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third ...
  • DRUG ABUSE AND DEPENDENCE
    None reported.
  • OVERDOSAGE
    There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea ...
  • DOSAGE AND ADMINISTRATION
    The dosage of sulfasalazine tablets should be adjusted to each individual's response and tolerance. Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not ...
  • HOW SUPPLIED
    Product: 50090-0086 - NDC: 50090-0086-4 90 TABLET in a BOTTLE
  • REFERENCES
    1. Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981; 80:72–6. 2. Kaufman DW, editor. Birth defects ...
  • SPL UNCLASSIFIED SECTION
    LAB-0243-18.0 - Revised: 02/2025
  • Sulfasalazine
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  • INGREDIENTS AND APPEARANCE
    Product Information