Sulfasalazine

Sulfasalazine

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Questions & Answers

Side Effects & Adverse Reactions

Only after critical appraisal should sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving sulfasalazine (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.

Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue sulfasalazine if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with sulfasalazine. For a patient who develops a new infection during treatment with sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Caution should be exercised when considering the use of sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections.

Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of sulfasalazine. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and
systemic symptoms have been reported in patients taking sulfasalazine. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Sulfasalazine tablets, USP are indicated:

  1. in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
  2. for the prolongation of the remission period between acute attacks of ulcerative colitis.

History

There is currently no drug history available for this drug.

Other Information

Sulfasalazine Tablets USP, 500 mg for oral administration.

Therapeutic Classification:

Anti-inflammatory agent.

Chemical Designation:

5-([ p-(2-Pyridylsulfamoyl)phenyl]azo) salicylic acid.

Structural Formula:
This is an image of the structural formula for sulfasalazine.
Inactive Ingredients:

corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc.

Therapeutic Classification:

Anti-inflammatory agent.

Chemical Designation:

5-([ p-(2-Pyridylsulfamoyl)phenyl]azo) salicylic acid.

Structural Formula:
This is an image of the structural formula for sulfasalazine.

Sulfasalazine Manufacturers


  • Blenheim Pharmacal, Inc.
    Sulfasalazine Tablet [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Sulfasalazine Tablet [A-s Medication Solutions Llc]
  • Major Pharmaceuticals
    Sulfasalazine Tablet [Major Pharmaceuticals]
  • Remedyrepack Inc.
    Sulfasalazine Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfasalazine Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc
    Sulfasalazine Tablet [Preferred Pharmaceuticals, Inc]
  • Remedyrepack Inc.
    Sulfasalazine Tablet [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Sulfasalazine Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Watson Laboratories, Inc.
    Sulfasalazine Tablet [Watson Laboratories, Inc.]
  • Remedyrepack Inc.
    Sulfasalazine Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Sulfasalazine Tablet [A-s Medication Solutions Llc]
  • Avpak
    Sulfasalazine (Sulfasalazine) Tablet [Avpak]
  • Aidarex Pharmaceuticals Llc
    Sulfasalazine Tablet [Aidarex Pharmaceuticals Llc]
  • Greenstone Llc
    Sulfasalazine Tablet, Delayed Release [Greenstone Llc]
  • Greenstone Llc
    Sulfasalazine Tablet [Greenstone Llc]
  • Qualitest Pharmaceuticals
    Sulfasalazine Tablet [Qualitest Pharmaceuticals]
  • Aphena Pharma Solutions – Tennessee, Llc
    Sulfasalazine Tablet [Aphena Pharma Solutions – Tennessee, Llc]

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