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AZULFIDINE®(sulfasalazine)

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AZULFIDINE® Quick Finder

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INDICATIONS AND USAGE

AZULFIDINE Tablets are indicated:

•
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
•
for the...
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DOSAGE AND ADMINISTRATION

The dosage of AZULFIDINE Tablets should be adjusted to each individual's response and tolerance.

Initial Therapy

Adults...

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CONTRAINDICATIONS

AZULFIDINE Tablets are contraindicated in:

 
Patients with intestinal or urinary obstruction,
 
Patients with porphyria as sulfonamides have been reported to precipitate...
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WARNINGS

Hepatic, Renal, and Hematologic Toxicity or Other Conditions

Only after critical appraisal should AZULFIDINE Tablets be given to...

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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 of the...

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DRUG ABUSE AND DEPENDENCE

None reported.

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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, vomiting, gastric...

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DESCRIPTION

AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration.

Therapeutic Classification: Anti-inflammatory agent.

Chemical Designation...

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CLINICAL PHARMACOLOGY

Pharmacodynamics

The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be...

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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 and...
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HOW SUPPLIED

AZULFIDINE Tablets, 500 mg, are round, gold-colored, scored tablets, monogrammed "101" on one side and "KPh" on the other. They are available in the following package sizes:

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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(800)-332-1088.