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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AZULFIDINE® (sulfasalazine)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
AZULFIDINE® Quick Finder
Indications and Usage
Dosage and Administration
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
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 and Precautions
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
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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Overdosage
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
DESCRIPTION
AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration.
Therapeutic Classification: Anti-inflammatory agent.
Chemical Designation...
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Clinical Pharmacology
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
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/Storage and Handling
...
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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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.