Brands, Medical Use, Clinical Data
Drug Category
- Antirheumatic Agents
- Gastrointestinal Agents
- Anti-inflammatory Agents
- Anti-Infectives
- Sulfonamides
Dosage Forms
Brands / Synonyms
Accucol; Alti-Sulfasalazine; Asulfidine; Azlufidine EN-Tabs; Azopyrin; Azopyrine; Azulfidine; Azulfidine EN-Tabs; Benzosulfa; Colo-Pleon; PMS-Sulfasalazine; Pms-Sulfasalazine E.C.; Reupirin; Rorasul; S.A.S. Enteric-500; Salazopiridazin; Salazopyridin; Salazopyrin; Salazopyrin EN-Tabs; Salazosulfapyridin; Salazosulfapyridine; Salicylazosulfapyridine; Salisulf; Sulcolon; Sulfasalazin; Sulfasalazine; Sulphasalazine; W-T Sasp Oral
Indications
For the treatment of Crohn's disease and rheumatoid arthritis as a second-line agent.
Pharmacology
Sulfasalazine is an anti-inflammatory indicated for the treatment of ulcerative colitis and rheumatoid arthritis.
Mechanism of Action
The mode of action of Sulfasalazine or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine, SP and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.
Absorption
Not Available
Toxicity
Not Available
Biotrnasformation / Drug Metabolism
Not Available
Contraindications
AZULFIDINE EN-tabs Tablets are contraindicated in:
Hypersensitivity to sulfasalazine, its metabolites, sulfonamides or salicylates,
Patients with intestinal or urinary obstruction,
Patients with porphyria, as the sulfonamides have been reported to precipitate an acute attack.
Drug Interactions
Reduced absorption of folic acid and digoxin have been reported when those agents were administered
concomitantly with sulfasalazine.
When daily doses of sulfasalazine 2 g and weekly doses of methotrexate 7.5 mg were coadministered to
15 rheumatoid arthritis patients in a drug-drug interaction study, the pharmacokinetic disposition of the drugs was
not altered.
Daily doses of sulfasalazine 2 g (maximum 3 g) and weekly doses of methotrexate 7.5 mg (maximum 15 mg)
were administered alone or in combination to 310 rheumatoid arthritis patients in two controlled 52-week clinical
studies. The overall toxicity profile of the combination revealed an increased incidence of gastrointestinal adverse
events, especially nausea, when compared to the incidence associated with either drug administered alone.
Drug/Laboratory Test Interactions: The presence of sulfasalazine or its metabolites in
body fluids has not been reported to interfere with laboratory test procedures.
REFERENCES
7.Farr M, et al. Immunodeficiencies associated with sulphasalazine therapy in inflammatory arthritis.
British Jnl Rheum 1991;30:413-417.
|
