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Basic Drug Info
Drug Name:Sulfasalazine
Manufacturer:Vintage Pharmaceuticals, Inc.
Other Info:Manufactured by:VINTAGE PHARMACEUTICALS, INC.Charlotte, NC 282068180829R12/06-R13



Clinical Trials:


Indications and Usage

Sulfasalazine Delayed-Release Tablets, USP, 500 mg are indicated:a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.Sulfasalazine Delayed-Release Tablets, USP, 500 mg is particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued.

Unlike anti-inflammatory drugs, Sulfasalazine Delayed-Release Tablets, USP, 500 mg does not produce an immediate response.

Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of Sulfasalazine Delayed-Release Tablets, USP, 500 mg is apparent.
Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

CHYLOMICRON RETENTION DISEASE --

Polyarticular juvenile rheumatoid arthritis --

Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Vomiting -- The forcible expulsion of the contents of the STOMACH through the MOUTH.

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Chronic Childhood Arthritis -- Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Contraindications
Sulfasalazine Delayed-Release Tablets, USP, 500 mg 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Obstructive Uropathy --

Porphyria -- group of disorders characterized by the excessive production of porphyrins or their precursors that arises from abnormalities in the regulation of the porphyrin-heme pathway; acquired porphyrias, which are due to inhibition of enzymes in the metabolic pathway by a drug, toxin or abnormal metabolite, are more common than those which are inherited.

Warnings

Only after critical appraisal should Sulfasalazine Delayed-Release Tablets, USP, 500 mg 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.

Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving Sulfasalazine Delayed-Release Tablets, USP, 500 mg (see PRECAUTIONS, Laboratory Tests).

Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.
Branded Drugs
The following US Branded drugs contain Sulfasalazine


AZULFIDINE -- PHARMACIA AND UPJOHN CO

AZULFIDINE EN-TABS -- PHARMACIA AND UPJOHN CO

S.A.S.-500 -- SOLVAY PHARMACEUTICALS


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