Indications:

Tablets and delayed-release tablets Treatment of mild to moderate ulcerative colitis; adjunctive therapy in severe ulcerative colitis; prolongation of the remission period between acute attacks of ulcerative colitis. Delayed-release tablets Treatment of rheumatoid arthritis in patients who have responded inadequately to salicylates or other NSAIDs; treatment of children with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other NSAIDs. Unlabeled Uses Ankylosing spondylitis, Crohn disease, granulomatous colitis, regional enteritis.

Contraindications:

Patients with intestinal or urinary obstruction; porphyria; hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates.

Adverse reactions:

CNS Ataxia, cauda equine syndrome, convulsion, depression, drowsiness, Guillain-Barré syndrome, hallucinations, headache, hearing loss, insomnia, meningitis, peripheral neuropathy, tinnitus, transient lesions of the posterior spinal column, transverse myelitis, vertigo. Dermatologic Orange-yellow discoloration of skin. GI Abdominal pain, anorexia, bloody diarrhea, diarrhea, impaired folic acid absorption, gastric distress, nausea, pancreatitis, pseudomembranous enterocolitis, stomatitis, vomiting. Genitourinary Crystalluria, elevated creatinine, hematuria, hemolytic-uremic syndrome, nephritis, nephrotic syndrome, orange-yellow urine, proteinuria, toxic nephrosis with oliguria and anuria, UTI. Hematologic Agranulocytosis, aplastic anemia, congenital neutropenia, Heinz body anemia, hemolytic anemia, hypoprothrombinemia, leukopenia, megaloblastic (macrocytic) anemia, methemoglobinemia, myelodysplastic syndrome, purpura, thrombocytopenia. Hepatic Hepatocellular necrosis; cholestatic jaundice, cirrhosis, elevated LFTs, jaundice, Kawasaki-like syndrome, possible hepatocellular damage including liver necrosis and failure (postmarketing). Hypersensitivity Allergic myocarditis, alopecia, anaphylactoid reactions, arthralgia, epidermal necrolysis with or without corneal damage, erythema multiforme of Stevens-Johnson type, exfoliative dermatitis, fibrosing alveolitis, fulminant hepatitis, hepatic necrosis, hepatitis, generalized skin eruptions, lupus erythematosus phenomenon, parapsoriasis varioliformis acuta, pericarditis with or without tamponade, periorbital edema, photosensitization, pleuritis, polyarteritis nodosa, pruritus, rhabdomyolysis, serum sickness, transient pulmonary changes with eosinophilia and decreased pulmonary function, urticaria. Respiratory Cyanosis, pulmonary infiltrates. Miscellaneous Arthralgia, chills, drug fever, myalgia, periarteritis nodosum, pyrexia.

Interactions:

Digoxin Absorption of digoxin may be decreased. Folic acid Signs of folate deficiency have occurred, but specific symptoms related to deficiency have not been reported. Methotrexate Risk of methotrexate-induced bone marrow suppression may be enhanced. Sulfonylureas Increased sulfonylurea half-lives and hypoglycemia have occurred.

Warnings:

Pregnancy Category B . Lactation Excreted in breast milk. Children Safety and efficacy not established for children younger than 2 yr of age with ulcerative colitis. Safety and efficacy of delayed-release tablets not established for children younger than 6 yr of age with rheumatoid arthritis. Renal Function Use with caution. Hepatic Function Use with caution. Fertility Oligospermia and infertility have been observed in men treated with sulfasalazine; effects appear to be reversible when drug is withdrawn. Allergy or asthma Use with caution. Contact lenses May permanently stain soft contact lenses yellow. Delayed-release tablets Isolated instances of delayed-release tablets being passed undisintegrated. Immediately discontinue use of this doseform if noted. Fluid intake Maintain adequate fluid intake to prevent crystalluria and stone formation. Glucose-6-phosphate dehydrogenase deficiency Can produce clinically significant hemolysis in patients with G-6-PD deficiency. Porphyria May precipitate acute attacks of porphyria. Severe reactions Reactions, including death, have been associated with hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, and renal and hepatic damage. Irreversible neuromuscular and CNS changes and fibrosing alveolitis may occur. Sulfonamides There are chemical similarities to some goitrogens, diuretics (acetazolamide and thiazides), and oral hypoglycemic agents. Goiter production, diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist.

Form:

SOLUTION FOR INJECTION