FDA label 6158462d-f953-413e-ad90-ae2ea3c41601

WARNINGS FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. SULFONAMIDES, INCLUDING SULFISOXAZOLE, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF AN ADVERSE REACTION. In rare instances, a skin rash may be followed by more severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis and serious blood disorders (see PRECAUTIONS ). Clinical signs such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions. Cough, shortness of breath and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment. The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including sulfisoxazole, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

ADVERSE REACTIONS The listing that follows includes adverse reactions both that have been reported with Gantrisin and some which have not been reported with this specific drug; however, the pharmacologic similarities among the sulfonamides require that each of the reactions be considered with the administration of Gantrisin. Allergic/Dermatologic: Anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, exfoliative dermatitis, angioedema, arteritis and vasculitis, allergic myocarditis, serum sickness, rash, urticaria, pruritus, photosensitivity, and conjunctival and scleral injection, generalized allergic reactions and generalized skin eruptions. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported (see WARNINGS ). Cardiovascular: Tachycardia, palpitations, syncope, cyanosis. Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and thiazides) and oral hypoglycemia agents. Cross-sensitivity may exist with these agents. Development of goiter, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Gastrointestinal: Hepatitis, hepatocellular necrosis, jaundice, pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, salivary gland enlargement, pancreatitis. Onset of pseudomembranous colitis symptoms may occur during or after treatment with sulfisoxazole (see WARNINGS ). Sulfisoxazole has been reported to cause increased elevations of liver-associated enzymes in patients with hepatitis. Genitourinary: Crystalluria, hematuria, BUN and creatinine elevations, nephritis and toxic nephrosis with oliguria and anuria. Acute renal failure and urinary retention have also been reported. The frequency of renal complications, commonly associated with some sulfonamides, is lower in patients receiving the more soluble sulfonamides such as sulfisoxazole. Hematologic: Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, purpura, hemolyticanemia, anemia, eosinophilia, clotting disorders including hypoprothrombinemia, and hypofibrinogenemia, sulfhemoglobinemia, methemoglobinemia. Musculoskeletal: Arthralgia, myalgia. Neurologic: Headache, dizziness, peripheral neuritis, paresthesia, convulsions, tinnitus, vertigo, ataxia, intracranial hypertension. Psychiatric: Psychosis, hallucination, disorientation, depression, anxiety, apathy. Respiratory: Cough, shortness of breath, pulmonary infiltrates (see WARNINGS ). Vascular: Angioedema, arteritis, vasculitis. Miscellaneous: Edema (including periorbital), pyrexia, drowsiness, weakness, fatigue, lassitude, rigors, flushing, hearing loss, insomnia, pneumonitis, chills.