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.

It has been reported that sulfisoxazole may prolong the prothrombin time in patients who are receiving anticoagulants, including warfarin. This interaction should be kept in mind when Gantrisin is given to patients already on anticoagulant therapy, and prothrombin time or other suitable coagulation test should be monitored.

It has been proposed that sulfisoxazole competes with thiopental for plasma protein binding. In one study involving 48 patients, intravenous sulfisoxazole resulted in a decrease in the amount of thiopental required for anesthesia and in a shortening of the awakening time. It is not known whether chronic oral doses of sulfisoxazole would have a similar effect. Until more is known about this interaction, physicians should be aware that patients receiving sulfisoxazole might require less thiopental for anesthesia.

Sulfonamides can displace methotrexate from plasma protein-binding sites, thus increasing free methotrexate concentrations. Studies in man have shown sulfisoxazole infusions to decrease plasma protein-bound methotrexate by one-fourth.

Sulfisoxazole can also potentiate the blood sugar lowering activity of sulfonylureas, as well as cause hypoglycemia by itself.

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