"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The amount of a single dose of sulfisoxazole that is associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.
General principles of treatment include the immediate discontinuation of the drug; institution of gastric lavage or emesis; forcing oral fluids; and the administration of intravenous fluids if urine output is low and renal function is normal. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If the patient becomes cyanotic, the possibility of methemoglobinemia should be considered and, if present, the condition should be treated appropriately with intravenous 1% methylene blue. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications.
Gantrisin (acetyl sulfisoxazole pediatric suspension) is contraindicated in the following patient populations: patients with a known hypersensitivity to sulfonamides; infants less than 2 months of age (except in the treatment of congenital toxoplasmosis as adjunctive therapy with pyrimethamine); pregnant women at term; and mothers nursing infants less than 2 months of age.
Use in pregnant women at term, in infants less than 2 months of age and in mothers nursing infants less than 2 months of age is contraindicated because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins.
Last reviewed on RxList: 9/16/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Gantrisin Information
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