Human experience of acute overdose with zileuton is limited. A patient in a clinical tria l took between 6.6 and 9.0 grams of zileuton in a single dose. Vomiting was induced and the patient recovered without sequelae. Zileuton is not removed by dialysis. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted as required. If indicated, elimination of unabsorbed drug should be achiev ed by emesis or gastric lavage; usual precautio ns should be observed to maintain the airway. A Certified Poison Control Center should be consulted for up-to-date information on management of overdose with ZYFLO.
The oral minimum lethal doses in mice and rats were 500-4000 and 300-1000 mg/kg in various preparations, respectively (providing greater than 3 and 9 times the systemic exposure [AUC] achieved at the maximum recommended human daily oral dose, respectively). No deaths occurred, but nephritis was re ported in dogs at an oral dose of 1000 mg/kg (providing in excess of 12 times the systemic exposure [AUC] achieved at the maximum recommended human daily oral dose).
ZYFLO tablets are contraindicated in patients with:
- Active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal ( ≥ 3xULN) (see PRECAUTIONS, Hepatic).
- Hypersensitivity to zileuton or any of its inactive ingredients.
Last reviewed on RxList: 6/29/2012
This monograph has been modified to include the generic and brand name in many instances.
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