SPL Set ID: bc29c998-1324-46aa-8386-e5b2fc9e0b16
1 drug(s) with this SPL Set ID
Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure: Zileuton has the molecular formula C 11 H 12 N 2 O 2 S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton USP is a white to off-white powder that is freely soluble in methanol and sparingly soluble in acetonitrile. The melting point ranges from 144.2ºC to 145.2ºC. Zileuton extended-release tablets for oral administration are bi-layer film-coated tablets comprised of an immediate-release layer, and an extended-release layer. Zileuton extended-release tablets are oblong biconvex, bilayer film-coated tablets with pink to red IR layer debossed with '66' on one side and white to off white ER layer debossed with 'V' on the other side. Each tablet contains 600 mg of zileuton USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate. The film coating contains hypromellose and polyethylene glycol. zileutonertabstructure