Zileutondrug info
12 HR zileuton 600 MG Extended Release Oral Tablet
What it is used for
Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. Zileuton extended-release tablets are a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Do not use zileuton extended-release tablet to treat an acute asthma attack.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 14, 2022. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
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 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 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
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 14, 2022. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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