Drug Catalog - Product Detail
ZILEUTON ER TAB 600MG 120CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0206-12 | RISING PHARMACEUTICALS | 120 | 600MG | NA |
PACKAGE FILES
Generic Name
ZILEUTON
Substance Name
ZILEUTON
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA204929
Description
11 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 practically odorless, white, crystalline powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2°C to 145.2°C. Zileuton Extended-Release Tablets for oral administration are bi-layer tablets comprising of an immediate-release layer and extended-release layer. Zileuton Extended-Release Tablets are oval shaped, biconvex tablets debossed with “656” on one side and “P” on the other side. Each tablet contains 600 mg of zileuton and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, yellow iron oxide. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Zileuton Extended-Release Tablets are yellow colored, oval shaped, biconvex tablets debossed with “656” on one side and “P” on the other side; they are supplied in bottles of 120 tablets (NDC 64980-206-12). Store between 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Zileuton Extended-Release Tablets is 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 Tablets can be continued during acute exacerbations of asthma. Zileuton Extended-Release Tablets is a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use Zileuton Extended-Release Tablets to treat an acute asthma attack. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of Zileuton Extended-Release Tablets for the treatment of patients with asthma is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. Tablets should not be chewed, cut or crushed. If a dose is missed, the patient should take the next dose at the scheduled time and not double the dose. Assess hepatic function enzymes prior to initiation of Zileuton Extended-Release Tablets and periodically during treatment [see Contraindications (4) , Warnings and Precautions (5) , and Use in Specific Populations (8.7) ]. Adults and children 12 years of age and older: The recommended dose of Zileuton Extended-Release Tablets is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. ( 2 ) Monitoring: Assess hepatic function enzymes prior to initiation of Zileuton Extended-Release Tablets and monitor periodically during treatment. ( 2 , 5.1 )