ZYFLO- zileuton tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ZILEUTON (UNII: V1L22WVE2S) (ZILEUTON - UNII:V1L22WVE2S)

Tersedia dari:

Chiesi USA, Inc.

INN (Nama Internasional):

ZILEUTON

Komposisi:

ZILEUTON 600 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. 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.

Ringkasan produk:

ZYFLO Tablets are available as 1 dosage strength: 600-mg white to off white, ovaloid, film coated tablets debossed “CT 1” on one side and bisect on the other side. High-density polyethylene bottles of: 120 Tablets.....................................................................................NDC 10122-901-12 Recommended storage: Store tablets at controlled room temperature between 20˚-25˚C, (68˚-77˚F). See USP. Protect from light. CTZI-003-0314-01-SPL-1  Manufactured for: Chiesi USA, Inc. Cary, NC  27518

Status otorisasi:

New Drug Application

Karakteristik produk

ZYFLO- ZILEUTON TABLET
CHIESI USA, INC.
----------
ZYFLO
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
Zileuton has the molecular formula C
H
N O 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. ZYFLO tablets for oral
administration are supplied in
one dosage strength containing 600 mg of zileuton.
INACTIVE INGREDIENTS: crospovidone, hydroxypropyl cellulose,
hypromellose,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
propylene glycol,
sodium starch glycolate, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Zileuton is a specific inhibitor of 5-lipoxygenase and thus inhibits
leukotriene (LTB , LTC ,
LTD , and LTE ) formation. Both the R(+) and S(-) enantiomers are
pharmacologically
active as 5-lipoxygenase inhibitors in _in vitro_ systems.
Leukotrienes are substances that
induce numerous biological effects including augmentation of
neutrophil and eosinophil
migration, neutrophil and monocyte aggregation, leukocyte adhesion,
increased capillary
permeability, and smooth muscle contraction. These effects contribute
to inflammation,
edema, mucus secretion, and bronchoconstriction in the airways of
asthmatic patients.
Sulfido-peptide leukotrienes (LTC , LTD , LTE , also known as the
slow-releasing
substances of anaphylaxis) and LTB , a chemoattractant for neutrophils
and
eosinophils, can be measured in a number of biological fluids
including bronchoalveolar
lavage fluid (BALF) from asthmatic patients.
Zileuton is an orally active inhibitor of _ex vivo_ LTB formation