ACCOLATE- zafirlukast tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)

Διαθέσιμο από:

State of Florida DOH Central Pharmacy

INN (Διεθνής Όνομα):

ZAFIRLUKAST

Σύνθεση:

ZAFIRLUKAST 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older. ACCOLATE is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients.

Περίληψη προϊόντος:

ACCOLATE 10 mg Tablets, white, unflavored, round, biconvex, film-coated, mini-tablets identified with “ACCOLATE 10” debossed on one side. ACCOLATE 20 mg Tablets, white, round, biconvex, coated tablets identified with “ACCOLATE 20” debossed on one side are supplied. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container. ACCOLATE is a trademark of the AstraZeneca group of companies. © AstraZeneca 2001, 2004, 2007, 2009 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 By: IPR Pharmaceuticals, Inc. Canovanas, PR 00729 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

ACCOLATE - ZAFIRLUKAST TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
ACCOLATE®
(_ZAFIRLUKAST_)
TABLETS
DESCRIPTION
Zafirlukast is a synthetic, selective peptide leukotriene receptor
antagonist (LTRA), with the chemical
name
4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-
tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7
and the structural formula is:
The empirical formula is: C
H N O S
Zafirlukast, a fine white to pale yellow amorphous powder, is
practically insoluble in water. It is
slightly soluble in methanol and freely soluble in tetrahydrofuran,
dimethylsulfoxide, and acetone.
ACCOLATE is supplied as 10 and 20 mg tablets for oral administration.
INACTIVE INGREDIENTS: Film-coated tablets containing croscarmellose
sodium, lactose, magnesium
stearate, microcrystalline cellulose, povidone, hypromellose, and
titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Zafirlukast is a selective and competitive receptor antagonist of
leukotriene D and E (LTD and
LTE ), components of slow-reacting substance of anaphylaxis (SRSA).
Cysteinyl leukotriene
production and receptor occupation have been correlated with the
pathophysiology of asthma, including
airway edema, smooth muscle constriction, and altered cellular
activity associated with the inflammatory
process, which contribute to the signs and symptoms of asthma.
Patients with asthma were found in one
study to be 25-100 times more sensitive to the bronchoconstricting
activity of inhaled LTD than
nonasthmatic subjects.
_In vitro_ studies demonstrated that zafirlukast antagonized the
contractile activity of three leukotrienes
(LTC , LTD and LTE ) in conducting airway smooth muscle from
laboratory animals and humans.
Zafirlukast prevented intradermal LTD -induced increases in cutaneous
vascular permeability and
inhibited inhaled LTD -induced influx of eosinophils into animal
lungs. Inhalational challenge studies in
sensitized sheep showed that zafirlukast suppressed the airway
responses to antig