ZAFIRLUKAST tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Camber Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Zafirlukast Tablets 10 mg: White to off-white, round, biconvex, film coated tablets debossed with ‘V’ on one side and ‘16’ on the other side. Bottle of 60 Tablets                                                                      NDC 31722-007-60 Bottle of 500 Tablets                                                                    NDC 31722-007-05 Carton of 100 (10 x 10) unit-dose Tablets                                   NDC 31722-007-01 Zafirlukast Tablets 20 mg: White to off-white, round, biconvex, film coated tablets debossed with ‘V’ on one side and ‘17’ on the other side. Bottle of 60 Tablets                                                                      NDC 31722-008-60 Bottle of 500 Tablets                                                                    NDC 31722-008-05 Carton of 100 (10 x 10) unit-dose Tablets                                   NDC 31722-008-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 08/2020

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ZAFIRLUKAST - ZAFIRLUKAST TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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ZAFIRLUKAST TABLETS
DESCRIPTION
Zafirlukast is a synthetic, selective peptide leukotriene receptor
antagonist (LTRA), with the chemical
name N-[3-[[2-Methoxy-4-[[[(2-methylphenyl) sulfonyl]amino]carbonyl]
phenyl]methyl]-1-methyl-1H-
1H-indol-5-yl]carbamic acid cyclopentyl ester; The molecular weight of
zafirlukast is 575.67 and the
structural formula is:
The empirical formula is: C
H N O S
Zafirlukast, a white to pale yellow colour powder, is soluble in
tetrahydrofuran, slightly soluble in
dimethyl sulphoxide, dimethyl formamide and practically insoluble in
water.
Zafirlukast is supplied as 10 mg and 20 mg tablets for oral
administration.
INACTIVE INGREDIENTS: Film-coated tablets containing croscarmellose
sodium, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, povidone K30,
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 to 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 airw