ZAFIRLUKAST tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zafirlukast (UNII: XZ629S5L50) (Zafirlukast - UNII:XZ629S5L50)

Available from:

Dr. Reddys Laboratories Limited

INN (International Name):

Zafirlukast

Composition:

Zafirlukast 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Zafirlukast tablets 10 mg are white to light pink, round, film coated tablets debossed with ‘R’ on one side and ‘625’ on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose blister packages of 100 (10 x 10). Bottles of 30                                                                                       NDC 55111-625-30                Bottles of 60                                                                                       NDC 55111-625-60    Bottles of 100                                                                                     NDC 55111-625-01    Bottles of 500                                                                                     NDC 55111-625-05 Unit dose packages of 100 (10 x 10)                                                  NDC 55111-625-78 Zafirlukast tablets 20 mg are white to light pink, round film coated tablets debossed with ‘R’ on one side and ‘626’ on other side and are supplied in bottles of 30, 60, 100, 500 and unit dose blister packages of 100 (10 x 10). Bottles of 30                                                                                       NDC 55111-626-30                Bottles of 60                                                                                       NDC 55111-626-60    Bottles of 100                                                                                     NDC 55111-626-01    Bottles of 500                                                                                     NDC 55111-626-05    Unit dose packages of 100 (10 x 10)                                                  NDC 55111-626-78  STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in air-tight container.  Rx Only  Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA Revised: 1216

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZAFIRLUKAST- ZAFIRLUKAST TABLET, FILM COATED
DR. REDDYS LABORATORIES LIMITED
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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 molecular formula is: C
H N O S
Zafirlukast, white to pale yellow coloured powder, freely soluble in
tetrahydrofuran, and
dimethylsulfoxide and practically insoluble in water.
Zafirlukast is supplied as 10 and 20 mg tablets for oral
administration.
Inactive ingredients: Film coated tablets containing hydroxypropyl
cellulose, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol 400, sodium starch
glycolate (Type-A) 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 airway
responses to antigen; t