ZAFIRLUKAST TABLETS

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

AvPAK

INN (International Name):

Zafirlukast

রচনা:

Zafirlukast 20 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Zafirlukast tablets 10 mg arewhite to light pink, round, film coated tablets debossed with ‘R’ on one side and ‘625’ on other side.   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 unit dose blister packages: NDC 50268-805-12 (10 tablets per card, 2 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container.  Rx Only   Manufactured for: AvKARE, Inc.                   Pulaski, TN 38478 Mfg. Iss. 1010 AV 09/17 (P) AvPAK

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ZAFIRLUKAST- ZAFIRLUKAST TABLET, FILM COATED
AVPAK
----------
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-
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
31
33
3
6
4
4
4
4
4
4
4
4
4
4
of eosinophils into animal lungs. Inhalational challenge studies in
sensitized sheep
showed that zafirlukast suppressed the airway responses to antigen;