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언어: 영어
출처: NLM (National Library of Medicine)
ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)
American Health Packaging
ZAFIRLUKAST
ZAFIRLUKAST 20 mg
ORAL
PRESCRIPTION DRUG
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.
Zafirlukast tablets 20 mg are white to light pink, round film coated tablets debossed with ‘R’ on one side and ‘626’ on other side. Unit dose packages of 30 (3 x 10) NDC 68084-059-21 STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Rx Only FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Dr. Reddy's Laboratories Limited as follows: (20 mg / 30 UD) NDC 68084-059-21 packaged from NDC 55111-626 Distributed by: American Health Packaging Columbus, OH 43217 8205921/1017
Abbreviated New Drug Application
ZAFIRLUKAST- ZAFIRLUKAST TABLET, FILM COATED AMERICAN HEALTH PACKAGING ---------- ZAFIRLUKAST TABLETS 8205921/1017 RX ONLY 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 31 33 3 6 4 4 4 4 4 4 4 4 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 suppres 전체 문서 읽기