מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)
Aurobindo Pharma Limited
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 10 mg , are white, round, biconvex, film-coated tablets debossed with “1” on one side and “B” on other side. Bottles of 60 NDC 59651-291-60 Zafirlukast Tablets 20 mg , are white, round, biconvex, film-coated tablets debossed with “2” on one side and “B” on other side. Bottles of 60 NDC 59651-292-60 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: June 2023
Abbreviated New Drug Application
ZAFIRLUKAST - ZAFIRLUKAST TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- ZAFIRLUKAST TABLETS 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, off-white to light pink color powder, is practically insoluble in water, freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast is supplied as 10 and 20 mg tablets for oral administration. INACTIVE INGREDIENTS: Film-coated tablets containing croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone 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 31 33 3 6 4 4 4 4 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; this included both the ear קרא את המסמך השלם