Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)
Camber Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
ZAFIRLUKAST - ZAFIRLUKAST TABLET, FILM COATED CAMBER PHARMACEUTICALS, INC. ---------- 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 Прочитајте комплетан документ