Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ZAFIRLUKAST (UNII: XZ629S5L50) (ZAFIRLUKAST - UNII:XZ629S5L50)
Rising Pharmaceuticals, Inc.
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. The safety of Zafirlukast Tablets at doses of 10 mg twice daily has been demonstrated in 205 pediatric patients 5 through 11 years of age in placebo-controlled trials lasting up to six weeks and with 179 patients in this age range participating in 52 weeks of treatment in an open label extension. The effectiveness of Zafirlukast Tablets for the prophylaxis and chronic treatment of asthma in pediatric patients 5 through 11 years of age is based on an extrapolation of the demonstrated efficacy of Zafirlukast Tablets in adults with asthma and the likelihood that the disease course, and pathophysiology and the drug’s effect are substantially similar betw
Zafirlukast Tablets 10 mg: (NDC 16571-654-06) Pink colored, round, biconvex tablets debossed with “654” on one side and “P” on the other side, and are supplied in opaque HDPE bottles of 60 tablets. Zafirlukast Tablets 20 mg: (NDC 16571-655-06) Pink colored, round, biconvex tablets debossed with “655” on one side and “P” on the other side, and are supplied in opaque HDPE bottles of 60 tablets. Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container. Manufactured by: RA Chem Pharma Ltd. Hyderabad, India 500076 Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 PIR65506-00 Issued: 09/2022
Abbreviated New Drug Application
ZAFIRLUKAST- ZAFIRLUKAST TABLET RISING PHARMACEUTICALS, INC. ---------- 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-3ylmethyl)-3- methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is: The empirical formula is: C H N O S. Zafirlukast, an off white to light pink color powder, is practically insoluble in water. It is freely soluble in tetrahydrofuran, dimethylsulfoxide and acetone. Zafirlukast Tablets are supplied as 10 and 20 mg tablets for oral administration. INACTIVE INGREDIENTS: Film-coated tablets containing Colloidal silicon Dioxide, Croscarmellose Sodium, Ferric Oxide Red, Hypromellose, Lactose Anhydrous, Macrogol 400, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, 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 31 33 3 6 4 4 4 4 4 4 4 4 4 increases in cutaneous vascular permeability and inhibited inhaled LTD -induced influx of eosinophils into animal lungs. Inhalational challenge studies in sensitized sheep showed th সম্পূর্ণ নথি পড়ুন