Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
montelukast sodium
Torrent Australasia Pty Ltd
montelukast sodium
T LUKAST 4 T LUKAST 5 T LUKAST 10 MONTELUKAST _ _SODIUM_ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about T Lukast. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking T Lukast against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT T LUKAST IS USED FOR T Lukast is used to prevent asthma symptoms, including those that occur during the day and at night-time. It also prevents the narrowing of airways triggered by exercise. If you have seasonal allergic rhinitis (hay fever), T Lukast also treats your allergic rhinitis symptoms. It can be used in children 2 years of age and older, teenagers and adults. T Lukast tablets are not used to treat an acute attack of asthma. If an acute attack occurs, follow your doctor's instructions for your reliever medicine, and keep taking your T Lukast each night or as prescribed. As a preventive medicine for asthma, T Lukast can be used alone or in combination with other preventive medicines, such as inhaled corticosteroids. Your doctor may reduce your dose of inhaled corticosteroid while you are taking T Lukast. Asthma is a lung disease and has the following characteristics: narrowed airways causing breathing to become difficult inflamed airways, which means the lining of airways become swollen sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air. Symptoms of asthma include coughing, wheezing and chest tightness. Not all people with asthma wheeze. For some, coughing may be the only symptom of asthma. Symptoms often occur during the night or after exercise. For further information about asthma, contact the Asthma Foundation in your state on 1800 645 130, or www.asthmaaustralia.org.au Seaso Read the complete document
Page 1 of 23 PRODUCT INFORMATION T LUKAST 4MG, 5MG AND 10MG NAME OF MEDICINE Montelukast sodium DESCRIPTION Montelukast sodium, the active ingredient in T Lukast, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinylleukotriene CysL T1 receptor. Montelukast sodium is described chemically as sodium [1-[[[(1_R_)-1-[3-[(_E_)-2-(7- chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1- methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate. The empirical formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18. The structural formula is: CAS NUMBER: 151767-02-1 Montelukast sodium is a hygroscopic, optically active, white to off-white, free-flowing powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Montelukast is the optically active R stereoisomer. Each 10-mg tablet contains 10.4 mg montelukast sodium, which is equivalent to 10.0 mg of montelukast, the free acid. Each 5-mg chewable tablet contains 5.2 mg montelukast sodium, which is equivalent to 5.0 mg of montelukast, the free acid. Each 4-mg chewable tablet contains 4.16 mg montelukast sodium, which is equivalent to 4.0 mg of montelukast, the free acid. Each 10-mg tablet contains the following inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, cherry flavour, aspartame and magnesium stearate. Each 4-mg and 5-mg chewable tablet contains the following inactive ingredients: mannitol, microcrystalline cellulose, iron oxide red, croscarmellose sodium, cherry flavour, aspartame, and magnesium stearate. Page 2 of 23 PHARMACOLOGY PHARMACODYNAMICS The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ), are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro- asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle ce Read the complete document