País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
CAMBER LABORATORIES SDN. BHD.
MONTELUKAST SODIUM
100tablet Tablets; 500tablet Tablets; 500tablet Tablets; 500tablet Tablets; 100tablet Tablets; 30tablet Tablets; 30tablet Tablets
Hetero Labs Ltd., Unit V
_Consumer Medication Information Leaflet (RiMUP) _ 1 MONULAIR CHEWABLE TABLET 5MG MONTELUKAST SODIUM 5MG WHAT IS IN THIS LEAFLET 1. What Monulair Chewable Tablet 5mg is used for 2. How Monulair Chewable Tablet 5mg works 3. Before you use Monulair Chewable Tablet 5mg 4. How to use Monulair Chewable Tablet 5mg 5. While you are using it 6. Side effects 7. Storage and Disposal of Monulair Chewable Tablet 5mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MONULAIR CHEWABLE TABLET 5MG IS USED FOR Your doctor has prescribed Monulair Chewable Tablet 5mg to treat: • Asthma, including preventing your asthma symptoms during the day and night. Monulair Chewable Tablet 5mg also prevents the narrowing of airways triggered by exercise. • Allergic rhinitis (seasonal and perennial), including daytime and nighttime symptoms: nasal congestion, runny nose, nasal itching, and sneezing; nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings; tearing, itchy, red, and puffy eyes. Asthma is a long term disease with characteristics that include: There are two types of allergic rhinitis: HOW MONULAIR CHEWABLE TABLET 5MG WORKS Monulair Chewable Tablet 5mg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Monulair Chewable Tablet 5mg improves asthma symptoms and helps control asthma. BEFORE YOU USE M ONULAIR CHEWABLE TABLET 5MG _-_ _ _ _When you must not use it _ Do not take Monulair Chewable Tablet 5mg if you or your child is allergic (hypersensitive) to montelukast or any of the other ingredients of Monulair Chewable Tablet 5mg. _-_ _ _ _Before you start to use it _ Tell your doctor about any medical problems or allergies you or your child has now or has had. _-_ _ _ _Taking other medicines _ Some medicines may affect how Monulair Chewable Tablet 5mg works, or Monulair Chewable Tablet 5mg may affect how other medicines work. Please tel Leer el documento completo
1 MONULAIR CHEWABLE TABLET 5 MG PRODUCT NAME Monulair Chewable Tablet 5 mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each tablet contains Montelukast sodium equivalent to 5 mg of Montelukast. PRODUCT DESCRIPTION Light pink to pink coloured, speckled, round, biconvex shaped, chewable tablets debossed with 'I' on one side and '113' on the other side. PHARMACODYNAMICS Montelukast is a selective and active leukotriene receptor antagonist. Montelukast inhibits bronchoconstriction due to antigen challenge. Montelukast is a selective leukotriene receptor antagonist of the cysteinyl leukotriene CysLT 1 receptor. The cysteinyl leukotrienes (LTC 4, LTD 4, LTE 4) are products of arachidonic acid metabolism that are released from various cells, including mast cells and eosinophils. They bind to cysteinyl leukotriene receptors (CysLT) found in the human airway. Binding of cysteinyl leukotrienes to leukotriene receptors has been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, factors that contribute to the signs and symptoms of asthma. It binds to cysteinyl leukotrienes (CysLT) type-1 receptors found in human airway (smooth muscle cells and macrophages), which prevents airway edema, smooth muscle contraction and other respiratory inflammation. The leukotrienes are also released from the nasal mucosa after allergen exposure where montelukast sodium may inhibit symptoms of allergic rhinitis. Montelukast binding to the CysLT1 receptor is high-affinity and selective, preferring the CysLT1 receptor to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta- adrenergic receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptors, without any agonist activity. Montelukast causes bronchodilation within 2 hours of oral administration; these effects were additive to the bronchodilation caused by a β-agonist. PHARMACOKINETICS ABSORPTION Montelukast is rapi Leer el documento completo