Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
ORGANON MALAYSIA SDN. BHD.
MONTELUKAST SODIUM
28Tablet Tablets; 7 Tablet Tablets
Organon Pharma (UK) Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SINGULAIR ® Montelukast Sodium (4mg Oral Granules, 4mg Chewable Tablets, 5mg Chewable Tablets, 10mg Film-Coated Tablets) Copyright 2021 Organon group of companies. All rights reserved. 1 WHAT IS IN THIS LEAFLET 1. What _SINGULAIR _ is used for 2. How _SINGULAIR _ works 3. Before you use _SINGULAIR _ 4. How to use _SINGULAIR _ 5. While you are using _SINGULAIR _ 6. Side effects 7. Storage and disposal of _SINGULAIR _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _SINGULAIR _IS USED FOR Your doctor has prescribed _SINGULAIR _ (montelukast sodium) to treat: • Asthma, including preventing your asthma symptoms during the day and night. _SINGULAIR _ 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. HOW _SINGULAIR _WORKS _SINGULAIR _ is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also cause allergy symptoms. Blocking leukotrienes improves allergic rhinitis (seasonal and perennial, also known as outdoor and indoor nasal allergies). BEFORE YOU USE _SINGULAIR _ _ _ _-When you must not take it _ Do not take _SINGULAIR _ if you or your child • are allergic to any of its components. _-Before you start to use it _ Tell your doctor (or health care provider) about any medical problems or allergies you or your child has now or has had. USE IN CHILDREN For children 6 to 14 years old, _SINGULAIR _ 5-mg chewable tablets are available. For children 2 to 5 years old, _SINGULAIR _ 4-mg chewable tablets WHAT IS ALLERGIC RHINITIS? • Seasonal allergic rhinitis Đọc toàn bộ tài liệu
Page 1 of 17 I. THERAPEUTIC CLASS II. INDICATIONS MECHANISM OF ACTION III. DOSAGE AND ADMINISTRATION LPC-OG0476-MF-052019-MALAYSIA LOCAL PRODUCT CIRCULAR TABLETS/CHEWABLE TABLETS/ORAL GRANULES SINGULAIR ® (MONTELUKAST SODIUM) SINGULAIR ® (montelukast sodium) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT 1 receptor. For the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. SINGULAIR is indicated in adults and pediatric patients 2 years of age and older for the relief of daytime and nighttime symptoms of seasonal allergic rhinitis. 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 (CysLT 1 ) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include a number of airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction. Montelukast is a potent, orally active compound that significantly improves parameters of asthmatic inflammation. Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT 1 receptor (in preference to other pharmacologically important airway receptors such as the prostanoid, cholinergic, or Đọc toàn bộ tài liệu