Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
Nano Medic Care Sdn. Bhd.
MONTELUKAST SODIUM
28tablet Tablets
CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.
Muka surat 1 dpd 2 _Consumer Medication Information leaflet (RiMUP) _ AVALAIR CHEWABLE TABLETS 5MG Montelukast Sodium 5.2mg, equivalent to Montelukast 5mg _WHAT IS IN THIS LEAFLET: _ a) What Avalair is used for b) How Avalair works c) Before you use Avalair d) How to use Avalair e) While you are using Avalair f) Side effects g) Storage and disposal of Avalair h) Product description i) Manufacturer j) Product Registration Holder k) Date of revision WHAT AVALAIR IS USED FOR The name of your medicine is Avalair Chewable Tablets 5mg (Called ‘Avalair’ in this leaflet). Avalair contains a medicine called montelukast sodium. Avalair is used to prevent and treat chronic asthma and for the relief of daytime and nighttime symptoms of seasonal allergic rhinitis (hay fever) in adults and pediatrics patients 12 months of age and older. HOW AVALAIR WORKS: Avalair 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 AVALAIR WHEN YOU MUST NOT USE IT. Do not take this medicine and tell your doctor if you or your child: Are allergic to any of its components. If you have ‘phenylketonurics’ as this product contains Aspartame. _BEFORE YOU START TO USE IT _ Check with your doctor or pharmacist before taking this medicine: • If you have any medical problems or allergies, you or your child has now or has had. • If you are pregnant or planning to become pregnant. • If you are breast feeding or plan to breastfeed. TAKING OTHER MEDICINES In general, Avalair does not interfere with other medicines that you or your child may be taking. However, some medicines may affect how Avalair works, or Avalair may affect how your other medicines work. They include: • Gemfibroz Прочитать полный документ
COMPOSITION: Each chewable tablet contains: Montelukast sodium 5.2mg, equivalent to Montelukast 5.0 mg PRODUCT DESCRIPTION: Avalair 5mg Tablet is a pink, round, bi-convex-shaped chewable tablets, 9.6mm diameter, engraved with “CCP 78” on one side. PHARMACOLOGICAL PROPERTIES: PHARMACODYNAMI c PROPERTIES ATC code : R03D C03 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. PHARMACOKINETIC PROPERTIES _ABSORPTION_ : Montelukast is rapidly and nearly completely Прочитать полный документ