Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
DCH AURIGA (MALAYSIA) SDN. BHD.
MONTELUKAST SODIUM
3x10'stablet Tablets; 10x10'stablet Tablets
Actavis Ltd.
_Consumer Medication Information Leaflet (RiMUP)_ BLOKTIENE CHEWABLE TABLETS Montelukast Sodium (4mg, 5mg) 1 WHAT IS IN THIS LEAFLET 1. What Bloktiene is used for 2. How Bloktiene works 3. Before you use Bloktiene 4. How to take Bloktiene 5. While you are using Bloktiene 6. Side Effects 7. Storage and Disposal of Bloktiene 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BLOKTIENE IS USED FOR Your doctor has prescribed BLOKTIENE (montelukast sodium, ACTAVIS) to treat: • Asthma, including preventing your asthma symptoms during the day and night. BLOKTIENE 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 BLOKTIENE WORKS BLOKTIENE 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 BLOKTIENE _-When you must not take it _ Do not take BLOKTIENE if you or your child • are allergic to any of its components. _-Before you start to take 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, BLOKTIENE 5-mg chewable tablets are available. For children 2 to 5 years old, BLOKTIENE 4-mg chewable tablets are available. Safety and effectiveness of BLOKTIENE in children less than 12 months old have not been established. Use in pregnancy Women who are pregnant or intend to become pregnant should consult their doctor before takin Baca dokumen lengkap
BLOKTIENE PRODUCT NAME Bloktiene_ _Chewable Tablet 4mg Bloktiene Chewable Tablet 5mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Montelukast sodium 4.16mg equivalent to 4mg montelukast Montelukast sodium 5.20mg equivalent to 5mg montelukast PRODUCT DESCRIPTION 4mg: Pink, mottled, oval, biconvex tablets, 7.8 x 11mm, with M4 on one side. 5mg: Pink, mottled, round, biconvex tablets, 9.5mm, with M5 on one 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 ß Baca dokumen lengkap