Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
MONTELUKAST SODIUM
30Tablet Tablets; 100 Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
_Consumer Medication Information Leaflet (RiMUP) _ ASTHATOR TABLET ® Montelukast Sodium (4mg, 5mg, 10mg) WHAT IS IN THIS LEAFLET 1. What Asthator is used for 2. How Asthator works 3. Before you use Asthator 4. How to use Asthator 5. While you are using it 6. Side effects 7. Storage and Disposal of Asthator 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ASTHATOR IS USED FOR Asthator is indicated in adults and pediatrics 2 years of age and older for: - The prevention and chronic treatment of asthma - The relief of day time and night time symptoms of allergic rhinitis (inflammation of the mucous membrane inside the nose). HOW ASTHATOR WORKS Asthator contains active ingredient montelukast. Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, it improves asthma symptoms, helps control asthma and improves allergy symptoms. BEFORE YOU USE ASTHATOR - _When you must not use it _ Do not use Asthator if you are hypersensitive to the active substance or to any of the excipients. - _Pregnancy and lactation _ • Do not take Asthator if you are pregnant, trying to get pregnant or think you may be pregnant. • Do not take Asthator if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ • Oral Asthator should not be used to treat acute asthma attacks. • Asthator should not be abruptly substituted for inhaled or oral corticosteroids. • If you were on therapy with anti- asthma agents including Asthator, you may present with systemic eosinophilia (a higher than normal level of eosinophils - a type of disease-fighting white blood cell), sometimes presenting with clinical features of vasculitis (an inflammation of blood vessels) consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. • Lue koko asiakirja
xxxxxxxx-5253 BRAND OR PRODUCT NAME : ASTHATOR 4 MG CHEWABLE TABLET ASTHATOR 5 MG CHEWABLE TABLET ASTHATOR 10 MG TABLET NAME AND STRENGTH OF ACTIVE SUBSTANCE(S): ASTHATOR 4 MG CHEWABLE TABLET Each chewable tablet contains: Montelukast sodium 4.16mg eq. to Montelukast 4 mg Colour: Red Oxide of Iron ASTHATOR 5 MG CHEWABLE TABLET Each chewable tablet contains: Montelukast sodium 5.20mg eq. to Montelukast 5 mg Colour: Red Oxide of Iron ASTHATOR 10 MG TABLET Each uncoated tablet contains: Montelukast sodium 10.40mg eq. to Montelukast 10 mg Colour: Red Oxide of Iron & Yellow Oxide of Iron PRODUCT DESCRIPTION: ASTHATOR 4: Pink colored, oval biconvex shaped, uncoated tablets, with break line on both the sides. ASTHATOR 5: Pink colored, round shaped, uncoated tablets, with break line on both the sides. ASTHATOR 10: Light brown colored, round biconvex shaped, uncoated tablets, with break line on both the sides. DOSAGE FORM: Uncoated / Chewable Tablets CLINICAL PHARMACOLOGY: PHARMACODYNAMICS: The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene receptors (CysLT) found in the human airway. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or (beta) -adrenergic receptor). Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. PHARMACOKINETICS: _ABSORPTION: _ Montelukast is rapidly absorbed following oral administration.After administration of the 10 mg tablet to fasted ad Lue koko asiakirja