Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
Y.S.P. INDUSTRIES (M) SDN BHD
MONTELUKAST SODIUM
100Tablet Tablets; 30Tablet Tablets; 500Tablet Tablets
Y.S.P. INDUSTRIES (M) SDN BHD
Manufacturer and Product Registration Holder: Y.S.P. INDUSTRIES (M) SDN. BHD. (192593 U) Lot 3, 5 & 7, Jalan P/7, Section 13, Kawasan Perindustrian Bandar Baru Bangi, 43000 Kajang, Selangor Darul Ehsan, Malaysia. Ordering Line:1 800 88 3027 Product Info: 1 800 88 3679 R 5. Montelukast is a long term controller medication which should not be substituted for short-acting β-agonists. It is effective alone or in combination with other prophylactic agent. 6. Montelukast is a preventive agent, and can be added to the asthma patient’s existing treatment regimen. Reduction in existing treatment can be made as tolerated. 7. With administration of montelukast, the dose of inhaled corticosteroids can be reduced gradually or even tapered off completely. However, montelukast should not be abruptly substituted for inhaled corticosteroids. Orally administration CONTRAINDICATIONS: Hypersensitivity to any component of this product. PRECAUTIONS / WARNINGS: 1. Montelukast should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available. 2. While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. 3. The reduction in systemic corticosteroid dose in patients receiving anti-asthma agents including leukotriene receptor antagonists has been followed in rare cases by the occurrence of one or more of the following: Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy sometimes diagnosed as Churg-Strauss Syndrome, a systemic eosinophilic vasculitis. 4. Patients with known aspirin sensitivity should continue avoidance of aspirin or nonsteroidal anti-inflammatory agents while taking Montelukast. 5. Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. 6. Tablet of 4mg and 5mg contains aspartame therefore it is unsuitable for phenylketourics. INTERACTION WITH O Läs hela dokumentet