البلد: أندونيسيا
اللغة: الإندونيسية
المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MONTELUKAST SODIUM
ORGANON PHARMA INDONESIA TBK - Indonesia
MONTELUKAST SODIUM
4.16 MG
TABLET KUNYAH
DUS, 4 BLISTER @ 7 TABLET KUNYAH
MERCK SHARP & DOHME LTD. - United Kingdom
2021-07-17
SINGULAIR TM (MONTELUKAST SODIUM) 4-MG CHEWABLE TABLET I. THERAPEUTIC CLASS SINGULAIR (montelukast sodium) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT 1 receptor. II. INDICATIONS SINGULAIR chewable tablet is indicated in pediatric 2-5 years of age for the prophylaxis and chronic treatment of asthma, including the prevention of exercise-induced bronchoconstriction. III. DOSAGE AND ADMINISTRATION ASTHMA Singulair should be taken once daily in the evening (one-4 mg chewable tablet) EXERCISE-INDUCED BRONCHOCONTRICTION (EIB) For prevention of EIB, a single dose (one-4mg chewable tablet) of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of previous dose. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. IV. CONTRAINDICATIONS Hypersensitivity to any component of this product V. PRECAUTIONS The efficacy of oral SINGULAIR for the treatment of acute asthma attacks has not been established. Therefore, oral SINGULAIR should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available. While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids. DISETUJUI OLEH BPOM : 08/12/2021 ID : EREG100373VR12100389 Neuropsychiatric events have been reported in patients taking SINGULAIR (see SIDE EFFECTS). Since other factors may have contributed to these events, it is not known if they are related to SINGULAIR. Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur. In rare cases patients receiving anti-a اقرأ الوثيقة كاملة