Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ambroxol Hydrochloride
HOVID BERHAD
Ambroxol Hydrochloride
10 Tablet Tablets; 100 Tablets
HOVID BERHAD
NOT APPLICABLE Διαβάστε το πλήρες έγγραφο
565 DESOLVON-30 TABLET VIDES03-var DESCRIPTION White, round, flat bevel edge, and uncoated tablets with break line on one side and plain on other side. COMPOSITION Ambroxol hydrochloride 30 mg. ACTIONS AND PHARMACOLOGY Ambroxol is a metabolite of bromhexine and is used similarly as a mucolytic. Preclinically, ambroxol has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Improvement of mucociliary clearance has been shown in clinical pharmacologic studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration and eases cough. PHARMACOKINETICS Ambroxol hydrochloride is completely absorbed after oral administration. It reaches maximum plasma concentration 9 to 10 hours. Time to peak concentration after oral administration is approximately two hours. After oral administration, 85% of the active substance is eliminated in the urine. INDICATIONS Secretolytic treatment for acute & chronic bronchopulmonary disease associated with abnormal mucus secretion & impaired mucus transport. CONTRAINDICATIONS Hypersensitivity to ambroxol or other components of the formulation. WARNINGS AND PRECAUTIONS • Medical advice should be sought for patients with liver and kidney problems before taking this medication. • Special care is recommended during the first three months of pregnancy. Risk-benefits should be considered against possible effects on the child. • Do not use ambroxol hydrochloride if allergic to ambroxol or to any of the other ingredients in Desolvon. Consult doctor or pharmacist of any allergies. • Ambroxol may increase the amount of antibiotic penetration. • Be aware that all the medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. • Medical advice should be sought if the symptoms last longer than 14 days and/or if the symptoms increase in spite of the treatment. Διαβάστε το πλήρες έγγραφο