País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ACETAZOLAMIDE
ZULAT PHARMACY SDN. BHD.
ACETAZOLAMIDE
0.5gm mcg/mL
BAG Health Care GMBH ( Bag Pharma)
THIS ARTWORK IS NOT TECHNICALLY APPROVED and technical approval needs to be taken, from the CMO, before Implementation. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 4.9. OVERDOSE Management No specific antidote. Supportive measures with correction of electrolyte and fluid balance. Force fluids. 5. PHARMACOLOGICAL PROPERTIES 5.1. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Carbonic anhydrase inhibitors. ATC Code: S01EC01. Mechanism of action Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by this enzyme in the renal tubules, acetazolamide increases the excretion of bicarbonate and of cations, chiefly sodium and potassium, and so promotes alkaline diuresis. Pharmacodynamic effects Continuous administration of acetazolamide is associated with metabolic acidosis and resultant loss of diuretic activity. Therefore the effectiveness of DIAMOX in diuresis diminishes with continuous use. By inhibiting carbonic anhydrase in the eye acetazolamide decreases intra- ocular pressure and is therefore useful in the treatment of glaucoma. 5.2. PHARMACOKINETIC PROPERTIES Distribution It is tightly bound to carbonic anhydrase and accumulates in tissues containing this enzyme, particularly red blood cells and the renal cortex. It is also bound to HEALTH PROFESSIONALS’ USER LEAFLET 1. NAME OF THE MEDICINAL PRODUCT DIAMOX Sodium 500mg Powder for Solution for Injection Acetazolamide 500mg Powder for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains Acetazolamide 500mg Excipient(s) with known effect For full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM White Leer el documento completo