TRADE NAME: Edemex 1mg Tablets GENERIC NAME: Bumetanide COMPOSITION: Each tablet contains: Active ingredient: Bumetanide 1mg : Excipients Avicel pH 102, croscarmellose sodium, polysorbate 80, magnesium stearate. PHARMACEUTICAL FORM: Tablets PHARMACOLOGICAL ACTION: Bumetanide is a potent, high ceiling, loop diuretic with a rapid onset and a short duration of action. The primary site of action is the ascending limb of the loop of Henle where it exerts inhibiting effects on electrolyte reabsorption causing the diuretic and natiuretic action observed. After oral administration of 1mg bumetanide, diuresis begins within 30 minutes with a peak effect between one and two hours. The diuretic effect is virtually complete three hours after a 1mg dose. PHARMACOKINETICS: Bumetanide is well absorbed after oral administration with the bioavailability reaching between 80 and 95%. The elimination half life ranges from between 0.75 to 2.6 hours. No active metabolites are known. Renal excretion accounts for approximately half the clearance with hepatic excretion responsible for the other half. There is an increase in half life and a reduced plasma clearance in the presence of renal or hepatic disease. In patients with chronic renal failure the liver takes more importance as an excretory pathway although the duration of action is not markedly prolonged. INDICATIONS: Bumetanide is indicated whenever diuretic therapy is required in the treatment of oedema, for example when associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. Bumetanide 5mg tablets may be used in oedema of cardiac or renal origin where high doses of a potent, short acting diuretic are required. DOSAGE AND ADMINISTRATION: Adults: The dose should be carefully titrated in each patient according to the patient’s response and the required therapeutic activity. Most patients require a daily dose of 1mg which can be given as a single morning or early evening dose
