Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DISODIUM EDETATE
DUOPHARMA (M) SDN. BHD.
DISODIUM EDETATE
20ml mL; 25Units Units
DUOPHARMA (M) SDN. BHD.
[DUOPHARMA (M) SDN BHD] Page 1 of 2 [REVISION DATE: 26.09.2019] EDTA INJECTION 150MG/ML (VIAL) DESCRIPTION: EDTA INJECTION 150 MG/ML (VIAL): A clear, aqueous, colourlesss sterile solution. COMPOSITION: Each ml contains Edetate Disodium Hydrous 166 mg (equivalent to 150 mg Edetate Disodium Anhydrous USP). PHARMACODYNAMICS: Edetate Disodium forms chelates with the cations of the calcium and many divalent and trivalent metals. Because of its affinity for calcium, edetate disodium will produce a lowering of the serum calcium level during intravenous infusion. _HYPERCALCEMIA _– Edetate Disodium forms soluble complexes with calcium in the blood, which are filtered by the glomeruli and not reabsorbed by the renal tubules. Chelation with calcium produces a lowering of serum concentrations and a mobilization of extracirculatory calcium stores, especially from bone, during slow intravenous infusion. Theoretically, 1 gram of edetate disodium will chelate 120 mg of calcium. Hypocalcemic tetany, seizures, severe cardiac arrhythmias, and respiratory arrest may occur with the rapid decrease in serum calcium concentration. However, the mobilization of calcium from bone may lessen the risk of hypocalcemia. Calcium ion concentrations in cerebrospinal fluid are not affected by edetate disodium. _DIGITALIS TOXICITY _– Edetate disodium exerts a negative inotropic effect on the heart. The chronotopic and inotropic effects of digitalis glycosides on the ventricles of the heart are transiently antagonized by the hypocalcemia induced by edetate disodium. Edetate disodium also forms chelates with and increases urinary excretion of other polyvalent metals, such as magnesium, zinc, and other trace elements. Although edetate disodium does not form a chelate with potassium, the serum concentration of potassium may be decreased and the urinary excretion of potassium increased. PHARMACOKINETICS: Rapidly excreted by kidneys, principally as the calcium chelate; 95% of a dose appears in the urine within 24 hours; changes in the urine flow and Citiți documentul complet