País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ANAGRELIDE HYDROCHLORIDE
COMBIPHAR - Indonesia
ANAGRELIDE HYDROCHLORIDE
0.57 MG
KAPSUL
DUS, 1 BOTOL PLASTIK @ 42 KAPSUL
HAUPT PHARMA WOLFRATSHAUSEN GMBH - Federal Republic of Germany
2019-09-10
THROMBOREDUCTIN ® ANAGRELIDE HCL 0.5 mg Capsule COMPOSITION Each one capsule contains: Anagrelide HCI 0.57 mg equivalent to anagrelide 0.5 mg MODE OF ACTION PHARMACODYNAMIC PROPERTIES In humans Anagrelide causes a dose dependent decrease in platelet count, the mechanism of action is unknown and species specific. There are no data a platelet count reducing effect in any experimental animal model. It is therefore hypothesized that Anagrelide acts via a metabolite that is generated in man. Anagrelide exerts its action via reducing the size and ploidy of megakaryocytes in the post mitotic phase of maturation. Anagrelide does not cause significant changes in white blood cells and coagulation parameters, minor changes in red blood cells were observed. When administered in high, non-therapeutic doses Anagrelide inhibits the c-AMP phosphodiesterase and ADP and collagen induced thrombocyte aggregation. PHARMACOKINETIC PROPERTIES The bioavailability of Anagrelide after oral administration is 70% according to data from a mass balanced study. In healthy volunteers the time to maximal plasma level (t max) was about 1 to 2 hours, the elimination half life is short (1 to 2 hours). Anagrelide has a high volume of distribution (120 L/kg), the distribution in different compartment is unknown, as is plasma protein binding. Anagrelide is intensively metabolised, at least 4 metabolites emerge. After administration of C 14 labeled Anagrelide 75% of radioactivity are excreted within 6 days via urine, 10% via faeces. The clinical experience in fasted or non-fasted patients shows that there is no effect of food on the efficacy of Anagrelide. Accumulation of Anagrelide should not occur upon long-term administration because of the short half-life. This assumption is supported by clinical experience: upon stopping treatment platelet counts recover to pre treatment levels within 4 to 8 days. No data are available for elderly patients and patients with renal or liver insufficiency. When using Anagrelide in these patients careful monitoring e Llegiu el document complet