البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
DIPYRIDAMOLE
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
B01AC07
75 mg
TABLET, SUGAR COATED
ORAL
Prescription Only
Delpharm Reims
1988-06-08
PROPOSED PI FOR MY/SG-DELPHARM-FINAL TEXT PERSANTIN abcd COMPOSITION 1 sugar coated tablet contains 25 mg or75 mg 2,6-bis(diethanolamino)-4,8-dipiperidino-pyrimido(5,4-d)-pyrimidine (= dipyridamole) PROPERTIES Dipyridamole inhibits the uptake of adenosine into erythrocytes, platelets and endothelial cells in vitro and in vivo; the inhibition amounts to 80% at its maximum and occurs dose- dependently at therapeutic concentrations (0.5 – 2 mcg/ml). Consequently,there is an increased concentration of adenosine locally to act on the platelet A2-receptor, stimulating platelet adenylate cyclase, thereby increasing platelet cAMP levels. Thus, platelet aggregation in response to various stimuli such as PAF, collagen and ADP is inhibited. Reduced platelet aggregation reduces platelet consumption towards normal levels. In addition, adenosine has a vasodilator effect and this is one of the mechanisms by which dipyridamole produces vasodilation. Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. Whilst the inhibition of cAMP-PDE is weak, therapeutic levels inhibit cGMP-PDE, thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, identified as NO). Dipyridamole also stimulates the biosynthesis and release of prostacyclin by the endothelium . Dipyridamole reduces the thrombogenicity of subendothelial structures by increasing the concentration of the protective mediator 13-HODE (13-hydroxyoctadecadienic acid). PHARMACOKINETICS (Most pharmacokinetic data refer to healthy volunteers.) Dipyridamole shows dose linearity for all doses used in therapy . After dosing with the sugar-coated tablets there is a lag time of 10 - 15 min associated with disintegration of the tablet and gastric emptying. Thereafter the drug is rapidly absorbed and peak plasma concentrations are attained after 1 hour. Geometric mean (range) peak plasma concentrations at ste اقرأ الوثيقة كاملة