Product Elements:
Dipyridamole dipyridamole dipyridamole dipyridamole ferric oxide yellow hypromellose 2910 (6 mpa.s) lactose monohydrate magnesium stearate polyethylene glycol 3350 povidone k30 titanium dioxide starch, corn light yellow round ze;43 dipyridamole dipyridamole dipyridamole dipyridamole ferric oxide yellow hypromellose 2910 (6 mpa.s) lactose monohydrate magnesium stearate polyethylene glycol, unspecified povidone k30 titanium dioxide starch, corn light yellow round ze;49 dipyridamole dipyridamole dipyridamole dipyridamole ferric oxide yellow hypromellose 2910 (6 mpa.s) lactose monohydrate magnesium stearate polyethylene glycol, unspecified povidone k30 titanium dioxide starch, corn light yellow round ze;50
Drug Interactions:
Drug interactions no pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. the following information was obtained from the literature. adenosinergic agents (e.g., adenosine, regadenoson) dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. adjustment of adenosine dosage may be necessary. dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine a 2a -receptor agonist. the potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing. cholinesterase inhibitors dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
Indications and Usage:
Indications and usage dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Dosage and Administration:
Dosage and administration adjunctive use in prophylaxis of thromboembolism after cardiac valve replacement the recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.
Contraindications:
Contraindications hypersensitivity to dipyridamole and any of the other components.
Adverse Reactions:
Adverse reactions adverse reactions at therapeutic doses are usually minimal and transient. on long-term use of dipyridamole tablets initial side effects usually disappear. the following reactions in table 1 were reported in two heart valve replacement trials comparing dipyridamole tablets and warfarin therapy to either warfarin alone or warfarin and placebo: table 1 adverse reactions reported in 2 heart valve replacement trials adverse reaction dipyridamole tablets/ placebo/ warfarin warfarin number of patients 147 170 dizziness 13.6% 8.2% abdominal distress 6. 1% 3.5% headache 2.3% 0.0% rash 2.3% 1.1% other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. in addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. on those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication. when dipyridamole tablets were administered conco
Read more...mitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. in rare cases, increased bleeding during or after surgery has been observed. in post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.
Adverse Reactions Table:
Table 1 Adverse Reactions Reported in 2 Heart Valve Replacement Trials | Adverse Reaction | Dipyridamole Tablets/ | Placebo/ |
| | Warfarin | Warfarin |
| Number of patients | 147 | 170 |
| Dizziness | 13.6% | 8.2% |
| Abdominal distress | 6. 1% | 3.5% |
| Headache | 2.3% | 0.0% |
| Rash | 2.3% | 1.1% |
Drug Interactions:
Drug interactions no pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. the following information was obtained from the literature. adenosinergic agents (e.g., adenosine, regadenoson) dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. adjustment of adenosine dosage may be necessary. dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine a 2a -receptor agonist. the potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing. cholinesterase inhibitors dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
Use in Pregnancy:
Pregnancy teratogenic effects: pregnancy category b reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 1/2 , 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m 2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, dipyridamole tablets should be used during pregnancy only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in the pediatric population below the age of 12 years have not been established.
Overdosage:
Overdosage in case of real or suspected overdose, seek medical attention or contact a poison control center immediately. careful medical management is essential. based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. a drop in blood pressure and tachycardia might also be observed. symptomatic treatment is recommended, possibly including a vasopressor drug. gastric lavage should be considered. administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of dipyridamole overdose. since dipyridamole is highly protein bound, dialysis is not likely to be of benefit.
Description:
Description dipyridamole is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-dipiperidinopyrimido[5,4- d ]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. it has the following structural formula: c 24 h 40 n 8 o 4 mol. wt. 504.63 dipyridamole, usp is intensely yellow crystalline powder or needles. it is very soluble in methanol, in alcohol, and in chloroform; slightly soluble in water; very slightly soluble in acetone and in ethyl acetate. each dipyridamole tablet intended for oral administration contains 25 mg or 50 mg or 75 mg of dipyridamole. in addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. structured formula for dipyridamole
Clinical Pharmacology:
Clinical pharmacology it is believed that platelet reactivity and interaction with prosthetic cardiac valve surfaces, resulting in abnormally shortened platelet survival time, is a significant factor in thromboembolic complications occurring in connection with prosthetic heart valve replacement. dipyridamole tablets have been found to lengthen abnormally shortened platelet survival time in a dose-dependent manner. in three randomized controlled clinical trials involving 854 patients who had undergone surgical placement of a prosthetic heart valve, dipyridamole tablets, in combination with warfarin, decreased the incidence of postoperative thromboembolic events by 62 to 91% compared to warfarin treatment alone. the incidence of thromboembolic events in patients receiving the combination of dipyridamole tablets and warfarin ranged from 1.2 to 1.8%. in three additional studies involving 392 patients taking dipyridamole tablets and coumarin-like anticoagulants, the incidence of thromboembo
Read more...lic events ranged from 2.3 to 6.9%. in these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyridamole tablets were begun between 24 hours and 10 days postoperatively. the length of follow-up in these trials varied from 1 to 2 years. dipyridamole tablets do not influence prothrombin time or activity measurements when administered with warfarin. mechanism of action dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to 1.9 mcg/ml). this inhibition results in an increase in local concentrations of adenosine which acts on the platelet a 2 -receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (camp) levels. via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (paf), collagen and adenosine diphosphate (adp). dipyridamole inhibits phosphodiesterase (pde) in various tissues. while the inhibition of camp-pde is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-pde (cgmp-pde), thereby augmenting the increase in cgmp produced by edrf (endothelium-derived relaxing factor, now identified as nitric oxide). hemodynamics in dogs intraduodenal doses of dipyridamole of 0.5 to 4.0 mg/kg produced dose-related decreases in systemic and coronary vascular resistance leading to decreases in systemic blood pressure and increases in coronary blood flow. onset of action was in about 24 minutes and effects persisted for about 3 hours. similar effects were observed following intravenous dipyridamole in doses ranging from 0.025 to 2.0 mg/kg. in man the same qualitative hemodynamic effects have been observed. however, acute intravenous administration of dipyridamole may worsen regional myocardial perfusion distal to partial occlusion of coronary arteries. pharmacokinetics and metabolism following an oral dose of dipyridamole tablets, the average time to peak concentration is about 75 minutes. the decline in plasma concentration following a dose of dipyridamole tablets fits a two-compartment model. the alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. the beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. dipyridamole is highly bound to plasma proteins. it is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile.
Mechanism of Action:
Mechanism of action dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to 1.9 mcg/ml). this inhibition results in an increase in local concentrations of adenosine which acts on the platelet a 2 -receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (camp) levels. via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (paf), collagen and adenosine diphosphate (adp). dipyridamole inhibits phosphodiesterase (pde) in various tissues. while the inhibition of camp-pde is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-pde (cgmp-pde), thereby augmenting the increase in cgmp produced by edrf (endothelium-derived relaxing factor, now identified as nitric oxide).
How Supplied:
How supplied dipyridamole tablets usp, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with 'ze 43' on one side and plain on the other side are supplied as follows: ndc 68382-187-01 in bottle of 100 tablets ndc 68382-187-05 in bottle of 500 tablets ndc 68382-187-10 in bottle of 1000 tablets ndc 68382-187-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets dipyridamole tablets usp, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ze 49' on one side and plain on the other side are supplied as follows: ndc 68382-188-01 in bottle of 100 tablets ndc 68382-188-05 in bottle of 500 tablets ndc 68382-188-10 in bottle of 1000 tablets ndc 68382-188-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets dipyridamole tablets usp, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ze 50' on one side and plain on the other side are supplied as follows: ndc 68382-189-01 in b
Read more...ottle of 100 tablets ndc 68382-189-05 in bottle of 500 tablets ndc 68382-189-10 in bottle of 1000 tablets ndc 68382-189-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets
Package Label Principal Display Panel:
Package label.principal display panel ndc 68382-187-05 in bottle of 500 tablets dipyridamole tablets usp, 25 mg r x only 500 tablets ndc 68382-188-05 in bottle of 500 tablets dipyridamole tablets usp, 50 mg r x only 500 tablets ndc 68382-189-05 in bottle of 500 tablets dipyridamole tablets usp, 75 mg r x only 500 tablets dipyridamole tablets, 25 mg dipyridamole tablets, 50 mg dipyridamole tablets, 75 mg