Dipyridamole 50 MG Oral Tablet
Generic Name: DIPYRIDAMOLE
Brand Name: Dipyridamole
- Substance Name(s):
- DIPYRIDAMOLE
DRUG INTERACTIONS
Drug Interactions: No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets.
The following information was obtained from the literature.
Adenosine: Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine.
Adjustment of adenosine dosage may be necessary.
Cholinesterase Inhibitors Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
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
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: C24H40N8O4 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
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 bottle 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
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 A2-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).
INDICATIONS AND USAGE
Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
PEDIATRIC USE
Pediatric Use: Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
PREGNANCY
Pregnancy: Teratogenic Effects: 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 11/2, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 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.
NUSRING MOTHERS
Nursing Mothers: As dipyridamole is excreted in human milk, caution should be exercised when dipyridamole tablets are administered to a nursing woman.
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.