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Persantine
Overview
What is Persantine?
PERSANTINE® (dipyridamole USP) is a platelet inhibitor chemically described as 2,2',2",2"'-[(4,8- Dipiperidinopyrimido[5,4-]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:
Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water.
PERSANTINE tablets for oral administration contain:
What does Persantine look like?
What are the available doses of Persantine?
Sorry No records found.
What should I talk to my health care provider before I take Persantine?
Sorry No records found
How should I use Persantine?
PERSANTINE tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement.
What interacts with Persantine?
Hypersensitivity to dipyridamole and any of the other components.
What are the warnings of Persantine?
Sorry No Records found
What are the precautions of Persantine?
General
Laboratory Tests
Dipyridamole has been associated with elevated hepatic enzymes.
Drug Interactions
No pharmacokinetic drug-drug interaction studies were conducted with Persantine (dipyridamole USP) tablets. The following information was obtained from the literature.
Adenosine:
Cholinesterase Inhibitors:
Carcinogenesis, Mutagenesis, Impairment of Fertility
In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis . The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when dipyridamole was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m basis).
Pregnancy
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 ½, 2 and 25 times the maximum recommended daily human oral
dose, respectively, on a mg/m 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, PERSANTINE tablets should be used during pregnancy only if clearly needed.
Nursing Mothers
As dipyridamole is excreted in human milk, caution should be exercised when PERSANTINE tablets are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
Array
What are the side effects of Persantine?
Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of PERSANTINE tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing PERSANTINE tablets and warfarin therapy to either warfarin alone or warfarin and placebo:
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 Persantine® (dipyridamole USP) tablets were administered concomitantly 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.
| 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% |
What should I look out for while using Persantine?
Hypersensitivity to dipyridamole and any of the other components.
What might happen if I take too much Persantine?
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.
How should I store and handle Persantine?
Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).PERSANTINE tablets are available as round, orange, sugar-coated tablets of 25 mg, 50 mg and 75 mg coded BI/17, BI/18 and BI/19, respectively.They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 0597-0017-01) 50 mg Tablets (NDC 0597-0018-01) 75 mg Tablets (NDC 0597-0019-01)PERSANTINE tablets are available as round, orange, sugar-coated tablets of 25 mg, 50 mg and 75 mg coded BI/17, BI/18 and BI/19, respectively.They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 0597-0017-01) 50 mg Tablets (NDC 0597-0018-01) 75 mg Tablets (NDC 0597-0019-01)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes and ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5–1.9 μg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A-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).
Non-Clinical Toxicology
Hypersensitivity to dipyridamole and any of the other components.Coronary Artery Disease:
Hepatic Insufficiency:
Hypotension:
Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of PERSANTINE tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing PERSANTINE tablets and warfarin therapy to either warfarin alone or warfarin and placebo:
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 Persantine® (dipyridamole USP) tablets were administered concomitantly 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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