NDC 0115-1070 Dipyridamole
What is NDC 0115-1070?
The NDC code 0115-1070 is assigned by the FDA to the product Dipyridamole which is product labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0115-1070-01 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Dipyridamole?
This medication is used in combination with "blood thinners" such as warfarin to keep clots from forming after heart valve replacements. Clots are a serious complication that can cause strokes, heart attacks, or blocked blood vessels in the lungs (pulmonary embolisms). Dipyridamole is an antiplatelet drug. It helps to keep blood flowing by stopping platelets from clumping together and by keeping heart blood vessels open.
|Color(s)||WHITE (C48325) |
|Shape||ROUND (C48348) |
|Size(s)||6 MM |
NDC Code 0115-1070-01
Package Description: 100 TABLET in 1 BOTTLE
Price per Unit: $1.06294 per EA
Dipyridamole Active Ingredients UNII Codes
- DIPYRIDAMOLE (UNII: 64ALC7F90C)
- DIPYRIDAMOLE (UNII: 64ALC7F90C) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 197622 - dipyridamole 50 MG Oral Tablet
- RxCUI: 309952 - dipyridamole 25 MG Oral Tablet
- RxCUI: 309955 - dipyridamole 75 MG Oral Tablet
Dipyridamole Inactive Ingredients UNII Codes
- STARCH, CORN (UNII: O8232NY3SJ)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- POVIDONE (UNII: FZ989GH94E)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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Dipyridamole is used with other drugs to reduce the risk of blood clots after heart valve replacement. It works by preventing excessive blood clotting.
What are blood thinners?
Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.
Who needs blood thinners?
You may need a blood thinner if you have:
- Certain heart or blood vessel diseases
- An abnormal heart rhythm called atrial fibrillation
- A heart valve replacement
- A risk of blood clots after surgery
- Congenital heart defects
What are the different types of blood thinners?
There are different types of blood thinners:
- Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
- Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.
How can I take blood thinners safely?
When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.
You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.
What are the side effects of blood thinners?
Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.
Other possible side effects can depend on which type of blood thinner that you are taking.
Call your provider if you have any sign of serious bleeding, such as:
- Menstrual bleeding that is much heavier than normal
- Red or brown urine
- Bowel movements that are red or black
- Bleeding from the gums or nose that does not stop quickly
- Vomit that is brown or bright red
- Coughing up something red
- Severe pain, such as a headache or stomachache
- Unusual bruising
- A cut that does not stop bleeding
- A serious fall or bump on the head
- Dizziness or weakness
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Dipyridamole Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- CLINICAL PHARMACOLOGY
- MECHANISM OF ACTION
- PHARMACOKINETICS AND METABOLISM
- INDICATIONS AND USAGE
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
- NURSING MOTHERS
- PEDIATRIC USE
- ADVERSE REACTIONS
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 25 MG TABLET LABEL
Dipyridamole is a platelet inhibitor chemically described as 2,2',2",2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The molecular weight is 504.63 and the molecular formula is C24H40N8O4. The structural formula is represented below:
Dipyridamole, USP is intensely yellow crystalline powder or needles. It is practically insoluble in water, sparingly soluble in ethyl alcohol, very slightly soluble in acetone and ethyl acetate.
Each tablet, for oral administration, contains 25 mg, 50 mg or 75 mg dipyridamole, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, Type A, talc, and titanium dioxide.
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 thromboembolic 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 mcg/mL 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).
In dogs intraduodenal doses of dipyridamole of 0.5 mg/kg 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 mg/kg 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.
Indications And Usage
Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Hypersensitivity to dipyridamole and any of the other components.
Coronary Artery Disease: Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (e.g., unstable angina or recently sustained myocardial infarction). Chest pain may be aggravated in patients with underlying coronary artery disease who are receiving dipyridamole.
Hepatic Insufficiency: Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.
Hypotension: Dipyridamole should be used with caution in patients with hypotension since it can produce peripheral vasodilation.
Stress Testing with Intravenous Dipyridamole and Other Adenosinergic Agents: Clinical experience suggests that patients being treated with dipyridamole tablets who also require pharmacological stress testing with intravenous dipyridamole or other adenosinergic agents (e.g. adenosine, regadenoson) should interrupt dipyridamole tablets for 48 hours prior to stress testing.
Intake of dipyridamole tablets within 48 hours prior to stress testing with intravenous dipyridamole or other adenosinergic agents may increase the risk for cardiovascular side effects of these agents and may impair the sensitivity of the test.
Dipyridamole has been associated with elevated hepatic enzymes.
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 A2A-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.
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/m2 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/m2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1,250 mg/kg (more than 30 times the MRHD on a mg/m2 basis).
Reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1,000 mg/kg, respectively (about 1½, 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.
As dipyridamole is excreted in human milk, caution should be exercised when dipyridamole tablets are administered to a nursing woman.
Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
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:
|Adverse Reaction||Dipyridamole Tablets/ Warfarin||Placebo/ Warfarin|
|Number of patients||147||170|
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 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.
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.
Dipyridamole Tablets USP, 25 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C81” on one side and plain on the other side.
They are available as follows:
Bottles of 100: NDC 0115-1070-01
Bottles of 1,000: NDC 0115-1070-03
Dipyridamole Tablets USP, 50 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C82” on one side and plain on the other side.
They are available as follows:
Bottles of 100: NDC 0115-1071-01
Bottles of 1,000: NDC 0115-1071-03
Dipyridamole Tablets USP, 75 mg are white to pale yellow, round, standard convex film-coated tablets debossed with “C83” on one side and plain on the other side.
They are available as follows:
Bottles of 100: NDC 0115-1072-01
Bottles of 1,000: NDC 0115-1072-03
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep this and all medication out of the reach of children.
Dispense in tightly-closed, light-resistant container as defined in the USP, with child-resistant closure, as required.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Principal Display Panel - 25 Mg Tablet Label
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