Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 25 mg; 200 mg Capsule, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Platelet Aggregation Inhibitor class.
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🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
The combination of aspirin and extended-release dipyridamole is used to reduce the risk of stroke in patients who have had or are at risk of stroke. It is in a class of drugs called antiplatelet agents. It works by preventing excessive blood clotting.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.559 | $33.55 / 60 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.8869 | $53.21 / 60 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg 25 mg/1; 200 mg 00904-7056-99 | Major | 20 capsules | $0.559 | AB | Availability likely | — |
| Aspirin and Dipyridamole 25 mg/1; 200 mg 16714-0964-01 | NorthStar | 60 capsules | $0.559 | AB | Availability likely | — |
| Aspirin And Extended-Release Dipyridamole 25 mg/1; 200 mg 42571-0274-60 | Micro | 60 capsules | $0.559 | AB | Availability likely | — |
| Aspirin and Dipyridamole 25 mg/1; 200 mg 43598-0339-60 | Dr. | 60 capsules | $0.559 | AB | Availability likely | — |
| Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg 25 mg/1; 200 mgthis 49884-0007-02 | Par | 60 capsules | $0.559 | AB | Availability likely | — |
| Aspirin and Extended-Release Dipyridamole 25 mg/1; 200 mg 65162-0596-06 | Amneal | 60 capsules | $0.559 | AB | Availability likely | — |
| Aspirin and Extended-Release Dipyridamole 25 mg/1; 200 mg 42291-0116-60 | AvKARE | 60 capsules | — | AB | FDA listed | — |
| Aspirin And Extended-Release Dipyridamole 25 mg/1; 200 mg 63629-5045-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Asprin And Extended-Release Dipyridamole 25 mg/1; 200 mg 68462-0405-30 | Glenmark | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 49884-0007-02 You're viewing this | 60 CAPSULE in 1 BOTTLE (49884-007-02) | 2017-01-30 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Aspirin and Extended-Release Dipyridamole Capsule is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. Aspirin and Extended-Release Dipyridamole Capsule is a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Aspirin and Extended-Release Dipyridamole Capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets. The recommended dose of Aspirin and Extended-Release Dipyridamole Capsules is one capsule given orally twice daily, one in the morning and one in the evening. Swallow capsules whole without chewing.
Aspirin and Extended-Release Dipyridamole Capsules can be administered with or without food. One capsule twice daily (morning and evening) with or without food ( 2 ) In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning; resume BID dosing within one week ( 2.1 ) Do not chew capsule ( 2 ) Not interchangeable with the individual components of aspirin and dipyridamole tablets ( 2 ) Dispense in this unit-of-use container ( 16 )
2.1Alternative Regimen in Case of Intolerable Headaches In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 25 mg/200 mg capsules are imprinted in black with ‘PAR’ on the cap and ‘730’ on the body, containing yellow colored extended-release pellets incorporating dipyridamole and a white to off white, film coated, circular, bi-convex tablet incorporating immediate-release aspirin. Capsule: 25 mg aspirin/200 mg extended-release dipyridamole ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to any product ingredients ( 4.1 ) Patients with known allergy to NSAIDs ( 4.2 ) Patients with the syndrome of asthma, rhinitis, and nasal polyps ( 4.2 )
4.1Hypersensitivity Aspirin and extended-release dipyridamole is contraindicated in patients with known hypersensitivity to any of the product components.
4.2Allergy Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (NSAID) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm.
4.3Reye Syndrome Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Aspirin and extended-release dipyridamole capsules increases the risk of bleeding ( 5.1 ) Avoid use in patients with severe hepatic or renal insufficiency ( 5.2 , 5.3 ) Interrupt aspirin and extended-release dipyridamole capsules 48 hours before using intravenous dipyridamole or other adenosinergic agents for stress testing ( 5.6 , 7.1 )
5.1Risk of Bleeding Aspirin and extended-release dipyridamole increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, heparin, anagrelide, fibrinolytic therapy, and chronic use of NSAIDs) [see Drug Interactions ( 7.1 )]. Intracranial Hemorrhage In European Stroke Prevention Study-2 (ESPS2), the annualized event rate for intracranial hemorrhage was 0.39%/year in the aspirin and extended-release dipyridamole group, 0.26%/year in the extended-release dipyridamole (ER-DP) group, 0.24%/year in the aspirin (ASA) group, and 0.29%/year in the placebo groups.
Gastrointestinal (GI) Side Effects GI side effects include stomach pain, heartburn, nausea, vomiting, and gross GI bleeding. Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms. Inform patients about the signs and symptoms of GI side effects and what steps to take if they occur .
In ESPS2, the annualized event rate for gastrointestinal bleeding was 2.97%/year in the aspirin and extended-release dipyridamole group, 1.58%/year in the extended-release dipyridamole group, 2.06%/year in the aspirin group, and 1.40%/year in the placebo groups. Peptic Ulcer Disease Avoid using aspirin in patients with a history of active peptic ulcer disease, which can cause gastric mucosal irritation and bleeding. Alcohol Warning Because aspirin and extended-release dipyridamole contains aspirin, counsel patients who consume three or more alcoholic drinks every day about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
5.2Renal Failure Avoid aspirin in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute) [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].
5.3Hepatic Insufficiency Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].
5.4Coronary Artery Disease Dipyridamole has a vasodilatory effect. Chest pain may be precipitated or aggravated in patients with underlying coronary artery disease who are receiving dipyridamole. For stroke or TIA patients for whom aspirin is indicated to prevent recurrent myocardial infarction (MI) or angina pectoris, the aspirin in this product may not provide adequate treatment for the cardiac indications.
5.5Hypotension Dipyridamole produces peripheral vasodilation, which can exacerbate pre-existing hypotension.
5.6Stress Testing with Intravenous Dipyridamole and Other Adenosinergic Agents Clinical experience suggests that patients being treated with aspirin and extended-release dipyridamole capsules who also require pharmacological stress testing with intravenous dipyridamole or other adenosinergic agents (e.g., adenosine, regadenoson) should interrupt aspirin and extended-release dipyridamole capsules for 48 hours prior to stress testing [see Drug Interactions ( 7.1 )] . Intake of aspirin and extended-release dipyridamole capsules 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.
5.7General Aspirin and extended-release dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Hypersensitivity [see Contraindications ( 4.1 ) ] Allergy [see Contraindications ( 4.2 ) ] Risk of Bleeding [see Warnings and Precautions ( 5.1 )] The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The efficacy and safety of aspirin and extended-release dipyridamole was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo-controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry.
Patients were randomized to either aspirin and extended-release dipyridamole, aspirin, ER-DP, or placebo [see Clinical Studies ( 14 )] ; primary endpoints included stroke (fatal or nonfatal) and death from all causes. This 24-month, multicenter, double-blind, randomized study (ESPS2) was conducted to compare the efficacy and safety of aspirin and extended-release dipyridamole with placebo, extended-release dipyridamole alone and aspirin alone. The study was conducted in a total of 6602 male and female patients who had experienced a previous ischemic stroke or transient ischemia of the brain within three months prior to randomization.
Table 1 presents the annualized event rate for adverse events that occurred in 1%/year or more of patients treated with aspirin and extended-release dipyridamole where the incidence was also at least 1%/year greater than in those patients treated with placebo. There is no clear benefit of the dipyridamole/aspirin combination over aspirin with respect to safety. Table 1 Incidence of Adverse Events in ESPS2 a Individual Treatment Group Body System/Preferred Term Aspirin and Extended-Release Dipyridamole n (%/year) b ER-DP Alone n (%/year) b ASA Alone n (%/year) b Placebo n (%/year) b Total Number of Patients 1,650 1,654 1,649 1,649 Central and Peripheral Nervous System Disorders Headache 647 (28.25) 634 (27.91) 558 (22.10) 543 (22.29) Gastrointestinal System Disorders Dyspepsia 303 (13.23) 288 (12.68) 299 (11.84) 275 (11.29) Abdominal Pain 289 (12.62) 255 (11.22) 262 (10.38) 239 (9.81) Nausea 264 (11.53) 254 (11.18) 210 (8.32) 232 (9.53) Diarrhea 210 (9.17) 257 (11.31) 112 (4.44) 161 (6.61) Vomiting 138 (6.03) 129 (5.68) 101 (4.00) 118 (4.84) Platelet, Bleeding and Clotting Disorders Hemorrhage NOS 52 (2.27) 24 (1.06) 46 (1.82) 24 (0.99) a Reported by ≥1%/year of patients during aspirin and extended-release dipyridamole treatment where the incidence was at least 1%/year greater than in those treated with placebo. b Annual event rate per 100 pt-years = 100* number of subjects with event/subject-years.
Subject-years is defined as cumulative number of days on treatment divided by 365.25. Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID.
NOS = not otherwise specified. Discontinuation due to adverse events in ESPS2 was 25% for aspirin and extended-release dipyridamole, 25% for extended-release dipyridamole, 19% for aspirin, and 21% for placebo (refer to Table 2). Table 2 Incidence of Adverse Events that Led to the Discontinuation of Treatment a Treatment Groups Aspirin and Extended-Release Dipyridamole n (%/year) b ER-DP n (%/year) b ASA n (%/year) b Placebo n (%/year) b Total Number of Patients 1,650 1,654 1,649 1,649 Patients with at least one Adverse Event that led to treatment discontinuation 417 (…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with anticoagulants, antiplatelets, or NSAIDs can increase risk of bleeding ( 7.1 ) Decreased renal function can occur with co-administration with NSAIDs ( 7.1 )
7.1Drug Interaction Study Information Obtained From 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. Angiotensin Converting Enzyme (ACE) Inhibitors Because of the indirect effect of aspirin on the renin-angiotensin conversion pathway, the hyponatremic and hypotensive effects of ACE inhibitors may be diminished by concomitant administration of aspirin. Acetazolamide Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.
Anticoagulants and Antiplatelets Patients taking aspirin and extended-release dipyridamole in combination with anticoagulants, antiplatelets, or any substance impacting coagulation are at increased risk for bleeding. Aspirin can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Aspirin can increase the anticoagulant activity of heparin, increasing bleeding risk.
A nagrelide Patients taking aspirin in combination with anagrelide are at an increased risk of bleeding. Anticonvulsants Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels. Beta Blockers The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.
Cholinesterase Inhibitors Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis. Diuretics The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention. Methotrexate Salicylate can inhibit renal clearance of methotrexate, leading to bone marrow toxicity, especially in the elderly or renal impaired.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concurrent use of aspirin with other NSAIDs may increase bleeding or lead to decreased renal function. Oral Hypoglycemics Moderate doses of aspirin may increase the effectiveness of oral hypoglycemic drugs, leading to hypoglycemia. Uricosuric Agents (probenecid and sulfinpyrazone) Salicylates antagonize the uricosuric action of uricosuric agents.
🆘 Overdosage ▾
10 OVERDOSAGE Because of the dose ratio of dipyridamole to aspirin, overdosage of aspirin and extended-release dipyridamole is likely to be dominated by signs and symptoms of dipyridamole overdose. 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. Salicylate toxicity may result from acute ingestion (overdose) or chronic intoxication.
Severity of aspirin intoxication is determined by measuring the blood salicylate level. The early signs of salicylic overdose (salicylism), including tinnitus (ringing in the ears), occur at plasma concentrations approaching 200 mcg/mL. In severe cases, hyperthermia and hypovolemia are the major immediate threats to life.
Plasma concentrations of aspirin above 300 mcg/mL are clearly toxic. Severe toxic effects are associated with levels above 400 mcg/mL. A single lethal dose of aspirin in adults is not known with certainty but death may be expected at 30 g.
Treatment of overdose consists primarily of supporting vital functions, increasing drug elimination, and correcting acid-base disturbances. Consider gastric emptying and/or lavage as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal as a slurry may be beneficial if less than 3 hours have passed since ingestion.
Charcoal absorption should not be employed prior to emesis and lavage. Follow acid-base status closely with serial blood gas and serum pH measurements. Maintain fluid and electrolyte balance.
Administer replacement fluid intravenously and augment with correction of acidosis. Treatment may require the use of a vasopressor. Infusion of glucose may be required to control hypoglycemia.
Administration of xanthine derivatives (e.g., aminophylline) may reverse the vasodilatory effects of dipyridamole overdose. Plasma electrolytes and pH should be monitored serially to promote alkaline diuresis of salicylate if renal function is normal. In patients with renal insufficiency or in cases of life-threatening intoxication, dialysis is usually required to treat salicylic overdose; however, since dipyridamole is highly protein bound, dialysis is not likely to remove dipyridamole.
Exchange transfusion may be indicated in infants and young children.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The antithrombotic action of aspirin and extended-release dipyridamole is the result of the additive antiplatelet effects of dipyridamole and aspirin. Dipyridamole 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).
Aspirin Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A 2 , a powerful inducer of platelet aggregation and vasoconstriction.
12.2Pharmacodynamics The effect of either agent on the other's inhibition of platelet reactivity has not been evaluated.
12.3Pharmacokinetics There are no significant interactions between aspirin and dipyridamole. The kinetics of the components are unchanged by their co-administration as aspirin and extended-release dipyridamole. Absorption Dipyridamole: Peak plasma levels of dipyridamole are achieved 2 hours (range 1 to 6 hours) after administration of a daily dose of 400 mg aspirin and extended-release dipyridamole (given as 200 mg BID).
The peak plasma concentration at steady-state is 1.98 mcg/mL (1.01 to 3.99 mcg/mL) and the steady-state trough concentration is 0.53 mcg/mL (0.18 to 1.01 mcg/mL). Aspirin: Peak plasma levels of aspirin are achieved 0.63 hours (0.5 to 1 hour) after administration of a 50 mg aspirin daily dose from aspirin and extended-release dipyridamole (given as 25 mg BID). The peak plasma concentration at steady-state is 319 ng/mL (175 to 463 ng/mL).
Aspirin undergoes moderate hydrolysis to salicylic acid in the liver and the gastrointestinal wall, with 50% to 75% of an administered dose reaching the systemic circulation as intact aspirin. Effect of Food Dipyridamole: When aspirin and extended-release dipyridamole capsules were taken with a high fat meal, dipyridamole peak plasma levels (C max ) and total absorption (AUC) were decreased at steady-state by 20 to 30% compared to fasting. Due to the similar degree of inhibition of adenosine uptake at these plasma concentrations, this food effect is not considered clinically relevant.
Aspirin: When aspirin and extended-release dipyridamole capsules were taken with a high fat meal, there was no difference for aspirin in AUC at steady-state, and the approximately 50% decrease in C max was not considered clinically relevant based on a similar degree of cyclooxygenase inhibition comparing the fed and fasted state. Distribution Dipyridamole: Dipyridamole is highly lipophilic (log P=3.71, pH=7); however, it has been shown that the drug does not cross the blood-brain barrier to any significant extent in animals.
The steady-state volume of distribution of dipyridamole is about 92 L. Approximately 99% of dipyridamole is bound to plasma proteins, predominantly to alpha 1-acid glycoprotein and albumin. Aspirin: Aspirin is poorly bound to plasma proteins and its apparent volume of distribution is low (10 L).
Its metabolite, salicylic acid, is highly bound to plasma proteins, but its binding is concentration-dependent (nonlinear). At low concentrations (<100 mcg/mL), approximately 90% of salicylic acid…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The antithrombotic action of aspirin and extended-release dipyridamole is the result of the additive antiplatelet effects of dipyridamole and aspirin. Dipyridamole 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).
Aspirin Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A 2 , a powerful inducer of platelet aggregation and vasoconstriction.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Aspirin and Extended-Release Dipyridamole Capsules are available as a hard gelatin capsule, with a red colored cap and an ivory-colored body, containing yellow colored extended-release pellets incorporating dipyridamole and a white to off white, film coated, circular, bi-convex tablet incorporating immediate-release aspirin. The capsule body is imprinted in black with ‘PAR’ on the cap and ‘730’ on the body. Aspirin and Extended-Release Dipyridamole Capsules are supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).
Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) [See USP Controlled Room Temperature]. Protect from excessive moisture.
📋 Description ▾
11 DESCRIPTION Aspirin and Extended-Release Dipyridamole Capsules are a combination of aspirin and dipyridamole, antiplatelet agents, intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole in an extended-release form and 25 mg aspirin, as an immediate-release tablet. In addition, each capsule contains the following inactive ingredients: acacia, alginic acid, anhydrous lactose, colloidal silicon dioxide, ethyl cellulose, hypromellose phthalate, hypromellose, lecithin, xanthan gum, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, tartaric acid, titanium dioxide and triacetin.
Each capsule shell contains gelatin, sodium lauryl sulfate, FD&C Red 40, FD&C Yellow 6, shellac, potassium hydroxide, red iron oxide, yellow iron oxide, titanium dioxide, black iron oxide and water. Dipyridamole Dipyridamole is an antiplatelet agent 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: Dipyridamole is an intensely yellow crystalline powder, having a bitter taste.
It is soluble in dilute acids, methanol and chloroform, and is practically insoluble in water. Aspirin The antiplatelet agent aspirin (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula: Aspirin is an odorless white crystals, commonly tabular or needle-like or white crystalline or powder. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor.
It is highly lipid soluble and slightly soluble in water. Dipyridamole aspirin
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Bleeding Inform patients that as with other antiplatelet agents, there is a general risk of bleeding including intracranial and gastrointestinal bleeding. Inform patients about the signs and symptoms of bleeding, including occult bleeding.
Tell patients to notify their physician if they are prescribed any drug which may increase risk of bleeding. Counsel patients who consume three or more alcoholic drinks daily about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aspirin and extended-release dipyridamole capsules [see Use in Specific Populations ( 8.1 )] .
H eadaches Some patients may experience headaches upon treatment initiation; these are usually transient. In case of intolerable headaches, tell patients to contact their physician. Stress Test Instruct patients who are scheduled to undergo a pharmacologic stress test to tell their healthcare provider that they are taking aspirin and extended-release dipyridamole capsules.
Dosage and Administration Tell patients that aspirin and extended-release dipyridamole capsules should be swallowed whole, and not chewed or crushed. If you miss a dose, continue with your next dose on your regular schedule. Do not take a double dose.
Storage Inform patients to protect aspirin and extended-release dipyridamole capsules from moisture.