Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg

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Overview

What is Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

Aspirin and Extended-Release Dipyridamole Capsulesare a combination antiplatelet agent 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, pregelatinzied 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-]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.

What does Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg look like?

What are the available doses of Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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.

What should I talk to my health care provider before I take Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

How should I use Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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 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 Capsulescan be administered with or without food.

What interacts with Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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What are the warnings of Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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What are the precautions of Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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What are the side effects of Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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What should I look out for while using Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

Hypersensitivity to any product ingredients

Patients with known allergy to NSAIDs

Patients with the syndrome of asthma, rhinitis, and nasal polyps

What might happen if I take too much Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

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 hemodynamic 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.

How should I store and handle Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?

Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F) Aspirin and Extended-Release Dipyridamole Capsulesare 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 bodyAspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02).Store at 25C (77F); excursions permitted to 15to 30C (59 to 86F)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 and ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to1.9 mcg/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).

Aspirin

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A, a powerful inducer of platelet aggregation and vasoconstriction.

Non-Clinical Toxicology

Hypersensitivity to any product ingredients

Patients with known allergy to NSAIDs

Patients with the syndrome of asthma, rhinitis, and nasal polyps

Phenoxybenzamine hydrochloride may interact with compounds that stimulate both and adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia. ( )

Phenoxybenzamine hydrochloride blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.

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) .

Intracranial Hemorrhage

In European Stroke Prevention Study-2 (ESPS2) the incidence of intracranial hemorrhage was 0.6% in the aspirin and extended-release dipyridamole group, 0.5% in the extended-release dipyridamole (ER-DP) group, 0.4% in the aspirin (ASA) group and 0.4% 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 incidence of gastrointestinal bleeding was 4.1% in the aspirin and extended-release dipyridamole group, 2.2% in the extended-release dipyridamole group, 3.2% in the aspirin group, and 2.1% 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.

The following adverse reactions are discussed elsewhere in the labeling:

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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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