aspirin-dipyridamole

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Overview

What is aspirin-dipyridamole?

Aspirin and extended-release dipyridamole capsules are a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin, USP as an immediate-release film-coated tablet. In addition, each capsule contains the following inactive ingredients: corn starch, hypromellose, hypromellose phthalate, lactose monohydrate, methacrylic acid copolymer type B, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, tartaric acid pellets, and triethyl citrate.

Each capsule shell contains D&C Yellow 10, FD&C red 40, gelatin, sodium lauryl sulfate, and titanium dioxide. Each capsule shell is imprinted with black pharmaceutical ink which contains following inactive ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, purified water, and potassium hydroxide.

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, USP is intensely yellow, crystalline powder or needles; soluble in methanol, in alcohol, freely soluble in chloroform; practically insoluble in water; slightly soluble in acetone and in ethyl acetate.

Aspirin

The antiplatelet agent aspirin (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula:

Aspirin, USP is white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor, is stable in dry air; in moist air it gradually hydrolyzes to salicylic and acetic acids and gives off a vinegary odor. Aspirin, USP is freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether; and slightly soluble in water.

What does aspirin-dipyridamole look like?

What are the available doses of aspirin-dipyridamole?

25 mg/200 mg : Two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and opaque white body, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin.

What should I talk to my health care provider before I take aspirin-dipyridamole?

How should I use aspirin-dipyridamole?

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.

What interacts with aspirin-dipyridamole?

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What are the warnings of aspirin-dipyridamole?

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What are the precautions of aspirin-dipyridamole?

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What are the side effects of aspirin-dipyridamole?

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What should I look out for while using aspirin-dipyridamole?

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-dipyridamole?

Because of the dose ratio of dipyridamole to aspirin, overdosage of aspirin and extended-release dipyridamole capsules are 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-dipyridamole?

Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals .Dispense in a tight, light-resistant container as defined in the USP/NF.Store at 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals .Dispense in a tight, light-resistant container as defined in the USP/NF.Store at 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals .Dispense in a tight, light-resistant container as defined in the USP/NF.Store at 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows:NDC 68382-618-14 in bottle of 60 capsulesStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]Protect from excessive moisture. Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows:NDC 68382-618-14 in bottle of 60 capsulesStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]Protect from excessive moisture. Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows:NDC 68382-618-14 in bottle of 60 capsulesStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]Protect from excessive moisture. Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows:NDC 68382-618-14 in bottle of 60 capsulesStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]Protect from excessive moisture.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The antithrombotic action of aspirin and extended-release dipyridamole capsules 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 to 1.9 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 ()

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

Aspirin and extended-release dipyridamole capsules increase 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 capsules 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 capsules 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 capsules contain 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.

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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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Review

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Professional

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. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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