Aspirin And Dipyridamole (Aspirin And Dipyridamole)

Trade Name : Aspirin and Dipyridamole

Teva Pharmaceuticals USA, Inc.

CAPSULE, EXTENDED RELEASE

Strength 25200 mg/1mg/1

Storage and handling for Aspirin and Dipyridamole

ASPIRIN; DIPYRIDAMOLE Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Aspirin And Dipyridamole (Aspirin And Dipyridamole) which is also known as Aspirin and Dipyridamole and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25; 200 mg/1; mg/1 per ml. Read more

Aspirin And Dipyridamole (Aspirin And Dipyridamole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Aspirin and extended-release dipyridamole capsules are 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 a combination antiplatelet agent 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 is not interchangeable with the individual components of aspirin and dipyridamole tablets.
The recommended dose of aspirin and extended-release dipyridamole 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 can be administered with or without food.
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.

One capsule twice daily (morning and evening) with or without food ()
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 ()
Do not chew capsule ()
Not interchangeable with the individual components of aspirin and dipyridamole tablets ()
Dispense in this unit-of-use container ()

25 mg/200 mg: Two-piece hard gelatin capsule with a Swedish orange opaque cap and white opaque body, imprinted in black ink with TEVA over 3064 on the cap and TEVA over 3064 on the body.

Capsule: 25 mg aspirin/200 mg extended-release dipyridamole ()

No data

Hypersensitivity to any product ingredients ()
Patients with known allergy to NSAIDs ()
Patients with the syndrome of asthma, rhinitis, and nasal polyps ()

No data

Aspirin and extended-release dipyridamole increases the risk of bleeding ()
Avoid use in patients with severe hepatic or renal insufficiency (, )
Interrupt aspirin and extended-release dipyridamole capsules 48 hours before using intravenous dipyridamole or other adenosinergic agents for stress testing (, )

The following adverse reactions are discussed elsewhere in the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea (n )

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 n
Angiotensin Converting Enzyme (ACE) Inhibitors
Because ofu00a0the 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.
Anagrelide
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.

Co-administration with anticoagulants, antiplatelets, or NSAIDs can increase risk of bleeding ()
Decreased renal function can occur with co-administration with NSAIDs ()

No data

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 vasodilatoryu00a0effects 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.

Aspirin and Extended-Release Dipyridamole Capsules are 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 sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: aluminum monostearate, colloidal silicon dioxide, copovidone, corn starch, hypromellose, hypromellose phthalate, lactose monohydrate, lecithin, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, simethicone, talc, tartaric acid, titanium dioxide, triacetin and xanthan gum. Each capsule shell also contains gelatin, red iron oxide and water.
The imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol and shellac glaze.
Dipyridamole
Dipyridamole, USPu00a0is 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:
CHNOt M.W. 504.63
Dipyridamole, USPu00a0is an odorless yellow crystalline substance, 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:
CHOtM.W. 180.16
Aspirin, USPu00a0is an odorless white needle-like crystalline or powdery substance. 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.

No data

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.
Combinations of dipyridamole and aspirin (1:5 ratio) tested negative in the Ames test, chromosome aberration tests (in mice and hamsters), oral micronucleus tests (in mice and hamsters) and oral dominant lethal test (in mice). Aspirin, alone, induced chromosome aberrations in cultured human fibroblasts. Mutagenicity tests of dipyridamole alone with bacterial and mammalian cell systems were negative.
Combinations of dipyridamole and aspirin have not been evaluated for effects on fertility and reproductive performance. 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). Aspirin inhibits ovulation in rats.

ESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic attack (TIA, 24%) within three months prior to entry. Patients were enrolled in 13 European countries between February 1989 and May 1995 and were randomized to one of four treatment groups: Aspirin and extended-release dipyridamole 25 mg/200 mg; extended-release dipyridamole (ER-DP) 200 mg alone; aspirin (ASA) 25 mg alone; or placebo. The mean age in this population was 66.7 years with 58% of them being males. Patients received one capsule twice daily (morning and evening). Efficacy assessments included analyses of stroke (fatal or nonfatal) and death (from all causes) as confirmed by a blinded morbidity and mortality assessment group. There were no differences with regard to efficacy based on age or gender; patients who were older had a trend towards more events.
Stroke Endpoint
Aspirin and extended-release dipyridamole reduced the risk of stroke by 22.1% compared to aspirin 50 mg/day alone (p = 0.008) and reduced the risk of stroke by 24.4% compared to extended- release dipyridamole 400 mg/day alone (p = 0.002) (Table 3). Aspirin and extended-release dipyridamole reduced the risk of stroke by 36.8% compared to placebo (p <0.001).
Table 3 Summary of First Stroke (Fatal or Nonfatal): ESPS2: Intent-to-Treat Population
Figure 1 n- ESPS2: Cumulative Stroke Rate (Fatal or Nonfatal)
Over 24 months of Follow-Up
Combined Stroke or Death Endpoint
In ESPS2, aspirin and extended-release dipyridamole reduced the risk of stroke or death by 12.1% compared to aspirin alone and by 10.3% compared to extended-release dipyridamole alone. These results were not statistically significant.
Aspirin and extended-release dipyridamole reduced the risk of stroke or death by 24.2% compared to placebo.
Death Endpoint
The incidence rate of all-cause mortality was 11.3% for aspirin and extended-release dipyridamole, 11.0% for aspirin alone, 11.4% for extended-release dipyridamole alone and 12.3% for placebo alone. The differences between the aspirin and extended-release dipyridamole, aspirin alone and extended-release dipyridamole alone treatment groups were not statistically significant. These incidence rates for aspirin and extended-release dipyridamole and aspirin alone are consistent with previous aspirin studies in stroke and TIA patients.

Aspirin and Extended-Release Dipyridamole Capsules are available as:
25 mg/200 mg: Two-piece hard gelatin capsule with a Swedish orange opaque cap and white opaque body. Imprinted in black ink with TEVA over 3064 on the cap and TEVA over 3064 on the body and available in unit-of-use bottles of 60 capsules (NDC 0093-3064-06).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Protect from excessive moisture.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
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.
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aspirin and extended-release dipyridamole .
Some patients may experience headaches upon treatment initiation; these are usually transient. In case of intolerable headaches, tell patients to contact their physician.
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.
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.
Inform patients to protect aspirin and extended-release dipyridamole from moisture.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev.u00a0Du00a02/2020

Aspirin (asu2032 pir in) and Extended-Release Dipyridamole (dyeu2032u2032 pir idu2032 a mole)u00a0Capsules
Read this Patient Information before you start taking aspirin and extended-release dipyridamole capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is aspirin and extended-release dipyridamole?
Aspirin and extended-release dipyridamole is a prescription medicine that contains aspirin and a medicine that is slowly released in your body, called dipyridamole. Aspirin and extended-release dipyridamole is used to lower the risk of stroke in people who have had a u201cmini-strokeu201d (transient ischemic attack or TIA) or stroke due to a blood clot.
It is not known if aspirin and extended-release dipyridamole is safe and effective in children. See u201cWho should not take aspirin and extended-release dipyridamole?u201d
Who should not take aspirin and extended-release dipyridamole?
Do not take aspirin and extended-release dipyridamole
Do not give aspirin and extended-release dipyridamole to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in aspirin and extended-release dipyridamole) is used in children and teenagers who have certain viral illnesses.
What should I tell my doctor before using aspirin and extended-release dipyridamole?
Before taking aspirin and extended-release dipyridamole, tell your healthcare provider if you:
Tell your doctor you are taking aspirin and extended-release dipyridamole capsules if you are scheduled to have a stress test for your heart.
Tell your doctor about all the medicines you take,
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.
How should I take aspirin and extended-release dipyridamole?
Symptoms of an overdose of aspirin and extended-release dipyridamole include:
What should I avoid while using aspirin and extended-release dipyridamole?
What are the possible side effects of aspirin and extended-release dipyridamole?
Aspirin and extended-release dipyridamole may cause serious side effects, including:
Call your healthcare provider right away if you have any of the symptoms listed above.
The most common side effects of aspirin and extended-release dipyridamole include:
These are not all the possible side effects of aspirin and extended-release dipyridamole. Tell your healthcare provider or pharmacist if you have any side effect that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store aspirin and extended-release dipyridamole?
Keep aspirin and extended-release dipyridamole and all medicines out of the reach of children.
General information about aspirin and extended-release dipyridamole
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use aspirin and extended-release dipyridamole for a condition for which it was not prescribed. Do not give aspirin and extended-release dipyridamole to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information summarizes the most important information about aspirin and extended-release dipyridamole. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about aspirin and extended-release dipyridamole that is written for health professionals.
For more information about aspirin and extended-release dipyridamole capsules call 1-888-838-2872.
What are the ingredients in aspirin and extended-release dipyridamole capsules?
Active Ingredients:
Inactive Ingredients:
Each capsule shell also contains gelatin, red iron oxide and water. The imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol and shellac glaze.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev.u00a0C 2/2020

NDCn- 3064
Aspirin and Extended-Release Dipyridamole Capsules
25 mg/200 mg
Rx only
60 CAPSULES (unit-of-use)
TEVA

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