Aspirin Dipyridamole Brand Name– Aggrenox
What is Aspirin Dipyridamole
Aspirin dipyridamole are two different antiplatelet agents used together for secondary stroke prevention.
Aspirin is a salicylate and dipyridamole is a coronary vasodilator with antiplatelet properties. Aggrenox™ combines these two drugs in a fixed dose (200 mg dipyridamole/25 mg aspirin) extended-release formulation.
The combination product is specifically indicated for the prophylaxis of stroke in patients who have sustained a previous stroke or transient ischemic attack (TIA) based on the European Stroke Prevention Study 2 (ESPS2) which included 6602 patients.
The fixed dose combination of aspirin-dipyridamole was twice as effective as either agent alone alone in the secondary prevention of stroke, but did not affect overall mortality in this one-year clinical trial.
Bleeding was more frequent with the combination product compared to extended-release dipyridamole alone, and headache was more frequent compared to aspirin alone.
The Antiplatelet Trialists Collaboration (1988) had previously concluded that dipyridamole and aspirin in combination was not more effective than aspirin, and that dipyridamole monotherapy had no role in the treatment of thromboembolic disorders.
The results of the ESPS2 study support the combined use of aspirin and dipyridamole in the dosage formulation studied for the secondary prevention of stroke in cerebrovascular disorders.
For patients with a history of noncardioembolic TIA or stroke, the American College of Chest Physicians (ACCP) recommends aspirin; dipyridamole as one of several first-line antiplatelet regimens including low-dose aspirin or clopidogrel.
These specific guidelines also suggest that clopidogrel be favored over aspirin; however, this Grade 2B recommendation places a high value on a small reduction in absolute stroke rates, and a lower value on drug expenditures.
For stroke or TIA patients for whom aspirin is indicated to prevent recurrent myocardial infarction (MI) or angina pectoris, the low aspirin dosage in Aggrenox™ may not be adequate for the cardiac indications.
Final FDA approval for Aggrenox™ was granted on November 22, 1999.
Indications
- stroke prophylaxis
For secondary stroke prophylaxis in patients who have had a transient ischemic attack (TIA) or ischemic stroke due to thrombosis
Side Effects
- abdominal pain
- agitation
- alopecia
- amnesia
- anemia
- angina
- angioedema
- anorexia
- aplastic anemia
- arthralgia
- asthenia
- back pain
- bleeding
- bronchospasm
- cerebral edema
- chest pain (unspecified)
- cholelithiasis
- coagulopathy
- coma
- confusion
- cough
- dehydration
- diarrhea
- disseminated intravascular coagulation (DIC)
- dizziness
- drowsiness
- dyspepsia
- dyspnea
- ecchymosis
- elevated hepatic enzymes
- epistaxis
- fatigue
- fetal death
- fever
- flushing
- GI bleeding
- GI perforation
- headache
- hearing loss
- heart failure
- hematemesis
- hematoma
- hematuria
- hemoptysis
- hemorrhoids
- hepatic failure
- hepatitis
- hyperglycemia
- hyperkalemia
- hyperuricemia
- hypoglycemia
- hypokalemia
- hypotension
- hypothermia
- infection
- interstitial nephritis
- intracranial bleeding
- jaundice
- laryngeal edema
- malaise
- melena
- metabolic acidosis
- migraine
- myalgia
- nausea
- palpitations
- pancreatitis
- pancytopenia
- paresthesias
- peptic ulcer
- peripheral vasodilation
- platelet dysfunction
- prolonged bleeding time
- proteinuria
- pruritus
- pulmonary edema
- purpura
- pyrosis (heartburn)
- rash
- renal failure (unspecified)
- renal papillary necrosis
- renal tubular necrosis
- Reye’s syndrome
- rhabdomyolysis
- seizures
- sinus tachycardia
- Stevens-Johnson syndrome
- supraventricular tachycardia (SVT)
- syncope
- tachypnea
- thrombocytopenia
- thrombocytosis
- tinnitus
- urticaria
- vasculitis
- vomiting
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- abrupt discontinuation
- acute bronchospasm
- agranulocytosis
- alcoholism
- anemia
- angina
- asthma
- bone marrow suppression
- breast-feeding
- children
- coagulopathy
- coronary artery disease
- diabetes mellitus
- esophagitis
- G6PD deficiency
- gastritis
- geriatric
- GI bleeding
- gout
- head trauma
- hepatic disease
- hyperuricemia
- hypoprothrombinemia
- immunosuppression
- increased intracranial pressure
- infants
- intracranial bleeding
- intramuscular injections
- labor
- myocardial infarction
- nasal polyps
- neonates
- neutropenia
- NSAID hypersensitivity
- obstetric delivery
- orthostatic hypotension
- peptic ulcer disease
- pregnancy
- renal disease
- renal failure
- renal impairment
- Reye’s syndrome
- salicylate hypersensitivity
- surgery
- syncope
- systemic lupus erythematosus (SLE)
- tartrazine dye hypersensitivity
- thrombocytopenia
- tobacco smoking
- urticaria
- viral infection
- vitamin K deficiency
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