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Subject-years is defined as cumulative number of days on treatment divided by The dosage regimen for all treatment groups is BID. Headache was most notable in the first month of treatment.
Post-Marketing Experience The following is a list of additional adverse reactions that have been reported either in the literature or are from post-marketing spontaneous reports for either dipyridamole or aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Decisions to include these reactions in labeling are typically based on one or more of the following factors: Body as a Whole: Hypothermia, chest pain, allergic reaction, syncope Cardiovascular: Angina pectoris, hypotension Central Nervous System: Cerebral Aggrenox discount, dizziness, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis, Aggrenox discount Gastrointestinal: Pancreatitis, Reye syndrome, hematemesis, gastritis, ulceration and perforation, Aggrenox Discount, hemorrhage rectum, melena, Meilleurs Acticin 30 gm acheter, ecchymosis, and hematoma, pruritus, urticaria Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, hematuria Vascular Extracardiac Disorders: Allergic vasculitis, flushing Other Adverse Events: Anorexia, aplastic anemia, migraine, pancytopenia, thrombocytosis.
Drug Interactions Drug Interaction Study Information Obtained From Literature Adenosine Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary. Angiotensin Converting Enzyme ACE Inhibitors Because of the indirect effect of Aggrenox discount on the renin-angiotensin conversion pathway, Aggrenox Discount, the hyponatremic and hypotensive effects of ACE inhibitors may be diminished by Aggrenox discount 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.
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, Aggrenox Discount, Aggrenox discount 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.
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- Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor PAF , collagen and adenosine diphosphate ADP.
- Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness, and dizziness may occur.
- Contraindications include heart failure, cardiac conduction disorders, asthma, and diabetes.
- Allergic vasculitis, flushing Other Adverse Events:
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, Aggrenox discount to bone Aggrenox discount toxicity, especially in the elderly or renal impaired.
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. Risk Aggrenox discounts for bleeding include the use of other drugs that increase the risk of bleeding e.
Although Aggrenox discount 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 Aggrenox discount effects and what steps to take if they occur. In ESPS2, the annualized event rate for gastrointestinal bleeding was 2. Peptic Ulcer Disease Avoid using Aggrenox discount in patients with a history of active peptic ulcer disease, which can cause gastric mucosal irritation and bleeding, Aggrenox Discount.
Coronary 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.
Hypotension Dipyridamole produces peripheral vasodilation, which can exacerbate pre-existing hypotension.
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 Aggrenox discount, heavy alcohol use while taking aspirin.
Headaches Some patients may experience headaches upon treatment initiation; these are usually transient, Aggrenox Discount. In case of intolerable headaches, tell patients to Aggrenox discount their physician. If you miss a dose, continue with your next dose on your regular schedule. Do not take a double dose. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility In studies in which dipyridamole was administered in the feed to mice up to weeks in males and females and rats up to weeks in males and up to weeks in femalesthere was no evidence of drug-related carcinogenesis.
Combinations of dipyridamole and aspirin 1: 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 Aggrenox discount have not been evaluated for Aggrenox discounts on Aggrenox discount and reproductive performance.
Aspirin inhibits ovulation in rats. In animal reproduction studies, there were adverse developmental effects with administration of aspirin in rats and rabbits at doses about 66 and 44 times, respectively, the human exposure at the maximum recommended daily Aggrenox discount of aspirin-dipyridamole.
Reproduction studies with dipyridamole in mice, rabbits, and rats have revealed no evidence of harm to the fetus up to doses about 25 times the maximum recommended daily human dose of aspirin-dipyridamole.
Nonclinical data are suggestive of a possible potentiation of aspirin-related fetal toxicity when combined with dipyridamole see Data. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown, Aggrenox Discount.
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All pregnancies have a background risk of birth defect, loss, Aggrenox Discount, or other adverse outcomes, Aggrenox Discount. Maternal use of high-dose aspirin can result in excessive blood loss at delivery, prolonged gestation, prolonged labor, intracranial hemorrhage in premature infants, low birth weight, stillbirth, and neonatal death.
Data Human Data Published data from clinical trials, observational studies, case series, and case reports over several Aggrenox discounts have not identified a clear association between aspirindipyridamole use in pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, these studies cannot definitively establish the absence of any aspirin-dipyridamole associated risks.
Methodological limitations of these studies include variability in the Aggrenox discount and dose of drug exposure e. Lactation Risk Summary Based on data from a clinical lactation study in breastfeeding women taking low-dose aspirin, the metabolite salicylic acid is present in human milk in low levels see Data.
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Dipyridamole is also present in human milk. There is insufficient information to determine the effects of aspirin on the breastfed infant and no information on the effects of aspirin on milk production. Data A published clinical study involved six exclusively breastfeeding women at 1 to 8 months postpartum who were taking 81 mg Aggrenox discount daily. Milk samples were collected at steady state, at 0, 1, 2, 4, 8, 12, and 24 hours after taking a dose of aspirin.
Aspirin was undetectable in human milk. No adverse effects on the breastfed Aggrenox discounts were noted. In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately, Aggrenox Discount. Careful medical management is essential. Based upon the known hemodynamic Aggrenox discounts of dipyridamole, symptoms such as Aggrenox discount feeling, flushes, sweating, restlessness, feeling of weakness, and dizziness may occur, Aggrenox Discount.
A drop in blood pressure and tachycardia might also be observed. Salicylate toxicity may result from acute ingestion overdose or chronic Aggrenox discount. Severity of aspirin intoxication is determined by measuring the blood salicylate level. In severe cases, hyperthermia and hypovolemia are the major immediate threats to life. 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.
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.
Plasma electrolytes and pH should be monitored serially to promote alkaline Aggrenox discount 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, Aggrenox Discount, dialysis is not likely to remove dipyridamole.
Exchange transfusion may be indicated in infants and young children.
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Allergy Aspirin is contraindicated in patients with known Aggrenox discount to nonsteroidal anti-inflammatory Aggrenox discount NSAID products and in patients with the syndrome of asthma, rhinitis, and nasal polyps.
Aspirin may cause severe urticaria, angioedema or bronchospasm. Reye Syndrome Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.
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