Drug: Dipyridamole Injection

Dipyridamole Injection USP is a coronary vasodilator described as 2,2',2",2'"-[(4,8-Dipiperidinopyrimido [5,4-d]pyrimidine-2,6-diyl)dinitrilo]tetraethanol. It has the following structural formula: Molecular Formula: C24H40N8O4 Molecular Weight: 504.64 Dipyridamole injection is an odorless, pale yellow liquid which can be diluted in sodium chloride injection or dextrose injection for intravenous administration. Each mL of sterile solution contains dipyridamole, 5 mg; polyethylene glycol 600, 50 mg; tartaric acid, 2 mg; water for injection, qs; hydrochloric acid and, if necessary, sodium hydroxide, added to adjust pH to 2.7 ± 0.5.Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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Adverse reaction information concerning intravenous dipyridamole is derived from a study of 3911 patients in which intravenous dipyridamole was used as an adjunct to thallium myocardial perfusion imaging and from spontaneous reports of adverse reactions and the published literature. Serious adverse events (cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, asystole, sinus node arrest, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm) are described above (see WARNINGS). In the study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocar-diographic changes (most commonly ST-T changes)(15.9%), headache (12.2%), and dizziness (11.8%). Adverse reactions occurring in greater than 1% of the patients in the study are shown in the following table:   Incidence (%) of Drug-Related Adverse Events Chest pain/angina pectoris 19.7 Headache 12.2 Dizziness 11.8 Electrocardiographic Abnormalities/ST-T changes 7.5 Electrocardiographic Abnormalities/Extrasystoles 5.2 Hypotension 4.6 Nausea 4.6 Flushing 3.4 Electrocardiographic Abnormalities/Tachycardia 3.2 Dyspnea 2.6 Pain Unspecified 2.6 Blood Pressure Lability 1.6 Hypertension 1.5 Paresthesia 1.3 Fatigue 1.2 Less common adverse reactions occurring in 1% or less of the patients within the study included: Cardiovascular System: Electrocardiographic abnormalities unspecified (0.8%), arrhythmia unspecified (0.6%), palpitation (0.3%), ventricular tachycardia (0.2% see WARNINGS), bradycardia (0.2%), myocardial infarction (0.1% see WARNINGS), AV block (0.1%), syncope (0.1%), orthostatic hypotension (0.1%), atrial fibrillation (0.1%), supraventricular tachycardia (0.1%), ventricular arrhythmia unspecified (0.03% see WARNINGS), heart block unspecified (0.03%), cardiomyopathy (0.03%), edema (0.03%). Central and Peripheral Nervous System: Hypothesia (0.5%), hypertonia (0.3%), nervousness/anxiety (0.2%), tremor (0.1%), abnormal coordination (0.03%), somnolence (0.03%), dysphonia (0.03%), migraine (0.03%), vertigo (0.03%). Gastrointestinal System: Dyspepsia (1%), dry mouth (0.8%), abdominal pain (0.7%), flatulence (0.6%), vomiting (0.4%), eructation (0.1%), dysphagia (0.03%), tenesmus (0.03%), appetite increased (0.03%). Respiratory System: Pharyngitis (0.3%), bronchospasm (0.2% see WARNINGS), hyperventilation (0.1%), rhinitis (0.1%), coughing (0.03%), pleural pain (0.03%). Other: Myalgia (0.9%), back pain (0.6%), injection site reaction unspecified (0.4%), diaphoresis (0.4%), asthenia (0.3%), malaise (0.3%), arthralgia (0.3%), injection site pain (0.1%), rigor (0.1%), earache (0.1%), tinnitus (0.1%), vision abnormalities unspecified (0.1%), dysgeusia (0.1%), thirst (0.03%), depersonalization (0.03%), eye pain (0.03%), renal pain (0.03%), perineal pain (0.03%), breast pain (0.03%), intermittent claudication (0.03%), leg cramping (0.03%). In additional postmarketing experience, there have been rare reports of allergic reaction including urticaria, pruritus, dermatitis and rash. Read the Dipyridamole Injection (dipyridamole injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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The dose of dipyridamole injection as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/minute (0.57 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient. Prior to intravenous administration, dipyridamole injection should be diluted in at least a 1:2 ratio with 0.45% sodium chloride injection, 0.9% sodium chloride injection, or 5% dextrose injection for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole injection may cause local irritation. Thallium-201 should be injected within 5 minutes following the 4-minute infusion of dipyridamole. Do not mix dipyridamole injection with other drugs in the same syringe or infusion container. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, when-ever solution and container permit.

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Oral maintenance theophylline and other xanthine derivatives such as caffeine may abolish the coronary vasodilation induced by intravenous dipyridamole administration. This could lead to a false negative thallium imaging result (see CLINICAL PHARMACOLOGY, Mechanism of Action). Myasthenia gravis patients receiving therapy with cholinesterase inhibitors may experience worsening of their disease in the presence of dipyridamole. Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Dipyridamole injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and dipyridamole assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests was almost identical.

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Hypersensitivity to dipyridamole. Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No cases of overdosage in humans have been reported. It is unlikely that overdosage will occur because of the nature of use (i.e., single intravenous administration in controlled settings). See WARNINGS.

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Dipyridamole Injection USP for intravenous injection is available as follows: Each 2 mL vial contains 10 mg of dipyridamole, NDC 55390-555-10; box of 10 vials. Each 10 mL vial contains 50 mg of dipyridamole, NDC 55390-555-90; box of 10 vials. Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. Avoid freezing. Protect from light. Retain in carton until time of use. Discard unused portion. Manufactured by: Ben Venue Laboratories, Inc. Bedford, Ohio 44146. Manufactured for: Bedford Laboratories™ Bedford, Ohio 44146. December 2007. Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

See WARNINGS. Carcinogenesis, Mutagenesis, Impairment of Fertility In studies in which dipyridamole was administered in the feed at doses of up to 75 mg/kg/day (9.4 times* the maximum recommended daily human oral dose) in mice (up to 128 weeks in males and up to 142 weeks in females) and rats (up to 111 weeks in males and females), there was no evidence of drug related carcinogenesis. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. 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 (63 times* the maximum recommended daily human oral dose). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg/day. *Calculation based on assumed body weight of 50 kg. Pregnancy Teratogenic Effects, Pregnancy Category B Reproduction studies performed in mice and rats at daily oral doses of up to 125 mg/kg (15.6 times* the maximum recommended daily human oral dose) and in rabbits at daily oral doses of up to 20 mg/kg (2.5 times* the maximum recommended daily human oral dose) have revealed no evidence of impaired embryonic development due to dipyridamole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, this drug should be used during pregnancy only if clearly needed. * Calculation based on assumed body weight of 50 kg. Nursing Mothers Dipyridamole is excreted in human milk. Pediatric Use Safety and effectiveness in the pediatric population have not been established. Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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