Dipyridamole

Dipyridamole is an FDA-registered drug product whose active ingredient is DIPYRIDAMOLE. It is labelled by Hikma Pharmaceuticals USA Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0641-2569, application ANDA074521, label effective 20260520. It is one of 5 FDA drug label records sharing the active ingredient DIPYRIDAMOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIPYRIDAMOLE are most often described in connection with: thallium imaging, dipyridamole injection, number patients, indicated alternative, myocardial perfusion, evaluation coronary, artery disease, cannot exercise. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE 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 Injection 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 were almost identical.

DOSAGE AND ADMINISTRATION The dose of intravenous 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/min (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 sodium chloride injection 0.45%, sodium chloride injection 0.9% or dextrose injection 5% for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole 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, whenever solution and container permit. Shaking the vial should redissolve any crystals that may have formed during storage.

CONTRAINDICATIONS Hypersensitivity to dipyridamole or any of the other components of the drug.

WARNINGS Serious adverse reactions associated with the administration of intravenous Dipyridamole Injection have included cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction, bronchospasm, severe hypotension, anaphylaxis with laryngospasm, and angioedema. There have been reported cases of asystole, sinus node arrest, sinus node depression and conduction block. Patients with abnormalities of cardiac impulse formation/conduction or severe coronary artery disease may be at increased risk for these events. In a study of 3911 patients given intravenous dipyridamole as an adjunct to thallium myocardial perfusion imaging, two types of serious adverse events were reported: 1) four cases of myocardial infarction (0.1%), two fatal (0.05%) and two non-fatal (0.05%) and 2) six cases of severe bronchospasm (0.2%). Although the incidence of these serious adverse events was small (0.3%, 10 of 3911), the potential clinical information to be gained through use of intravenous dipyridamole thallium imaging (see INDICATIONS AND USAGE noting the rate of false positive and false negative results) must be weighed against the risk to the patient. Patients with a history of unstable angina may be at a greater risk for severe myocardial ischemia. Patients with a history of asthma may be at a greater risk for bronchospasm during Dipyridamole Injection use. When thallium myocardial perfusion imaging is performed with intravenous dipyridamole, parenteral aminophylline should be readily available for relieving adverse events such as bronchospasm or chest pain. Vital signs should be monitored during, and for 10-15 minutes following, the intravenous infusion of dipyridamole and an electrocardiographic tracing should be obtained using at least one chest lead. Should severe chest pain or bronchospasm occur, parenteral aminophylline may be administered by slow intravenous injection (50-100 mg over 30-60 seconds) in doses ranging from 50 to 250 mg. In the case of severe hypotension, the patient should be placed in a supine position with the head tilted down if necessary, before administration of parenteral aminophylline. If 250 mg of aminophylline does not relieve chest pain symptoms within a few minutes, sublingual nitroglycerin may be administered. If chest pain continues despite use of aminophylline and nitroglycerin, the possibility of myocardial infarction should be considered. If the clinical condition of a patient with an adverse event permits a one-minute delay in the administration of parenteral aminophylline, thallium-201 may be injected and allowed to circulate for one minute before the injection of aminophylline. This will allow initial thallium perfusion imaging to be performed before reversal of the pharmacologic effects of dipyridamole on the coronary circulation.

ADVERSE REACTIONS Adverse reaction information concerning intravenous Dipyridamole Injection 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, angioedema, and bronchospasm) are described above (see WARNINGS ). In a study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocardiographic 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: Table 1 Drug-Related Adverse Reactions (%) Occurring in Greater than 1% of Patients 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 (0.8%), arrhythmia (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 (0.03%–see WARNINGS ), heart block (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 increase (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.

FDA lists 5 drug label records with DIPYRIDAMOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Dipyridamole used for?
INDICATIONS AND USAGE 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 Injection assisted thallium imaging, the results of both tests were interpreted blindly and …

Who makes Dipyridamole?
Hikma Pharmaceuticals USA Inc. is the labeler of record for Dipyridamole. 5 FDA label records share the active ingredient DIPYRIDAMOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Dipyridamole come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Dipyridamole prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPYRIDAMOLE?
Yes. 5 FDA drug label records list DIPYRIDAMOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Dipyridamole been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.