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PERSANTINE is a brand name for Dipyridamole, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PERSANTINE (5 mg/mL dipyridamole) is indicated for: • intravenous use to induce pharmacologic vasodilation for myocardial perfusion imaging. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dose of intravenous PERSANTINE used as an adjunct to myocardial perfusion imaging should be adjusted according to the weight of the patient. , infused over 4 minutes. A total dose of greater than 60 mg is not recommended for use in any patient.
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use. ) should be diluted at least 1:2 with Dextrose Injection, USP 5%. 4 Administration The imaging agent should be injected within 5 minutes following the 4 minute infusion of PERSANTINE.
v. with other drugs in the same syringe or infusion container. Infusion of undiluted PERSANTINE may cause local irritation. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portion.
are expected to occur. Aminophylline, as described in 7 WARNINGS AND PRECAUTIONS, Cardiovascular, may be administered. Due to its wide distribution to tissue and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING PERSANTINE Dipyridamole Product Monograph Page 6 of 27 Table 1: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form/ Strength / Composition Non-medicinal Ingredients Intravenous Solution 5 mg/mL hydrochloric acid, polyethylene glycol, sterile water for injection and tartaric acid.
PERSANTINE is provided in 10 mL ampoules containing 5 mg/mL dipyridamole. PERSANTINE ampoules are supplied in packages of 5 ampoules. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Rare serious adverse reactions associated with the administration of intravenous PERSANTINE for myocardial imaging have been reported.
These have included fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke and transient cerebral ischemia. Cardiovascular Since excessive doses of dipyridamole (intravenous or oral) or intravenous doses given too rapidly can produce peripheral vasodilation, PERSANTINE should be used with caution in patients with hypotension, coronary artery disease, including rapidly worsening angina, left ventricular outflow obstruction, (including subvalvular aortic stenosis), or hemodynamic instability.
In rare cases, such patients may be at risk for developing myocardial ischemia and infarction. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole for twenty-four hours prior to stress testing.
, Cardiovascular, may be administered. Due to its wide distribution to tissue and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING PERSANTINE Dipyridamole Product Monograph Page 6 of 27 Table 1: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form/ Strength / Composition Non-medicinal Ingredients Intravenous Solution 5 mg/mL hydrochloric acid, polyethylene glycol, sterile water for injection and tartaric acid.
PERSANTINE is provided in 10 mL ampoules containing 5 mg/mL dipyridamole. PERSANTINE ampoules are supplied in packages of 5 ampoules. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Rare serious adverse reactions associated with the administration of intravenous PERSANTINE for myocardial imaging have been reported.
These have included fatal and non-fatal myocardial infarction, ventricular fibrillation, symptomatic ventricular tachycardia, stroke and transient cerebral ischemia. Cardiovascular Since excessive doses of dipyridamole (intravenous or oral) or intravenous doses given too rapidly can produce peripheral vasodilation, PERSANTINE should be used with caution in patients with hypotension, coronary artery disease, including rapidly worsening angina, left ventricular outflow obstruction, (including subvalvular aortic stenosis), or hemodynamic instability.
In rare cases, such patients may be at risk for developing myocardial ischemia and infarction. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole for twenty-four hours prior to stress testing.
• Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Intravenous administration of PERSANTINE is not recommended in states of shock or collapse.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dipyridamole in Canada.
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Failure to do so may impair the sensitivity of the test. An intravenous bolus of PERSANTINE (40-50 mg over 4 minutes) can result in chest pain in patients with coronary artery disease. v. bolus. The infusion rate should be monitored to minimize this risk.
The symptoms can generally be reversed with an intravenous injection of 50-250 mg of aminophylline over several minutes. Intravenous PERSANTINE (dipyridamole) as an adjunct to myocardial perfusion imaging should PERSANTINE Dipyridamole Product Monograph Page 7 of 27 be used with caution in patients with unstable angina; as such patients may be at risk for severe myocardial infarction.
As with exercise induced stress, the use of intravenous PERSANTINE as an adjunct to myocardial perfusion imaging may occasionally precipitate cardiac arrhythmias in patients with severe heart disease. Scanning should therefore be performed with constant monitoring of the patient's ECG.
Parenteral aminophylline should be readily available and should be administered as a slow intravenous injection of 50-250 mg in the event of occurrences such as chest pain, bronchospasm, severe nausea/vomiting, hypotension, severe headache.
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 PERSANTINE on the coronary circulation. v. Therefore, caution should be recommended when driving a car or operating machinery.
If patients experience dizziness they should avoid potentially hazardous tasks such as driving or operating machinery 24h after drug administration. Hepatic/Biliary/Pancreatic A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone).
These patients were all elderly, had evidence of ascending cholangitis and had been treated with oral dipyridamole for a number of years. There is no evidence that dipyridamole was the initiating factor in causing gallstones to form in these patients.
It is possible that bacterial deglucuronidation of conjugated dipyridamole in bile may be the mechanism responsible for the presence of dipyridamole in gallstones. v. Non-clinical studies with dipyridamole did not indicate direct or indirect harmful effects with respect to the fertility index (see 16 NON-CLINICAL TOXICOLOGY).
Respiratory Patients with a history or presence of bronchial hyperreactivity may be at risk of developing bronchospasm during the use of intravenous PERSANTINE as an adjunct to myocardial perfusion imaging. 2%), the clinical information to be gained through the use of intravenous PERSANTINE should be weighed against the potential risk to the patient.
1 Pregnant Women Reproductive studies have been performed in mice, rats, and rabbits […]
Failure to do so may impair the sensitivity of the test. An intravenous bolus of PERSANTINE (40-50 mg over 4 minutes) can result in chest pain in patients with coronary artery disease. v. bolus. The infusion rate should be monitored to minimize this risk.
The symptoms can generally be reversed with an intravenous injection of 50-250 mg of aminophylline over several minutes. Intravenous PERSANTINE (dipyridamole) as an adjunct to myocardial perfusion imaging should PERSANTINE Dipyridamole Product Monograph Page 7 of 27 be used with caution in patients with unstable angina; as such patients may be at risk for severe myocardial infarction.
As with exercise induced stress, the use of intravenous PERSANTINE as an adjunct to myocardial perfusion imaging may occasionally precipitate cardiac arrhythmias in patients with severe heart disease. Scanning should therefore be performed with constant monitoring of the patient's ECG.
Parenteral aminophylline should be readily available and should be administered as a slow intravenous injection of 50-250 mg in the event of occurrences such as chest pain, bronchospasm, severe nausea/vomiting, hypotension, severe headache.
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 PERSANTINE on the coronary circulation. v. Therefore, caution should be recommended when driving a car or operating machinery.
If patients experience dizziness they should avoid potentially hazardous tasks such as driving or operating machinery 24h after drug administration. Hepatic/Biliary/Pancreatic A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone).
These patients were all elderly, had evidence of ascending cholangitis and had been treated with oral dipyridamole for a number of years. There is no evidence that dipyridamole was the initiating factor in causing gallstones to form in these patients.
It is possible that bacterial deglucuronidation of conjugated dipyridamole in bile may be the mechanism responsible for the presence of dipyridamole in gallstones. v. Non-clinical studies with dipyridamole did not indicate direct or indirect harmful effects with respect to the fertility index (see 16 NON-CLINICAL TOXICOLOGY).
Respiratory Patients with a history or presence of bronchial hyperreactivity may be at risk of developing bronchospasm during the use of intravenous PERSANTINE as an adjunct to myocardial perfusion imaging. 2%), the clinical information to be gained through the use of intravenous PERSANTINE should be weighed against the potential risk to the patient.
1 Pregnant Women Reproductive studies have been performed in mice, rats, and rabbits at doses of up to 125 mg/kg and have not revealed evidence of impaired […]