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Details for: DIPYRIDAMOLE INJECTION, USP

Company: FRESENIUS KABI CANADA LTD

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02244475DIPYRIDAMOLE INJECTION, USPDIPYRIDAMOLE5 MG / MLLIQUIDINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Dipyridamole Injection vials for intravenous injection are used in a medical test (cardiac perfusion imaging) together with a radioactive substance to assess the flow of blood to the heart muscle. The test will help your doctor determine if there are areas of your heart which do not receive enough blood supply due to coronary artery disease.

Generally, cardiac perfusion imaging is done after an exercise/treadmill stress test. For patients who are unable to exercise adequately, the test is done after injection of dipyridamole injection that mimics the effect of exercise on the heart.

What it does

Dipyridamole Injection dilates the blood vessels of the heart muscle and increases the blood flow to your heart.

When it should not be used

Dipyridamole Injection should not be used by patients with allergic reactions to dipyridamole or any component of the drug.

What the medicinal ingredient is

Dipyridamole

What the non-medicinal ingredients are

Tartaric acid, polyethylene glycol, hydrochloric acid and water for injection.

What dosage form it comes in

Dipyridamole Injection, USP comes in 10 mL single-dose vials, containing 50 mg of dipyridamole.

Warnings and precautions

Warnings and Precautions

Since this drug may cause sudden death, cardiac arrest and ECG change, it should be only used in a clinical setting with appropriate equipment and under the monitoring of trained health professionals.

BEFORE you use Dipyridamole injection talk to your doctor or pharmacist if:

  • You are allergic to dipyridamole or any other ingredient in the drug.
  • You have or ever had any heart problems, such as a recent heart attack (within the last 4 weeks), coronary artery disease, angina (chest pain) at rest, irregular heart beat, heart block (this usually causes a slow heart beat), heart failure or a problem affecting the heart valves.
  • You have low blood pressure.
  • You had a stroke or something called a transient ischemic attack (temporary stroke symptoms lasting less than 24 hours).
  • You have breathing problems such as asthma, shortness of breath or wheezing.
  • You have myasthenia gravis (a rare muscle problem).
  • You are pregnant, likely to become pregnant, or are breast-feeding.

During the test, reactions similar to exercise-induced stress may occur; therefore your doctor will monitor you. Patients with a history of severe coronary heart disease or history of asthma may be at a greater risk. Abnormal heart beat, chest pain, bronchospasm or severe drop in blood pressure can occur. Your doctor may use another medication (aminophylline and nitroglycerin) to reverse these symptoms.

Interactions with this medication

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Drugs that may interact with dipyridamole injection include: adenosine, other drugs that prevent blood clotting, blood pressure lowering drugs, and cholinesterase inhibitors.

Tell your doctor about all medication that you are currently taking. Some medication may have to be stopped temporarily 24 hours before the test.

Theophylline or caffeine-containing drugs or food products and beverages (soft drinks, coffee, tea and chocolates) containing caffeine should be stopped 24 hours before the stress test.

Proper use of this medication

Usual Dose

Dipyridamole Injection vials are usually given as an injection by a doctor or nurse.

Another injection containing the imaging agent is given within 5 minutes of the dipyridamole injection.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

No cases of overdose have been reported in this indication. In case of overdose you may feel warm, flushes, sweating, accelerated pulse, restlessness, feeling of weakness and dizziness, and may have chest pain or difficulty breathing. A drop in blood pressure and fast heart rate might be observed. Your doctor may use another medication (aminophylline) to reverse these symptoms.

Missed Dose

Side effects and what to do about them

Like all medicines, dipyridamole injection can cause side effects although not everybody gets them.

The following side effects have been observed during cardiac perfusion imaging with dipyridamole injection. If you experience any of the following side effects, tell your doctor immediately:

Frequency Symptom / effect
Very common Headache
Dizziness
Chest pain/angina pectoris
Common Tingling, prickling sensation
Irregular heartbeat
Rapid heartbeat
Drop in blood pressure (feeling lightheaded, dizzy or faint)
Hot flush (feeling intensive warmth with sweating and rapid heartbeats)
Nausea
Uncommon Heart attack
Slow heartbeat
Difficulty breathing, wheezing
Abdominal pain
Rare Excessive allergic reaction (symptoms could be itchy rash, swelling of lips, tongue and /or throat, runny nose, light headedness, headache, shortness of breath, hoarseness, cough and low blood pressure)
Temporary symptoms of stroke
Very rare Stroke
Seizure
Uncoordinated contraction of the cardiac muscle of the ventricles in the heart
Not known* Swelling of the skin and the mucosa of the mouth and/or throat and tongue
Fainting
Temporary pause in the normal heart rhythm
Impairment of the conduction between the atria and ventricles of the heart.
Spasmodic closure of the voice box
Diarrhea
Vomiting
Hives
Rash
Muscle pain

*A precise estimation of frequency is not possible as the adverse drug reactions did not occur in a clinical trial.

If you experience dizziness during the test, you should avoid potentially dangerous tasks such as driving or operating machines 24 hours after the test.

This is not a complete list of side effects. For any unexpected effects while taking dipyridamole injection, contact your doctor or pharmacist.

How to store

Protect dipyridamole injection vials from direct light, and avoid freezing.

Dipyridamole Injection should be stored at room temperature (15 to 30°C).

Keep out of the reach and sight of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 1908C
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.

This leaflet was prepared by
Fresenius Kabi Canada Ltd.,
165 Galaxy Blvd, Suite 100,
Toronto, ON M9W 0C8

Last revised: November 14, 2017

Date modified: