Patient Medication Information: uses, side effects, how to take - Dipyridamole Injection, USP
ABOUT THIS MEDICATION
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 forms it comes in:
Dipyridamole Injection, USP comes in 10 mL single-dose vials, containing 50 mg of dipyridamole.
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.
IMPORTANT: PLEASE READ
Dipyridamole Injection, USP – Product Monograph Page 18 of 18
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 IT
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 (http://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http:// www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html).
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.
Fresenius Kabi Canada Ltd.,
165 Galaxy Blvd, Suite 100,
Toronto, ON M9W 0C8