Adenocard Injection -Pre-Filled Syringe: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Adenocard is a injectable medication used to treat a condition called paroxysmal supraventricular tachycardia (rapid rhythm of the heart), including a condition called Wolff-Parkinson-White Syndrome (abnormal electrical communication from the atria to the ventricles). These conditions cause your heart to beat too fast. Adenocard helps your heart go back to a normal rhythm (stop beating too fast). Adenocard is also used to help your doctor determine if you have an abnormal heart beat called broad or narrow supraventricular tachycardia.

What it does:

Adenosine, the active ingredient in Adenocard, is a substance that occurs naturally in all cells of your body. Adenocard works by slowing down the electrical impulses which control your heart rhythm. This allows your heart rhythm to return to normal.

When it should not be used:

You should not use Adenocard if :

• you have had an allergic reaction to adenosine.

• you have any of the following conditions, unless you have

  an artificial pacemaker that works:

• a type of heart condition called second or third degree

  atrioventricular (AV) block,

• an abnormal heart rhythm called sick sinus syndrome,
• bradycardia (a slow heart beat)

What the medicinal ingredient is:

adenosine

What the nonmedicinal ingredients are:

Sodium chloride, Water for Injection

What dosage forms it comes in:

Adenocard is supplied as a sterile solution in normal saline containing 3 mg adenosine/mL for injection into the vein (blood stream). It is packaged in vials and pre-filled syringes as follows:

• 6 mg/2 mL vial
• 6 mg/2 mL prefilled syringe
• 12 mg/4 mL prefilled syringe

WARNINGS AND PRECAUTIONS

BEFORE Adenocard is given be sure to tell your doctor:

• If you have a history of heart problems such as heart

  block or atrial fibrillation/flutter (fast heart beat or palpitations)

  • If you have asthma or other lung diseases such as chronic obstructive pulmonary disease (COPD)
  • About all other health conditions you have now, or have had in the past

  • If you are pregnant or plan to become pregnant

INTERACTIONS WITH THIS MEDICATION

Adenocard and other medicines may interact with each other. Tell your doctor about all the medicines you take including prescription medicines, over the counter medicines, vitamins, and herbal supplements. In particular you should tell your doctor if you are taking any of the following:

• Digoxin
• Verapamil

• Methylxanthines, such as theophylline and caffeine

  (present in many foods and drinks such as coffee, tea and chocolate)

• Dipyridamole
• Carbamazepine

PROPER USE OF THIS MEDICATION

Usual dose:

For Adults and Children Over 50 kg

The initial dose is 6 mg. If this does not slow your heart rate, you may receive one or two more injections of 12 mg.

For Children Weighing Less Than 50 kg

The amount of drug given will depend on how much you weigh. If the first injection does not slow your heart rate, you may get more injections.

Overdose:

No cases of overdose associated with the use of Adenocard have been reported. If you feel you have been given too much medication, discuss it with your doctor.

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication may cause undesirable effects.

The most common side effects of Adenocard include facial flushing, dyspnea (shortness of breath), chest pressure, and nausea. These side effects start immediately after Adenocard is given and usually last less than one minute.

ADENOCARD is given to patients by injection directly into the blood system. This drug should only be used in a setting with appropriate cardiac monitoring and resuscitative facility.

IMPORTANT: PLEASE READ

Adenocard Page 18 of 18

Other side effects include:

headache, sweating, palpitations, chest pain, hypotension (less than 1%), a variety of arrhythmias and conduction disturbances were observed in about 55% of patients at the time of conversion, hyperventilation, head pressure, lightheadedness, dizziness, tingling in arms, numbness, apprehension, blurred vision, burning sensation, heaviness in arms, neck and back pain, metallic taste, tightness in throat, pressure in groin.

In addition to the above reports, the below adverse events listed have been reported post marketing:

Prolonged asystole (cardiac arrest), transient increase in blood pressure and bronchospasm (sudden constriction of the muscles in the walls of bronchioles).

*Unable to determine frequency since this is a post-marketing event

This is not a complete list of side effects. For any unexpected effects while taking Adenocard, contact your doctor

HOW TO STORE IT

Store at controlled room temperature between 15 ^oC to 30 ^oC.

DO NOT REFRIGERATE.

The solution must be clear at the time of use.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.astellas.com/ca/

or by contacting the sponsor, Astellas Pharma Canada, Inc. at: 1-888-338-1824.

Last revised: March 24, 2011

10H042-ADC-CAN