Adenosine Injection, USP (Mylan Pharmaceuticals, PM 00025904): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Adenosine Injection, USP is an 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. Adenosine Injection, USP helps your heart go back to a normal rhythm (stop beating too fast). Adenosine Injection, USP 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 Adenosine Injection, USP, is a substance that occurs naturally in all cells of your body. Adenosine Injection, USP 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 Adenosine Injection, USP 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:

Adenosine Injection, USP is supplied as a sterile solution in normal saline containing 3 mg adenosine/mL for injection into the vein (bloodstream). It is packaged in 6 mg/2 mL vials.

WARNINGS AND PRECAUTIONS

BEFORE Adenosine Injection, USP 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

Adenosine Injection, USP 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

ADENOSINE INJECTION, USP 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.

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 adenosine injection 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.

IMPORTANT: PLEASE READ

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

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 Adenosine Injection, USP, contact your doctor

HOW TO STORE IT

HOW TO STORE IT

Store at controlled room temperature between 15ºC to 30º C.

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 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM 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 can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Prepared on: July 16, 2014

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca