Patient Medication Information: uses, side effects, how to take - Brevibloc Premixed Injection
ABOUT THIS MEDICATION
What the medication is used for:
BREVIBLOC is used to manage rapid heart rates and
high blood pressure during surgical operations when there is a risk for heart attacks.
BREVIBLOC is also used to rapidly control the heart rate
in patients with rapid or irregular heart rhythm.
What it does:
BREVIBLOC is classified as a beta-adrenergic receptor blocking agent which blocks the actions of the involuntary nervous system which affects the heart. It is quick-acting and has a short duration of action.
When it should not be used:
BREVIBLOC Injection / BREVIBLOC PREMIXED Injection is not for use in chronic settings.
BREVIBLOC should not be used in patients:
- With low blood pressure
- With a slow heart rate
With heart block problems [Second and third degree A-V
block]
With abnormally high blood pressure in the arteries of
the lung
With a disease in the natural pacemaker (conduction
system) of the heart
Who are using medications to manage heart conditions or
maintain their blood pressure (see Note)
- With heart failure
- With shock caused by a decreased heart output
- With an untreated tumour of the adrenal gland
Who are allergic to esmolol hydrochloride or any of the
nonmedicinal ingredients (see the section What the nonmedicinal ingredients are)
Note: Your physician will determine if BREVIBLOC should be administered. This medication is only administered by a physician familiar with its effects.
What the medicinal ingredient is:
Esmolol Hydrochloride
What the non-medicinal ingredients are:
Glacial Acetic Acid USP, Hydrochloric Acid NF, Sodium Acetate Trihydrate USP, Sodium Chloride USP, Sodium Hydroxide, Water for Injection USP
What dosage forms it comes in:
Solution, 10 mg/mL
BREVIBLOC INJECTION: 10 mL vials
BREVIBLOC PREMIXED INJECTION: 250 mL bags
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
DURING THE ADMINISTRATION OF BREVIBLOC INJECTION / BREVIBLOC PREMIXED INJECTION PATIENTS SHOULD BE CAREFULLY MONITORED, WITH PARTICULAR ATTENTION TO HEART RATE AND BLOOD PRESSURE.
BEFORE you use BREVIBLOC Injection / BREVIBLOC PREMIXED Injection talk to your doctor if you:
- Have a heart condition or low blood pressure
- Have kidney disease where you cannot remove enough acid from your body or if for other reasons you have generalized acidosis
- Have a body temperature below 35°C
- Are taking any prescription and/or over the counter medications
- Are diagnosed with Prinzemetal’s angina
Are pregnant, plan to become pregnant, or are breastfeeding
- Are taking medications which increase potassium levels in your blood
- Have hyperthyroidism
- Have blood volume that is too low
- Have peripheral circulatory disorders
- Have psoriasis
- Have muscle weakness
- Have impaired renal function
- Have asthma, bronchitis or other conditions causing bronchial spasm
INTERACTIONS WITH THIS MEDICATION
Talk to your doctor if you are taking any prescription and/or over the counter medications, especially the medications listed below:
- Medicines used to treat high blood pressure including clonidine, guanfacine, moxonidine, and reserpine
Medicines used to treat heart rhythm problems, chest pain
(angina), or heart failure (e.g., verapamil, diltiazem, digoxin)
- Medicines used to treat diabetes, including insulin and medicines taken by mouth
- ‘Tricyclic’ antidepressant medicines (e.g. imipramine and amitriptyline) or any other drugs for mental health problems
- Epinephrine, such as Epi-Pen, which is used to treat allergic reactions
- Warfarin (Coumadin), which is used to thin your blood
- Morphine, which is a strong pain killer
Medicines used to treat low blood pressure (e.g.
norepinephrine, epinephrine, and dopamine) that are usually administered at the hospital
- Medications used to treat asthma (e.g. isoproterenol and terbutaline)
- Suxamethonium chloride (also known as succinylcholine or scoline), which is used to relax your muscles, and inhalation anesthetics. Brevibloc may prolong the effects of some medications you may receive during anesthesia and surgery.
PROPER USE OF THIS MEDICATION
Usual dose:
Your physician will decide what dose of BREVIBLOC Injection / BREVIBLOC PREMIXED Injection you will receive.
The safety and effectiveness of BREVIBLOC Injection / BREVIBLOC PREMIXED Injection in children (younger than 18 years of age) and elders (65 years of age and older) have not been established.
This medication is for short term use only (up to 24 hours).
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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
Very Common | Low blood pressure (with dizziness lightheadedness or excessive sweating) | |||
| Common | Slow heart rate | |||
| Abnormal heart rate and shortness of breath | ||||
| Nausea | ||||
| Vomiting | ||||
| Skin inflammation or hardening at the injection site | ||||
| Headache | ||||
| Dizziness | ||||
| Somnolence (feeling sleepy) | ||||
| Confusion | ||||
| Agitation | ||||
| Fatigue (feeling tired) | ||||
Dyspnea (shortness of breath) | ||||
| Uncommon | Ventricular extrasystoles (heart palpitations) | |||
| Visual impairment | ||||
| Abdominal pain | ||||
| Constipation | ||||
Dyspepsia (upset stomach or indigestion) | ||||
| Dry mouth | ||||
| Skin discoloration | ||||
| Weakness (asthenia) | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | Fever or chills, cold sweat | |||
Musculoskeletal pain (midscapular pain) - (pain in your muscles /tendons, including around the shoulder blades and ribs) | ||||
| Syncope (fainting) | ||||
| Convulsion | ||||
| Speech Disorder | ||||
| Abnormal thoughts | ||||
| Anxiety | ||||
| Irritability | ||||
Difficult or painful urination | ||||
| Wheezing | ||||
Rales or rhonchi (abnormal rattling/cracklin g sounds when breathing) | ||||
Nasal congestion | ||||
| Pallor or Flushing | ||||
| Sensation of numbness, burning or tingling | ||||
This is not a complete list of side effects. For any unexpected effects while taking BREVIBLOC Injection / BREVIBLOC PREMIXED Injection, contact your doctor or pharmacist.
HOW TO STORE IT
For vial, store at 15°C to 25°C.
For premixed bag store at 15°C to 25°C. Protect from freezing. Avoid excessive heat.
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 0701D
Ottawa, Ontario
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 obtained by contacting the sponsor, Baxter Corporation, at:
1-888-719-9955
Brevibloc, Brevibloc Premixed and IntraVia are trademarks of Baxter International Inc.