Patient Medication Information: uses, side effects, how to take - Propranolol Hydrochloride Injection USP
ABOUT THIS MEDICATION
What the medication is used for:
Propranolol Hydrochloride Injection USP contains propranolol hydrochloride, one of a group of substances called beta-adrenergic receptor-blocking agents (beta blockers). It is used in the following conditions:
- Certain life-threatening cardiac arrhythmias.
- Pheochromocytoma.
What it does:
Propranolol hydrochloride acts to reduce blood pressure and correct arrhythmias.
It works by the effects it has on the heart and circulation and also on other parts of the body.
When it should not be used:
Do not use Propranolol Hydrochloride Injection USP if you:
- are hypersensitive (allergic) to propranolol hydrochloride or another beta-blocker;
- are hypersensitive to any ingredient in the formulation. For a complete listing, see below What the important nonmedicinal ingredients are;
- have had or currently have bronchial asthma or bronchospasm (a sudden closing of muscles in the throat, making it hard to breathe) ;
- have allergic rhinitis (for example, runny nose during the pollen season);
- have a heart condition known as heart failure (a condition where the heart is unable to pump enough blood);
- have pulmonary hypertension (high blood pressure in blood vessels of the lungs, which lead to heart failure);
- are prone to having hypoglycaemia (episodes of low blood sugar);
have any of the following heart or cardiovascular conditions:
- bradycardia (abnormally slow heart beat)
- hypotension (unusually low blood pressure)
metabolic acidosis (when there is too much acid in the
body’s fluids)
- poor blood circulation
- sick sinus syndrome (a group of heart rhythm disorders);
untreated phaeochromocytoma (a tumour condition in the
adrenal glands)
uncontrolled heart failure
- Prinzmetal’s angina (a condition that produces chest pain and pressure while at rest)
What the medicinal ingredient is:
Propranolol hydrochloride
What the important nonmedicinal ingredients are:
Citric acid to adjust pH and water for injection. Preservative free.
What dosage forms it comes in:
Solution containing propranolol hydrochloride at a concentration of 1 mg/mL.
WARNINGS AND PRECAUTIONS
Propranolol Hydrochloride Injection USP is reserved for life-threatening arrhythmias or those occuring under anesthesia. Temporary maintenance with oral therapy may be indicated.
BEFORE Propranolol Hydrochloride Injection USP is used tell your doctor if you:
- have a heart condition;
- have poor circulation;
- have a history of serious allergies;
- have a history of skin reactions;
- are prone to chronic bronchitis and emphysema not related to allergies;
- have diabetes;
- have a condition involving an over-active thyroid gland
- have or have had a severe allergic condition involving the eyes and skin;
- have liver or kidney problems;
are pregnant or intending to become pregnant;
- are nursing;
- are taking any other medications.
Propranolol Hydrochloride Injection USP is not recommended for children.
INTERACTIONS WITH THIS MEDICATION
If taken with some other medicines, the effects of Propranolol Hydrochloride Injection USP or the other medication may change. Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including non-prescription medicines, vitamins, minerals, natural supplements, or alternative medicines.
Examples of drugs or substances that may interact with Propranolol Hydrochloride Injection USP include:
Alcoholic beverages
- Diuretics (drugs used to increase urine output, such as hydrochlorothiazide)
- Drugs used to control heart rhythm, e.g., disopyramide, amiodarone, procainamide, quinidine, propafenone
- Warfarin (to thin the blood)
- Insulin
- Drugs used to reduce high blood pressure, e.g., guanethidine,
- clonidine, calcium channel blockers (verapamil, diltiazem, nifedipine)
- Rizatriptan and zolmitriptan (drugs used to treat migraine headaches)
- Digitalis glycosides (a drug used to control heart rate and rhythm)
- Epinephrine (a drug used to treat severe allergic reactions)
- Cimetidine (a drug used to treat stomach ulcers and pain)
- Chlorpromazine (a drug used to treat psychoses)
- Lidocaine (a drug used as a local anesthetic)
- Pain relief or anti-inflammatory drugs available with or whithout prescriptions such as ibuprofen
- Theophylline (a drug used for respiratory problems)
- Diazepam (a drug used for anxiety)
Please check with your doctor before taking any other medications with Propranolol Hydrochloride Injection USP.
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dose is from 1 to 3 mg intravenously. If necessary, a second dose may be given after two minutes. Thereafter, additional drug should not be given in less than four hours.
Overdose:
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669).
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Propranolol Hydrochloride Injection USP can cause side effects, although not everybody gets them.
The most common side effects are abdominal pain, nausea, vomiting, loss of appetite and diarrhea. Other side effects include disturbed sleep and nightmares, cold hands and feet, numbness and spasm in your fingers followed by warmth and pain (Raynaud’s phenomenon).
The most serious side effects with Propranolol Hydrochloride Injection USP are heart failure and bronchospasm (see When it should not be used and WARNINGS AND PRECAUTIONS).
The following table contains a list of side effects that may occur with Propranolol Hydrochloride Injection USP. The table does not include a complete list. Therefore, check with your doctor immediately if you notice or are bothered by any unusual symptoms.
| 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 pharmacis t | |||||
| Only if severe | In all cases | ||||||
Frequency unknown | Allergic reactions (skin rash, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing or swallowing, wheezing, blisters of the skin, sores or pain in the mouth or eyes) | ✓ | |||||
| Difficulty breathing and swollen ankles (Congestive heart failure) | ✓ | ||||||
| Abnormally low blood pressure, dizziness (particularly, when standing up), tiredness fainting | ✓ | ||||||
| Bronchospasm | ✓ | ||||||
| Weakness, insomnia, headache, fatigue | ✓ | ||||||
| Changes in mood, hallucinations, memory loss | ✓ | ||||||
| Common | Dry eyes, visual disturbances | ✓ | |||||
| Abdominal pain, nausea, vomiting, diarrhea, loss of appetite | ✓ | ||||||
| Uncommon | Ringing in the ears | ✓ | |||||
| Low level of sugar in the blood (hypoglycemia) | ✓ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking Propranolol Hydrochloride Injection USP, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15°C and 30°C. Discard unused portion.
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:
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- 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™ 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 by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062
or by written request at:
4600, rue Armand-FrappierSaint-HubertQC
J3Z 1G5
Or by e-mail at :
medinfo@sandoz.com
