Patient Medication Information: uses, side effects, how to take - Apresoline
What is APRESOLINE used for?
APRESOLINE is used in adults in:
- the emergency treatment of severe high blood pressure when the oral form of the drug cannot be given.
- medical situations where there is an urgent need to lower blood pressure.
How does APRESOLINE work?
APRESOLINE works to lower blood pressure by widening blood vessels. It does this by interfering with the movement of calcium in the blood vessels. This reduces blood vessel contraction.
What are the ingredients in APRESOLINE?
Medicinal ingredients: hydralazine hydrochloride
Non-medicinal ingredients: hydrochloric acid, propylene glycol, sodium hydroxide, and water for injection
APRESOLINE comes in the following dosage forms:
Solution, 20 mg / mL
Serious Warnings and Precautions
Serious Heart Problems:
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Do not use APRESOLINE if:
- you are allergic to hydralazine or dihydrazine, or any of the non-medicinal ingredients in APRESOLINE (See What are the ingredients in APRESOLINE?).
- you have lupus, an autoimmune disease, or a related disease.
- you have a high heart rate or heart failure.
- you have a blockage in your heart such as a narrowing of the valves or blood vessels.
- you have isolated heart failure in the right side of the heart which affects your blood pressure.
- you have a tear in your main artery (the aorta).
- you have coronary artery disease.
- you have porphyria, a genetic blood disorder.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APRESOLINE. Talk about any health conditions or problems you may have, including if you:
- have heart disease or have survived a heart attack.
- have cerebrovascular disease, a condition that affects blood flow in the brain.
- have liver or kidney problems.
are pregnant.
- are breastfeeding. APRESOLINE passes into breastmilk.
Other warnings you should know about:
Pulmonary renal syndrome: Treatment with APRESOLINE may cause inflammation of arteries and veins in the lungs and kidneys which can lead to respiratory or kidney failure. These symptoms can be sudden and severe and can sometimes be fatal. See the Serious side effects and what to do about them table, below, for information on this and other serious side effects.
Driving and operating machines: Give yourself time after being given APRESOLINE to see how you feel before driving a vehicle or using machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APRESOLINE:
Other medications used to lower blood pressure such as:
- vasodilators
- calcium channel blockers
- ACE inhibitors
- diuretics
- beta blockers, e.g. acebutolol, atenolol, metaprolol, propranolol
- diazoxide
- anaesthetics, used during medical procedures to keep you from feeling pain
- medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs), e.g. moclobemide, phenelzine, procarbazine, tranylcypromine and tricyclic antidepressants
- nitrates, used to treat chest pain
- epinephrine, used to treat severe allergic reactions
- non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation, e.g. celecoxib, diclofenac, ibuprofen, indomethacin, naproxen
- medicines that contain estrogens, such as hormonal birth control and hormone replacement therapy
medicines that depress the nervous system, including alcohol
How to take APRESOLINE:
- APRESOLINE will be given to you by a healthcare professional in a healthcare setting.
- It will be given by an injection directly into your vein.
Usual dose:
Your healthcare professional will decide on the dose that is right for you according to your individual needs and based on your blood pressure.
Overdose:
| If you think you, or a person you are caring for, have been given too much APRESOLINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using APRESOLINE?
These are not all the possible side effects you may have when taking APRESOLINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- flushing
- headache
- dizziness
- stuffy nose
- pink eye, eye inflammation, eye tearing
- blurred vision
- diarrhea or constipation
- nausea, vomiting
- loss of appetite
- weight loss
- muscle pain, muscle cramps
- joint pain, joint swelling
- rash
- anxiety, agitation
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fever, chills, cough, stomach pain, weakness, confusion | √ | ||
| Blood problems (low levels of red or white blood cells or platelets): fatigue, weakness, pale skin, shortness of breath, skin rash with purple spots, bleeding for longer than usual when you cut yourself, nose bleeds, symptoms of infections (fever, chills, sore throat, mouth sores, body aches) | √ | ||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles, face or airway passages | √ | ||
Heart attack: sudden chest pain, discomfort, pressure or heaviness, sensation of squeezing or fullness in the shoulder, chest, arm or below the breastbone, feeling of being full, having indigestion or choking, sweating, nausea, vomiting, dizziness, weakness, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| anxiety, shortness of breath, rapid or irregular heartbeat | |||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | √ | ||
| Heart problems: irregular heartbeat, palpitations, fast heartbeat, chest pain or discomfort | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
| Liver problems: yellowing of the skin or eyes, dark urine, pale stool, abdominal pain, nausea, vomiting, loss of appetite | √ | ||
| Lupus-like syndrome: butterfly shaped skin rash typically on the face, skin sensitivity to sunlight, fever, joint pain, swelling or stiffness | √ | ||
| Neuropathy (nerve damage): numbness, tingling, muscle weakness, pain | √ | ||
| Pulmonary renal syndrome (lung and kidney failure): cough, shortness of breath, coughing up blood, fever, reduced or lack of urination, blood in the urine, swelling of | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help |
|---|
| Only if severe | In all cases |
|---|---|
| the extremities, nausea, vomiting | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Store at 15ºC to 30ºC. Protect vials from heat and light.
Keep out of reach and sight of children.
If you want more information about APRESOLINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.sterimaxinc.com, or by calling 1-800-881-3550.