Patient Medication Information: uses, side effects, how to take - Cleviprex
What is CLEVIPREX used for?
CLEVIPREX is used in adults to manage increases in blood pressure during surgery.
How does CLEVIPREX work?
CLEVIPREX belongs to a group of medicines called “calcium channel blockers” or “calcium antagonists”. It relaxes the arteries, which allows blood to flow freely through them. This helps to lower blood pressure.
What are the ingredients in CLEVIPREX?
Medicinal ingredients: clevidipine
Non-medicinal ingredients: edetate disodium, glycerin, oleic acid, purified egg yolk phospholipids, sodium hydroxide (for pH adjustment), soybean oil, and water for injection
CLEVIPREX comes in the following dosage forms:
Injectable emulsion: 0.5 mg/mL
Do not use CLEVIPREX if:
- you have an allergy to clevidipine or to any other ingredients in CLEVIPREX or its container. This includes soybean, soybean oil or soy products, eggs or egg products, peanuts or peanut products.
- you have a condition where you have extremely high levels of fat in your blood (e.g., pathologic hyperlipidemia, lipoid nephrosis, or acute pancreatitis accompanied with hyperlipidemia).
- you have severe aortic stenosis (narrowing of the opening of the biggest artery in the body).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLEVIPREX. Talk about any health conditions or problems you may have, including if you:
- Have or have had heart failure or low blood pressure. CLEVIPREX can worsen these conditions.
- Have a tumour of the gland on top of the kidney (adrenal gland) that causes high blood pressure (pheochromocytoma).
Other warnings you should know about:
CLEVIPREX can cause serious side effects, including:
- Hypotension (low blood pressure)
- Tachycardia (abnormally fast heartbeat)
See the Serious side effects and what to do about them table for more information on these and other serious side effects.
Pregnancy: It is not known if CLEVIPREX can harm an unborn baby. Tell your healthcare professional if you are pregnant or think you may be pregnant before your treatment with CLEVIPREX. You and your healthcare professional will decide if you should be given CLEVIPREX during pregnancy.
Breastfeeding: It is not known if CLEVIPREX can pass into your breast milk and harm your baby. Tell your healthcare professional that you are breastfeeding.
Check-ups and testing: Your healthcare professional will monitor your health during and after your treatment with CLEVIPREX. They will check your blood pressure and your heart rate.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Drug interactions are unlikely to occur with CLEVIPREX. This is due to the way the body processes it.
How to take CLEVIPREX:
CLEVIPREX will be given to you by a healthcare professional in a hospital or medical office. It will be injected into a vein.
Usual dose:
Your healthcare professional will decide what dose of medication you will receive and for how long. This will depend on your blood pressure and how you respond to CLEVIPREX.
Overdose:
Symptoms of an overdose with CLEVIPREX include:
- mild reddening of the skin;
- low blood pressure;
- abnormally fast heartbeat.
| If you think you, or a person you are caring for, have been given too much CLEVIPREX, 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 CLEVIPREX?
These are not all the possible side effects you may have when taking CLEVIPREX. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- headache
- dizziness
- trouble sleeping or staying asleep
- nausea
- fever
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when taken with medicines called beta-blockers). | √ | ||
| Tachycardia (abnormally fast heartbeat) | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitation. | √ | ||
| UNCOMMON | |||
| Acute kidney failure (severe kidney problems): confusion, itchiness or rashes, puffiness in your face and hands, swelling in your feet or ankles, urinating less or not at all, weight gain. | √ | ||
| Atrial fibrillation (abnormal heart rhythm which is rapid and | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| irregular): chest discomfort with unpleasant awareness of your heartbeat, faintness, shortness of breath, weakness. | |||
| Atelectasis (collapse of part or all of a lung): shortness of breath, rapid, shallow breathing, wheezing, cough, chest pain, skin and lips turning blue. | √ | ||
| UNKNOWN FREQUENCY | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives, rash, or swelling of the face, lips, tongue or throat. | √ | ||
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 vials in the carton at 2°C to 8°C. Vials in the carton may be stored for up to 2 months at room temperature (25°C). Do not freeze or re-refrigerate. Leave vials in carton to protect from light until use.
- Vials must be discarded 2 months after the date they have been removed from the refrigerator or after the expiration date (whichever date comes first).
If you want more information about CLEVIPREX:
- 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); or by calling the importer Methapharm Inc. at 1-800-287-7686 ext. 7804.