Patient Medication Information: uses, side effects, how to take - Ropivacaine Hydrochloride Injection, USP (Fresenius Kabi Canada, 2 mg, 5 mg, 10 mg)
Serious warnings and precautions box
- Ropivacaine Hydrochloride Injection, USP is for healthcare professional use only.
- Your healthcare professional will be trained in the management and care of local anaesthetics, such as Ropivacaine Hydrochloride Injection, USP. They will prepare and give you Ropivacaine Hydrochloride Injection, USP in a hospital setting with the adequate equipment for the proper management of unwanted side effects. They will also monitor your health throughout the treatment.
What Ropivacaine Hydrochloride Injection, USP is used for:
Ropivacaine Hydrochloride Injection, USP is used in adults to prevent or relieve pain to an area of the body. This can include before and after a surgery, during labour, or after a sudden injury.
How Ropivacaine Hydrochloride Injection, USP works:
Ropivacaine Hydrochloride Injection, USP belongs to a group of medicines known as local anaesthetics. They act by temporarily preventing the nerves around the injection site from transmitting sensations of pain, heat or cold. However, you may still experience sensations such as pressure and touch. In many cases, the nerves to the muscles in the area will also be blocked. This may cause temporary weakness or paralysis (loss of voluntary muscle function). Overall, this helps to prevent or relieve pain to an area of the body.
The ingredients in Ropivacaine Hydrochloride Injection, USP are:
Medicinal ingredient: ropivacaine hydrochloride.
Non-medicinal ingredients: sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injection.
Ropivacaine Hydrochloride Injection, USP comes in the following dosage forms:
- Ropivacaine Hydrochloride Injection, USP 2 mg / mL for epidural infusion is available in 100 and 200 mL freeflex® infusion bags.
- Ropivacaine Hydrochloride Injection, USP 10 mg / mL is available in 10 mL and 20 mL ampoules. The 5 mg/mL is available in 10 mL ampoules only.
Do not use Ropivacaine Hydrochloride Injection, USP if:
- you are allergic to ropivacaine, other anesthetics that end with “-caine”, or any of the other ingredients in Ropivacaine Hydrochloride Injection, USP. If you are unsure, ask your healthcare professional.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive Ropivacaine Hydrochloride Injection, USP. Talk about any health conditions or problems you may have, including if you:
- are taking any other medications, including other local anesthetics or medicines used to treat abnormal heartbeat and heart rhythms.
- have inflamed skin or a severe reaction to an infection (sepsis) at or near the proposed site of injection for Ropivacaine Hydrochloride Injection, USP.
- have a condition that causes weakness or frailty.
- are severely ill.
- have low blood pressure.
- have heart, blood vessel or blood circulation problems.
- have liver or kidney disease.
- have porphyria (an inherited or acquired disorder involved in making red blood pigment).
are pregnant or planning to become pregnant. Ropivacaine Hydrochloride Injection, USP should only be used during pregnancy if your healthcare professional has decided that the potential benefits outweigh the potential risks to your unborn child.
- are breastfeeding or planning to breastfeed. Ropivacaine Hydrochloride Injection, USP can pass into your breast milk.
Other warnings you should know about:
Ropivacaine Hydrochloride Injection, USP may cause serious side effects, including:
- Hypotension (low blood pressure) or Bradycardia (low heart rhythm) when Ropivacaine Hydrochloride Injection, USP is administered into the space around the spinal cord (epidural). The risk of experiencing hypotension and bradycardia increases as you get older.
- Cardiac arrest (heart suddenly stops beating): This rarely occurred during the usual administration of ropivacaine hydrochloride injection, and occurred after its accidental administration into a blood vessel in patients with heart disease.
See the Serious side effects and what to do about them table for more information on this and other serious side effects.
Irreversible chondrolysis (permanent loss of cartilage in a joint): You may experience this side effect if Ropivacaine Hydrochloride Injection, USP is not administered as it should be. In most reported cases, the shoulder joint was affected. Symptoms included joint pain, stiffness and loss of motion, and began as early as 2 months after administration. Tell your healthcare professional right away if you experience these symptoms after surgery. You may require further therapeutic procedures or surgery.
Horner’s syndrome (a rare neurological syndrome): You may experience this side effect when Ropivacaine Hydrochloride Injection, USP is administered into the space around the spinal cord (epidural). It usually goes away once your treatment with Ropivacaine Hydrochloride Injection, USP is discontinued. Tell your healthcare professional right away if you experience decreased size of the pupil of the eye, drooping eyelid, decreased sweating on the affected side of the face.
Driving and using machines: Ropivacaine Hydrochloride Injection, USP may temporarily interfere with your reactions and coordination. Before you do tasks that may require your attention, you should wait until you know how you react to your treatment.
Testing and monitoring: Your healthcare professional will regularly monitor your health throughout your treatment. This may include monitoring:
- how you react to your dose;
- your blood pressure, heart rate, heart rhythm, and heart and blood vessel functions;
- your breathing and lung function;
- your vision.
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 Ropivacaine Hydrochloride Injection, USP:
- antiarrhythmics, medicines used to treat abnormal heartbeat and heart rhythms (e.g., procainamide, disopyramide, flecainide, mexiletine, amiodarone)
- other local anaesthetics, medicines used to prevent pain during surgery (e.g., lidocaine, bupivacaine, mepivacaine, prilocaine)
- sedatives, medicines that can increase drowsiness
- antidepressants, medicines used to treat depression (e.g., fluvoxamine, imipramine)
- theophylline, used to treat asthma and other lung problems
How Ropivacaine Hydrochloride Injection, USP is given:
will be administered to you:
- by a healthcare professional in a healthcare setting.
- into the space around your spinal cord (epidural) or near a nerve or a group of nerves (block/infiltration). Ropivacaine Hydrochloride Injection, USP should not be given by any other route.
- slowly and gradually.
Your healthcare professional may administer a test dose at first before administering Ropivacaine Hydrochloride Injection, USP. The test dose will consist of a fast-acting local anesthetic. This is to ensure you react well to this type of medication and to ensure the needle or catheter is properly placed.
Usual dose:
Ropivacaine Hydrochloride Injection, USP will be administered by your healthcare professional. Your dose will depend on:
- your age and weight,
- your medical condition,
- how you respond to the treatment,
- if you take other medicines, and/or
- the type of surgery.
The lowest effective dose of Ropivacaine Hydrochloride Injection, USP will be used.
Overdose:
Your healthcare professional will monitor you for signs and symptoms of an overdose. If an overdose is suspected, your healthcare professional will act accordingly to manage your side effects.
Symptoms of an overdose with Ropivacaine Hydrochloride Injection, USP include:
- feeling dizzy or light-headed
- numbness of the lips and around the mouth
- numbness of the tongue
- hearing problems
- tingling in the ears
- problems with your vision
- problems with speech
- twitching muscles or tremors (shaking)
- seizures (fits)
- loss of consciousness
- change in heart rhythm
- low blood pressure
- cardiac arrest (heart suddenly stops beating)
If you notice any of these symptoms, tell your healthcare professional right away.
If you think you, or a person you are caring for, have been given too much Ropivacaine Hydrochloride Injection, USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using Ropivacaine Hydrochloride Injection, USP:
These are not all the possible side effects you may have during your treatment with Ropivacaine Hydrochloride Injection, USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with Ropivacaine Hydrochloride Injection, USP include:
- Back pain
- Headache
- Itching
- Nausea or vomiting
- Reactions at the site of injection (e.g., bruising, pain, redness, burning sensation)
- Sensation of tingling, numbness or burning in the skin
- Feeling dizzy or anxious
- Low body temperature
- Bladder infection
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| 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) | √ | ||
| Common | |||
| Arrhythmias (abnormal heart rhythms): rapid (tachycardia), slow (bradycardia), or irregular 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 palpitations | √ | ||
| Urinary retention (inability to pass urine or to empty the bladder): hard to start the flow of urine, slow urine stream, or unable to completely empty your bladder when urinating | √ | ||
| High body temperature (fever) or chills | √ | ||
| Uncommon | |||
| Fainting | √ | ||
| Difficulty breathing | √ | ||
| Toxicity symptoms: convulsions, seizures, feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, problems with speech, stiff muscles, and trembling | √ | ||
| Numbness | √ | ||
| Nerve problems: back pain, loss or impairment of motor and sensory function, paralysis, decreased sensitivity or feeling in the skin, or other sensory disturbances | √ | ||
| Rare | |||
| Cardiac arrest (heart suddenly stops beating): fatigue, loss of consciousness, dizziness, difficulty breathing, nausea, chest pain, or heart palpitations | √ | ||
| Allergic reaction: difficulty swallowing, wheezing, drop in blood pressure, feeling sick to your stomach, vomiting, hives, rash, swelling of the face, lips, tongue or throat, itching, shortness of breath, difficulty breathing, skin redness, fast heart rate, sneezing, nausea, dizziness, or excessive sweating | √ | ||
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:
Visiting the Web page on Adverse Reaction Reporting
(canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Ropivacaine Hydrochloride Injection, USP will be stored by your healthcare professional or the hospital as follows:
- The medicine should be stored at 15 °C to 30 °C.
- It should not be frozen and should not be autoclaved.
Your healthcare professional should not use this medicine if they see particles in the ampoule or infusion bag, if the solution appears cloudy or discoloured, or if the product is leaking.
Keep out of reach and sight of children.
If you want more information about Ropivacaine Hydrochloride Injection, USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Fresenius Kabi Canada’s website (http://www.fresenius-kabi.ca); or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Authorization: 2026-04-10