Details for: ROPIVACAINE HYDROCHLORIDE INJECTION, USP
Company: FRESENIUS KABI CANADA LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02439379 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE | 2 MG / ML | SOLUTION | EPIDURAL |
| 02439379 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE | 2 MG / ML | SOLUTION | INFILTRATION |
| 02439387 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 02439387 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | EPIDURAL |
| 02439409 | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE | 10 MG / ML | SOLUTION | EPIDURAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Ropivacaine Hydrochloride Injection, USP is used as an anesthetic and for pain relief. It can be used:
- to anesthetize the area of the body where surgery is performed;
- to provide pain relief in labour and after surgery or acute injury.
Ropivacaine Hydrochloride Injection, USP is not for use in children under 18 years of age.
What it does
Ropivacaine Hydrochloride Injection, USP temporarily prevents the nerves in the injected area from transmitting feelings of pain, heat or cold. You may still feel 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.
The duration of pain relief depends on the dose and how it is given
When it should not be used
Ropivacaine Hydrochloride Injection, USP should not be used in patients who:
- are allergic to ropivacaine, any other “-caine” type anesthetics, or any of the non-medicinal ingredients in the product
What the medicinal ingredient is
Ropivacaine hydrochloride 2 mg / mL, 5 mg / mL, 7.5 mg / mL and 10 mg / mL.
What the non-medicinal ingredients are
sodium chloride, hydrochloric acid and/or sodium hydroxide and water for injection.
What dosage form it comes in
Ropivacaine Hydrochloride Injection, USP 2 mg / mL for epidural infusion is available in 100 and 200 mL freeflex® infusion bags.
Ropivacaine Hydrochloride Injection, USP 2 mg / mL, 7.5 mg / mL and 10 mg / mL are available in 10 mL and 20 mL ampoules. The 5 mg/mL is available in 10 mL ampoules only.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Ropivacaine Hydrochloride Injection, USP. Talk about any health conditions or problems you may have, including:
- about all health problems you have now or have had in the past;
- about other medicines you take, including ones you can buy without a prescription;
- if you are taking drugs used to treat irregular heart activity (anti-arrhythmics, such as
- amiodarone);
- if you have ever had a bad, unusual allergic reaction to ropivacaine or any other medicines ending with “-caine”;
- if you have a heart, liver or kidney disease, since the dose of Ropivacaine Hydrochloride Injection, USP may have to be adjusted;
- if you are pregnant, plan to become pregnant or are breastfeeding;
- if you have been diagnosed with porphyria, a rare hereditary disorder.
Other warnings you should know about
- Ropivacaine Hydrochloride Injection, USP could cause irreversible joint damage if it is used to manage your pain after joint surgery.
- Ropivacaine Hydrochloride Injection, USP may temporarily interfere with your ability to drive or operate tools or machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- drugs that treat heart rhythm problems (e.g. mexiletine, amiodarone);
- other local anesthetics;
- sedative drugs;
- if using Ropivacaine Hydrochloride Injection, USP for a long time:
- fluvoxamine or imipramine, used to treat depression
- enoxacin, an antibiotic
- theophylline, used to treat lung diseases
Usage of some medicines at the same time as Ropivacaine Hydrochloride Injection, USP may increase the risk of serious side effects.
Proper use of this medication
Usual Dose
Ropivacaine Hydrochloride Injection, USP should be administered by a doctor. It can be administered by an anesthesia professional under the supervision of a doctor.
The dose to be given is decided by the doctor, based on the clinical need and your physical condition.
Overdose
You can have serious side effects from getting too much Ropivacaine Hydrochloride Injection, USP. You may need treatment to deal with the side effects from the overdose. The doctor treating you is trained to deal with these situations. The first signs of being given too much ropivacaine hydrochloride injection are usually as follows:
- 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 sight (vision).
More serious side effects from being given too much Ropivacaine Hydrochloride Injection, USP include:
- problems with speech
- twitching muscles
- tremors
- trembling
- seizures
- loss of consciousness
- change in heart rhythm
- heart attack
- decrease in blood pressure
To reduce the risk of serious side effects, your doctor will stop giving you Ropivacaine Hydrochloride Injection, USP as soon as these signs appear.
If you think you have taken too much ROPIVACAINE HYDROCHLORIDE INJECTION, USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Ropivacaine Hydrochloride Injection, USP. If you experience any side effects not listed here, contact your healthcare professional.
Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them.
Tell your doctor as soon as possible if you do not feel well during treatment with Ropivacaine Hydrochloride Injection, USP.
Possible side effects include:
Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long
Possible side effects seen with other local anesthetics which might also be caused by Ropivacaine Hydrochloride
Injection, USP include:
Damaged nerves. Rarely (affecting less than 1 in 1000 people), this may cause permanent problems.
If too much Ropivacaine Hydrochloride Injection, USP is given into the spinal fluid, the whole body may become numbed (anesthetized).
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Low blood pressure: feeling dizzy or light-headed | ✔ | ||
| Nausea | ✔ | ||
| COMMON | |||
| Pins and needles | ✔ | ||
| Feeling dizzy | ✔ | ||
| Headache | ✔ | ||
| Slow or fast heart beat | ✔ | ||
| High blood pressure | ✔ | ||
| Vomiting | ✔ | ||
| Difficulty in passing urine | ✔ | ||
| High temperature (fever) or stiffness (rigor) | ✔ | ||
| Back Pain | ✔ | ||
| UNCOMMON | |||
| Anxiety | ✔ | ||
| Decreased sensitivity or feeling in the skin | ✔ | ||
| Fainting | ✔ | ||
| Difficulty breathing | ✔ | ||
| Low body temperature | ✔ | ||
| Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Ropivacaine Hydrochloride Injection, USP: seizures, feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with sight, problems with speech, stiff muscles, and trembling | ✔ | ||
| Numbness | ✔ | ||
| Nerve Damage | ✔ | ||
| RARE | |||
| Heart attack | ✔ | ||
| Severe allergic reaction (anaphylaxis): sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing | ✔ | ||
| Uneven heart beat | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Your doctor or the hospital will normally store Ropivacaine Hydrochloride Injection, USP. The staff is responsible for storing, dispensing and disposing of Ropivacaine Hydrochloride Injection, USP in the correct way.
Store at 15 °C to 30 °C. Do not freeze. Do not autoclave.
Ropivacaine Hydrochloride Injection, USP will be kept out of reach and sight of children
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
- 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://health-products.canada.ca/dpdbdpp/index-eng.jsp); Fresenius Kabi Canada’s website (http://www.fresenius-kabi.com/en-ca/), or by calling 1-877-821-7724.