Patient Medication Information: uses, side effects, how to take - Clorotekal
What is CLOROTEKAL used for?
CLOROTEKAL belongs to a group of medicines called ‘local anesthetics’. It is used to anesthe-tise (numb) specific parts of the body and prevent pain during surgery. CLOROTEKAL is used in adults undergoing surgical procedures that are no longer than 40 minutes in duration. It is only given to you by a trained healthcare professional.
How does CLOROTEKAL work?
CLOROTEKAL is a solution for injection via the spinal cord. It prevents the nerves in the injected area from transmitting signals to the brain. This causes a temporary loss of feeling or numbness, so you do not feel sensations such as pain during surgery.
What are the ingredients in CLOROTEKAL?
Medicinal ingredients: chloroprocaine hydrochloride
Non-medicinal ingredients: hydrochloric acid 1N (for pH adjustment), sodium chloride, water for
Serious Warnings and Precautions
CLOROTEKAL is only given by a healthcare professional who is trained in the management and care of local anesthetics. They will prepare and give you CLOROTEKAL in a hospital set-ting with the adequate equipment for proper management of unwanted side effects. They will monitor your health throughout the treatment.
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injection.
CLOROTEKAL comes in the following dosage forms:
Solution for Injection: 10 mg/mL.
Do not use CLOROTEKAL if:
- you are allergic to chloroprocaine hydrochloride, medicinal products of the PABA (para-aminobenzoic acid) ester group, or any of the other ingredients of this medicine,.
- you have serious problems with heart conduction,.
- you suffer from severe anaemia,.
- you are taking a blood thinner medication, or have any type of bleeding disorder.
- you have a blood condition called septicemia (blood poisoning), or an infection at the site of the injection.
- you have ever had any problems with spinal anesthesia.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLOROTEKAL. Talk about any health conditions or problems you may have, including if you:
- have heart, blood vessel, or blood circulation problems.
- have total or partial heart block.
- are using any ester-type local anesthetics.
- have a neuromuscular disorder.
- have impaired kidney function.
are pregnant, think you are pregnant, or are a woman of childbearing potential not using an effective contraceptive.
- are breastfeeding or plan to breastfeed.
Other warnings you should know about:
Driving and Using Machines: CLOROTEKAL may affect your ability to drive or operate ma-chinery. See how you feel after receiving CLOROTEKAL before performing these tasks.
Monitoring: Your healthcare professional will regularly monitor you while you receive CLOROTEKAL and after your procedure. This may include monitoring your:
- blood pressure, heart rate, heart rhythm and heart and blood vessel function.
- breathing and lung function.
- state of consciousness during and after your procedure.
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 CLOROTEKAL:
- medicines used to treat low blood pressure.
- medicines known as “ergot-type oxytocic medicines”, such as ergotamine, dihydroer-gotamine.
- sulfonamide medicines.
- medicines used to treat an irregular heartbeat, such as amiodarone.
- other local anesthetics such as chloroform, halothane, cyclopropane, trichloroethylene.
How to take CLOROTEKAL:
- CLOROTEKAL is given to you by a healthcare professional who is well trained in the use of local anesthetics.
- In the case of an emergency, all equipment, medicines and personnel capable of deal-ing with an emergency will be available.
- If you have any questions about CLOROTEKAL, ask your healthcare professional.
Usual dose:
Your healthcare professional will decide what dose is right for you and will administer it during your procedure.
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.
What are possible side effects from using CLOROTEKAL?
These are not all the possible side effects you may have when taking CLOROTEKAL. If you experience any side effects not listed here, tell your healthcare professional.
- drowsiness
- headache
Serious Drug Interactions
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| If you think you, or a person you are caring for, have been given too much CLOROTEKAL, 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. |
- nausea
- vomiting
- diarrhea
- injection site pain
- restlessness
- muscle spasm
- muscle weakness
- light-headedness, feeling like you are about to faint
- loss of consciousness
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare profes-sional | Get immediate medical help | |
| Only if se-vere | In all cases | ||
| COMMON | |||
| Anxiety (emotional state of nerv-ousness, and uneasiness that can happen with or without an identifia-ble cause): sweating, nausea, short-ness of breath, dizziness, palpita-tions | X | ||
| Bradycardia (abnormally slow heartbeat) | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headed-ness, blurred vision, nausea, vomit-ing, fatigue (may occur when you go from lying or sitting to standing up) | X | ||
| Post Lumbar Puncture Syndrome (spinal fluid leaking into nearby tis-sues after spinal tap): headache, nausea, vomiting, dizziness, back pain, bleeding | X | ||
| UNCOMMON | |||
| Hearing Problems: change in hearing, dizziness, problems with balance, ringing in the ears, a sense of spinning | X | ||
| Vision Problems: blurred vision, double vision, sensitivity to light. | X | ||
| RARE | |||
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare profes-sional | Get immediate medical help | |
| Only if se-vere | In all cases | ||
| Allergic Reaction: difficulty swal-lowing or breathing, wheezing, feel-ing sick to your stomach and throw-ing up, hives or rash, swelling of the face, lips, tongue or throat. | X | ||
| Cauda Equina Syndrome (extreme pressure and swelling of the nerves at the end of the spinal cord): burn-ing feeling that may become con-stant and unbearable, back and/or leg pain, loss of bladder or bowel control, loss of perineal sensation and sexual function | X | ||
| Nerve Problems: headache, drowsiness, severe back pain, loss of feeling or tingling, limb weakness, lack of coordination, bladder or bowel dysfunction, loss of perineal sensation and sexual function | X | ||
| Respiratory Depression: slow, shallow or weak breathing; blue lips, fingers, toes; confusion; headaches | X | ||
| UNKNOWN FREQUENCY | |||
| Cardiac Arrest (heart suddenly stops beating) | X | ||
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:
Your healthcare professional will store CLOROTEKAL in a hospital setting.
If you want more information about CLOROTEKAL:
- 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 https://www.bbraun.ca/en.html, or by calling 1-800-227-2862