Patient Medication Information: uses, side effects, how to take - Lidocaine Hydrochloride Injection USP (Formative Pharma)
What is Lidocaine Hydrochloride Injection USP used for?
Lidocaine Hydrochloride Injection USP is used in adults and children (2 years of age or older), to provide pain relief by producing a temporary loss of feeling or numbness to the area that it is injected. It can be used:
- to numb the area of the body where surgery is to be performed;
- to provide pain relief in labour and after surgery.
Lidocaine Hydrochloride Injection USP should be used with caution in children younger than 2 years of age.
How does Lidocaine Hydrochloride Injection USP work?
Lidocaine Hydrochloride Injection USP belongs to a group of medicines called ‘local anesthetics’. Lidocaine Hydrochloride Injection USP 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, heat or cold.
What are the ingredients in Lidocaine Hydrochloride Injection USP?
Medicinal ingredients: lidocaine hydrochloride.
Non-medicinal ingredients: sodium chloride, water for injection, sodium hydroxide and/or hydrochloric acid (to adjust pH).
Lidocaine Hydrochloride Injection USP comes in the following dosage forms:
Sterile solution: 1% lidocaine hydrochloride contains 10 mg/mL lidocaine hydrochloride, and 2% lidocaine hydrochloride contains 20 mg/mL lidocaine hydrochloride.
Do not use Lidocaine Hydrochloride Injection USP if:
- you are allergic to lidocaine, any other "-caine" type anesthetics, or any of the non-medicinal ingredients in the product;
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Lidocaine Hydrochloride Injection USP. Talk about any health conditions or problems you may have, including if you:
- are allergic to any other drugs, including any other local anesthetics;
- have an irregular heartbeat (arrhythmias) or other heart problems such as heart block;
- have inflammation and/or sepsis in the region of the injection;
- have sepsis;
- have liver disease;
- have severe kidney problems;
- have untreated heart disease;
- have untreated or severe high blood pressure;
- have a neurological disease or spinal deformities;
- have uncontrolled hyperthyroidism (an overactive thyroid) or diabetes;
- have epilepsy;
- have or have a family history of porphyria;
- have a condition called hypovolemia;
- have a blood circulation condition called 'peripheral vascular disorder';
- have problems with the blood supply to your brain because of obstructed arteries;
- are experiencing severe shock;
are pregnant, think you are pregnant, or plan to become pregnant;
- are breastfeeding.
Other warnings you should know about:
Driving and using machines: In addition to the temporary loss of feeling and numbness, Lidocaine Hydrochloride Injection USP may have an effect on your mental function and coordination. This may impair your ability to move and decrease your alertness. Avoid driving or operating machinery on the day you receive Lidocaine Hydrochloride Injection USP.
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 Lidocaine Hydrochloride Injection USP:
- other local anesthetics;
- erythromycin, a medication used to treat bacterial infections;
- itraconazole, a medication used to treat fungal infections;
- propranolol, a medication used to treat high blood pressure;
- cimetidine, a medication used to treat heartburn and peptic ulcers;
- medications used to treat irregular heartbeat such as mexiletine or amiodarone;
- medications used to treat depression such as fluvoxamine, imipramine, triptyline drugs and monoamine oxidase inhibitors;
- certain medications used to treat headaches and migraines
- medications used to treat psychosis such as phenothiazine or butyphenones
- sedative medications
- inhaled anesthetics such as halothane or enflurane
How to take Lidocaine Hydrochloride Injection USP:
Usual Dose:
Lidocaine Hydrochloride Injection USP is given to you by a healthcare professional who is experienced in the use of anesthesia. The dose is decided by the healthcare professional and is based on the clinical need and your physical condition. In children, the dose is based on the child’s weight, age and physical condition.
Overdose:
Lidocaine Hydrochloride Injection USP is only given by healthcare professionals who are well experienced in the use of anesthesia. If you experience an overdose or any serious side effects after receiving Lidocaine Hydrochloride Injection USP, the proper equipment and personnel will be immediately available to help you. Symptoms of an overdose may include:
- numbness of the lips and around the mouth,
- light-headedness or dizziness
- blurred vision
- hearing problems or tingling in the ears
In the event of a serious overdosage or a misplaced injection, trembling, seizures or unconsciousness may occur.
If the early signs of overdosage are noticed and no further Lidocaine Hydrochloride Injection USP is given, the risk of serious side effects occurring rapidly decreases. If you have any of these symptoms, tell your healthcare professional immediately.
If you think you, or a person you are caring for, have taken too much Lidocaine Hydrochloride Injection USP, contact a healthcare professional, hospital emergency department, regional
What are possible side effects from using Lidocaine Hydrochloride Injection USP?
These are not all the possible side effects you may have when taking Lidocaine Hydrochloride Injection USP. If you experience any side effects not listed here, tell your healthcare professional.
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 | |||
| Bradycardia (abnormally slow heartbeat) | X | ||
| Dizziness, abnormal sensations (pins and needles) | X | ||
| Feeling of sickness/nausea, vomiting (These side effects occur more frequently after epidural block). | X | ||
| 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 | X | ||
| 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) | X | ||
| UNCOMMON | |||
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.
| 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 | ||
| Toxicity symptoms: convulsions, seizures, light-headedness, numbness of the lips and around the mouth, hearing, visual, or speech disturbances, trembling. | X | ||
| RARE | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | X | ||
| Cardiac arrest and/or irregular heartbeat | X | ||
| Double vision | X | ||
| Nervous system disorders: weakness or paralysis of limbs or face, tingling of extremities, difficulty speaking, confusion, disorientation, trembling | X | ||
| UNKNOWN | |||
| Kounis syndrome (heart problems caused by an allergic reaction): chest pain, chest pressure or discomfort, heart palpitations, sweating, shortness of breath (may occur with symptoms of an allergic reaction; see above in this table) | 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:
- 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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
The healthcare professional is responsible for storing Lidocaine Hydrochloride Injection USP.
Lidocaine Hydrochloride Injection USP should be stored at controlled room temperature (15-30ºC). Protect from freezing. Keep out of the reach and sight of children.
If you want more information about Lidocaine Hydrochloride Injection USP:
- Talk to your healthcare professional
- Find the full prescribing information 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.formativepharma.com, or by calling 1-855-808-9528
Formative Pharma Inc.
Burlington, Ontario, L7L 6A3