Lidocaine HCl Topical Solution: Uses, Side Effects and Dosage

WHAT THE MEDICATION IS USED FOR:

LIDOCAINE HCL TOPICAL SOLUTION may be used to produce temporary loss of feeling or numbness of the area where it is applied in adults and children, and can be used:

• before certain types of examination and instrumentation are performed by your doctor.

WHAT IT DOES:

LIDOCAINE HCL TOPICAL SOLUTION is the brand name for a topical anesthetic that contains the drug lidocaine hydrochloride. Topical anesthetics are used to produce a temporary loss of feeling or numbness on the area where they are applied. LIDOCAINE HCL TOPICAL SOLUTION should start to work within 5 minutes after it is applied and its effect should last about 15 to 30 minutes.

WHEN IT SHOULD NOT BE USED:

Do not use LIDOCAINE HCL TOPICAL SOLUTION if you:

• are allergic to lidocaine, any other "-caine" type anesthetics, or any of the non-medicinal ingredients in the product (see NONMEDICINAL INGREDIENTS below)
• are allergic to methylparaben (preservative used in LIDOCAINE HCL TOPICAL SOLUTION) or PABA.

• Undergoing surgery where sterile anesthesia is

  • required.

WHAT THE MEDICINAL INGREDIENT IS:

lidocaine hydrochloride 4%

NONMEDICINAL INGREDIENTS:

LIDOCAINE HCL TOPICAL SOLUTION also contains methylparaben, sodium hydroxide and purified water.

Tell your doctor if you think you may be sensitive to any of the above ingredients.

WHAT DOSAGE FORMS IT COMES IN:

LIDOCAINE HCL TOPICAL SOLUTION, 50 mL bottle.

BEFORE you use LIDOCAINE HCL TOPICAL SOLUTION tell your doctor or dentist:

• 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 other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
• if you have ever had a bad, unusual or allergic reaction to LIDOCAINE HCL TOPICAL SOLUTION or any other medicines ending with "caine";
• if you think you may be allergic or sensitive to any ingredients in LIDOCAINE HCL TOPICAL SOLUTION (see above);
• if there is an infection, skin rash, cut or wound at or near the area you want to apply LIDOCAINE HCL TOPICAL SOLUTION;
• if you have a skin condition that is severe or that covers a large area;
• if you have a severe heart, kidney or liver disease (see PROPER USE OF THIS MEDICATION);
• if you have epilepsy (there is very low risk if used as per PROPER USE OF THIS MEDICATION section);
• If you or someone in your family has been diagnosed with porphyria;
• if you are experiencing severe shock;

• if you are pregnant, plan to become pregnant or are breastfeeding.

Tell your doctor about any other drugs you take, or have recently taken, including:

• drugs you can buy without a prescription;
• anti-arrhythmic drugs for heart problems (e.g.

WARNINGS AND PRECAUTIONS

ABOUT THIS MEDICATION

LIDOCAINE HCL TOPICAL SOLUTION

Lidocaine Hydrochloride Topical Solution USP, 4%

2 g / 50 mL (40 mg / mL)

INTERACTIONS WITH THIS MEDICATION

• mexiletine, amiodarone) (see PROPER USE OF THIS MEDICATION);
• other anesthetics (see PROPER USE OF THIS MEDICATION);
• propranolol for heart problems or cimetidine for gastrointestinal problems, if high doses of LIDOCAINE HCL TOPICAL SOLUTION will be used for a long time;
• fluvoxamine, for depression, if high doses of LIDOCAINE HCL TOPICAL SOLUTION will be used for a long time.

Usage of such medicines at the same time as LIDOCAINE HCL TOPICAL SOLUTION may increase the risk of serious side effects.

USUAL DOSE:

A doctor/nurse will give you LIDOCAINE HCL TOPICAL SOLUTION. The dose given is decided by the doctor. If you have the impression that the effect of LIDOCAINE HCL TOPICAL SOLUTION is too strong or too weak, talk to your doctor.

Conditions where dose adjustments may be required:

• elderly patients
• acutely ill patients
• patients with severe liver disease
• patients with severe kidney disease
• patients also treated with other anesthetics or certain antiarrhythmic drugs (such as amiodarone or mexiletine)

Dose for Adults:

The recommended dose of LIDOCAINE HCL TOPICAL SOLUTION is:

• 2-7.5 mL (80-300 mg lidocaine hydrochloride);
• During long procedures (more than 5 minutes), up to 400 mg may be used;
• When combined with other lidocaine products, the total dose should not exceed 400 mg;

Dose for Children (Unser 12 Years of Age):

The dose depends on the child's weight and physical condition.

• No more than 3 mg/kg of body weight should be used.

OVERDOSE:

Early signs of overdosage are numbness of the lips and around the mouth, lightheadedness, dizziness and sometimes blurred vision. In the event of a serious overdosage, trembling, seizures or unconsciousness may occur.

If the early signs of overdosage are noticed and no further LIDOCAINE HCL TOPICAL SOLUTION is given, the risk of serious side effects occurring rapidly decreases. If you think you or anyone else is experiencing any of the above signs, telephone your doctor or go to the nearest hospital right away.

Like any medication, LIDOCAINE HCL TOPICAL SOLUTION may cause side effects in some people.

Methylparaben (one of the other ingredients of the topical solution) may also cause allergic reaction.

Avoid eating or chewing gum when LIDOCAINE HCL TOPICAL SOLUTION is used in the mouth or throat since numbness in these areas may interfere with swallowing and could potentially cause choking. Numbness of the tongue or gums may also increase the danger of injury due to biting.

Avoid exposure to extreme hot or cold temperatures (e.g. food, drink) until complete sensation has returned.

Avoid contact with the eyes because numbness in the eyes may prevent you from noticing if you get something in your eye.

With the recommended doses, LIDOCAINE HCL TOPICAL SOLUTION has no effect on the ability to drive and use machines.

Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them. If any side effects bother you, or if you experience any unusual effects while you are using LIDOCAINE HCL TOPICAL SOLUTION, stop using it and check with your doctor or dentist as soon as possible.

PROPER USE OF THIS MEDICATION

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking LIDOCAINE HCL TOPICAL SOLUTION, contact your doctor or pharmacist.

LIDOCAINE HCL TOPICAL SOLUTION can cause serious side effects if too much is used. These include: drowsiness, numbness of your tongue, light-headedness, ringing in your ears, blurred vision, vomiting, dizziness, unusually slow heart beat, fainting, nervousness, unusual sweating, trembling or seizures.

The above are extremely rare and usually require large amounts of LIDOCAINE HCL TOPICAL SOLUTION over a long period of time. Consult your doctor immediately if any of these symptoms appear.

Keep LIDOCAINE HCL TOPICAL SOLUTION at room temperature. Protect from freezing. Your doctor or the hospital will normally store LIDOCAINE HCL TOPICAL SOLUTION. The staff are responsible for the storing, using and disposing of the solution in the correct way.

Important Note: This leaflet alerts you to some of the times you should call your doctor. Other situations which cannot be predicted may arise. Nothing about this leaflet should stop you from calling your doctor with any questions or concerns you have about using LIDOCAINE HCL TOPICAL SOLUTION.

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer

Information Leaflet plus the full Prescribing Information, prepared for health professionals can be found at:

www.canada.ca/en/health-canada.html or by calling, Hikma Canada Limited at 1-800-656-0793

Hikma Canada Limited, Mississauga, ON L5R 3P9

Questions or concerns? Contact: Hikma Canada Limited

Mississauga, ON L5R 3P9, 1-800-656-0793

Last revised: June 14, 2022

HOW TO STORE IT

MORE INFORMATION

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/health-canada/services/drugs-health-products/medeffect-canada.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.