Ametop Gel 4%: Uses, Side Effects and Dosage

What is AMETOP Gel 4% used for?

AMETOP Gel 4% is used to temporarily numb the skin. This reduces the pain experienced when needles are used to take a blood sample or when an intravenous line is inserted.

How does AMETOP Gel 4% work?

AMETOP Gel 4% is an anaesthetic which is applied to the skin. It blocks nerves in the skin to reduce sensation and cause numbness. This prevents you from feeling pain.

What are the ingredients in AMETOP Gel 4%?

Medicinal ingredients: tetracaine hydrochloride

Non-medicinal ingredients: potassium phosphate, purified water, sodium chloride, sodium hydroxide, sodium methylparaben, sodium propylparaben and xanthan gum

AMETOP Gel 4% comes in the following dosage forms:

Gel; 4% w/w

Do not use AMETOP Gel 4%:

• in premature babies or newborns less than one month of age.
• if you or your child are allergic to tetracaine, any other drug product ending in “caine”, or any of the non-medicinal ingredients in AMETOP Gel 4% (see What are the ingredients in AMETOP Gel 4%?).
• on broken skin, large areas of the body, inside your nose or mouth or on your eyes, ears or genitals.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMETOP Gel 4%. Talk about any health conditions or problems you may have, including if you:

• have epilepsy.

• are pregnant.

• are breastfeeding. It is not known if AMETOP Gel 4% passes into breastmilk.

Other warnings you should know about:

• AMETOP Gel 4% contains sodium methylparaben and sodium propylparaben which may cause allergic reactions. These reactions can happen immediately after AMETOP Gel 4% is applied or can be delayed.
• Do not use more than the recommended dose. Larger amounts of AMETOP Gel 4% must only be applied under the direct supervision of a healthcare professional.
• Children and infants are more likely to experience side effects. Watch your child/infant closely while you are applying AMETOP Gel 4% and after it has been applied.
• Talk to your healthcare professional immediately if the following symptoms appear: weakness, confusion, headache, breathing difficulties and/or change in the colour of the skin.
• Side effects are more likely to occur if you apply large amounts of AMETOP Gel 4% to irritated or broken skin, or if you apply large amounts and cover the treated area with a bandage.

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 AMETOP Gel 4%:

• Do not use AMETOP Gel 4% to numb the skin before receiving a vaccine.

How to take AMETOP Gel 4%:

• AMETOP Gel 4% is for external use only.
• Do not apply AMETOP Gel 4% for longer than the recommended times. The numbing effect of AMETOP Gel 4% will last for 4 to 6 hours after a single application.
• Apply AMETOP Gel 4% only to the area of skin to be numbed.
• Apply AMETOP Gel 4% to the skin starting from the centre of the site where the needle is to be inserted. After is has been applied cover the area with a bandage that protects from air and water.
• The contents from one tube (1.5g ) is enough to cover and numb an area of skin up to 30 cm² (6 x 5 cm). Smaller areas can be numbed in children and infants.
• Wait 30 minutes after applying AMETOP Gel 4% before getting a needle or having blood taken. Wait 45 minutes after applying AMETOP Gel 4% before getting an intravenous line inserted.
• Wear a rubber glove to apply or remove AMETOP Gel 4%.
• Always wash your hands carefully after using AMETOP Gel 4%.

Usual dose:

Adults (including the elderly):

• Do not apply more than 1 tube per site where a needle or an intravenous line is to be inserted.
• A maximum of 5 sites may be numbed at the same time.
• Do not use more than 7 tubes of AMETOP Gel 4% in a 24-hour period.

Children (over 1 month of age):

• Do not apply more than 1 tube at separate sites in a single application.
• Do not use more than 2 tubes of AMETOP Gel 4% in a 24-hour period.

Overdose:

What are possible side effects from using AMETOP Gel 4%?

These are not all the possible side effects you may have when taking AMETOP Gel 4%. If you experience any side effects not listed here, tell your healthcare professional.

Side effects on the skin where AMETOP Gel 4% is applied may include:

• redness
• swelling
• itching
• blistering. If blisters occur, removed AMETOP Gel 4% immediately

Serious side effects and what to do about them

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

Storage:

Keep refrigerated at 2° to 8° C. Do not freeze. Protect from heat.

Keep out of sight and reach of children.

If you want more information about AMETOP Gel 4%:

• 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 www.valeopharma.com, or by calling 1-855-694-0151.

AMETOP is a registered trademark of Alliance Pharmaceuticals Limited. © Alliance Pharmaceuticals Limited 2022

Last Revised April 5, 2022