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Tetracaine gel 4%

Updated 2 Feb 2023 | Tetracaine (amethocaine)


Gel containing tetracaine 4% w/w (40mg/g).

Drugs List

  • AMETOP 4% gel
  • AMETOP 4% gel with adhesive film dressing
  • tetracaine 4% gel
  • tetracaine 4% gel with adhesive film dressing
  • Therapeutic Indications


    Anaesthesia - local, prior to venepuncture or venous cannulation


    Apply the contents of the tube to the centre of the area to be anaesthetised and cover with occlusive dressing. One tube (approximately 1 gram) will cover an area of up to 30 square centimetre.
    Adequate anaesthesia is usually obtained after 30 minutes for venepuncture and 45 minutes for venous cannulation. After this time, remove the gel with a gauze swab and prepare the skin with an antiseptic wipe.
    Anaesthesia persists for 4 to 6 hours after application. Application can be repeated after a minimum of 5 hours if necessary.
    Each tube is intended for use on a single occasion only.


    Maximum of 5 tubes (approximately 5 grams) at a single time.


    Children aged 5 to 18 years
    Maximum of 5 tubes (approximately 5 grams) at a single time.

    Children aged 1 month to 5 years
    No more than 1 tube at a single time.

    Children under 1 month (unlicensed)
    Apply contents of tube, or the appropriate proportion, to site the of venepuncture or venous cannulation and cover with occlusive dressing.
    For venepuncture remove the gel and dressing after 30 minutes.
    For venous cannulation remove the gel and dressing after 45 minutes.


    Blistered or raw skin surfaces
    Third degree atrioventricular block

    Precautions and Warnings

    Premature infants
    Cardiac conduction defects
    Cardiovascular disorder
    Epileptic disorder
    Myasthenia gravis
    Respiratory impairment

    Avoid contact with ears
    Avoid contact with middle ear
    Avoid contact with mucous membranes
    Avoid use in or near eyes
    Do not apply to broken or denuded skin
    Avoid prolonged use

    Epileptic patients should be treated with caution. Systemic availability may increase risk of seizure, although this risk is very low as systemic absorption is limited.

    Repeat applications may increase the risk of sensitisation reactions.

    Like other local anaesthetics, tetracaine may be ototoxic and should not be instilled into the middle ear or used for procedures which might involve penetration into the middle ear.

    Pregnancy and Lactation


    Use tetracaine with caution during pregnancy.

    The manufacturer does not provide any specific recommendations for use of tetracaine during pregnancy.

    There are no studies regarding the amount of tetracaine reaching the systemic circulation after topical (other than the skin patch) or spinal administration. Nevertheless, based on very small numbers, tetracaine does not appear to represent a risk of embryo and/or foetal harm any greater than that of other local anaesthetics. Briggs (2015) concludes that, although the combined data are inadequate, the risk of embryo-foetal harm from tetracaine is probably low.


    Use tetracaine with caution in breastfeeding.

    The manufacturer does not recommend the use of tetracaine during breastfeeding.

    No information is available on the use of tetracaine during breastfeeding. The low molecular weight suggests that tetracaine will be excreted into human breast milk. However, the amount of tetracaine in the systemic circulation appears to be very low, so the amount excreted into breast milk will also be very low. Based on these estimates, Briggs (2015) concludes that the risk to a nursing infant from tetracaine given to the mother appears to be nil.

    Side Effects

    Erythema at application site
    Itching at application site
    Oedema at application site


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2020

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics. Ametop gel 4%. Alliance Pharamaceuticals. Revised March 2018.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Tetracaine Last revised: 03 December 2018
    Last accessed: 21 May 2020

    NICE Evidence Services Available at: Last accessed: 24 August 2017

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