Drugs List

Therapeutic Indications

Uses

Local anaesthesia of genital skin in adults before anaesthetic inj
Local anaesthetic for genital mucosa for treatment of lesions in adults
Local anaesthetic for surface anaesthesia of the skin

Administration

Use of an occlusive dressing is required following application to the skin (including genital skin) and leg ulcers. It is not required prior to application to genital mucosa.

Contraindications

Premature infants

Precautions and Warnings

Open wounds
Anaemia
Breastfeeding
Dermatitis
G6PD deficiency
Methaemoglobinaemia
Pregnancy

Avoid broken or inflamed skin
Avoid contact with eyes
Do not allow contact with middle ear
Do not apply to genital mucosa in children
If accidental contact with the eyes occurs, rinse thoroughly with water
Monitor immune response to intracutaneous injections of live vaccines

Contact with the eyes may affect their protective reflexes potentially allowing corneal irritation or abrasion. Following contact, immediately wash the eye with water or sodium chloride solution and protect until sensation returns.

Do not allow contact with the middle ear. Animal studies have suggested application onto a (pre-existing) impaired tympanic membrane may result in ototoxicity.

If used prior to administration of intracutaneous live vaccines, clinical response should be monitored. Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5-2%, potentially affecting response to the vaccine, although evidence is conflicting.

Take care to limit the dose and area of application. Exceeding recommended regimes (particularly in children) may increase the risk of systemic effects including methaemoglobinaemia. A higher absorption rate and/or incidence of adverse effects is also seen following application to areas of skin that are newly shaven or have atopic dermatitis.

Methaemoglobinaemia occurs more frequently in children under 12 years of age. Concomitant use with other methaemoglobin-inducing agents is contraindicated in this age group. When used within recommended doses, an increase in methaemoglobin levels is commonly observed in infants under 3 months of age. This is usually transient and clinically insignificant. Patients with G6PD deficiency or methaemaglobinaemia are more susceptible to active-substance-induced signs of methaemaglobinaemia. In patients with G6PD deficiency, the antidote methylene blue is ineffective.

Pregnancy and Lactation

Pregnancy

Lidocaine and prilocaine cross the placental barrier. However, both of these drugs have been widely used for many years and many women of child bearing age have been exposed to them. No specific effects on reproductive processes have been reported. At the time of writing, no reports on the use of topical lidocaine or prilocaine during pregnancy have been identified. However caution should be exercised when used in pregnant women.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Lidocaine and prilocaine are excreted in breast milk in small amounts. At the time of writing, no reports of the use of topical lidocaine or prilocaine during breastfeeding have been located, but the oral bioavailability of each of these agents is low. However caution should be exercised when used in breastfeeding women.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylactic shock
Burning sensation (local)
Cutaneous lesions
Erythema
Itching at application site
Localised areas of paraesthesia
Methaemoglobinaemia
Oedema at application site
Paleness at application site
Petechiae
Purpura
Sensation of warmth
Skin tingling

Presentation

Cream containing lidocaine and prilocaine.

Drugs List

Therapeutic Indications

Uses

Local anaesthesia of genital skin in adults before anaesthetic inj
Local anaesthetic for genital mucosa for treatment of lesions in adults
Local anaesthetic for surface anaesthesia of the skin

Dosage

Adults

Children

Adolescents

Additional Dosage Information

Administration

Use of an occlusive dressing is required following application to the skin (including genital skin) and leg ulcers. It is not required prior to application to genital mucosa.

Contraindications

Premature infants

Precautions and Warnings

Open wounds
Anaemia
Breastfeeding
Dermatitis
G6PD deficiency
Methaemoglobinaemia
Pregnancy

Avoid broken or inflamed skin
Avoid contact with eyes
Do not allow contact with middle ear
Do not apply to genital mucosa in children
If accidental contact with the eyes occurs, rinse thoroughly with water
Monitor immune response to intracutaneous injections of live vaccines

Contact with the eyes may affect their protective reflexes potentially allowing corneal irritation or abrasion. Following contact, immediately wash the eye with water or sodium chloride solution and protect until sensation returns.

Do not allow contact with the middle ear. Animal studies have suggested application onto a (pre-existing) impaired tympanic membrane may result in ototoxicity.

If used prior to administration of intracutaneous live vaccines, clinical response should be monitored. Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5-2%, potentially affecting response to the vaccine, although evidence is conflicting.

Take care to limit the dose and area of application. Exceeding recommended regimes (particularly in children) may increase the risk of systemic effects including methaemoglobinaemia. A higher absorption rate and/or incidence of adverse effects is also seen following application to areas of skin that are newly shaven or have atopic dermatitis.

Methaemoglobinaemia occurs more frequently in children under 12 years of age. Concomitant use with other methaemoglobin-inducing agents is contraindicated in this age group. When used within recommended doses, an increase in methaemoglobin levels is commonly observed in infants under 3 months of age. This is usually transient and clinically insignificant. Patients with G6PD deficiency or methaemaglobinaemia are more susceptible to active-substance-induced signs of methaemaglobinaemia. In patients with G6PD deficiency, the antidote methylene blue is ineffective.

Pregnancy and Lactation

Pregnancy

Lidocaine and prilocaine cross the placental barrier. However, both of these drugs have been widely used for many years and many women of child bearing age have been exposed to them. No specific effects on reproductive processes have been reported. At the time of writing, no reports on the use of topical lidocaine or prilocaine during pregnancy have been identified. However caution should be exercised when used in pregnant women.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Lidocaine and prilocaine are excreted in breast milk in small amounts. At the time of writing, no reports of the use of topical lidocaine or prilocaine during breastfeeding have been located, but the oral bioavailability of each of these agents is low. However caution should be exercised when used in breastfeeding women.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylactic shock
Burning sensation (local)
Cutaneous lesions
Erythema
Itching at application site
Localised areas of paraesthesia
Methaemoglobinaemia
Oedema at application site
Paleness at application site
Petechiae
Purpura
Sensation of warmth
Skin tingling

Effects on Laboratory Tests

In suspected methaemoglobinaemia, oxygen saturation is best measured using co-oximetry as pulse oximeter readings may overestimate oxygen saturation.

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2017

Reference Sources

Summary of Product Characteristics: EMLA cream 5% . AstraZeneca UK Ltd. Revised May 2017.

Summary of Product Characteristics: Denela 5% cream. Auden McKenzie Ltd. Revised April 2013.

Summary of Product Characteristics: Nublia 5% cream. Glenmark Pharmaceuticals Ltd. Revised June 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 November 2017