Drugs List

Contraindications

Hypersensitivity to local anaesthetics of the amide type

Infants under 1 month of age

Dermatitis and open wounds

Precautions and Warnings

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Application of lidocaine to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine resulting in serious adverse effects. Repeated doses of lidocaine may increase blood levels of lidocaine.

Use with caution in acutely ill, debilitated or elderly patients as they may be more sensitive to the systemic effects of lidocaine.

Dermal application of lidocaine may cause transient local blanching followed by transient erythema. The production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.

Do not apply to irritated or damaged skin, wounds, dermatitis or mucous membranes. If excessive irritation develops or if irritation persists unaltered for more than seven days or clear up and occur again within only a few days, discontinue use of this product and consult a doctor.

Patients with severe hepatic impairment should be treated with caution. Due to their inability to metabolize local anaesthetics normally they are at greater risk of developing toxic plasma concentrations of lidocaine.

Avoid contact with the eyes as eye irritation may occur. Loss of protective reflexes may also lead to corneal irritation and potential abrasion. If contact does occur, the eye should be immediately rinsed with water or sodium chloride solution and protected until sensation in the area returns.

Local anaesthetics may be ototoxic. Lidocaine should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Lidocaine concentrations greater than 0.5% have bactericidal and antiviral properties. Therefore, when the cream is used, the results of intracutaneous injections of live vaccines (such as BCG) should be monitored.

Contains propylene glycol which may cause skin irritation.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

There are no well controlled studies in pregnant women and lidocaine crosses the placental barrier. However, this drug has 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.

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 14-17 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

The manufacturer recommends caution when treating breastfeeding women.

Lidocaine is excreted in human milk, the milk: plasma ratio is 0.4. Briggs (8th edition) suggests that the potential harm to the infant from exposure to lidocaine in breast milk is probably very low.

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

Irritation
Slight redness of the skin
Itching
Rash
Allergic reaction
Anaphylactic shock

Drugs List

Dosage

Adults

Elderly

Children

Patients with Hepatic Impairment

Contraindications

Hypersensitivity to local anaesthetics of the amide type

Infants under 1 month of age

Dermatitis and open wounds

Precautions and Warnings

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Application of lidocaine to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine resulting in serious adverse effects. Repeated doses of lidocaine may increase blood levels of lidocaine.

Use with caution in acutely ill, debilitated or elderly patients as they may be more sensitive to the systemic effects of lidocaine.

Dermal application of lidocaine may cause transient local blanching followed by transient erythema. The production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.

Do not apply to irritated or damaged skin, wounds, dermatitis or mucous membranes. If excessive irritation develops or if irritation persists unaltered for more than seven days or clear up and occur again within only a few days, discontinue use of this product and consult a doctor.

Patients with severe hepatic impairment should be treated with caution. Due to their inability to metabolize local anaesthetics normally they are at greater risk of developing toxic plasma concentrations of lidocaine.

Avoid contact with the eyes as eye irritation may occur. Loss of protective reflexes may also lead to corneal irritation and potential abrasion. If contact does occur, the eye should be immediately rinsed with water or sodium chloride solution and protected until sensation in the area returns.

Local anaesthetics may be ototoxic. Lidocaine should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Lidocaine concentrations greater than 0.5% have bactericidal and antiviral properties. Therefore, when the cream is used, the results of intracutaneous injections of live vaccines (such as BCG) should be monitored.

Contains propylene glycol which may cause skin irritation.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

There are no well controlled studies in pregnant women and lidocaine crosses the placental barrier. However, this drug has 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.

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 14-17 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

The manufacturer recommends caution when treating breastfeeding women.

Lidocaine is excreted in human milk, the milk: plasma ratio is 0.4. Briggs (8th edition) suggests that the potential harm to the infant from exposure to lidocaine in breast milk is probably very low.

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

Irritation
Slight redness of the skin
Itching
Rash
Allergic reaction
Anaphylactic shock

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 ).

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: LMX4 cream. Ferndale Pharmaceuticals Ltd. Revised March 2011.