Local anesthesia of healthy skin, for example

· Before venous or subcutaneous punctures

· Before skin, superficial, instrumental or laser surgery

Anesthesia of the genital mucosa in adults, for example

· Before superficial surgery, biopsy or lesion removal (instrumental or laser beam).

· Before infiltration with the local anesthetic needle: at the dosage of 5 to 10 g for an application period of 5 to 10 minutes.
Local anesthesia of leg ulcers requiring debridement, long and painful mechanical

Skin channel.

Dosage

Local anesthesia of leg ulcers requiring debridement, long and painful mechanical

1 to 2 g per 10 cm 2 area not exceeding the maximum quantity of 10 g.

Local anesthesia of healthy skin

Age

Recommended Dose

Minimum duration of application

Dose, maximum

Duration, maximum application

Adult and child over 12 years old

2 to 3 g (for acts involving small areas)

1; time

50; g

4; hours **

1 to 1.5 g per 10 cm 2 (for larger areas)

Child

From 0 to 3 months

0.5 g (for acts involving small areas)

1; time

1 g (for a surface area of ​​10 cm 2).
1; time *

Not to be renewed before 12 pm

From 3 to 12 months

0.5 g (for acts involving small areas)

1; time

2 g (for a surface area of ​​20 cm 2)

4; hours **

From 12 months to 6 years

1 to 2 g (for acts involving small areas)

1; time

10 g (for a surface area of ​​100 cm 2)

4; hours **

From 6 years old to 12 years old

1 to 2 g (for acts involving small areas)

1; time

20 g (for a surface area of ​​200 cm 2)

4; hours **

In this age group, a duration of application exceeding 1 hour has not been studied.

** After 4 hours, the anesthetic effect decreases.
Mode of administration

Apply the quantity of prescribed cream in a thick layer to the skin area to be treated and cover with a dressing, hermetic adhesive

At the end of the application period, the cream is carefully removed with a compress.

The anesthesia obtained persists 1 to 2 hours.
In children with atopic skin lesions: before molluscum curettage an application time of 30 minutes is recommended.


Apply 5 to 10 g of cream, depending on the extent of the lesions over a period of 5 to 10 minutes. It is not necessary to cover with an occlusive dressing.

The therapeutic action must be carried out immediately after the removal of the cream, because the anesthetic effect lasts only 15 to 20 minutes.
In case of penile application, dermal prior to injection, local anesthetics, the dose should not exceed 1 g / 10 cm 2 and an application time of 15 minutes is recommended. >

The application of the cream for 60 and 90 minutes on the cutaneous side of the vulva and on the perineum does not allow for anesthesia, sufficient for the treatment of condylomas by electrocoagulation.

Local anesthesia of leg ulcers

Apply the amount of cream needed 30 minutes before the beginning of the debridement and cover with a dressing, hermetic adhesive

Given the opaque white color of the cream, its removal must be complete to carry out a guided debridement.

Pharmacotherapeutic group: LOCAL ANESTHETICS, ATC code: N01BB20.
Lidocaine and prilocaine are two local anesthetics of the amide - linked group. At room temperature, the mixture, in equal parts of lidocaine base and prilocaine base, spontaneously forms an oil, which constitutes an eutectic mixture.
The emulsion of this oil in water is able to cross the skin barrier and provides effective anesthesia of the skin due to the high content of local anesthetics of the lipid phase.

Local anesthetics act directly on the nerves by specifically, totally and reversibly blocking nerve conduction.
The pH of the solution is 9.4.

Not applicable.

· Congenital methemoglobinemia

· Porphyries.

· Known hypersensitivity to local anesthetics of the amide-binding group or to any other component of the cream

Special warnings

Do not apply to the eye or near the eyes because of the risk of irritation, marked

Do not apply in the ear canal, external if the eardrum is injured or must be perforated, because of the risk of damage to the hearing device

The efficacy of this drug during capillary and heel sampling in newborns has not been demonstrated clinically.


Before molluscum curettage in children with atopic skin lesions, an application time of 30 minutes is recommended.

In the case of newborns and premature infants, because of the potential risk of methemoglobinemia, it is recommended that this medication be used in hospitals

It is recommended that this medication is not used in infants 0-3 months with a known or suspected G6PD deficiency
It is recommended that this medication is not used repeatedly, especially in infants 0 to 3 months of age.
Use with caution in children (especially infants 0-3 months), treated with medicines, methemoglobinemic agents (see section Interactions with other medicinal products and other forms of interaction).

In children less than 3 months of age, an increase in methemoglobinemia, transient is commonly observed up to 12 hours after application.
Do not apply to premature babies under 37 weeks of age, corrected

Do not apply on the mucous membranes of the child given data, insufficient on absorption and absence of data, clinical

There is no current data, on possible secondary histological changes, on the application of the anesthetic cream on the biopsied tissue

As a precautionary measure, this anesthetic must not be used for the anesthesia of the intradermal injection of a live vaccine such as BCG because of the antibacterial properties of the active ingredients. Br>

During the local anesthesia of leg ulcers requiring a long and painful mechanical displacement

The use of the cream should be reserved for ulcers, requiring long and painful debridement. It should be limited to a maximum of 8 applications for an ulcerative episode (eg, once a week for 8 weeks).
Do not use permanently from one dressing to another for an analgesic purpose.

Due to the presence of castor oil, risk of sensitization, especially in children under 3 years of age.
Precautions for use

This cream should not be left out of the reach of children. In the case of small children, the dose, for example on the hand, should not be applied to the mouth due to the risk of absorption by the oral mucosa or the eye due to Risk of severe irritation

In the case of use prior to regional anesthesia, the quantities of local anesthetics administered by the transcutaneous route should be taken into account.
Associations to be taken into account

+ Other anesthetics, local

When administering large doses, the combination with other local anesthetics may result in an additive risk of toxicity, systemic.


Risk of addition of effects, methemoglobinizers

In the absence of compatibility studies, this drug should not be mixed with other medicines.
The application of extremely large doses of the lidocaine and prilocaine combination could lead to overdose, in which case monitoring in specialized settings should be maintained for several hours after removal of the cream due to The delayed absorption.

Neurological manifestations (convulsions, CNS depression) should be treated by symptomatic means (resuscitation, respiratory in particular) and anticonvulsant agents such as benzodiazepine or barbiturate, rapid action. Br>

In the event of methaemoglobinaemia, upon confirmation of the biological diagnosis, the treatment will involve the slow intravenous administration of 1 to 2 mg / kg of diluted methylene blue
< Br>

Pregnancy

Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals in well-conducted studies of two species

In clinical terms, there is currently no adequate data to evaluate a possible malformative or fetotoxic effect of this drug when used during pregnancy.

Therefore, as a precautionary measure, it is preferable not to use this medication during pregnancy.


Lidocaine and prilocaine are excreted in milk, but the negligible absorption of local anesthetics via the digestive tract permits their administration, if necessary, to the nursing woman. >

Dermal or mucosal application may induce local erythema or paleness. These skin reactions are benign, always reversible and do not prejudge the quality of the anesthesia obtained.

Very rarely, the appearance of a pruritus or local burning sensation

Exceptional allergy to lidocaine or prilocaine.

Methemoglobinemia, especially in children less than 3 months of age, and in case of overdose

Rare cases of local lesions, discrete at the site of application to purpura or petechiae, have been reported, especially after application times, above the recommended duration in children with atopic skin lesions Or a molluscum contagiosum (see Warnings and Precautions for Special Warnings)

Related to the presence of castor oil, risk of contact eczema

Local anesthesia of healthy skin, eg · before venous or subcutaneous punctures · before skin, superficial, instrumental or laser surgery · Anesthesia of the genital mucosa in, for example, the adult; · Before surgery, biopsy or lesion removal (instrumental or laser beam) · before infiltration with the local anesthetic needle: at the dosage of 5 to 10 g for a period of 5 At 10 minutes Local anesthesia of leg ulcers requiring debridement, long and painful mechanics