Emla patch Uses, Dosage, Side Effects, Precautions & Warnings

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Emla patch Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Lidocaine, Prilocaine

What is EMLA patch?

This drug is indicated for local anesthesia of healthy skin, for example:

• before venous or subcutaneous punctures,
• before superficial, instrumental or laser skin surgery.

What is EMLA used for and indication?

Emla patch is indicated for:

• Topical anesthesia of healthy skin during:
  • the insertion of needles, for example insertion of intravenous catheters or blood samples;
  • superficial surgical procedures;

in adults and in the pediatric population.

Emla patch Dosage

– The adhesive bandage is applied at least one hour before the procedure.

– At the end of the application time, the residue of the emulsion is carefully removed with a compress. The anesthesia obtained persists for 1 to 2 hours.

– The number of adhesive skin dressings to be applied depends on the surface to be treated:

• 1 g (1 adhesive bandage) for a surface to be anesthetized by 10 cm².

– The maximum theoretical dose is:

Adult

50 g in adults.

The size of the patch may not be suitable for application to certain parts of the body of the newborn or infant. The use of the patch in the newborn and up to 3 months is reserved for application on a maximum surface of 10 cm² .

Age: Minimum duration of application. Theoretical maximum dose. Maximum duration of application. 

– Adult and children over 12 years old : 1 hour. 50 g. 4 hours**.

Child :

. from 0 to 3 months : 1 hour. 1 g per 10 cm²: do not apply more than one patch at a time, do not renew before 12 hours. 1 hour * .

• . from 3 to 12 months : 1 hour. 2 g: Do not apply more than two patches at a time. 4 hours**.
• . from 12 months to 6 years : 1 hour. 10 g. 4 hours**.
• . from 6 to 12 years old : 1 hour. 20 g. 4 hours**.

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

** Beyond 4 hours, the anesthetic effect decreases.

In children with atopic skin lesions: before curettage of molluscum, a 30-minute application time is recommended.

How it works Emla patch

Pharmacotherapeutic group: anesthetics, local; amides; ATC code N01B B20.

Action mechanism

EMLA produces anesthesia of the skin by releasing lidocaine and prilocaine in the epidermis and dermis layers of the skin and in the vicinity of dermal pain receptors and nerve endings.

Lidocaine and prilocaine are local amide anesthetics. These two components stabilize the neuronal membranes by inhibiting the ionic flux necessary for the initiation and the conduction of the influxes, thus producing a local anesthesia. The quality of the anesthesia depends on the application time and the dose used.

Skin

EMLA Patch is applied to intact skin The time required to achieve reliable anesthesia of intact skin is 1 to 2 hours, depending on the type of procedure. The local anesthetic effect is reinforced with longer application times of 1 to 2 hours in most parts of the body, with the exception of facial skin. Given the fineness of the skin of the face and a high blood supply of tissues, a maximum local anesthetic effect is obtained after 30 to 60 minutes on the forehead and cheeks. The duration of anesthesia after the application of EMLA for 1 to 2 hours is at least 2 hours after removal of the dressing, except on the face where this delay is shorter. EMLA is just as effective and has the same trigger time of the

In clinical studies with the application of EMLA to intact skin, no difference in terms of safety or efficacy (including time to anesthesia) was found between elderly patients (65-96 years old) and younger patients.

EMLA produces a biphasic vascular response involving initial vasoconstriction followed by vasodilation at the site of application (see section 4.8 ). Regardless of the vascular response, EMLA facilitates insertion of the needle compared to placebo.

In patients with atopic dermatitis, a similar but shorter vascular reaction was observed, with erythema occurring within 30-60 minutes, indicating faster absorption through the skin (see Warnings and Precautions section). of employment ). EMLA can cause a transient increase in skin thickness, caused in part by the hydration of the skin under the occlusive dressing. The thickness of the skin is reduced during the 15 minutes following exposure to air.

The depth of cutaneous anesthesia increases with the application time. In 90% of patients, anesthesia is sufficient for the insertion of a biopsy punch (4 mm in diameter) at a depth of 2 mm after 60 minutes and 3 mm after 120 minutes of treatment with EMLA.

Pediatric population

Clinical studies involving over 2,300 pediatric patients of all ages have demonstrated efficacy for needle pain (venous blood sampling, catheterization, subcutaneous and intramuscular vaccination, lumbar puncture), for the treatment of vascular lesions by laser , and curettage of molluscum contagiosum . EMLA has decreased pain during needle insertion and during injection of vaccines. The analgesic efficacy increased from a 15-minute application to a 90-minute application to normal skin; but on vascular lesions, a 90-minute application did not provide a benefit greater than a 60-minute application. EMLA does not show a benefit versus placebo regarding cryotherapy at

Eleven clinical studies in neonates and infants have shown that peaks of methemoglobin concentrations that occurred approximately 8 hours after epicutaneous administration of EMLA were clinically insignificant at the recommended dosage and returned to normal values ​​after approximately 12-13 hours. The formation of methemoglobin is associated with the cumulative amount of prilocaine absorbed percutaneously and can therefore increase as a function of the lengthening of the duration of application of EMLA.

The use of EMLA prior to measles-mumps-rubella vaccination or prior to intramuscular administration of inactivated diphtheria-pertussis-tetanus-poliovirus vaccine – Haemophilus influenzae b or hepatitis B vaccine did not affect the antibody titres, the rate of seroconversion, or the proportion of patients achieving protective or positive antibody titres after immunization, compared with placebo-treated patients.

Emla patch Side Effects

1. – Cutaneous or mucosal application may locally induce erythema, pallor, pruritus, burning sensation or edema of the application site. These cutaneous reactions are benign, always reversible and do not prejudge the quality of the anesthesia obtained.
2. – Exceptionally, allergic reaction or anaphylactic shock.
3. – Methemoglobinemia, especially in children under 3 months, and in case of overdose.
4. – Due to the presence of castor oil , risk of eczema of contact.
5. – Rare cases of discrete local lesions at the application site, such as purpura or petechiae have been reported, especially after application times longer than the recommended duration in children with atopic skin lesions or a molluscum contagiosum (see section on warnings and precautions for use).

Emla patch Interactions

CONTRAINDICATED:

• – Hypersensitivity to local anesthetics with amide bond or any other component of the dressing.
• – Congenital methemoglobinemia.
• – Porphyries.
• – Do not apply the anesthetic adhesive bandage to the eye or to the eyes, because of the risk of marked irritation.
• – Do not apply to premature infants less than 37 weeks of corrected age.

RECOMMENDED:

• It is recommended not to use EMLA PATCH in infants 0 to 3 months with G6PD deficiency known or suspected.

Emlapatch Warnings and Precautions

Patients with congenital deficiency of glucose-6-phosphate dehydrogenase or idiopathic methemoglobinemia are more likely to exhibit methemoglobinemia induced by the active substance. In patients with glucose-6-phosphate dehydrogenase deficiency, methylene blue lantidote is ineffective in reducing methemoglobin levels and can oxidize hemoglobin itself. Therefore, methylene blue therapy can not be performed.

Due to insufficient data on absorption, EMLA should not be applied to open wounds.

Care should be taken when applying EMLA to patients with atopic dermatitis. A reduced application time of 15 to 30 minutes may be sufficient (see section 5.1). Application times greater than 30 minutes in patients with atopic dermatitis may lead to increased incidence of local vascular reactions, particularly redness at the application site, and in some cases petechiae and purpura (see section 4.8). . Before curettage of molluscum in children with atopic dermatitis a time of application of 30 minutes is recommended.

When applying near the eyes, EMLA should be used with caution as it may cause irritation to the eyes. Loss of eye protection reflexes can also lead to corneal irritation and potential abrasion . In case of eye contact, the eyes should be rinsed immediately with water or saline solution and protected until the sensitivity returns.

Lidocaine and prilocaine have bactericidal and antiviral properties for concentrations greater than 0.5%. Therefore, although the results of a clinical study suggest that the use of EMLA before vaccination against tuberculosis (BCG) does not influence the immune response, assessed by the formation of a local papule, it is necessary to follow the intradermal injection results for live vaccines. .

EMLA contains macrogolglycerol hydroxystearate which can cause skin reactions.

Pediatric population

• In studies, the efficacy of EMLA in heel capillary sampling in neonates has not been demonstrated.
• In neonates and infants less than 3 months of age, a clinically unrecognized transient increase in methemoglobin levels is commonly observed, up to 12 hours after the recommended dose of EMLA.
• If the recommended dose is exceeded, the patient should be monitored for the occurrence of systemic adverse events secondary to methemoglobinemia .

EMLA should not be used

• · In neonates / infants up to 12 months treated with methemoglobin-inducing drugs;
• · In preterm infants less than 37 weeks of gestational age as they may develop high methemoglobin levels.

Drive and use machines

EMLA has no effect on the ability to drive and use machines when used at the recommended doses.

Emlapatch and PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

1. Although topical application is only associated with a low rate of systemic absorption, the use of Emla in pregnant women should be considered with caution as the available data regarding the use of Emla in pregnant women are insufficient. .
2. However, animal studies have not shown direct or indirect harmful effects on pregnancy, embryonal / fetal development, childbirth or postnatal development. Reproductive toxicity has been shown during subcutaneous / intramuscular administration of high doses of lidocaine or prilocaine significantly exceeding the exposure during topical application ( see Preclinical Safety ).
3. Lidocaine and prilocaine cross the placental barrier and can be absorbed by fetal tissues. It is reasonable to assume that lidocaine and prilocaine have been used in many pregnant women and women of childbearing age. So far, no specific disorders of reproductive function have been reported, for example an increased incidence of malformations or other effects directly or indirectly harmful to the fetus.

Breastfeeding

• Lidocaine and probably prilocaine are excreted in milk, but in such small amounts that there is usually no risk of the child being assigned therapeutic doses. Emla can be used during breastfeeding if clinically necessary.

Fertility

Studies in animals have shown no alteration in the fertility of male or female rats ( see Preclinical Safety ).

What is  Forms and Composition Emlapatch?

FORMS and PRESENTATIONS

5% cutaneous adhesive dressing:   Single box.
Hospital model: Box of 20.

	p dressing *
Lidocaine (INN)	25mg
Prilocaine (DCI)	25mg

Excipients: polyoxyethylenated hydrogenated castor oil (Arlatone 289), carbomer (974P carbopol), sodium hydroxide, purified water. Composition of the dressing: laminated sheet (aluminum / plastic), absorbent disc (cellulose), circular adhesive foam tape (PE), adhesive (acrylate).

^*  1 g of emulsion for a skin adhesive bandage of 10 cm ² .

NOT’s

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general information:

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Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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