EMLA 5% Aspen pills anesthesia skin surface (5 tubes x 5g)

Dosage form Box of 5 tubes
Specifications Lidocaine, prilocain

Ingredient

Thành phần cho 5g

Composition information	Content
Lidocaine	125mg
Prilocain	125mg

Uses

Indications

5% EMLA medicine is indicated in the following cases:

Anesthesia of the skin surface in the needle and surgical procedure. Anesthetic in place amids.

ATC code: N01B B20

Emla cream contains lidocaine and prilocaine, which are anesthetic in the tonsils. When absorbed through the epidermis and the skin, the drug will have anesthetic effect in the skin. The level of anesthesia depends on the topical and dose.

On healthy skin

With 1-2 hours of applying the drug, the impact will last for about 2 hours after the irritation.

In Emla clinical studies on healthy skin, there is no difference in safety or effectiveness (including numbness) recorded in the elderly patients (65 - 96 years old) and younger patients.

EMLA acts on shallow blood vessels and this can cause pale or fleeting redness. These reactions seem to occur faster in patients with atopic dermatitis after only 30-60 minutes, showing that the drug absorbs faster through the skin (see special attention and caution when used).

A study on healthy skin in healthy volunteers shows that 90% of the drug has enough anesthetic effect to use a biopsy device (with 4mm diameter needle) at a depth of 2mm after 60 minutes of applying the drug and to a depth of 3mm after 120 minutes of topical.

Effect of Emla does not depend on skin color or skin pigmentation (skin type I - IV).

EMLA can be used before the vaccine under the skin or intramuscularly. In case of injection in the skin with a living vaccine like BCG, see note and caution especially when used.

On the mucosa of the genital tract

Time to onset the anesthetic is needed shorter because the drug absorbs faster than when applied on healthy skin.

After 5 - 10 minutes apply Emla on the genital mucosa of women, the anesthetic effect against the pain caused by the laser projection containing Argon ions lasts 15-20 minutes (this time varies with individuals from 5 to 45 minutes).

Sores in the foot

Not recorded has an adverse effect in healing ulcers or on bacteria. When cleaning the ulcers, EMLA has anesthetic effect for 4 hours after applying the drug.

pharmacokinetics

The absorption of EMLA into the blood depends on the amount of cream, the time of applying the drug, the thickness of the skin (varies depending on the different positions of the body) and other skin conditions, such as skin diseases (for example: increase absorption in atopic dermatitis, see notes and caution especially when used) When used with foot ulcers, the characteristic of the ulcer can affect absorption, such as increasing absorption when the sores area increases.

Good leather

After applying 60g EMLA above 400cm2 (1.5g over 10cm2) for 3 hours on the healthy skin (thighs) of adults, the drug absorbs in the blood of about 3% for lidocaine and 5% for prilocaine. The absorption occurs slowly.

With the above mentioned dose, the peak concentration of lidocaine plasma (average 0.12μg/ml) and Prilocaine (average 0.07μg/ml) reached about 4 hours after application. Only at a concentration of 5 - 10μg/ml is at risk of toxic symptoms. In this case, the topical skin is shaved from 8 to 12 hours before applying the cream.

Lidocaine and prilocaine concentrations in plasma in elderly and not elderly patients after applying EMLA on the skin of the tower and under the poisoning levels.

Sores in the foot

After applying 5 - 10g EMLA to foot ulcers for 30 minutes, the peak concentration of plasma of lidocaine and prilocaine reaches after about 1 - 2.5 hours (for lidocaine in the range of 0.05 - 0.84μg/ml and for Prilocaine 0.02 - 0.08μg/ml).

After applying EMLA repeated on the sores on the foot, there is no lidocaine, prilocaine or metabolic. Emla has been applied 2 - 10g for 30-60 minutes on a maximum surface of 62cm2, a total of 15 times in 1 month, 3-7 times per week.

Genital sugar mucosa

After applying 10g of EMLA cream on the vaginal mucosa for 10 minutes, the peak concentration of lidocaine and prilocaine in plasma has been measured after about 35 minutes (average Lidocaine 0.18μg/ml and prilocaine 0.15μg/ml).

Children

When applying 1g of Emla cream on 10cm2 skin area in 1 hour in infants is less than 3 months old, the maximum lidocaine and prilocaine concentration in plasma are 0.135μg/ml and 0.107μg/ml.

When applying 2g of Emla cream on about 16cm2 of the skin area for 4 hours at 3 to 12 months of emulsion, the maximum lidocaine and prilocaine concentration in the plasma are 0.155 μg/ml and 0.131μg/ml.

When applying 10g of Emla cream on about 100cm2 of the skin area in 2 hours in children from 2 to 3 years old, the maximum level of lidocaine and prilocaine in plasma is 0.315 μg/ml and 0.215μg/ml.

When applying 10 - 16g of Emla cream on about 100 - 160cm2 of the skin area in 2 hours in children from 6 to 8 years old, the maximum level of lidocaine and prilocaine in the plasma is 0.299μg/ml and 0.110μg/ml.

Before taking EMLA 5% Aspen pills anesthesia skin surface (5 tubes x 5g)

How to use

EMLA 5% use skin.

Dosage

Adults

healthy skin:

Dosage and usage

Applying time Apply thick cream to the skin and cover with sealed tape. 1 hour; Maximum of 5 hours

Small surgical procedures, such as scraping damage caused by epithelial soft tumors 1.5 - 2g over 10cm2. Apply thick cream to the skin and cover with sealed tape. 1 hour; Maximum of 5 hours

Agricultural surgical procedures on a larger area, such as leather transplant 1.5 - 2g over 10cm2. Apply thick cream to the skin and cover with sealed tape. 2 hours; Maximum of 5 hours

on the large area of the newly shaved skin (in outpatient treatment)

Maximum doses of recommendation: 60g. The maximum area of the cream area: 600cm2 1 hour; Maximum of 5 hours

Cleaning ulcer: about 1 - 2g over 10cm2. Apply thick cream on the surface of the ulcer, but not more than 10g each time performing the treatment procedure. Cover the surface of the ulcer with a closed tape. The pipe opened the lid is only used once, and therefore throw away the excess cream after each treatment procedure.

Time to apply: minimum 30 minutes. It is advisable to start cleaning the ulcer for 10 minutes after cleaning the cream.

DA:

Used before local anesthetic injection:

Men: 1g over 10cm2. Apply thick cream on the skin. Apply thick cream on the skin.

To remove the Condilom or before the local anesthetic injection: about 5 - 10g, depending on the treated area. The entire surface must be applied, including mucosal folds. There is no need to cover.

Time to apply: 5 - 10 minutes. The surgery must be performed immediately after cleaning the cream.

Children

When threading needles or scraping caused by soft epithelial tumors and other small surgical procedures: 1g over 10cm2.

Apply thick cream to the skin and cover with a sealed tape. The dosage does not exceed 1 grams above 10cm2 and must be adjusted according to the topical area:

age The area of topical topical Applying time for drugs Month up to 20cm2 (total 2g)

1 hour

Maximum of 5 hours 1

6 - 12 years old maximum 200cm2 (total 20g)

1 hour; Maximum 5 hours 1

Children with atopic dermatitis: Reduce the time to apply the drug to 30 minutes.

What to do when overdose? When there is a toxic event, the symptoms are thought to be similar to the symptoms recorded after local anesthetic, such as: central nervous stimulating symptoms and in severe cases, central neurological inhibition and cardiography.

Some rare cases of clinical meanings have been recorded (see adverse effects). High doses of prilocaine can increase blood methhooglobin levels.

A case used on the spot 125mg Prilocaine for 5 hours has caused the average methhaemoglobin in a 3 -month -old child. Applying on the spot 8.6 - 17.2mg/kg lidocaine has been very heavy toxicity in children.

Severe neurological symptoms (convulsions, central neurological inhibition) need symptomatic treatment such as ventilation and anti -convulsions.

In the case of blood methhaemoglobin, detoxification is methylthionin. Because the absorption occurs slowly, the patient with toxic symptoms should be monitored for a few hours after the symptoms have been treated.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

DA Common (≥ 1/100, Reaction to the drug, such as pale, red and edema 2) 2) 3) 3) Feeling hot, itchy or warm at the beginning at the top of the drug. 1/1000, Smooth heat at first, itching (on the top of the drug). Application, the heaviest case is anaphylaxis. 1) 2) 3)

Methaemoglobin blood.1) (see drug interaction and overdose).

Reaction on the skin on the spot, such as rash or bleeding, especially after a longer time of use such as children with atopic dermatitis or soft tumors.

2) Genital mucosa.

3) Element in the leg.

Adultery reactions with local anesthetic in the true sense of this term occur less than 1/1000 patients treated.

Instructions on how to handle ADR:

Notify the physician the unwanted effects when using the drug.

Warnings

Contraindicated

already know hypersensitivity to amid anesthetic or any excipients of the drug. 5% EMLA is not used for premature babies (born before 37 weeks of pregnancy).

Be cautious when taking drugs

Patients with glucose-6-phosphate dehydrogenase enamel patients or congenital or idiopathic hematoma methhaemoglobin syndrome.

The studies have not shown the effect of 5% EMLA when injecting heels in newborns.

Be cautious when applying the drug near the eye area, as Emla can cause eye irritation. In addition, the loss of protective reflexes can cause corneal irritation and eye scratches. If the drug is exposed to the eyes, immediately wash the eyes with water or sodium chloride solution and protect the eyes until the eye feels back.

Be cautious when used on allergic dermatitis; Should reduce the time to apply the drug (15 - 30 minutes). Applying the drug for more than 30 minutes for patients with atopic dermatitis may increase the rate of local blood vessel reactions, especially red in the topical area and in some cases can rash and bleeding.

apply the cream for 30 minutes before removing the soft epithelium in children with atopic dermatitis.

In children Do not use EMLA on the eardrum or other conditions that the drug may absorb into the middle ear.

Do not use Emla on open wounds.

Do not use EMLA on children's genital mucosa because of lack of data on absorption.

Lidocaine and Prilocaine have antibacterial and anti -virus properties at concentrations greater than 0.5 - 2%. For this reason, the injection results should be monitored in the skin of the vaccine containing raw bacteria (such as BCG).

Until more clinical experiences, you should not use Emla for children from 0 to 12 months of age are being treated simultaneously with blood methhooglobin drugs.

Emla cream contains macrogolglycerol hydroxystearat that can cause skin reactions.

The ability to drive and operate machinery

The ability to react is not affected when treated with EMLA.

Pregnant and lactating women

Pregnant women:

Cattle studies show that there is no direct or indirect harmful effect on pregnancy, fetal/embryonic development, birth or postpartum development.

On both animals and humans, lidocaine and prilocaine beyond the placenta and can be absorbed by the fetus. It can be said that Lidocaine and Prilocaine have been used for a large number of pregnant and pregnant women.

So far, there has not been a special disorder on the reproductive system, such as increasing the frequency of malformation or direct or indirect harm on the fetus. However, be careful when used for pregnant women.

Lactating women: Lidocaine and Prilocaine are excreted into breast milk, but in treatment doses does not seem to be at risk of affecting children.

Drug interaction

EMLA can worsen the formation of methhaemoglobin in patients who are being treated with methhaemoglobin products (such as sulphonamid, acetanilid, Aniline dyes, benzocain, chloroquin, dapson, metoclopramid, naphththide, nitrats, nitrats and nitrats and nitrats Nitrite, nitrofurantoin, nitroglycerin, nitroprussid, pamaquin, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquin, quinin).

When using high -dose EMLA should pay attention to the risk of general combination effects in patients using local anesthetic or preparations that are similar to local anesthetic, such as tocainide.

Specialized drug interactive studies with lidocaine/prilocaine and anti -arrhythmic drugs Group III (for example, Amiodaron) have not been done, but should be cautious when combined with these drugs (See also special attention and caution especially when used).

Lidocaine elimination (such as cimetidin or beta blockers) can cause increased blood lidocaine levels to toxic threshold when lidocaine is used in high doses repeated for a long time. These interactions have no clinical significance when treating in a short time with lidocaine at the recommended dose.

Storage

Do not store more than 30 ° C. Avoid freezing.

Expiry date: 36 months from the date of manufacture.

Expiry date: After opening the lid is 30 days.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.