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Emla, cream 5 g 5 pcs
€47.96
Description
Pharmacotherapeutic group: local anesthetic agent
ATX code:Pharmacodynamics
EMLA cream contains as active ingredients lidocaine and prilocaine, which are local anesthetic amide type. Anesthesia of the skin is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis. The degree of anesthesia depends on the dose of the drug and the duration of application.
intact skin
After applying EMLA cream to intact skin for 1-2 hours, the duration of anesthesia after removing the occlusive dressing is 2 hours. No differences in efficacy (including time of achieving anesthetic effect) and safety were found when applying the cream to intact skin between elderly (65-96 years) and younger patients.
Due to the action of EMLA cream on the surface vessels, temporary paling or reddening of the skin is possible. Such reactions in patients with widespread neurodermatitis (atopic dermatitis) may occur more quickly, 30-60 minutes after application of the cream, indicating faster penetration of the cream through the skin.
In case of puncture biopsy (4 mm in diameter) the use of EMLA cream provides adequate anesthesia of the intact skin in 90% of patients in 60 minutes after applying the cream in case of needle insertion to a depth of 2 mm, and in 120 minutes after the needle insertion to a depth of 3 mm. The efficiency of EMLA cream does not depend on skin color or pigmentation (skin type I-IV).
When using combined vaccines against such infections as measles, rubella, mumps, or intramuscular combined vaccines against diphtheria, pertussis, tetanus, polio and infection caused by Haemophilius influenzae type b, as well as during vaccination against hepatitis B, the use of EMLA cream had no effect on the average antibody titer, the rate of appearance or disappearance of specific antibodies in the blood serum or the number of patients who reached a protective or positive antibody titer after immunization.
Genital mucosa
Anesthesia of the genital mucosa is achieved faster compared to anesthesia of intact skin due to faster absorption of the drug.
In women 5-10 minutes after applying EMLA cream to the genital mucosa anesthesia is achieved sufficient to relieve pain caused by the use of an argon laser; anesthesia lasts 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).
Trophic ulcers of the lower extremities
After the application of the cream in the treatment of trophic ulcers of the lower extremities the duration of anesthesia is up to 4 hours. No negative effect of the drug on the healing process of ulcers or with respect to bacterial flora was noted.
Pharmacokinetics
Systemic absorption of EMLA cream depends on the dose, duration of application and skin thickness (depends on body area) as well as other skin conditions such as skin diseases and shaving. When applied to the ulcerous surface of the lower extremities, the absorption of the drug may be affected by features of the ulcers, such as the size (absorption increases with increasing area of the ulcer).
Intact skin:
In adults, after applying 60 g of cream to 400 cm2 (1.5 g per 10 cm2) intact thigh skin for 3 hours, systemic absorption for lidocaine was approximately 3% and for prilocaine 5%. Absorption was slow. Maximum plasma concentrations of lidocaine (mean 0.12 µg/ml) and prilocaine (mean 0.07 µg/ml) were reached approximately 4 hours after application of the cream. There is a risk of toxic symptoms only at plasma concentrations of the active substances of 5-10 µg/ml. When EMLA cream is applied to intact skin 8-12 hours after shaving, the maximum plasma concentrations of lidocaine and prilocaine in both young and elderly patients are very low and well below possible toxic levels.
Trophic ulcers of the lower extremities:
The time to reach maximum plasma concentrations of lidocaine (0.05-0.84 µg/ml) and prilocaine (0.02-0.08 µg/ml) is 1-2.5 hours from application to the ulcerous surface (5-10 g cream for 30 min).
No cumulation in plasma of prilocaine, lidocaine or their metabolites was observed during repeated application of the cream on the ulcerous surface. 2-10 g of EMLA cream was applied to the ulcerous surface up to 62 cm2 for 30-60 minutes from 3 to 7 times a week (15 times during the month).
Genital mucosa:
Time to reach maximum plasma concentrations of lidocaine and prilocaine (0.18 µg/mL and 0.15 µg/mL on average, respectively) is approximately 35 min from application to the vaginal mucosa (10 g cream for 10 min).
Indications
Indications
In adults:
– superficial skin anesthesia for injections (including vaccinations), punctures and vascular catheterization, and superficial surgical interventions, including minor cosmetic procedures and waxing;
– superficial anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissue;
– superficial anesthesia of the mucous membrane of the genitals before painful manipulations and for anesthesia before injections of local anesthetic.
In children:
– surface anesthesia of the skin during injections (including vaccinations), punctures and catheterization of vessels and superficial surgical interventions (including the removal of molluscum contagiosum).
Active ingredient
Active ingredient
Lidocaine, Prilocaine
Composition
Composition
Constitution (per 1 g of cream)
acting ingredients: lidocaine 25.0 mg, prilocaine 25.0 mg;
auxiliary substances: macrogoal glyceryl hydroxystearate (ARLATON 289) 19.0 mg, carbomer 974 P (carboxypolymethylene) 10.0 mg, sodium hydroxide 5.2 mg to bring the pH to 8.7 – 9.7, purified water to 1.0 g.
How to take, the dosage
How to take, the dosage
externally, on the skin or mucous membranes.
Adults
Superficial anesthesia of intact skin.
| indication | Dose and method of application | Time of application | ||
Injection of a needle, such as in vascular catheterization and blood sampling | half 5 g tube (approximately 2 g) per 10 cm2 | 1 hour, maximum 5 hours | ||
Perfectly apply to the skin.For minor surgical procedures, such as molluscum contagiosum curettage, wart removal, minor cosmetic procedures and waxing | 1.5-2 g/10 cm2 Apply a thick layer to the skin and cover with an occlusive dressing | 1 hour, maximum 5 hours | ||
.On large areas of freshly shaved skin (outpatient), including before waxing | maximum recommended dose 60 g, maximum recommended application area 600 cm2; Apply a thick layer to the skin and cover with an occlusive dressing | 1 hour, maximum 5 hours | ||
In superficial procedures over large areas (in stationary conditions), such as skin taking using the split flap method | 1.5-2 g/10 cm2 Apply a thick layer to the skin and cover with an occlusive dressing | 2 hours, 5 hours maximum |
Surface anesthesia of trophic ulcers of the lower extremities:
In surgical treatment (mechanical cleaning) of trophic ulcers of the lower extremities: single dose of about 1-2 g/10 cm2; apply cream thickly to the ulcerous surface, not more than 10 g of cream per procedure. Apply an occlusive dressing. Application time: at least 30 minutes.
Opened tube of cream is intended for single use, the tube with the remains of the cream should be thrown away after use in one patient.
In case of treatment of ulcers where the drug penetration into the tissues is difficult, the duration of application can be increased up to 60 minutes. Mechanical cleansing should be started not later than 10 minutes after the cream is removed.
In manipulations on lower limb ulcers the EMLA cream was applied up to 15 times during 1-2 months without reducing the effectiveness and increasing the frequency of local reactions.
Surface genital anesthesia:
Genital skin:
Anesthesia before local anesthetic injections:
Men: 1 g/10 cm2. Apply the cream in a thick layer to the skin. Application time: 15 min.
Women: 1-2 g/10 cm2. Apply the cream in a thick layer on the skin. Application time: 60 min.
Superficial anesthesia of the genital mucosa:
When removing condylomas and for pain relief before injecting local anesthetics: about 5-10 grams of cream, depending on the surface treated. The cream should be applied to the entire surface of the mucosa, including the folds of the mucosa. No occlusive dressing is required. Application time: 5-10 min. The procedure immediately after removal of the cream.
Children
Anesthesia for needle insertion (including vaccination), cure of molluscum contagiosum and other minor superficial surgical manipulations.
Apply the cream in a thick layer on the skin and cover with an occlusive dressing. The dosage should correspond to the surface to be treated and should not exceed 1 g of cream per 10 cm2.
| Age | Area of application | Length of application | 1 hour (important: No more than 1 hour) | |
3-12 months |
td width=”189″> 1 hour | |||
1-6 years | 100 cm max2 (total of 10 g cream) |
|||
6-12 years | maximum 200 cm2 (total of 20 grams of cream) | maximum 200 cm2 (total of 20 grams of cream)/p> | 1 hour, maximum 4 hours |
A 3.5 cm long strip of Emla cream approximately corresponds to a 1 g dose.
Increasing the application time reduces anesthesia. In children with atopic dermatitis the application time should be reduced to 30 minutes.
Apply the cream in a thick layer to the skin and cover with an occlusive dressing.
Recommendations for applying the drug
1. 1. Pierce the protective membrane of the aluminum tube using the screw cap, squeeze a sufficient amount of cream from the tube and apply to the site of the proposed procedure. For anesthesia of the skin it is possible to use occlusive stickers (included in the package of 5 x 5 g).
2. a. Take one of the occlusive stickers and remove its central part.
b. Separate the paper lining from the paper trim on the back side of the dressing.
When anesthetizing trophic ulcers of the lower extremities, use a PVC occlusive dressing.
3. Cover the dressing with the applied cream so that the layer of cream underneath is thick and does not squeeze out from under the dressing. Carefully smooth out the edges of the bandage to prevent the cream from dripping.
4. If you use the occlusion sticker included in the package, remove the paper frame. The time of application can be recorded directly on the dressing.
5. After the recommended time, remove the bandage and residues of cream from the surface.
Interaction
Interaction
In patients receiving drugs inducing the development of methemoglobinemia (e.g., drugs containing sulfo-group), EMLA cream may contribute to an increase in the concentration of methemoglobin in the blood.
During treatment with other local anesthetics and structurally similar drugs (including tocainide) the risk of increased systemic effects should be taken into account when using high doses of EMLA cream.
Special studies to assess the interaction of lidocaine/prilocaine with class III antiarrhythmic drugs have not been conducted, caution should be exercised when using drugs together.
Pharmaceutical interactions: not found.
Drugs that reduce lidocaine clearance (such as cimetidine or beta-adrenoblockers) may cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used over an extended period of time. This interaction is not clinically significant with short-term therapy with lidocaine (e.g., EMLA cream) at recommended doses.
Special Instructions
Special Instructions
Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more prone to drug-dependent methemoglobinemia.
The effectiveness of the cream in infants during heel blood sampling procedures has not been established.
Care should be taken when applying EMLA cream around the eyes, as the drug causes eye irritation. Elimination of protective reflexes may cause irritation or damage to the cornea. If the cream gets into the eyes, immediately flush the eyes with water or 0.9% sodium chloride solution, and protect the eyes until the restoration of protective reflexes.
Care should be taken when applying the drug to the skin in atopic dermatitis; application time should be reduced (15-30 minutes).
In children under 3 months of age the safety and effectiveness of EMLA cream was determined after a single dose application. In these children, a temporary increase in methemoglobin in the blood lasting up to 13 hours was often observed after application of the cream. However, the observed increase in methaemoglobin in the blood is probably of no clinical significance.
Patients taking class III antiarrhythmic drugs (such as amiodarone) should be under constant observation and ECG monitoring because of the possible effect on cardiac activity.
Do not apply EMLA cream to damaged eardrums or in other cases of possible penetration of the cream into the middle ear.
Do not apply the cream to open wounds.
Due to lack of data on absorption of the drug it is not recommended to apply the cream to the mucous membrane of the genitals in children.
Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, it is recommended to take special care when using the cream prior to subcutaneous administration of live vaccines (e.g. BCG).
Due to lack of data, combined use of EMLA cream and drugs causing methemoglobinemia in children aged from 0 to 12 months is not recommended.
Influence on the ability to drive vehicles and operate machinery
Does not affect the ability to drive vehicles and operate machinery.
Synopsis
Synopsis
homogeneous cream of white color.
Contraindications
Contraindications
– Hypersensitivity to local anesthetics of the amide type or any other component of the drug;
– premature infants born at less than 37 weeks’ gestation;
– newborns with a body weight of less than 3 kg.
With caution
Inadequacy of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, disseminated neurodermatitis (atopic dermatitis), patients taking antiarrhythmic drugs of class III (for example, amiodarone) (see section “Indications.
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Side effects
Side effects
When applied to intact skin
Frequent (≥1%, < 10%) | Skin: transient local reactions in the area of application, such as pallor, redness, and swelling. |
Infrequent (≥0.1%, < 1%) | Skin: at the first moment after application, slight burning, itching and feeling of heat (in the area where the product is applied). |
Rare (< 0.1%) | General: allergic reactions, anaphylactic shock in the most severe cases. Methemoglobinemia and/or cyanosis. Reactions in the area where the product is applied, such as hemorrhagic rash or pinpoint hemorrhages, especially after prolonged application in children with atopic dermatitis or molluscs. |
When applied to trophic ulcers of the lower extremities
Frequent (≥1%, < 10%) | Skin: transient local reactions in the area of application, such as pallor, redness, and swelling; mild burning, itching, and feeling of heat (in the area of application) for the first moment after application. |
Infrequent (≥0.1%, < 1%) | Skin: skin irritation (in the area where the drug is applied). |
Rare (< 0.1%) | General: allergic reactions, in the most severe cases – anaphylactic shock. |
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Overdose
Overdose
If the recommended dosing regimen is followed, the development of signs of systemic toxicity is unlikely. Symptoms of intoxication are likely to be the same as with other local anesthetics such as central nervous system (CNS) agitation and in severe cases CNS and cardiac depression.
In rare cases the development of clinically significant methemoglobinemia has been noted. Prilocaine in high doses may cause increased methemoglobin.
Superficial application of 125 mg prilocaine for 5 hours caused moderate methemoglobinemia in a 3-month-old infant. Surface application of 8.6-17.2 mg/kg lidocaine caused severe intoxication in neonates.
Treatment
Severe neurologic symptoms (seizures, central nervous system depression) require symptomatic treatment, including anticonvulsants and if necessary artificial ventilation. In case of methemoglobinemia the antidote is methylthioninium chloride (methylene blue).
Due to the slow systemic absorption of the drug, patients should be monitored for several hours after the start of intoxication treatment.
Pregnancy use
Pregnancy use
Pregnancy
There are insufficient data on the use of EMLA cream in pregnant women. Animal studies have shown no direct or indirect negative effects of the drug on pregnancy, intrauterine development of the fetus, the process of delivery or postnatal development. Lidocaine and prilocaine penetrate the placental barrier and may be absorbed into fetal tissues. No specific reproductive disturbances such as increased incidence of malformations or other direct or indirect adverse effects on the fetus have been reported.
Lactation.
Lidocaine and prilocaine are excreted with breast milk in amounts that pose no risk to the child when the drug is used in therapeutic doses.
Similarities
Similarities
Acryol Pro
Additional information
| Weight | 0.080 kg |
|---|---|
| Shelf life | 3 years. Do not use after the expiration date stated on the package. |
| Conditions of storage | Store at temperatures below 300C, out of the reach of children. Do not freeze. |
| Manufacturer | Recipharm Karlskoga AB, Sweden |
| Medication form | exterior cream |
| Brand | Recipharm Karlskoga AB |
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