Acryol Pro, cream 2.5% + 2.5% 30 g

Acriol Pro is a combined preparation containing lidocaine and prilocaine, local anesthetics of the 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 application to intact skin for 1-2 hours, the duration of anesthesia after removal of the occlusive dressing is 2 hours. No differences in efficacy (including time to anesthetic effect) and safety were found when the drug was applied to intact skin in elderly (65-96 years) and younger patients.

Transient pallor or redness of the skin may occur due to the effect of the drug on superficial vessels. Patients with widespread neurodermatitis (atopic dermatitis) may show these reactions more quickly, within 30-60 minutes after application, which indicates faster penetration of the cream through the skin.

In case of puncture biopsy (4 mm in diameter), application of Akriol Pro provides adequate anesthesia of intact skin in 90% of patients in 60 minutes after needle application at a depth of 2 mm and in 120 minutes after needle application at a depth of 3 mm. The efficacy of the drug is independent of skin color or pigmentation (skin type I-IV).

. When using combination vaccines against infections such as measles, rubella, mumps, or intramuscular combination vaccines against diphtheria, pertussis, tetanus, polio and infection caused by Haemophilius influenzae type b, and hepatitis B vaccination, use of the drug had no effect on the average antibody titer, the rate at which specific antibodies appeared or disappeared in serum, or the number of patients who achieved a protective or positive antibody titer after immunization.

Genital mucosal anesthesia:

Genital mucosal anesthesia is achieved faster compared to that of intact skin due to faster absorption of the drug.

In women anesthesia is achieved in 5-10 minutes after application of the drug to the genital mucosa and is sufficient to relieve the pain caused by the use of the argon laser; the duration of anesthesia is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).

Trophic ulcers of the lower extremities:

After application of the drug in the treatment of trophic ulcers of the lower extremities, the duration of anesthesia is up to 4 hours. No negative effects of the drug on the healing process of ulcers or with respect to bacterial flora have been noted.

Indications

In adults:

– superficial skin anesthesia for injections (including. in vaccinations), punctures and vascular catheterization and superficial surgical interventions, including minor cosmetic procedures and waxing;

– superficial anesthesia of trophic ulcers of the lower extremities in surgical treatment (mechanical cleaning), such as 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 anesthetics.

In children:

– superficial anesthesia of the skin during injections (including vaccinations), punctures and vascular catheterization and superficial surgical interventions (including the removal of molluscum contagiosum).

Active ingredient

Composition

100 g of the cream contains:

Active ingredients: lidocaine – 2.5 g, prilocaine – 2.5 g.

Auxiliary substances: PEG-54 hydrogenated castor oil – 1.9 g; carbomer – 1.0 g; sodium hydroxide – 0.52 g; purified water – up to 100 g

.

How to take, the dosage

Overtically, on the skin or mucous membrane.

Surface anesthesia of trophic ulcers of the lower extremities

In surgical treatment (mechanical cleaning) of trophic ulcers of the lower extremities: a single dose of about 1-2 g/10 cm2; apply the cream in a thick layer to the ulcerous surface, no more than 10 g of cream per procedure. Apply an occlusive dressing. Application time: at least 30 minutes.

The opened tube of cream is for single use, the tube with the remaining cream should be discarded after use in one patient.

If ulcers are treated where it is difficult to penetrate the tissue, the application can be extended up to 60 minutes. Mechanical cleaning should be started no later than 10 minutes after removal of the cream.

In manipulation of lower limb ulcers, the drug has been applied up to 15 times over a period of 1-2 months with no decrease in efficacy or increased incidence 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.

Surface anaesthesia of the genital mucosa:

For condyloma removal and for pain relief before local anaesthetic injections: approximately 5-10 g cream, depending on the surface area to be treated. The cream should be applied to the entire surface of the mucosa, including the mucosal folds. No occlusive dressing is required. Application time: 5-10 min. The procedure should be carried out 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 dose should be adjusted to the surface to be treated and should not exceed 1 g of cream per 10 cm2. A 3.5 cm strip of Acriol Pro corresponds approximately to a dose of 1 g. Increasing the application time reduces anaesthesia. 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.

Admonstrations for application

Pierce the protective membrane of the aluminum tube with the screw cap, squeeze a generous amount of cream from the tube and apply to the spot of application intended.

In case of skin anesthesia, occlusive stickers may be used. For anesthesia of trophic ulcers of the lower extremities, use a PVC occlusive dressing. 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 the edges of the bandage to avoid leakage of the cream.

After the recommended time, remove the bandage and any remaining cream from the surface.

Interaction

In patients receiving drugs inducing methemoglobinemia (e.g., drugs containing sulfogroups), Acriol Pro may increase the concentration of methemoglobin in blood.When treating with other local anesthetics and structurally similar drugs (including tocainide), the risk of increased systemic effects with high doses of the drug should be taken into account.

Special studies to evaluate the interaction of lidocaine/prilocaine with Class III antiarrhythmic drugs have not been performed, caution should be exercised when using the drugs together.

Pharmaceutical interactions: have not been found.

Drugs that decrease lidocaine clearance (e.g., 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 (including Akriol Pro) at recommended doses.

Special Instructions

Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more prone to drug-dependent methemoglobinemia.

The efficacy of the drug in neonates in heel blood sampling procedures has not been established.

Please use caution when applying Acryol Pro around the eyes because the drug causes eye irritation. Eliminating protective reflexes can irritate or damage the cornea. If the drug gets into the eyes, immediately flush the eyes with water or 0.9% sodium chloride solution, and protect the eyes until protective reflexes are restored.

Caution should be exercised if the drug is applied to the skin in atopic dermatitis; the application time should be reduced (15-30 minutes).

In children less than 3 months of age, the safety and effectiveness of the drug were determined after a single dose application. In these children, a temporary increase in methemoglobin levels in the blood lasting up to 13 hours was often observed after application. However, the observed increase in methemoglobin levels in the blood is probably not clinically significant.

Patients taking Class III antiarrhythmic drugs (e.g., amiodarone) should be monitored and ECG monitored at all times, as cardiac activity may be affected.

The drug should not be applied to a damaged eardrum or in other cases of possible penetration of the drug into the middle ear.

Acryol Pro should not be used on open wounds.

Because of lack of data on absorption, it is not recommended to apply the product to the mucosa of the genitals in children.

Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. Therefore, special care is recommended when using the drug prior to subcutaneous administration of live vaccines (e.g., BCG).

Accriol Pro and agents causing methemoglobinemia are not recommended for combined use in children from 0 to 12 months because of lack of data.

Contraindications

– Hypersensitivity to amide-type local anesthetic agents 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:

Glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, advanced neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (such as amiodarone).

Side effects

The following adverse reactions are categorized by frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); infrequent (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), frequency unknown (insufficient data to estimate frequency of development).

When applied to intact skin

Skin and subcutaneous tissue disorders: Frequent – transient local reactions in the area of application, such as pallor, redness, and swelling; infrequent – mild burning, itching, and feeling of heat (in the area of application) in the first moment after application.

General disorders and disorders at the injection site: Rarely – allergic reactions, in the most severe cases – anaphylactic shock; methemoglobinemia and/or cyanosis. Reactions in the area of application of the drug, such as hemorrhagic rash or petechial hemorrhages, especially after prolonged application in children with atopic dermatitis or molluscum contagiosum. Corneal irritation due to accidental contact of the cream with the eye.

When applied to trophic ulcers of the lower extremities

Dermal and subcutaneous tissue disorders:often, transient local reactions in the area of application, such as pallor, redness, and swelling; in the first moment after application, mild burning, itching, and sensation of heat (in the area of application); infrequent, skin irritation (in the area of application).

General disorders and disorders at the injection site: frequently – allergic reactions, in the most severe cases – anaphylactic shock.

Overdose

The development of signs of systemic toxicity is unlikely if the recommended dosing regimen is followed.

The symptoms of intoxication are probably 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 an increase in methemoglobin. Superficial application of 125 mg of prilocaine for 5 hours caused the development of 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 respiration. 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.

Similarities