Acryol Pro - instructions for use, doses, side effects, contraindications

Active substanceLidocaine + PrilocaineLidocaine + Prilocaine

Similar drugsTo uncover

Acryol Pro

cream locally externally

AKRIKHIN HFK, JSC Russia

Emla®

cream locally externally

AstraZeneca AB Sweden

Emla®

patch externally

AstraZeneca AB Sweden

Dosage form: & nbspcream for local and external use

Composition:

100 g of cream contains:

active ingredients: lidocaine - 2.5 g, prilocaine - 2.5 g;

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

Description:ABOUTwhite or almost white color. A weak specific odor is allowed.

Pharmacotherapeutic group:Local anesthetic

ATX: & nbsp

N.01.B.B.52 Lidocaine in combination with other drugs

Pharmacodynamics:

Acryol Pro is a combined preparation that includes 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 the application.

Intact skin

After applying the drug to the intact skin for 1-2 hours, the duration of anesthesia after the removal of the occlusive dressing is 2 hours. There were no differences in efficacy (including the time to achieve an analgesic effect) and safety when the drug was applied to intact skin in the elderly (65-96 years) and younger patients.

Due to the action of the drug on the surface vessels, temporary blanching or redness of the skin is possible. Similar reactions in patients with advanced neurodermatitis (atopic dermatitis) can occur more quickly, as early as 30-60 minutes after application, indicating a faster penetration of the cream through the skin.

With puncture biopsy (diameter 4 mm), the use of Acryol Pro provides adequate anesthesia of the intact skin in 90% of patients 60 minutes after application of the drug when the needle is inserted to a depth of 2 mm and after 120 minutes when the needle is inserted at a depth of 3 mm. The effectiveness of the drug does not depend on the color or skin pigmentation (skin type I-IV).

When using combined vaccines against infections such as measles, rubella, mumps, or intramuscular combined vaccines against diphtheria, whooping cough, tetanus, polio, and infection caused by Haemophilius influenzae type b, as well as for vaccination against hepatitis B, the use of the drug did not affect the average antibody titer, the rate of appearance or disappearance of specific antibodies in the serum of the blood, or the number of patients who achieved a protective or positive titer of antibodies after immunization.

Mucous membrane of genital organs

Anesthesia of the mucous membrane of the genital organs is achieved faster in comparison with anesthesia of intact skin due to faster absorption of the drug.

In women, 5-10 minutes after application of the drug to the mucous membrane of the genital organs, anesthesia is obtained sufficient for the relief of pain caused by the use of an argon laser; The duration of anesthesia is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).

Trophic ulcers of lower extremities

After applying the drug in the treatment of trophic ulcers of the lower extremities, the duration of anesthesia is up to 4 hours. There was no adverse effect of the drug on the healing process of ulcers or against bacterial flora.

Pharmacokinetics:

Systemic absorption of the drug depends on the dose, the duration of the application and the thickness of the skin (depends on the area of the body), as well as other skin features such as skin diseases and shaving.

When applied to the ulcerous surface of the lower limbs, the absorption of the preparation may be affected by ulcer features, for example, the magnitude (as the area of the ulcer increases, the absorption increases).

Intact skin

In adults, after applying 60 g of cream to the intact skin of the thigh area of 400 cm² (1.5 g per 10 cm²) at 3 hours the systemic absorption for lidocaine was approximately 3% and for prilocaine 5%.

Suction - slow. The maximum concentration of lidocaine (mean value 0.12 μg / ml) and prilocaine (mean value 0.07 μg / ml) in blood plasma was achieved approximately 4 hours after the application of the drug. The risk of toxic symptoms exists only when the concentration of active substances in the blood plasma is 5-10 μg / ml. When applying the drug to intact skin after 8-12 hours after shaving, the maximum plasma concentration of lidocaine and prilocaine in both young and old patients is very low and well below the possible toxic level.

Trophic ulcers of lower extremities

The time to reach the maximum concentration of lidocaine (0.05-0.84 μg / ml) and prilocaine (0.02-0.08 μg / ml) in blood plasma is 1 -2.5 hours from the moment the drug is applied to the ulcer surface (5 -10 g of cream for 30 minutes).

With repeated application of the drug to the ulcerous surface, cumulation in the blood plasma of prilocaine, lidocaine or their metabolites was not observed.2-10 g of the drug were applied to a ulcerous area of up to 62 cm² for 30-60 minutes from 3 to 7 times a week (15 times a month).

Mucous membrane of genital organs

The time to reach the maximum concentration of lidocaine and prilocaine in the blood plasma (an average of 0.18 μg / ml and 0.15 μg / ml, respectively) is approximately 35 minutes from the time of application of the drug to the vaginal mucosa (10 g of the preparation for 10 minutes).

Indications:

In adults:

- superficial anesthesia of the skin during injection (including during vaccination), puncture and catheterization of vessels and superficial surgical interventions, including small cosmetic procedures and hair removal;

- superficial anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues;

- superficial anesthesia of the mucous membrane of the genital organs before carrying out painful manipulations and for anesthetizing before injecting local anesthetics.

Children:

- superficial anesthesia of the skin with injections (including vaccination), puncture and catheterization of vessels and superficial surgical interventions (incl.when removing molluscum contagiosum).

Contraindications:

Hypersensitivity to local anesthetics of the amide type or any other component of the preparation.

Premature newborns born at gestation less than 37 weeks.

Newborns weighing less than 3 kg.

Carefully:

Insufficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, common neurodermatitis (atopic dermatitis), patients taking antiarrhythmic drugs of class III (eg, amiodarone).

Pregnancy and lactation:

Pregnancy

There is insufficient data on the use of the drug in pregnant women. In animal studies, there was no direct or indirect adverse effect of the drug on pregnancy, fetal development, on the process of labor or postnatal development. Lidocaine and prilocaine penetrate the placental barrier and can be absorbed in the fetal tissues. No specific violations of the reproductive process have been reported, such as an increase in the frequency of malformations or other direct or indirect adverse effects on the fetus.

Breastfeeding period

Lidocaine and prilocaine are excreted in breast milk in quantities that do not pose a risk to the child when the drug is used in therapeutic doses.

Dosing and Administration:

Externally, on the skin or mucous membrane.

Surface anesthesia of intact skin

Indication	Dose and method of application	Time of application
When the needle is inserted, for example, by catheterization of blood vessels when taking blood samples	Half 5 g tube (about 2 g) per 10 cm²apply a thick layer on the skin and cover with an occlusive dressing	1 hour, maximum 5 hours
At small surgical manipulations, for example, at a scraping out of a contagious molluscum, removal of warts, small cosmetic procedures and epilation	1.5-2 g / 10 cm² apply a thick layer on the skin and cover with an occlusive dressing	1 hour, maximum 5 hours
On large areas of freshly shaved skin (in outpatient settings), incl. before epilation	The maximum recommended dose is 60 g, the maximum recommended area of application is 600 cm²; apply a thick layer on the skin and cover with an occlusive dressing	1 hour, maximum 5 hours
In surface treatments on large areas (in stationary conditions), for example, skin taking by the split flap method	1.5-2 g / 10 cm² apply a thick layer on the skin and cover with an occlusive dressing	2 hours, maximum 5 hours

Surface anesthesia of trophic ulcers of lower extremities

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

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

In the case of treatment of ulcers in the tissues of which penetration of the drug is difficult, the duration of the application can be increased to 60 minutes. Mechanical cleaning should be started no later than 10 minutes after removal of the cream.

At manipulations on ulcers of the lower limbs the drug was applied up to 15 times within 1-2 months without reducing the efficiency and increasing the frequency of local reactions.

Superficial anesthesia of genital organs

Genital Skin:

Anesthesia before injections of local anesthetics:

Men: 1 g / 10 cm². Apply a thick layer of cream on the skin. Time of application: 15 min.

Women: 1-2 g / 10 cm². Apply a thick layer of cream on the skin.Time of application: 60 min.

Surface anesthesia of the mucous membrane of the genital organs:

When removing genital warts and for anesthesia before injecting local anesthetics: about 5-10 g of cream, depending on the area of the treated surface. The cream should be applied to the entire surface of the mucous membrane, including the folds of the mucous membrane. An occlusive dressing is not required. Application time: 5-10 min. Carry out the procedure immediately after removing the cream.

Children

Anesthesia with the introduction of a needle (including when vaccinated), when scraping molluscum contagiosum and with other small superficial surgical manipulations.

Apply a thick layer of cream on the skin and cover with an occlusive dressing. The dose should correspond to the surface to be treated and should not exceed 1 g of cream per 10 cm².

Age	Area of application	Duration applications
0-3 months	Maximum 10 cm² (total 1 g of cream) (the maximum daily dose)	1 hour (important: not more than 1 hour)
3-12 months	Maximum 20 cm² (total 2 g of cream)	1 hour
1-6 years old	Maximum 100 cm² (total 10 g of cream)	1 hour, maximum 4 hours
6-12 years old	Maximum 200 cm² (total 20 g of cream)	1 hour, maximum 4 hours

A strip of Acriol Pro preparation 3.5 cm long corresponds approximately to a dose of 1 g.Increasing the time of application reduces anesthesia.

In children with atopic dermatitis The application time should be reduced to 30 minutes. Apply a thick layer of cream on the skin and cover with an occlusive dressing.

Recommendations for application of the drug

Pierce the protective membrane of the aluminum tube, using a screw cap, squeeze out a sufficient amount of cream from the tube and apply to the place of the proposed procedure.

With anesthesia of the skin, occlusal stickers can be used. When anesthesia of trophic ulcers of the lower extremities, use an occlusive dressing made of PVC. Cover the applied cream with cream so that the layer of cream under it was thick and not squeezed out from under the bandage. Gently smooth the edges of the dressing to avoid leakage of the cream.

After the recommended time, remove the dressing and the cream residues from the surface.

Side effects:

The following undesirable reactions are distributed according to frequency of occurrence as follows: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1 000, <1/100); rarely (≥ 1/10 000, <1/1 000), very rarely (<1/10 000), the frequency is unknown (insufficient data to estimate the frequency of development).

When applied to intact skin

Disturbances from the skin and subcutaneous tissues: often - transient local reactions in the application area, such as pallor, redness and swelling; infrequently - at the first moment after application, slight burning, itching and a sensation of heat (in the area of application of the drug).

General disorders and disorders at the site of administration: rarely - allergic reactions, in the most severe cases - anaphylactic shock; methemoglobinemia and / or cyanosis. Reactions in the application area, such as hemorrhagic rash or pinpoint hemorrhage, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum. Irritation of the cornea due to accidental contact of the cream in the eyes.

When applied to trophic ulcers of the lower extremities

Disturbances from the skin and subcutaneous tissues: often - transient local reactions in the application area, such as pallor, redness and swelling; at the first moment after application, slight burning, itching and sensation of heat (in the application area); infrequently - irritation of the skin (in the area of application of the drug).

General disorders and disorders at the site of administration: rarely - allergic reactions, in the most severe cases - anaphylactic shock.

Overdose:

When observing the recommended dosage regimen, development of signs of systemic toxicity is unlikely.

Symptoms intoxications are probably the same as when using other local anesthetics, for example, excitation of the central nervous system (CNS), and in severe cases, CNS depression and heart activity.

In rare cases, the development of clinically significant methemoglobinemia was noted. Prilokain in high doses can cause an increase in the content of methaemoglobin. Surface application of 125 mg of prilocaine lasting 5 hours caused the development of moderate methaemoglobinemia in a 3 month old child. Surface application of lidocaine in a dose of 8.6-17.2 mg / kg caused severe intoxication in newborns.

Treatment: Severe neurological symptoms (seizures, central nervous system depression) require symptomatic treatment, including prescribing

anticonvulsants and if necessary artificial ventilation. In the case of development of methemoglobinemia and antidote is methylthioninium chloride (methylene blue).

Due to the slow systemic absorption of the drug, patients should be monitored within a few hours of initiating treatment for intoxication.

Interaction:

In patients receiving drugs that induce the development of methemoglobinemia (for example, preparations containing a sulfo group), the drug Acriol Pro can help increase the concentration of methemoglobin in the blood.

When treating other local anesthetics and structurally similar drugs (including tokaine), the risk of enhancing systemic effects when using high doses of the drug should be taken into account.

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

Pharmaceutical interaction: not detected.

Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used for an extended period of time.This interaction has no clinical significance for short-term therapy with lidocaine (including Acrool Pro) at the recommended doses.

Special instructions:

Patients with insufficiency of glucose-6-phosphate dehydrogenase or hereditary or idiopathic methemoglobinemia are more susceptible to drug-dependent methaemoglobinaemia.

The effectiveness of the drug in neonates is not established in the procedure for taking blood samples from the heel.

Care should be taken when applying Acryol Pro around the eyes, as the product causes eye irritation. Elimination of protective reflexes can cause irritation or damage to the cornea. If the product gets into the eyes, immediately flush eyes with water or 0.9% solution of sodium chloride, and protect the eyes until protective reflexes are restored.

Care should be taken when applying the drug to the skin in atopic dermatitis; The time of application should be reduced (15-30 minutes).

In children under 3 months of age, the safety and efficacy of the drug was determined after a single dose.In such children, after the application of the drug, a temporary increase in the levels of methemoglobin in the blood lasting up to 13 hours was often observed. However, the observed increase in methaemoglobin in the blood probably does not have clinical significance.

Patients taking antiarrhythmic drugs of class III (for example, amiodarone), should be under constant supervision and ECG-control, tk. possibly affecting cardiac activity.

Do not apply the drug to the damaged eardrum or in other cases of possible penetration of the drug into the middle ear.

Do not apply Acryol Pro on open wounds.

Due to a lack of data on the absorption of the drug, it is not recommended to apply the drug to the mucous membrane of the genital organs in children.

Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, it is recommended to pay special attention to the use of the drug before subcutaneous administration of a live vaccine (for example, BCG).

Due to the lack of data, the combined use of Acriol Pro and the drugs that cause methemoglobinemia in children aged 0 to 12 months is not recommended.

Effect on the ability to drive transp. cf. and fur:

Does not affect.

Form release / dosage:

Cream for local and external use, 2.5% + 2.5%.

Packaging:

By 5, 30 or 100 g in an aluminum tube.

1 tube of 5, 30 or 100 g together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 30 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004175

Date of registration:03.03.2017

Expiration Date:03.03.2022

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp04.04.2017

Illustrated instructions

Instructions

Acryol Pro (Acriol Pro)