Akriol Pro Cream 2.5% + 2.5%, 5g

Composition

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of 100 g of 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.

Pharmacological action

Akriol Pro is a combination drug that includes lidocaine and prilocaine, local anesthetics of the amide type. Skin anesthesia 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 the drug to the intact skin for 1-2 hours, the duration of anesthesia after removing the occlusive dressing is 2 hours. There were no differences in efficacy (including time to achieve an analgesic effect) and safety when using the drug on intact skin in elderly (65-96 years) and younger patients.

Due to the action of the drug on the surface vessels, temporary paling or reddening of the skin is possible. Similar reactions in patients with advanced neurodermatitis (atopic dermatitis) may occur faster, as early as 30-60 minutes after applying the drug, which indicates a faster penetration of the cream through the skin.

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

When using combination vaccines against such infections as measles, rubella, mumps, or intramuscular combination vaccines against diphtheria, pertussis, tetanus, polio, and Haemophilius influenzae type b infections, as well as when vaccinating 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 blood serum, or the number of patients who achieved a protective or positive antibody titer after immunization.

Mucous membrane of the genitals:  

Anesthesia of the genital mucosa is achieved faster than anesthesia of intact skin due to faster absorption of the drug.

In women,5-10 minutes after applying the drug to the genital mucosa, anesthesia is achieved sufficient to relieve 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 the 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 negative effect of the drug on the healing process of ulcers or in relation to the bacterial flora.

Indications

For adults:

surface anesthesia of the skin with injections (including vaccines), the puncture and catheterization of blood vessels and superficial surgical procedures, including cosmetic procedures and hair removal;

surface anesthesia of trophic ulcers of the lower extremities with surgical treatment (mechanical cleaning), for example, removal of fibrin, pus and necrotic tissue;

superficial anesthesia of the mucous membrane of the genital organs before performing painful procedures and for numbing before the injection of local anesthetics.

For children:

– surface anesthesia of the skin during injections (including vaccination), punctures and catheterization of blood vessels and surface surgical interventions (including the removal of molluscum contagiosum).

Contraindications

Hypersensitivity to local anesthetics of the amide type or any other component of the drug. Premature newborns born with a gestation period of less than 37 weeks. Newborns weighing less than 3 kg should be treated with caution:  Glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, advanced neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (for example, amiodarone).

Side effects

The following adverse reactions are distributed by frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000), very rare (

When applied to intact skin

Skin and subcutaneous tissue disorders:  often-transient local reactions in the area of application of the drug, such as pallor, redness and swelling; infrequently – in the first moment after application, a slight burning sensation, itching and a feeling of warmth (in the area of application of the drug).

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 spot hemorrhages, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum. Corneal irritation due to accidental contact of the cream with the eyes.

When applied to trophic ulcers of the lower extremities

Skin and subcutaneous tissue disorders:  often-transient local reactions in the area of application of the drug, such as pallor, redness and swelling; in the first moment after application, a slight burning sensation, itching and a feeling of warmth (in the area of application of the drug); infrequently – skin irritation (in the area of application of the drug).

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

Interaction

In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfogroup), the drug Akriol Pro may increase the concentration of methemoglobin in the blood.

When treating 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 the drug.

No specific studies have been conducted to evaluate the interaction of lidocaine/prilocaine with class III antiarrhythmic drugs, and caution should be exercised when using the 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 administered over an extended period of time. This interaction is not clinically relevant for short-term lidocaine therapy (including Acriol Pro) at the recommended doses.

How to take, course of use and dosage

Externally, on the skin or mucous membrane.

Surface anesthesia of trophic ulcers of the lower extremities

For surgical treatment (mechanical cleaning) of trophic ulcers of the lower extremities: a single dose of about 1-2 g/10 cm 2; apply a thick layer of cream on the ulcerated surface, no more than 10 g of cream per procedure. Apply an occlusive dressing. Application time: minimum 30 min.

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

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

When manipulating ulcers of the lower extremities, the drug was used up to 15 times for 1-2 months without reducing the effectiveness and increasing the frequency of local reactions.

Surface anesthesia of the genitals

Skin of the genitals:

Pain relief before injecting local anesthetics:

Men:  1 g / 10 cm 2. Apply the cream in a thick layer on the skin. Application time: 15 min.

Women:  1-2 g / 10 cm 2. Apply the cream in a thick layer on the skin. Application time: 60 min.

Surface anesthesia of the genital mucosa:

When removing warts and for analgesia before injecting local anesthetics: approximately 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. No occlusive dressing is required. Application time: 5-10 min. Perform the procedure immediately after removing the cream.

Children

Anesthesia during needle insertion (including vaccination), scraping of molluscum contagiosum and other small surface surgical procedures. Apply the cream in a thick layer 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 cm 2. A strip of Akriol Pro with a length of 3.5 cm approximately corresponds to a dose of 1 g. 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 on the skin and cover with an occlusive dressing.

Recommendations for applying the drug

Pierce the protective membrane of the aluminum tube using a screw-on lid, squeeze out a sufficient amount of cream from the tube and apply it to the site of the intended procedure.

Occlusal stickers may be used for anesthesia of the skin.For anesthesia of trophic ulcers of the lower extremities, use an occlusive dressing made of PVC. Cover the applied cream with a bandage so that the layer of cream under it is thick and does not squeeze out from under the bandage. Gently smooth the edges of the dressing to avoid cream leakage.

After the recommended time has elapsed, remove the dressing and any remaining cream from the surface.

Overdose

If the recommended dosage regimen is followed, signs of systemic toxicity are unlikely to develop.

The symptoms of intoxication are probably the same as with other local anesthetics, for example, excitement of the central nervous system( CNS), and in severe cases, depression of the central nervous system and heart activity.

In rare cases, the development of clinically significant methemoglobinemia was noted. Prilocaine in high doses can cause an increase in the content of methemoglobin. A 5-hour surface application of 125 mg of prilocaine caused moderate methemoglobinemia in a 3-month-old child. Surface application of lidocaine at a dose of 8.6-17.2 mg / kg caused serious intoxication in newborns.

Treatment: Severe neurological symptoms (seizures, central nervous system depression) require symptomatic treatment, including anticonvulsant medications and, if necessary, mechanical ventilation. In the 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.

Special instructions

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

The effectiveness of using the drug in newborns during the procedure of taking blood samples from the heel has not been established.

Caution should be exercised when applying Akriol Pro around the eyes, as the drug causes eye irritation. Eliminating defensive reflexes can cause irritation or damage to 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 the protective reflexes are restored.

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

In children under 3 months of age, the safety and efficacy of the drug was determined after applying a single dose. These children often experienced a temporary increase in blood methemoglobin levels lasting up to 13 hours after applying the drug. However, the observed increase in blood methemoglobin is probably not clinically relevant.

Patients taking Class III antiarrhythmic drugs (for example, amiodarone) should be constantly monitored and monitored by an ECG, as it may affect 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 Akriol Pro to open wounds.

Due to the lack of data on the absorption of the drug, it is not recommended to apply the drug to the genital mucosa 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 when using the drug before subcutaneous use of a live vaccine (for example, BCG).

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

Form of production

A homogeneous mass of white or almost white color. The presence of a weak specific smell is allowed.

Active ingredient

Lidocaine, Prilocaine

Dosage form

cream