Description
Latin name
Acriol Pro
Release form
Cream vaginal liquid, homogeneous, yellow .
Pharmacological action
Acriol Pro is a combined preparation, which includes lidocaine and prilocaine, local amide type anesthetics. 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 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 analgesic effect) and safety when using the drug on intact skin in elderly (65-96 years old) and younger patients.
Due to the effect of the drug on the superficial vessels, temporary blanching or redness of the skin is possible. Similar reactions in patients with common neurodermatitis (atopic dermatitis) can occur faster, already 30-60 minutes after applying the drug, which indicates a faster penetration of the cream through the skin.
For puncture biopsy (4 mm in diameter), the use of the drug Akriol Pro provides adequate anesthesia for intact skin in 90% of patients 60 minutes after applying the drug with the needle inserted to a depth of 2 mm and 120 minutes after the needle is inserted 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 combined vaccines against infections such as measles, rubella, mumps, or intramuscular combined vaccines against diphtheria, pertussis, tetanus, polio and Haemophilius influenzae type b infection, as well as vaccination against hepatitis B, the use of the drug did not affect the average titer of antibodies, the rate of appearance or disappearance of specific antibodies in the blood serum or the number of patients, having achieved a protective or positive antibody titer after immunization.
Genital mucosa:
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 mucous membrane of the genital organs, anesthesia is sufficient to stop the pain caused by the use of an argon laser, the anesthesia duration is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).
Trophic ulcers of the lower extremities:
After applying the drug during the treatment of trophic ulcers of the lower extremities, the anesthesia lasts 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
In adults:
– surface anesthesia of the skin during injections (including during vaccination), puncture and catheterization of vessels and superficial surgical procedures, including minor cosmetic procedures and hair removal
– surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, for the removal of fibrin, pus and necrotic tissue
– superficial anesthesia of the genital mucosa before painful manipulations and for pain relief before local injections anesthetics.
In children:
– surface anesthesia of the skin during injection (including during vaccination), puncture and catheterization of vessels and superficial surgical procedures (including during removal of molluscum contagiosum).
Contraindications
Hypersensitivity to local amide type anesthetics or any other component of the drug.
Premature infants born with a gestational age of less than 37 weeks. Newborns weighing less than 3 kg.
Precautions: Glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, common neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (eg, amiodarone).
Use during pregnancy and lactation
Pregnancy
Insufficient data on the use of the drug in pregnant women. In animal studies, there was no direct or indirect negative effect of the drug on pregnancy, intrauterine development of the fetus, on the birth process or postnatal development. Lidocaine and prilocaine cross the placental barrier and can be absorbed in fetal tissues. No specific impairments to the reproductive process were 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 baby when using the drug in therapeutic 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 newborns during the procedure of taking blood samples from the heel has not been established.
Caution should be exercised when applying Acriol Pro around the eyes, as this causes eye irritation. Elimination of protective reflexes can cause irritation or damage to the cornea. In case of contact with eyes, rinse immediately with water or 0.9% sodium chloride solution and protect your eyes until protective reflexes are restored.
Caution must be exercised if the product is applied to the skin with atopic dermatitis, the application time should be reduced (15-30 minutes).
In children under the age of 3 months, the safety and effectiveness of the drug was determined after applying a single dose. In these children, after application of the drug, a temporary increase in blood hemoglobin levels of up to 13 hours was often observed. However, the observed increase in methemoglobin in the blood probably does not have clinical significance.
Patients taking class III antiarrhythmic drugs (e.g. amiodarone) should be under constant monitoring and ECG monitoring, as possible effect on cardiac activity.
The drug should not be applied to a damaged eardrum or in other cases of possible penetration of the drug into the middle ear.
Do not use Acriol Pro on open wounds.
Due to the lack of data on the absorption of the drug, it is not recommended to apply the drug 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 pay special attention when using the drug before subcutaneous administration of a live vaccine (for example, BCG).
Due to the lack of data, the combined use of the drug Akriol Pro and drugs that cause methemoglobinemia is not recommended, in children aged 0 to 12 months.
Composition of
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 0 g
sodium hydroxide – 0, 52 g
purified water – up to 100 g.
Dosage and administration
Externally, on the skin or mucous membrane.
Superficial anesthesia of trophic ulcers of the 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 the cream with a thick layer on the ulcer surface, not more than 10 g of cream per procedure. Apply an occlusive dressing. Application time: at least 30 minutes.
The opened tube with cream is intended for single use, the tube with the remainder of the cream should be discarded after use in one patient.
In the case of treatment of ulcers in the tissues of which the penetration of the drug is difficult, the duration of application can be increased to 60 minutes. Mechanical cleaning must begin no later than 10 minutes after removing the cream.
During manipulations on ulcers of the lower extremities, the drug was used up to 15 times within 1-2 months without reducing effectiveness and increasing the frequency of local reactions.
Superficial genital anesthesia
Genital skin:
Analgesia before local anesthetics injection:
Men: 1 g / 10 cm2. Apply the cream in a thick layer on 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:
For removal of genital warts and for pain relief before local anesthetics injections: 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. An occlusive dressing is not required. Application time: 5-10 minutes. Carry out the procedure immediately after removing the cream.
Children
Anesthesia with the introduction of the needle (including during vaccination), with curettage of the molluscum contagiosum, and with other small superficial surgical procedures.
Apply the cream in a thick layer on the skin and cover with an occlusive dressing. The dose should correspond to the treated surface and should not exceed 1 g of cream per 10 cm2. Strip of the drug Acriol Pro, length 3, 5 cm approximately corresponds to a dose of 1 g. An increase in 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
Pierce the protective membrane of the aluminum tube using a screw cap, squeeze enough cream out of the tube and apply to the place of the intended procedure.
With anesthesia of the skin, the use of occlusive stickers is possible. For anesthesia of trophic ulcers of the lower extremities, use an PVC occlusive dressing. Cover the applied cream with a bandage so that the cream layer under it is thick and does not squeeze out from under the bandage. Gently smooth the edges of the dressing to avoid leakage of cream.
After the recommended time, remove the dressing and the rest of the cream from the surface.
Side effects
The following adverse reactions are distributed by frequency of occurrence as follows: very often (? 1/10) often (? 1/100, <1/10) infrequently (? 1/1000, <1/100) rarely (? 1/10 000, <1/1 000), very rarely. When applied to intact skin Disorders of the skin and subcutaneous tissues: often – transient local reactions in the area of application of the drug, such as paleness, redness and swelling infrequently – at the first moment after application, slight burning, itching and sensation of heat (in the area of application 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 field of application of the drug, such as a hemorrhagic rash or spot hemorrhage, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum. Corneal irritation due to accidental contact with the cream in the eyes. When applied to trophic ulcers of the lower extremities Disorders of the skin and subcutaneous tissues: often transient local reactions in the area of application of the drug, such as paleness, redness and swelling at the first moment after application, slight burning, itching and sensation of heat (in the area of application 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. Overdose If the recommended dosage regimen is observed, the development of signs of systemic toxicity is unlikely. The symptoms of intoxication are probably the same as those of other topical anesthetics, such as central nervous system (CNS) arousal, and in severe cases, CNS depression and cardiac activity. In rare cases the development of clinically significant methemoglobinemia has been noted. High-dose prilocaine can cause an increase in methemoglobin content. Superficial application of 125 mg of prilocaine for a duration of 5 hours caused the development of moderate methemoglobinemia in a 3-month-old baby. Superficial application of lidocaine at a dose of 8.6-17.2 mg / kg caused serious intoxication in newborns. Treatment: Severe neurological symptoms (convulsions, central nervous system depression) require symptomatic treatment, including prescribing anticonvulsants and, if necessary, ventilation. In the case of methemoglobinemia, the antidote is methylthioninium chloride (methylene blue). Due to the slow systemic absorption of the drug, it should be possible to monitor patients for several hours after the start of intoxication treatment. Form of Treatment cream Appointment Children at the doctor’s appointment, Pregnant at the doctor’s appointment, Lactating mothers at the doctor’s appointment, Adult prescription Indications Anesthesia Possible product names Acriol Pro cream 2.5% + 2.5% 5 g
