Akriol Pro cream for local and external use, 5 g
Registration Certificate Holder
Chemical and pharmaceutical plant AKRIKHIN (Russia)
Dosage form
Medicine - Akriol Pro
Description
Cream for local and external use
in the form of a homogeneous mass of white or almost white color; A slight specific odor is allowed.
100 g
lidocaine 2.5 g prilocaine 2.5 g
Excipients
: PEG-54 hydrogenated castor oil - 1.9 g, carbomer - 1 g, sodium hydroxide - 0.52 g, purified water - up to 100 g.
5 g - aluminum tubes with bouchons (1) - cardboard packs. 30 g - aluminum tubes with bouchons (1) - cardboard packs. 100 g - aluminum tubes with bouchons (1) - cardboard packs.
Indications
In adults, superficial skin anesthesia for injections (including vaccinations), punctures and catheterization of blood vessels and superficial surgical interventions, including minor 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 tissue; superficial anesthesia of the mucous membrane of the genital organs before painful manipulations and for pain relief before injections of local anesthetics.
In children: superficial skin anesthesia for injections (including vaccinations), punctures and catheterization of blood vessels and superficial surgical interventions (including removal of molluscum contagiosum).
Contraindications for use
Premature newborns born at less than 37 weeks of gestation; newborns weighing less than 3 kg; hypersensitivity to amide-type local anesthetics.
pharmachologic effect
Combined local anesthetic for external and local use. Contains lidocaine and prilocaine, which are amide-type local anesthetics. Skin anesthesia is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis. When applied to the mucous membrane of the genital organs, anesthesia is achieved faster than when applied to intact skin due to faster absorption of active substances. The degree of anesthesia depends on the dose and duration of application.
Drug interactions
In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfo group), the use of drugs containing this combination may increase the concentration of methemoglobin in the blood.
When treating with other local anesthetics and structurally similar drugs (including tocainide), the risk of increased systemic effects when using this combination in high doses should be taken into account.
No specific studies have been conducted to evaluate the interaction of lidocaine/prilocaine with class III antiarrhythmic drugs; caution should be exercised when using drugs together.
Drugs that reduce the clearance of lidocaine (eg, cimetidine or beta-blockers) may cause potentially toxic plasma concentrations when repeated high doses of lidocaine are administered over an extended period of time.
Dosage regimen
Externally on the skin, locally on the mucous membrane of the genital organs.
The dose and time of application are determined depending on the indications, clinical situation and age of the patient.
Side effect
Local reactions: transient local reactions are possible in the area of application, such as pallor, redness and swelling; at the first moment after application - a slight burning sensation, itching and a feeling of warmth. Hemorrhagic rash or pinpoint hemorrhages, especially after prolonged application in children with atopic dermatitis or molluscum contagiosum. Corneal irritation due to accidental contact of the drug with the eyes.
General reactions: allergic reactions, in the most severe cases – anaphylactic shock. Methemoglobinemia and/or cyanosis.
special instructions
With caution: glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, common neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (for example, amiodarone).
Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more susceptible to drug-dependent methemoglobinemia.
Caution must be exercised when applying the drug to the skin for atopic dermatitis; Application time should be reduced (15-30 min).
Patients taking class III antiarrhythmic drugs (for example, amiodarone) should be under constant monitoring and ECG control, because 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 apply the drug containing this combination to open wounds.
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 drug before subcutaneous administration of a live vaccine (for example, BCG).
Due to a lack of data on absorption, it is not recommended to apply to the genital mucosa in children.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.
Animal studies have not revealed any direct or indirect negative effects of this combination on pregnancy, intrauterine development of the fetus, the process of childbirth or postnatal development. Lidocaine and prilocaine penetrate the placental barrier and can be absorbed into fetal tissues. No specific reproductive effects, such as increased incidence of malformations or other direct or indirect adverse effects on the fetus, have been reported.
Lidocaine and prilocaine are excreted in breast milk in quantities that do not pose a risk to the baby when drugs containing this combination are used as indicated in recommended doses.
Use for renal impairment
Restrictions for impaired renal function - With caution. There are no special instructions for limiting use.
Use for liver dysfunction
Restrictions for liver dysfunction - With caution. There are no special instructions for limiting use.
Use in elderly patients
Restrictions for elderly patients - With caution. Use with caution to avoid exacerbation of concomitant diseases.
Use in children
Restrictions for children - With caution. Premature newborns born at less than 37 weeks of gestation; newborns weighing less than 3 kg.
Akriol about cream 2.5%+2.5%-30g tube for places. and adv. approx.
Method of administration and dosage Externally, on the skin or mucous membrane. Superficial 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 cm2; Apply the cream in a thick layer to the ulcer surface, no more than 10 g of cream per procedure. Apply an occlusive dressing. Application time: minimum 30 min.
An opened tube of cream is intended for single use; the tube with any remaining cream should be discarded after use on one patient.
In the case of treating ulcers, into the tissues of which 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.
When manipulating ulcers of the lower extremities, the drug was used up to 15 times over 1-2 months without reducing the effectiveness and increasing the incidence of local reactions.
Superficial anesthesia of the genital organs
Genital skin:
Pain relief 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 to the skin. Application time: 60 min.
Superficial anesthesia of the genital mucosa:
When removing condylomas and for pain relief before injections of 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. Carry out the procedure immediately after removing the cream.
Children
Anesthesia during needle insertion (including vaccination), curettage of molluscum contagiosum and other minor superficial surgical procedures.
Apply the cream in a thick layer to the skin and cover with an occlusive dressing. The dose should correspond to the surface being treated and should not exceed 1 g of cream per 10 cm2.
A strip of Acriol Pro 3.5 cm long 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 to the skin and cover with an occlusive dressing.
Recommendations for applying the drug
Pierce the protective membrane of the aluminum tube using the screw cap, squeeze out a sufficient amount of cream from the tube and apply to the site of the intended procedure.
When anesthetizing the skin, it is possible to use occlusive stickers. When anesthetizing trophic ulcers of the lower extremities, use an occlusive PVC dressing. Cover the applied cream with a bandage so that the layer of cream underneath is thick and does not squeeze out from under the bandage. Gently smooth the edges of the bandage to avoid cream leakage.
After the recommended time has passed, remove the bandage and any remaining cream from the surface.
Akriol pro cream 2.5% for local and external use 30g
Dosage form: cream for local and external use
Compound.
active ingredients: lidocaine - 2.5 g, prilocaine - 2.5 g;
Description.
A homogeneous mass of white or almost white color. A slight specific odor is allowed.
Action.
Akriol Pro is a combination drug that contains lidocaine and prilocaine, amide-type local 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 the time to achieve an 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 superficial vessels, temporary paleness or redness of the skin is possible. Similar reactions in patients with widespread neurodermatitis (atopic dermatitis) may occur faster, within 30-60 minutes after application of the drug, which indicates faster penetration of the cream through the skin.
For puncture biopsy (4 mm in diameter), the use of Acriol Pro provides adequate anesthesia of 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 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 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 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 blood serum, or the number of patients who achieve a protective or positive antibody titer after immunization.
Mucous membrane of the genital organs
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 the drug to the mucous membrane of the genital organs, anesthesia sufficient to relieve pain caused by the use of an argon laser is achieved; 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 when treating trophic ulcers of the lower extremities, the duration of pain relief is up to 4 hours. There was no negative effect of the drug on the healing process of ulcers or on bacterial flora.
Indications.
In adults:
— superficial anesthesia of the skin during injections (including vaccinations), punctures and catheterization of blood vessels and superficial surgical interventions, including minor 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 tissue;
— superficial anesthesia of the mucous membrane of the genital organs before painful manipulations and for pain relief before injections of local anesthetics.
In children:
— superficial anesthesia of the skin during injections (including vaccinations), punctures and catheterization of blood vessels and superficial surgical interventions (including removal of molluscum contagiosum).
Contraindications.
Hypersensitivity to amide-type local anesthetics or any other component of the drug.
Premature newborns born at less than 37 weeks' gestation.
Newborns weighing less than 3 kg.
With caution: Glucose-6-phosphate dehydrogenase deficiency, hereditary or idiopathic methemoglobinemia, common neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (eg, amiodarone).
