Akriol Pro®
Bibliography
1 GRLS, r/u LP-004175 dated 03/03/2017
2 Certificate GMP-0036-000221/18
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4 J. Cassuto, R. Sinclair, M. Bonderovic, Anti-inflammatory properties of local anesthetics and their present and potential clinical implications. Acta Anaesthesiol Scand 2006; 50; 265-282]
5 Based on IQVIA report March 2022 - September 2022
6 Russian medical journal. Zhigultsova T.I., Parkaeva L.V., Ilyina E.E., Vissarionov V.A.: “Experience of using 5% Emla cream in the practice of dermatocosmetologists”
7 Instructions for use of the medicinal product for medical use Acriol Pro
8 T.N. Calvey, N.E. Williams. Pharmacology for anesthesiologists. Publishing house Binom, Moscow, 2007, 119-128
9 Based on the report “Anesthetics in injection cosmetology for 2016” Vademecum Analytical Center for sales volume.
10 T.I. Zhigultsova, Ph.D. L.V. Parkaeva, E.E. Ilyina, professor V.A. Vissarionov: “Experience of using 5% Emla cream in the practice of dermatocosmetologists” Cosmetology and plastic surgery. Vol. 16, No. 9, 2008
11 On the Russian market there are so-called cosmetic products containing lidocaine and not registered as medicines
12 Cling film can be used as an occlusive dressing
13 Drug Release Studies on an Oil-Water Emulsion Based on a Eutectic Mixture of Lidocaine and Prilocaine as the Dispersed Phase
14 Federal Law-61 “On the Circulation of Medicines” dated April 12, 2010, Federal Law-323 “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011 and Federal Law-532 “On Amendments to Certain Legislative Acts of the Russian Federation Regarding Counteraction to Trafficking falsified, counterfeit, substandard and unregistered medicines, medical devices and counterfeit dietary supplements" dated December 31, 2014.
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17 According to GMP News. Analysis of the market for local anesthetics used in cosmetic injections in 2022.
18 One type of occlusive dressing, namely: bandage, cling film, adhesive tape or rubberized fabric
19 The combination of lidocaine and prilocaine in concentrations above 0.5-2% has bactericidal and antiviral properties. In Akriol Pro the concentration is 5%.
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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.
