Surface anesthesia of the skin in connection with needle insertion and in cases of surface surgical procedures (such as excision of various skin lesions and biopsy with a trepan) on unchanged diseased, intact skin in adults. Surface anesthesia of the skin associated with needle insertion in unchanged diseased, intact skin in children over 3 years.
Composition:
1 treatment patch contains 70 mg Lidocaine and 70 mg tetracaine. The preparation contains: methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Action:
The patches contain two substances with local anesthetic effect: lidocaine (with amide structure) and tetracaine (with ester structure). After placing the patch on the skin, lidocaine and tetracaine are released into the layers of the epidermis and dermis. The preparation causes a reversible inhibition of the impulse transmission in the nerve fibers by blocking the sodium potassium pump and inhibiting the neuron membrane permeability for sodium ions, which leads to local anesthesia. The degree of anesthesia depends on the time the patch remains on the skin. The systemic exposure to both active substances depends on the dose, the time the patch remains on the skin, the thickness and condition of the skin. Lidocaine is about 75% bound to plasma proteins. It is eliminated through metabolism mainly mediated by CYP1A2 and to a lesser extent by CYP3A4, CYP2A6 is also involved in the Next stage of metabolism. Lidocaine and its metabolites are mainly excreted by the kidneys. Tetracaine undergoes rapid hydrolysis due to the action of esterases in plasma.
Contraindications:
Hypersensitivity to active substances, sodium borate or to any of the excipients. Hypersensitivity to locally acting anesthetics with amide or ester structure or to paraaminobenzoic acid (a by-product of tetracaine metabolism). The patch should not be used on mucous membranes or in places with a damaged skin barrier.
Precautions:
The patch should be used with caution in patients with hepatic, renal or cardiac failure, and in patients with increased sensitivity to lidocaine and tetracaine on systemic circulation (sudden malaise or asthenia). Use the patch carefully near your eyes (risk of corneal irritation). Lidocaine has a bactericidal and antiviral effect at concentrations of 0.5-2% - the immune response should be closely monitored after subcutaneous administration of live vaccines (eg BCG). The product contains a heat release component that can reach a maximum temperature of 40 ° C (at an average temperature of 26-34 ° C) - do not use under occlusive dressings. It is not recommended to use the patch in children under 3 years of age - limited clinical experience. The preparation contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions (possible late-type reactions).
Pregnancy and lactation:
Data on the limited number of exposures to pregnant women did not show any side effects of lidocaine and tetracaine on pregnancy or the health of the fetus or newborn baby. Caution should be exercised when used in pregnant women. Lidocaine, and possibly also tetracaine, are excreted in human milk, but the risk of having a child at the recommended doses is low - breast-feeding may continue during the use of the patches.
Side effects:
Very common: erythema, skin paleness, edema. Common: rash. Uncommon: alveolar rash, pruritus, contact dermatitis, reaction at the application site. Rarely: pain, disorder of taste, urticaria, maculopapular rash, discoloration of the skin. Allergic or anaphylactoid reactions associated with lidocaine, tetracaine or other patch components may occur. With tetracaine may be associated with a higher incidence of such reactions than with lidocaine. Systemic adverse reactions after the correct use of the patch are unlikely due to the small dose absorbed.
Dosage:
Adults: 1 to a maximum of 4 patches at once. Up to 4 slices in 24 hours. Children over 3 years: 1 or up to 2 slices at a time. Up to 2 slices in 24 hours.The patch should be used for 30 min before needle insertion or surface surgery (shorter application time may reduce the effectiveness of the patch). If necessary, the hair from the area where the patch is to be applied can be cut (not shaved) before applying the patch to ensure that the patch comes into contact with the skin.
(C)
