Local anesthesia of the skin (intact) before dermatological procedures in adult patients.
Composition:
1 g of cream contains 70 mg Lidocaine and 70 mg tetracaine; the cream contains methyl and propyl p-hydroxybenzoate.
Action:
Local anesthetic. Lidocaine and tetracaine are released into the epidermal and dermal layer of the skin with the accumulation of lidocaine and tetracaine in the area of pain receptors and nerve endings in the skin. Both lidocaine and tetracaine block the sodium ion fluxes necessary to initiate and transmit impulses, which leads to local anesthesia. The degree of anesthesia depends on the time of application of the drug. The mean and median duration of anesthesia are 9.4 and 11 h respectively, with a minimum anesthesia time of 2 h and the maximum estimated anesthesia time of 13 h. Systemic exposure to the active substances depends on the dose, application time, skin thickness (different in different parts of the body) and skin condition. After proper use of the drug, the absorbed doses of lidocaine and tetracaine are small. The extent to which lidocaine and tetracaine are metabolized in the skin is unknown. Lidocaine and its metabolites are excreted through the kidneys. Mean half-life of lidocaine excretion from plasma after topical administration for 30 min 9 g (200 cm2) of the preparation is up to 12.1 h, indicating that a prolonged portion of the medicine is placed in the skin tissue, whereupon the drug is released into the circulatory system. Half-life of tetracaine excretion and removal in humans has not been established, however, hydrolysis in plasma occurs rapidly.
Contraindications:
Hypersensitivity to Lidocaine, tetracaine, other anesthetic agents of the amide or ester type, p-aminobenzoic acid (known by-product of tetracaine metabolism), methyl p-hydroxybenzoate, propyl p-hydroxybenzoate or other auxiliary substances. Do not use on mucous membranes or on damaged or irritated skin.
Precautions:
Avoid contact of the cream with eyes. Use cautiously around eyes. Do not use under occlusive dressings. A relationship between tetracaine and methemoglobinemia was found; the risk of methemoglobinemia is greatest in patients with congenital or idiopathic methemoglobinemia - care should be taken to ensure that dosages, application sites and drug application times are consistent with the recommendations for a specific group of patients. Use with caution in patients with impaired liver, kidney or heart function, as well as in people with increased sensitivity to the effects of lidocaine and tetracaine on the cardiovascular system (eg in people with an acute or weakened disease). Lidocaine has been shown to inhibit the growth of viruses and bacteria; the effect of the cream on lidocaine and tetracaine on intradermal injections of live vaccines has not been established, therefore it is not recommended to use the cream before injecting a live vaccine. Due to the content of methyl and propyl p-hydroxybenzoate, the cream can cause allergic reactions (also of the late type). The safety and efficacy of the medicine in children and adolescents up to 18 years of age have not been established - use is not recommended.
Pregnancy and lactation:
Use caution when pregnant. Lidocaine and tetracaine are excreted in human milk, however at the recommended doses of cream only slight effects on newborns or breast-fed infants are expected. It can be used during breastfeeding, unless it is applied on the breast.
Side effects:
Very common: erythema, discoloration of the skin. Common: swelling of the skin. Uncommon: pruritus, skin pain, pain. Rarely: paresthesia, swelling of the eyelid, paleness, burning sensation of the skin, swelling of the face, exfoliation of the skin, skin irritation. Not known: urticaria. Rare allergic or anaphylactoid reactions to lidocaine and tetracaine or other components of the drug may occur. After proper application of the cream, the occurrence of systemic adverse reactions is unlikely because the absorbed doses of lidocaine and tetracaine are small.
Dosage:
Outwardly. Adults: a layer of cream with a thickness of approx.Apply 1 mm on intact skin for 30 min (for dermatological procedures such as pulsed pigment laser therapy, laser hair removal, non-ablative laser facial rejuvenation, wrinkle filling and injection) or 60 min (for dermatological procedures such as laser tattoo removal and laser removal of varicose veins). After the required time has elapsed, the mask should be removed from the skin before the procedure. The maximum application area of the cream should not exceed 400 cm2. For face treatments, the medicine should be applied by a specialist medical staff. When treating on other parts of the body, the drug should be applied by professional medical personnel or by patients properly instructed in the proper way of using the drug. Avoid direct contact with cream or skin covered with cream to prevent contact dermatitis. The cream should not be applied with your fingers; use a tool with a flat surface such as a spatula or a tongue pressing blade.
(C)
