Index of drugs

Symptomatic treatment of neuropathic pain associated with previous virus infectionHerpes zoster (postherpetic neuralgia, PHN) in adults.

1 patch with dimensions of 10 x 14 cm contains 700 mg (5% w / w) of lidocaine. 1 g of adhesive substrate contains 50 mg lidocaine. The preparation contains: methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol 700 mg.

A preparation with local analgesic activity from the group of amide derivatives. The preparation has a dual system of action: pharmacological action associated with Lidocaine diffusion and mechanical action associated with the protection of hypersensitive sites by a hydrogel patch. Lidocaine contained in the patch penetrates continuously through the skin, causing local analgesia. The mechanism of this action is associated with the stabilization of neuronal cell membranes, which is believed to reduce the activity of sodium channels and reduce the perception of pain. When applying the patch while maintaining the maximum recommended dose (3 patches applied simultaneously for 12 hours), the systemic absorption is 3 ± 2% of the total administered dose of lidocaine; this value is similar for single and repeated use of the preparation. There was no tendency to accumulation of lidocaine and its metabolites (MEGX, GX and 2,6-xylidine), steady-state concentrations were achieved within the first 4 days of treatment. At the concentration of lidocaine in the blood plasma caused by the patch, about 70% of lidocaine is in a form bound to plasma proteins. The drug passes through the placenta and the blood-brain barrier. Lidocaine is metabolised rapidly in the liver. The main pathway for the conversion of lidocaine is N-dealkylation to xylidine monoethylglycinate (MEGX) and xylidin glycinate (GX) (both metabolites have less activity than lidocaine and are present in lower concentrations). The metabolites are then hydrolyzed to 2,6-xylidine, which is converted to conjugated 4-hydroxy-2,6-xylidine. Lidocaine and its metabolites are excreted through the kidneys. Less than 10% of the dose is excreted unchanged. T_0,5 lidocaine after applying the patch is 7.6 hours.

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to other local anesthetic drugs such as bupivacaine, etidocaine, mepivacaine and prilocaine. The plaster must not be applied to the skin affected by inflammation or to damaged skin, for example, active dissection of zoster, atopic dermatitis, wounds.

The patch should not be applied to mucous membranes. Avoid contact of the patch with eyes. The patch contains propylene glycol, which may cause skin irritation, as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (delayed occurrence of this type of reaction is possible). The patch should be used with caution in patients with severe cardiac dysfunction, severe renal or hepatic impairment. One of the lidocaine metabolites, 2,6 xylidine, has genotoxic and carcinogenic effects in rats. Secondary (secondary) lidocaine metabolites have shown mutagenic effects. The clinical relevance of these observations is unknown. Long-term use of the preparation is justified only if the patient benefits from therapeutic benefit.

It must not be used during pregnancy unless clearly necessary. Very small amounts of lidocaine are excreted in breast milk. There are no studies on the use of a patch in women during breastfeeding.

Very common: reactions at the place of use. Uncommon: skin changes, skin damage. Very rare: open wounds, anaphylactic reactions, hypersensitivity.

Adults: cover the painful area with the plaster once a day, using it for up to 12 hours during the 24 h period. Only use as many patches as needed to achieve effective treatment. If necessary, before removing the protective layer, the slices can be cut with scissors into smaller parts. At the same time, you can use a maximum of 3 slices.The patch should be applied to undamaged, dry, non-irritated skin (after healing of skin eruptions). The patch may be adhered no longer than for a period of 12 hours. The period without applying the patch must be at least 12 hours. The patch should be applied to the skin immediately after removal from the sachet and after removing the protective layer from the gel surface. Hair from the surface of the skin on which the patch is applied should be removed with scissors (do not shave). The treatment effect should be evaluated after 2-4 weeks. In the absence of reaction to the preparation after this period or if the possible beneficial effect may be associated only with skin protection by the patch itself, treatment should be discontinued, as the potential risk may exceed the potential benefits of treatment. During clinical trials of long-term treatment with the preparation, it was observed that over time, the number of patches used in patients decreased. For this reason, the treatment should be evaluated at regular intervals to decide whether the number of patches necessary to cover the painful area of ​​the skin can be reduced or whether the period can be extended without using a patch. No dose adjustment is required in patients with mild or moderate renal impairment. The drug should be used with caution in patients with severe renal impairment. No dose adjustment is required in patients with mild or moderate hepatic impairment. The drug should be used with caution in patients with severe hepatic impairment. The safety and efficacy of the preparation in children and adolescents under 18 years have not been established.