LIDODERM (patch 5% lidocaine) consists of an adhesive material containing 5% lidocaine applied on a felt nonwoven substrate polyester and coated with a protective polyethylene film separating terephthalate (PET). This film is removed before applying to the skin. Size patch is 10 x 14 cm Lidocaine has the chemical name acetamide, 2 – (diethylamino)-N-(2,6 – dimethylphenyl) with a coefficient of octanol: water equal to 43 at pH 7.4 and has the following structure: Each patch contains 700 mg of lidocaine (50 mg per gram adhesive material), water osnove.V of the patch also includes the following Inert ingredients: aminatsetat digidroksialyuminiya, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid and urea.
CLINICAL PHARMACOLOGY Lidoderm Patches
Pharmacodynamics Lidocaine is a local anesthetic of amide type and assigned to stabilization of neuronal membranes by inhibiting ionic fluxes, necessary for the initiation and transmission of impulses. The penetration of lidocaine through intact skin after application Lidoderm Patches is sufficient to achieve analgesia effect, but not enough to create a complete sensory block.
INDICATIONS AND USAGE Lidoderm Patches
LIDODERM designed to relieve pain associated with post-gerpetichnoy neuralgia. It should be used exclusively on the intact skin.
CONTRAINDICATIONS Lidoderm Patches
LIDODERM is contraindicated in patients with hypersensitivity to local anesthetics of amide type, or to any other component this drug.
CLINICAL RESEARCH Lidoderm Patches
Treatment of single dose Lidoderm Patches compared with treatment with a plaster filler (without lidocaine), as well as those in untreated (Only follow-up) through a cross-clinical trial double-blind method among 35 patients post-herpetic neuralgia. Pain intensity and the degree of removal Pain was assessed periodically for 12 hours. Action Lidoderm Patches in period from 4 to 12 hours was statistically better than in the case of the patch with filler in terms of reducing pain intensity. Treatment of reusable Lidoderm Patches doses for two weeks compared with treatment of adhesive with a filler (without lidocaine) through crossover clinical trial using a double-blind method, in which patients are allowed to stop treatment if desired among 32 patients who are respondents to the free use of Lidoderm Patches before the study. Subjected to constant evaluation of pain type, rather than the pain caused by sensory stimuli (dysesthesia). Statistically significant differences in favor of Lidoderm Patches observed in terms of Since the end of treatment patients (14 compared with 3.8 days for value of p <0.001), average daily pain, as well as preferences patient treatment. Approximately half of patients while also take medication, often used to treat post-herpetic neuralgia. Admission conducted orally. The utilization of concomitant medications coincided in both treatment groups.
PRECAUTIONS Lidoderm Patches
Overview Liver disease: Patients with severe liver disease prone increased risk of reaching toxic concentrations of lidocaine in blood, that is the result of the limited ability of normal metabolism of lidocaine. Allergic reactions: In patients with allergy to derive para- aminobenzoic acid (procaine, tetracaine, benzocaine, etc.) was not observed cross sensitivity to lidocaine. However, one should be cautious using Lidoderm Patches patients are sensitive to drugs, especially if the etiologic agent is not installed. Damaged skin: Despite the lack of experimental data use in case of damaged or inflamed skin may lead to elevated concentrations of lidocaine in the blood as a result of increased absorption. Application Lidoderm Patches recommended only for intact skin. Eye contact: Despite the lack of experimental data should Avoid contact with eyes Lidoderm Patches, since it was observed that the use of similar drugs leads to serious eye irritation from animals. If in eyes, they should immediately wash or saline and protect until the return of sensitivity.
ADVERSE REACTIONS Lidoderm Patches
Reaction at the application site During or immediately after application Lidoderm Patches (patch 5% lidocaine) on the skin at the site of application may experience symptoms of erythema, swelling, bruising, papules, vesicles, skin color changes, depigmentation, burning sensations, itching, dermatitis, petechiae, blistering, peeling, and may be a region of disturbed sensation. These reactions are usually is moderate and quickly pass by themselves within period of time from several minutes to several hours. Allergic reactions Occasionally may experience allergic and anaphylactoid reactions, associated with the use of lidocaine. These reactions may be characterized appearance of urticaria, angioedema, bronchospasm, spasm glottis, dermatitis, itching, shortness of breath and shock. To suppress these reactions use conventional methods. Efficiency of probes in skin sensitivity is questionable. Other adverse events In view of the nature and limitations of the random responses received during post-marketing studies, was not established a causal link on additional adverse events, including the following: Asthenia, zameshatlstvo, disorientation, dizziness, headache, giperesteziya, gipoesteziya, faint and dizzy, metallic taste, nausea, nervousness, worsening pain, paresteziya, drowsiness, changes in taste, vomiting, impaired visual function, for example, blurred vision, flushing, tinnitus, and tremor. System (depending on dose) reaction Appearance of systemic adverse reactions that result appropriate use of Lidoderm Patches unlikely in view of low dose absorption. Systemic adverse effects of lidocaine are similar in nature to effects that are observed in the case of other anesthetics on the based on amides, and include central nervous system stimulation and / or depression (faint and dizzy state, nervousness, fearfulness, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred vision or double vision, vomiting, feeling heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, inhibition or cessation of breathing). Reactions leading to excitation of the CNS, may be short-lived or may not occur at all. In the latter case the first signs of drowsiness will be turning into unconsciously. Cardiovascular symptoms may include bradycardia, hypotension and cardiovascular failure, leading to cardiac arrest.
DOSAGE AND METHOD OF USE Lidoderm Patches
LIDODERM should be applied to intact skin and plaster so that it covered the most painful area. You can apply one to three patches at the same time duration of wearing, not exceeding 12 hours in a 24-hour time interval. Before removing the protective film adhesive can be cut scissors into fragments of smaller size. Surface area of the application can be wear odezhdu.U infirm patients or patients with disturbances in the system allocation is recommended to use smaller field of treatment. If irritation or burning sensations in the process of carrying patch, take it down and not put up until irritation subsides. When using Lidoderm Patches in combination with other drugs, containing local anesthetics, should take into account the total number of lidocaine absorbed from all drugs.
HANDLING AND DISPOSAL Lidoderm Patches
After treatment with LIDODERMOM should wash your hands and avoid contact Lidoderm Patches in the eye. The patch should only be stored in sealed package. Applied immediately following the withdrawal of the protective packaging. Used or unused patches should immediately trim throw in the trash so as to prevent accidental contact or the possibility of ingestion of children, pets, etc. LIDODERM should be stored in a place not accessible to children.
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