Lidocaine aerosol 10% 50ml 38g Egis
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Active ingredients
Lidocaine
Release form
Spray
Composition
1 vial (50ml) contains: Active substance: lidocaine 3.8 g. Adjuvants: peppermint leaf oil - 0.08 g, propylene glycol - 6.82 g, ethanol 96% - 27.3 g. 650 doses - dark glass bottles with a dosing pump (1) complete with a spray nozzle - packs cardboard.
Pharmacological effect
Local anesthetic for surface anesthesia. The action is caused by the blockade of voltage-dependent sodium channels, which prevents the generation of impulses in the terminations of sensory nerves and the conduction of pain impulses along the nerve fibers. When applied locally, it dilates the vessels and does not have a local irritating effect. It has an analgesic effect. The effect develops in 1-5 minutes after application to the mucous membranes or skin and lasts 30-60 minutes.
Pharmacokinetics
AbsorptionQuickly absorbed from the mucous membranes (especially the pharynx and respiratory tract). The degree of absorption of the drug is determined by the degree of blood supply to the mucous membrane, the total dose of the drug, the localization of the area and the duration of the application. After application to the mucous membrane of the upper respiratory tract is partially swallowed and inactivated in the gastrointestinal tract. The time to reach Cmax when applied to the mucous membrane of the oral cavity and upper respiratory tract is 10-20 minutes. Distribution Protein binding depends on the concentration of the drug and is 60-80% at a drug concentration of 1-4 μg / ml (4.3-17.2 mcmol / l) . It is distributed quickly (T1 / 2 distribution phase - 6-9 min), first enters well-supplied blood (heart, lungs, brain, liver, spleen), then into adipose and muscle tissues. It penetrates the BBB and placental barrier, is secreted with breast milk (40% of the plasma concentration of the mother). Metabolism and elimination Metabolizes in the liver (90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and breaking the amide bond with the formation of less active compared to lidocaine metabolites (monoethylglycine and glycine), T1 / 2 which is 2 hours and 10 hours, respectively. Excreted in the bile and kidneys (up to 10% unchanged) .Pharmacokinetics in special groups of patients in liver diseases and intensity of metabolism and decreases from 50% to 10% normal velichiny.Pri chronic renal insufficiency possible accumulation of metabolites.
Indications
For terminal (surface) anesthesia of mucous membranes. In dentistry: - anesthesia of the injection area before local anesthesia; - stitching on the mucous membrane; - removal of mobile milk teeth; - removal of tartar; - anesthesia of the gums before fixing the crown or bridge-like prosthesis; children during the operation of excision of the frenulum of the tongue and opening of cysts of the salivary glands. In otorhinolaryngology: - operations on the nasal septum; - electrocoagulation. In obstetrics and gynecology: - episiotomy and incision treatment; - removal of sutures; - in Testing on the vagina and cervix. During instrumental and endoscopic examinations: - insertion of the probe, rectoscopy, intubation, etc.; - X-ray examination (to eliminate nausea and pharyngeal reflex). In surgery and dermatology: - as an analgesic drug for burns ( including solar), small wounds (including scratches); - surface anesthesia of the skin with minor surgical interventions.
Contraindications
- use for tonsillectomy and adenotomy in children under 8 years of age; - hypersensitivity to lidocaine and other components of the drug. The drug should be used with caution during instrumental studies (rectoscopy) in patients with hemorrhoidal bleeding, local infection in the area of application, injury to the mucous membrane or skin covers in the field of application, severe somatic pathology, epilepsy, bradycardia, impaired cardiac conduction, abnormal liver function, severe shock, in children of younger children hundred elderly patients, during pregnancy and lactation.
Precautionary measures
Application for violations of liver functionWith caution, you should use the drug for liver dysfunction. The use of children in children under 2 years old is preferable to use the drug by applying a swab, thus avoiding the fear that occurs during spraying, as well as burning sensation. It should be borne in mind that The swallowing reflex in children occurs much more frequently than in adults. Lidocaine in the form of an aerosol is not recommended for local anesthesia before tonsillectomy and adenotomy in children under the age of 8 years. in elderly patientsWith caution, the drug should be used in elderly patients.
Use during pregnancy and lactation
The results of controlled clinical trials in pregnant women are absent.If necessary, local anesthesia and the absence of a safer treatment, lidocaine spray can be used during pregnancy. Lidocaine is excreted in breast milk, but after topical use in conventional therapeutic doses, the amount excreted in milk is too small to cause any harm to the infant .
Dosage and administration
The drug is used topically, externally. The dose depends on the indications and the area of the anesthetized surface. The dose of the spray, released by pressing the metering valve, contains 4.8 mg of lidocaine. To avoid high concentration of lidocaine in the blood plasma, the lowest dose should be used, which provides a satisfactory effect. 1-2 sprays are usually sufficient, although 15-20 or more sprays are used in obstetrics (maximum dose - 40 sprays / 70 kg body weight). The preparation can also be applied with a cotton swab moistened with it. During dental procedures and operations Children Lidocaine spray is preferably applied with a cotton swab, which avoids fright when spraying the drug, as well as tingling sensations (the usual side effect).
Side effects
Local reactions: a feeling of light tingling, which disappears as the anesthetic effect develops (within 1 min); transient erythema, edema, and sensitivity disorders may occur. Allergic reactions: very rarely - urticaria, angioedema, bronchospasm; in exceptional cases, anaphylactic shock. Use of the drug should be immediately discontinued if any allergic reaction occurs. The frequency of systemic effects after topical administration of the drug is extremely low, since Only a very small amount of the active substance can enter the bloodstream. From the CNS: very rarely - nervous excitement, systemic dizziness, insomnia, loss of consciousness and respiratory paralysis. From the cardiovascular system: decreased blood pressure, myocardial function depression, bradycardia, cardiac arrest .
Overdose
Symptoms: increased sweating, paleness of the skin, dizziness, headache, blurred vision, tinnitus, diplopia, decreased blood pressure, bradycardia, arrhythmia, drowsiness, chills, numbness, tremor, anxiety, agitation,convulsions, methemoglobinemia, cardiac arrest. Treatment: when the first signs of intoxication appear (dizziness, nausea, vomiting, euphoria), further administration is stopped, the patient is transferred to a horizontal position; prescribe inhalation of oxygen; with convulsions - in / in 10 mg of diazepam; in bradycardia, m-anticholinergics (atropine), vasoconstrictors (norepinephrine, phenylephrine). Dialysis is ineffective.
Interaction with other drugs
Cimetidine and propranolol reduce hepatic clearance of lidocaine (decreased metabolism due to inhibition of microsomal oxidation and decreased hepatic blood flow) and increase the risk of toxic effects (including stunned condition, drowsiness, bradycardia, paresthesia, etc.). inducers of liver microsomal enzymes) reduce efficacy (an increase in the dose may be required). If prescribed with Aymaline, phenytoin, verapamil, quinidine, amiodarone, negative effects may increase from the effect. Joint appointment with beta-blockers increases the risk of developing bradycardia. Curative drugs increase muscle relaxation. Procainamide increases the risk of CNS stimulation, hallucinations. If lidocaine and sedatives are used simultaneously, sedative effects on the central nervous system can be increased. hexobarbital or sodium thiopental on the background of the action of lidocaine, respiratory depression is possible. Under the influence of MAO inhibitors, it is possible to enhance local anesthetic actions of lidocaine. With simultaneous use of lidocaine and polymyxin B, it is possible to increase the inhibitory effect on neuromuscular transmission, therefore, in this case, it is necessary to monitor the patient's respiratory function.
special instructions
It is important to prevent lidocaine from entering the airways (risk of aspiration). Application to the pharynx requires special attention. Applying to the mucous membrane of the cheeks is accompanied by the risk of dysphagia and subsequent aspiration, especially in children. When the sensitivity of the tongue and mucous membrane of the cheeks increases, the risk of biting them increases. Lidocaine is well absorbed through the mucous membranes (especially in the trachea) and damaged skin.This should be taken into account, especially when treating large areas of tissue in children. In cases of spray application in surgical operations in the pharynx or nasopharynx, it should be noted that lidocaine suppresses the pharyngeal reflex and enters the larynx and trachea and suppresses the cough reflex, which can to bronchopneumonia. This is especially important in children, as they are more likely to have a swallowing reflex. In this regard, the spray is not recommended for local anesthesia before tonsillectomy and adenotomy in children under the age of 8. Care should be taken when applying lidocaine to damaged mucosa and / or infected areas. The drug should be used with caution in patients with epilepsy, as well as bradycardia, impaired conduction in the heart, abnormal liver function, and severe shock, especially when a large amount of the drug can be expected to be absorbed when large areas of tissue are treated with high doses. in lower doses should be used in debilitated and elderly patients, in acute diseases, as well as in children - in accordance with age and general condition. In children under 2 years of age, Lidocaine spray is recommended to be applied with a cotton swab dipped in the preparation. drug bottle should be kept as vertical as possible. Spray should not get into the eyes. The bottle should not be opened or heated. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.