LIDOKAIN (Spray for topical use)

Active material: Lidokain
When ATH: D04AB01
CCF: The local anesthetic for surface anesthesia
ICD-10 codes (testimony): Z51.4
When CSF: 21.02.04
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Spray for topical use 10% as a colorless liquid with an odor of menthol and menthol taste bitter.

Excipients: peppermint oil, propylene glycol, ethanol 96%.

650 doses – vials of dark glass (1) with a metering pump set to the spray nozzle – cardboard boxes.

Pharmacological action

Mestnый anesthetic, derivative of acetanilide. It has properties antiarrhythmic class IB and membrane stabilizing activity.

It provides local anesthesia by blocking the generation and conduction of impulses in nerve terminals. The mechanism of action is associated with the stabilization of neuronal membrane permeability to sodium ions. The threshold rises electroexcitability.

Reaching the larynx and trachea, drug suppresses pharyngeal reflex and inhibits the cough reflex, it can lead to aspiration, ʙronxopnevmonii.

At therapeutic doses do not generally affect the force and heart rate.

The action of lidocaine aerosol form develops within 1 minutes and lasts 5-6 m. Reductions achieved sensitivity slowly disappears within 15 m.

Pharmacokinetics

Absorption

When applied topically to the mucous membranes of lidocaine is absorbed in varying degrees, depending on the dose and site of application. The rate of perfusion in the mucosa affect absorption.

Lidocaine is well absorbed from the respiratory tract, that requires care and prevent the possibility of introducing in toxic doses.

Testimony

For local anesthesia of the mucous membranes in the dental practice, Oral Surgery:

- Dissection of superficial abscesses;

- Removal of mobile primary teeth;

- The removal of bone fragments and suture the wounds of the mucous membranes;

- Anesthesia gums for fixing the crown or bridge (using only elastic impression material);

- Manual or removal tool (or excision) enlarged buds;

- To reduce or suppress the gag reflex increased in preparation for X-ray examination;

- Anesthesia for excision of superficial benign tumors of the oral mucosa;

- Children – frenuloektomii for opening and cysts of the salivary glands.

In ENT practice:

- Before electrocoagulation (in the treatment of nasal bleeding), septektomiey and resection of nasal polyps;

- Before tonsillectomy to reduce the gag reflex and anesthesia injection site (except for tonsillectomy and adenektomii children under the age of 8 years);

- As an additional anesthesia before opening peritonsillar abscess or prior puncture of the maxillary sinus;

- Anesthesia before washing the sinuses.

When endoscopy and instrumental examinations:

- Anesthesia prior to administration through the nose or mouth of various probes (duodenal probe, before the fractional food test);

- Anesthesia before rectoscopy in the case of replacing catheters.

In obstetrics and gynecology:

- Perineal anesthesia for the treatment and / or perform an episiotomy;

- Anesthesia of the surgical field in vaginal surgery or surgery of cervical;

- Anesthesia for excision and treatment of rupture of the hymen;

- Anesthetic for suturing abscesses.

In dermatology:

- Anesthesia mucous membranes for small surgery.

Dosage regimen

The aerosol is sprayed onto the mucosa. Each atomization 1 portions of the surface of the aerosol is ejected 4.8 mg of lidocaine. The dose depends on the evidence and the surface area of ​​anesteziruemoy. To avoid a high concentration of lidocaine in the blood plasma of the lowest dose should be used, providing satisfactory effect. Usually enough 1-3 sprays, although in obstetrics apply 15-20 sprays (the maximum dose – 40 spray / 70 kg body weight).

Estimated dose (the number of sprays) for various indications:

Using the impregnated tampon drug can be applied to large surfaces.

In children aged 2 years drug is preferably applied by applying a swab, avoiding fear, appears when spraying, as well as a burning sensation.

To Patients with liver and / or cardiac failure recommended dose reduction 40%.

When using a spray bottle to be kept upright.

Side effect

Local reactions: feeling light burning, which disappears with the development of the anesthetic effect (during 1 m).

Allergic reactions: in a few cases – anaphylactic shock.

CNS: in a few cases – anxiety.

Cardio-vascular system: in a few cases – hypotension, bradycardia.

Contraindications

- Indicate a history of seizures, associated with drug;

- AV-block II and III, and intraventricular conduction disorders (except in cases, when a probe to stimulate the ventricles);

- Adams' disease;

- Vыrazhennaya bradycardia;

- SSS;

- Cardiogenic shock;

- A significant reduction in left ventricular function;

- Hypersensitivity to lidocaine and other ingredients.

When used as a dental plaster impression material spray contraindicated because of the risk of aspiration.

Pregnancy and lactation

Lidocaine aerosol can be used during pregnancy, tk. at recommended doses, it is not dangerous.

The use of the drug during lactation is possible after a thorough evaluation of the preliminary expected benefit of therapy for the mother and the potential risk for the baby.

Cautions

To use caution in patients with impaired hepatic function, circulatory failure, hypotension, renal failure, epilepsy. In these cases, a reduction in dose.

With extreme caution should be used drug in the presence of mucosal injury, in mental retardation, as well as in patients with elderly and / or debilitated patients, already receiving drugs with similar effects on the cardio-vascular diseases.

Avoid getting spray into or contact with eyes, it is important to prevent the ingress of aerosol in the respiratory tract (risk aspirations). Application of the drug on the back of the throat requires special care.

Use in Pediatrics

It will be appreciated, that children swallowing reflex occurs much more frequently, than in adults.

Lidocaine in the form of aerosol is not recommended for the local anesthesia before tonsillectomy and at adenotomy children aged 8 years.

Effects on ability to drive vehicles and management mechanisms

If side effects after the drug does not cause discomfort, restrictions on driving and control mechanisms are no.

Overdose

Symptoms: Possible symptoms of CNS (incl. convulsions) and the cardiovascular system.

Treatment: the symptoms of the nervous system and cardiovascular system, make sure the airway, provide fresh air, supply of oxygen and / or artificial respiration. When seizures should enter as soon as possible 50-100 mg ditilina and / or 5-15 mg diazepam, possible to use derivatives of barbituric acid (thiopental sodium). In the acute phase of an overdose of lidocaine dialysis is ineffective.

If bradycardia, cardiac conduction disturbances can be assigned to atropine 0.5-1 mg / in.

Drug Interactions

While the use of antiarrhythmic drugs Class IA (incl. with quinidine, prokaynamydom, dizopiramidom) It occurs QT prolongation and, In very rare cases, possible development of AV-block or ventricular fibrillation.

Difenin cardiodepressive enhances the action of lidocaine.

The combined administration of lidocaine and procaine (novocaine) can cause mental disorders (hallucinations).

Lidocaine may increase the effects of drugs, causing a blockade of neuromuscular transmission, tk. these reduce the conductivity of nerve impulses.

Against the background of digitalis glycosides lidocaine intoxication may exacerbate the severity of AV-blockade.

Ethanol increases the inhibitory effect of lidocaine on the breath.

Pharmaceutical interaction

With simultaneous use of these drugs increase the concentration of lidocaine in the blood serum: aminazin, cimetidine, propranolol, pethidine, ʙupivakain, quinidine, disopyramide, Amitriptyline, imipramine, nortryptylyn.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C . Shelf life – 5 years.