Luan - instructions for use, dose, side effects, contraindications

Excipients: sodium carmellose 3.0 g / 2.75 g, glycerol (glycerol) 20 g / 20 g, methyl parahydroxybenzoate 0.009 g / 0.009 g, ethyl parahydroxybenzoate 0.0045 g / 0.0045 g, propyl parahydroxybenzoate 0.0045 g / 0.0045 g, sodium benzoate 0.0375 g / 0.0375 g, water purified to 100 g.

Description:Transparent, homogeneous, almost colorless gel.

Pharmacotherapeutic group:Local anesthetic

ATX: & nbsp

N.01.B.B Amides

N.01.B.B.02 Lidocaine

C.01.B.B.01 Lidocaine

C.01.B.B Antiarrhythmic drugs Ib class

Pharmacodynamics:

The local anesthetic effect is due to the blockade of potential-dependent Na + channels, which prevents the generation of pulses in the endings of the sensory nerves and pain impulses along nerve fibers. With topical application dilates blood vessels, does not have a locally irritating effect.

The effect develops within 1-5 minutes after application to mucous membranes and lasts 15-20 minutes.

Pharmacokinetics:

Quickly absorbed from the mucous membranes (especially the swallowing of the respiratory tract), the degree of absorption of lidocaine is determined by the degree of blood supply to the mucous membrane, the total dose of lidocaine, the localization of the site and the duration of exposure. After application to the mucous membrane of the upper respiratory tract is partially swallowed and inactivated in the gastrointestinal tract. Time to reach the maximum concentration (TC_max) when applied to the mucous membrane of the oral cavity and upper respiratory tract - 10-20 min. The association with proteins depends on the concentration of lidocaine and is 60-80% at a lidocaine concentration of 1-4 μg / ml (4.3-17.2 μmol / L).

It is distributed rapidly (T1 / 2 phases of distribution - 6-9 min), first it enters well-blood-supplying tissues (heart, lungs, brain, liver, spleen), then into adipose and muscle tissue. It penetrates the blood-brain barrier and the placental barrier, is secreted with the mother's milk (40% of the concentration in the mother's plasma).

Metabolised in the liver (by 90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and breaking of the amide bond with the formation of metabolites less active than lidocaine (monoethylglycinexylidine and glycinexylidine), T1 / 2 of which are 2 h and 10 h respectively.With liver diseases, the intensity of metabolism decreases and ranges from 50% to 10% of the normal value.

It is excreted with bile and kidneys (up to 10% unchanged). With chronic renal failure, cumulation of metabolites is possible. Acidification increases the excretion of lidocaine.

Indications:

1% gel: carrying out endoscopic procedures (pharyngoscopy, laryngoscopy, tracheobronchoscopy, esophagogastroduodenoscopy, rectoscopy, etc.).

2.5% gel: diagnostic and therapeutic endourethral procedures (cytoscopy, bladder catheterization, urethral expansion).

Contraindications:

Hypersensitivity to the components of the drug.

Younger children's age.

Carefully:Hemorrhoidal bleeding (for rectal examination), local infection in the field of application, mucosal damage in the field of application, acute diseases, weakened patients, children under 18 years of age, elderly.

Pregnancy and lactation:

No teratogenic or embryotoxic properties of the drug were detected experimentally, however, the use of the drug during pregnancy is contraindicated.

During the period of drug use, it is recommended to stop breastfeeding.

Dosing and Administration:

Locally, with anesthesia of the mucosa of the esophagus, larynx, trachea, the outer surfaces of instruments intended for examination are smeared; for superficial anesthesia of the oral mucosa, apply a sterile glass rod or gel-moist sterile cotton swab 0.2-2 g of 1% gel; with insufficient anesthesia after 2-3 min repeat.

In urology, the maximum dose for children is up to 4.5 mg / kg, for adults - 6 g 2.5% gel for 12 hours: for women - 0.75-1.0 g 2.5% gel lubricate the urethral mucosa before the test, men before the catheterization - 1-2 g 2.5%, before cystoscopy for filling and dilatation of the urethra - 6 g 2.5% gel in 2 divided doses at intervals of several minutes (the distal section of the urethra is temporarily clamped for 5-10 min for obtaining the maximum effect, in women the dose is selected individually depending on the features of the anatomical structure of the urethra s). To apply the drug, it is necessary to rinse and disinfect the external opening of the urethra.Break off the inner tip, by squeezing the tube, smoothly insert the contents through the plastic extension.

To stop painful syndrome with cystitis and urethritis, 10 g of gel are administered 1 time per day for 5-7 days in combination with other drugs.

Side effects:

Allergic reactions: allergic contact dermatitis (hyperemia at the site of application, skin rash, hives, itching, burning), angioedema.

Other: urethritis.

Overdose:

Symptoms: increased sweating, pale skin, dizziness, headache, blurred vision, ringing in the ears, diplopia, lowering blood pressure, bradycardia, arrhythmia, drowsiness, chills, numbness, tremor, anxiety, agitation, convulsions, methhemoglobinaemia, cardiac arrest.

Treatment: with the appearance of the first signs of intoxication (dizziness, nausea, vomiting, euphoria), further use is stopped, the patient is transferred to a horizontal position; prescribe oxygen inhalation; with convulsions - iv 10 mg: diazepam; at a bradycardia - m-holinoblokatory (atropine), vasoconstrictors (norepinephrine, phenylephrine). Dialysis is ineffective.

Interaction:

Cimetidine and propranolol reduce liver lidocaine clearance (decrease in metabolism due to inhibition of microsomal liver enzymes and decrease in hepatic blood flow) and increase the risk of toxic effects (including deafness, drowsiness, bradycardia, paresthesia, etc.). Barbiturates, phenytoin, rifampicin (inducers of microsomal liver enzymes) reduce efficacy (an increase in dose may be required).

With simultaneous application with aymalin, phenytoin, verapamil, quinidine, amiodarone, an increase in the negative inotropic effect is possible. Simultaneous use with beta-blockers increases the risk of bradycardia.

Cardiac glycosides weaken the cardiotonic effect, curare-like drugs enhance muscle relaxation.

Procainamide increases the risk of developing CNS excitement, hallucinations.

With the simultaneous use of lidocaine and hypnotics and sedatives, it is possible to intensify their inhibitory effect on the central nervous system.

With iv injection of hexobarbital or thiopental sodium on the background of the action of lidocaine, respiratory depression is possible.

Under the influence of monoamine oxidase (MAO) inhibitors, local anesthetic action of lidocaine is possible. Patients taking MAO inhibitors should not be prescribed lidocaine parenterally.

With the simultaneous use of lidocaine and tsolimixin B, it is possible to intensify the inhibitory effect on neuromuscular transmission, so in this case it is necessary to monitor the function of the patient's breathing.

Special instructions:

When using Luane, as with any other local anesthetic, the minimum effective dose should be used.

To prevent the appearance of allergic reactions, you should avoid using the drug's applications on extensive areas of the mucosa or in the presence of foci of infection in the area of allowable application.

Due to the complete dissolution of the gel in water and the absence of fatty substances, the preparation does not damage the rubber and plastic parts and does not contaminate the optical parts of the equipment.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Gel for topical application 1%.

Gel for topical application 2.5%.

Packaging:

Gel for topical application 1%.

Primary packaging. 100 g of gel in a sealed tube with a screw cap, having a control device for the first opening.

The tube is made from flexible aluminum, coated on the inside with plastic, varnish and applied by screen printing on the outside. The cover is made of white plastic.

Secondary packaging: The tube together with the instruction for use is placed in a cardboard box.

Gel for topical application 2.5%.

Primary packaging: 15 grams of gel in a sealed tube with a screw cap, which has a device for monitoring the first opening.

The tube is made from flexible aluminum, coated on the inside with plastic, varnish and applied by screen printing on the outside. The cover is made of white plastic.

Device for the introduction of the gel: polyethylene extension (cannula), closed with a polyethylene cover.

Secondary packaging: Tube together with the device for the introduction of gel and instructions for use is placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of 8 to 30 ° C.

Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N016168 / 01

Date of registration:02.12.2009

Expiration Date:Unlimited

The owner of the registration certificate:L. Molteni and K. dei Fratelli Alitti Soetica di Ezerchicio SpAL. Molteni and K. dei Fratelli Alitti Soetica di Ezerchicio SpA Italy

Manufacturer: & nbsp

L.Molteni & C. dei F.Lli Alitti Societa di Esercizio, S.p.A. Italy

Representation: & nbspPolarStar PharmaPolarStar Pharma

Information update date: & nbsp20.03.2018

Illustrated instructions

Instructions

Luan (Luan)