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Xylocaine, Lidocaine

Xylocaine

Brand Names: Xylocaine, Xylocard
Generic Name:
Lidocaine
Manufacturer: Astra Zeneca

Pump spray for topical anaesthesia

Composition
1 dose Xylocaine pump spray contains : Lidocaine base 10 mg
For excipients see List of excipients.

Description:
Cutaneous spray, solution
The solution is a clear to almost clear, slightly pink-coloured liquid with menthol and banana flavour.

Xylocaine pump spray is intended for use on mucous membranes and provides an efficient surface anaesthesia, which lasts for approximately 10-15 minutes The anaesthesia usually occurs within 1-3 minutes depending on the area of application.

Lidocaine is absorbed following topical administration to mucous membranes, its rate and extent of absorption being dependent upon the concentration and total dose administered, the specific site of application, and the duration of exposure. In general, the rate of absorption of local anaesthetic agents following topical application is most rapid after intratracheal and bronchial administration.
Normally about 64% of the lidocaine is bound to plasma proteins. The main elimination pathway of lidocaine is by liver metabolism. Approximately 90% of the lidocaine administered is excreted in the form of various metabolites and less than 10% is excreted unchanged in the urine.

Indications :
- Nasal procedures, e.g. puncture of the maxillary sinus
- Oral and dental procedures, e.g. prior to injection
- Procedures in the oropharynx, e.g. gastrointestinal endoscopy
- Procedures in the respiratory tract, e.g. insertion of instruments and tubes
- Procedures in the larynx, trachea and bronchi
- Procedures in obstetrics and gynaecology, e.g. vaginal delivery, suturing of ruptures in the mucosa and cervical biopsies

Dosage and administration:
As with any local anaesthetic, the safety and effectiveness of lidocaine depend on the proper dosage, the correct technique, adequate precautions and readiness for emergencies.
The following dosage recommendations should be regarded as a guide. The clinician's experience and knowledge of the patient's physical status are of importance in calculating the required dose
Each actuation of the metered-dose valve delivers 10 mg Xylocaine base. It is unnecessary to dry the site prior to application.
Xylocaine spray 10% should not be used on cuffs of endotracheal tubes (ETT) made of plastic.

Dose recommendations for adults


Area

Recommended
dose (mg)

Maximum dose
for short 1) procedures (mg)

Maximum dose for prolonged 2) procedure* (mg)

Nasal procedures, e.g. puncture of the maxillary sinus.

20-60

500

eoo

Oral and dental procedures, e.g. prior to injection.

20-200

500

600

Procedures in the oropharynx, e.g. gastrointestinal endoscopy.

20-200

500

600

Procedures in the respiratory tract, e.g. insertion of instruments and tubes

50-400

400

600

Procedures in the larynx, trachea and bronchi.

50-200

200 3)

400

Procedures in obstetrics and gynaecology, e.g. vaginal delivery suturing of ruptures in the mucosa and cervical biopsies

50-200

400

 

1)  For short procedures the drug is given for less than one minute.
2)  For prolonged procedures, the duration of application is more than 5 minutes.
3) During controlled ventilation the dose should be reduced.

Since absorption is variable and especially high in the trachea and bronchi the maximum recommended doses vary depending on the area of application. In children doses should not exceed 3 mg/kg for laryngotracheal use and 4-5 mg/kg for nasal, oral and oropharyngeal use.

In neonates and infants less concentrated lidocaine solutions are recommended.

Contraindications:
Known history of hypersensitivity to local anaesthetics of the amide type or to other components of the spray solution.

Precautions:
Excessive dosage or short Intervals between doses may result In high plasma levels and serious adverse effects Absorption from mucous membranes is variable but is especially high from the bronchial tree. Such applications may therefore result in rapidly rising or excessive plasma concentrations, with an increased risk for toxic symptoms, such as convulsions Lidocaine spray should be used with caution in patients with wounds or traumatized mucosa in the region of the proposed application. A damaged mucosa will permit increased systemic absorption. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs. (See 'Overdosage').

In paralysed patients under general anaesthesia, higher blood concentrations may occur than in spontaneously breathing patients. Unparalysed patients are more likely to swallow a large proportion of the dose which then undergoes considerable first-pass hepatic metabolism following absorption from the gut.

The oropharyngeal use of topical anaesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
If the dose or administration is likely to result In high blood levels, some patients will require special attention to prevent potentially dangerous side effects
- Patients with cardiovascular disease and heart failure
- Patients with partial or complete heart block
- The elderly and patients in poor general health
- Patients with low protein-binding capacity or nephrotic syndrome
- Patients with advanced liver disease or severe renal dysfunction

Avoid contact with the eyes.
Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECQ monitoring considered, since cardiac effects may be additive.
Xylocaine spray 10% should not be used on cuffs of endotracheal tubes (ETT) made of plastic. Lidocaine base In contact with both PVC and non-PVC cutis of endotracheal tubes may cause damage of the cuff. This damage Is described as pinholes, which may cause leakage that could lead to pressure loss in the cuff.

Use in pregnancy and lactation:
It is reasonable to assume that a large number of pregnant women and women of childbearing age have been given lidocaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations.

Like other local anaesthetics lidocaine may enter the mother's milk, but in such small amounts that there is generally no risk of this affecting the neonate

Adverse reactions:
Local reactions
Local irritation at the application site has been described. Following application to laryngeal mucosa before endtracheal intubation, reversible symptoms such as "sore throat". "hoarseness' and "loss of voice* have been reported. The use of Xytocaine pump spray provides surface anaesthesia during an endotracheal procedure but does not prevent post-intubation soreness.

Allergic reactions
Allergic reactions (in the most severe instances anaphylactic shock) to local anaesthetics of the amide type are rare (<0.1%).

Acute systemic toxicity
Lidocaine may cause acute toxic effects if high systemic levels occur due to rapid absorption, e.g. application to areas below the vocal cords, or overdosage (See "Overdosage")

Effects on ability to drive and use machines:
Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

Interaction:
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anesthetics, e.g. antiarrhythmics such as mexiletiri and tocainide. since the toxic effects are additive.

Specific interaction studies with lidocaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised.
Drugs that reduce the clearance of lidocaine are normally inhibitors of CYP2D6 and CYP3A4 e.g. fluoxetine, ritronavir. diclofenac and clarithromycin. Drugs that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. Xylocaine spray) at recommended doses.

Incompatibilities:
Not applicable

Overdosage:
Acute systemic toxicity:
Toxic reactions originate mainly In the central nervous and the cardiovascular systems.

Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are circumoral paresthesia, numbness of the tongue, light-headedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalized convulsions Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration. In severe cases apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.
Recovery is duo to redistribution and metabolism of the local anaesthetic drug from the central nervous system Recovery may be rapid unless large amounts of the drug have been administered.

Cardiovascular effects are only seen in cases with high systemic concentrations. Severe hypotension, bradycardia, arrhythmia and cardiovascular collapse may be the result in such cases.

Cardiovascular toxic effects are generally preceded by signs of toxicity In the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as a benzodiazepine or barbiturate

Treatment of acute toxicity
Treatment of acute toxicity should be instituted at the latest when twitches occur. The necessary drugs and equipment should be Immediately available. The objectives of treatment are to maintain oxygenation, stop the convulsions and support the circulation.
Oxygen must be given and, if necessary, assisted ventilation (mask and bag). An anticonvulsant should be given I.V. if the convulsions do not stop spontaneously in 15-30 sec. Thiopentone sodium 1-3 mg/kg I.V. will abort the convulsions rapidly. Alternatively diazepam 0.1 mg/kg bw I.V. may be used although its action is slower. Prolonged convulsions may jeopardise the patient's ventilation and oxygenation. If so, injection of a muscle relaxant (eg, succinylcholine 1 mg/kg bw) will facilitate ventilation, and oxygenation can be controlled. Early endotracheal intubation must be considered in such situations.

Suxamethonium will stop the muscle convulsions rapidly, but will require tracheal intubation and artificial ventilation, and should only be used by those familiar with these procedures.
If cardiovascular depression is evident (hypotension, bradycardia), ephedrine 5-10 mg I.V. should be given and repeated, if necessary, after 2-3 min. Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance, since hypoxia and acidosis will increase the systemic toxicity of local anaesthetics. Adrenaline (0.1 -0.2 mg as intravenous on intracardiac injections) should be given as soon as possible and repeated, if necessary. Children should be given doses commensurate with their age and weight.

Pharmacodynamic properties
ATC Code: N01BB02
Pharmacotherapeutic group: Local anaesthetic

Pharmacokinetic properties
The extent of absorption of lidocaine is dependent upon the total dose administered, and also upon the specific site of application and the duration of exposure. In general, the rate of absorption following topical administration is most rapid after intratracheal and bronchial administration. Such applications may therefore result in rapidly rising plasma concentrations, with an increased risk of toxic symptoms, such as convulsions. Lidocaine is well absorbed from the gastrointestinal tract, but undergoes extensive first-pass metabolism.

The plasma protein binding is predominantly to alpha-1 -glycoprotein.

The main elimination pathway of lidocaine is by liver metabolism. De-alkylation to monoethylglycme xylidide (MEGX) is mediated mainly by cytochrome P450 3A4. MEGX is metabolised to 2,6-xylidine and glycine xylidide (GX). 2.6-xylidine is metabolised further by CYP2A6 to 4-hydroxy-2,6-xylidine, which Is the major metabolite in the urine (80%) and is excreted as conjugate. MEGX has a convulsant activity equivalent to that of lidocaine, while GX is devoid of convulsant activity. MEGX appears to occur in similar plasma concentrations as the parent substance. The elimination half-life of lidocaine and MEGX following an Intravenous bolus dose are approx. 1.5-2 and 2.5 hours respectively.
On account of the rapid hepatic metabolism, the kinetics are sensitive to all alterations in liver function. The half-life can be more than doubled in patients with impaired liver function. Impaired renal function does not affect the kinetics, but can increase the accumulation of metabolites.
Factors such as acidosis and the use of CNS stimulants and depressants affect the levels of lidocaine required to produce systemic effects. With plasma levels from 5 to 10 mg/ml signs of overdosage become apparent.

Pharmaceutical Particulars
Bottle made of glass with a metering spray pump. The package includes a plastic spray nozzle.
The spray nozzle Is already bent to its final appearance and no further actions should be done before using the spray nozzle-
The nozzle must not be shortened, otherwise the spray function will be destroyed. If cleaning of the nozzle is desired, the entire nozzle can be submersed in boiling water tor 5 minutes. The nozzle can be autociaved (20 minutes at 120ºC).

List of excipients
Ethanol. Polyethylene glycol 400, Essence of banana, Menthol, Saccharin. Purified water

Shelf-life
36 months

Pack size
50 ml

Storage conditions
Store at temperatures below 25ºC During storage at the temperatures below +8ºC precipitation may occur, This precipitation is dissolved when warming up in room temperature.


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