XYLOCAINE Spray Ref.[6413] Active ingredients: Lidocaine

As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children should be given doses commensurate with their age and physical condition.

Xylocaine Spray should not be used on cuffs of endotracheal tubes (ETT) made of plastic (see also section 4.4).

Each activation of the metered dose valve delivers 10 mg lidocaine base. It is unnecessary to dry the site prior to application. No more than 20 spray applications should be used in any adult to produce the desired anaesthetic effect.

The number of sprays depend on the extent of the area to be anaesthetised.

Dental practice: 1–5 applications to the mucous membranes.

Obstetrics: Up to 20 applications (200 mg lidocaine base).

Insertion of instruments and catheters into the respiratory and digestive tract: Up to 20 applications (200 mg lidocaine base) for procedures in pharynx, larynx, and trachea.

Method of administration

Xylocaine spray is administered using the supplied nozzle. Nozzles are supplied in the finished product packaging and also available separately in boxes of 50. Nozzles are non-sterile single patient single use only. Appropriate measures should be undertaken to avoid cross contamination (see Section 6.6).

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 paraesthesia, 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.

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.

Recovery is due 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.

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 body-weight i.v. may be used, although its action will be slow. Prolonged convulsions may jeopardise the patient’s ventilation and oxygenation. If so, injection of a muscle relaxant (e.g. succinylcholine 1 mg/kg body-weight) will facilitate ventilation, and oxygenation can be controlled. Early endotracheal intubation must be considered in such situations.

If cardiovascular depression is evident (hypotension, bradycardia), ephedrine 5–10 mg i.v. should be given and repeated, if necessary, after 2–3 minutes.

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.

Children should be given doses commensurate with their age and weight.

3 years.

Do not store above 25°C. During storage at temperatures below +8°C precipitation may occur. The precipitate dissolves on warming up to room temperature.

50 ml glass spray bottles (approx. 500 spray doses) with a metering spray pump. The package includes a single use plastic spray nozzle approximately 120 mm long. Additional short spray nozzles are available separately.

Each depression of the metered spray pump delivers 10 mg lidocaine base. The contents of the spray bottles are sufficient to provide approximately 500 sprays.

The spray nozzle is bent to ensure correct spray function. Do not try to alter the shape as this could affect its performance.

The nozzle must not be shortened, as it will affect the spray function.

Nozzles are non-sterile single patient single use and national/local procedures should be adhered to in order to prevent cross contamination. The nozzles should be handled using gloves and the box of 50 should be kept closed between procedures. Nozzles should not be reused and should be discarded immediately after use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.