Xylocaine + Adrenaline 2% Injection (5 x 20ml)

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (400 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).

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Description

Xylocaine + Adrenaline 2% Injection

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (400 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).

Product Details

  • Xylocaine 2% with Adrenaline is indicated for regional anaesthesia in adults and children above 12 years of age.
  • Store between 2°C and 8°C.
  • 5 x 20ml
  • Prescription Medicine
  • Use within 3 days of first opening.

Special warnings and precautions for use

Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. When performing major blocks, or using large doses, an IV cannula should be inserted before the local anaesthetic is injected. Clinicians should have received adequate and appropriate training in the procedure to be performed and should be familiar with the diagnosis and treatment of side effects, systemic toxicity or other complications (see sections 4.8 and 4.9).

Xylocaine with Adrenaline should not be given intravenously.

The effect of local anaesthetics may be reduced if an injection is made into an inflamed or infected area.

Attempts should be made to optimise the patient’s condition before major blocks.

Although regional anaesthesia is frequently the optimal anaesthetic technique, some patients require special attention in order to reduce the risk of dangerous side effects:

– Patients with epilepsy.

– Patients with impaired respiratory function.

– Older people and patients in poor general condition.

– Patients with partial or complete heart conduction block – due to the fact that local anaesthetics may depress myocardial conduction.

– Patients with advanced liver disease or severe renal dysfunction.

– Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive (see section 4.5).

– Patients with acute porphyria. Xylocaine solution for injection is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used, e.g.:

– Injections in the head and neck regions may be made inadvertently into an artery, causing cerebral symptoms even at low doses.

– Paracervical block can sometimes cause foetal bradycardia/tachycardia, and careful monitoring of the foetal heart rate is necessary.

– There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Xylocaine.

Solutions containing adrenaline should be used with caution in patients with hypertension, cardiac disease, cerebrovascular insufficiency hyperthyroidism, advanced diabetes and any other pathological condition that may be aggravated by the effects of adrenaline.

Xylocaine with adrenaline contains sodium metabisulphite, which may cause allergic reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulphite sensitivity in the general population is unknown and probably low. Sulphite sensitivity is seen more frequently in asthmatic than non-asthmatic people.

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