- lidocaine hydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Lidocaine Injection BP with Preservative 2 %
Each 1 ml contains 20.0 mg of lidocaine hydrochloride, corresponding to 16.2 mg lidocaine.
Each 20 ml solution contains 400 mg Lidocaine Hydrochloride
For the full list of excipients, see section 6.1
Solution for injection.
Clear and colourless solution.
There may be an increased risk of enhanced and prolonged neuromuscular blockade in patients treated concurrently with muscle relaxants (e.g. suxamethonium).
Effects of other medicinal products on LidocaineThere may be an increased risk of ventricular arrhythmia in patients treated concurrently with antipsychotics which prolong or may prolong the QT interval (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine), or 5HT3 antagonists (e.g. tropisetron, dolasetron). Concomitant use of quinupristin/dalfopristin should be avoided. Hypokalaemia produced by acetazolamide, loop diuretics and thiazides antagonises the effect of lidocaine. The clearance of lidocaine may be reduced by beta-adrenoceptor blocking agents (e.g. propranolol) and by cimetidine, requiring a reduction in the dosage of lidocaine. Increase in serum levels of lidocaine may also occur with anti-viral agents (e.g. amprenavir, atazanavir, darunavir, lopinavir). Cardiovascular collapse has been reported following the use of bupivacaine in patients on treatment with verapamil and timolol; lidocaine is closely related to bupivacaine. While adrenaline (epinephrine) when used in conjunction with lidocaine might decrease vascular absorption, it greatly increases the danger of ventricular tachycardia and fibrillation if accidentally injected intravenously.
PregnancyAlthough animal studies have revealed no evidence of harm to the foetus, lidocaine crosses the placenta and should not be administered during early pregnancy unless the benefits are considered to outweigh the risks.Lidocaine given by local perineal infiltration prior to delivery crosses rapidly into the foetal circulation. Elevated lidocaine levels may persist in the newborn for at least 48 hours after delivery. Foetal bradycardia or neonatal bradycardia, hypotonia or respiratory depression may occur.
LactationSmall amounts of lidocaine are secreted into breast milk and the possibility of an allergic reaction in the infant, albeit remote, should be borne in mind when using lidocaine in nursing mothers.
Immune system disordersHypersensitivity reactions (allergic or anaphylactoid reactions, anaphylactic shock) see also Skin & subcutaneous tissue disorders)Skin testing for allergy to Lidocaine is not considered to be reliable.
Nervous & Psychiatric disordersNeurological signs of systemic toxicity include dizziness or light-headedness, nervousness, tremor, circumoral paraesthesia, tongue numbness, drowsiness, convulsions, coma.Nervous system reactions may be excitatory and or depressant. Signs of CNS stimulation may be brief, or may not occur at all, so that the first signs of toxicity may be confusion and drowsiness, followed by coma and respiratory failure.Neurological complications of spinal anaesthesia include transient neurological symptoms such as pain of the lower back, buttock and legs. These symptoms usually develop within twenty-four hours of anaesthesia and resolve within a few days. Isolated cases of arachnoiditis or cauda equina syndrome, with persistent paraesthesia, bowel and urinary dysfunction, or lower limb paralysis have been reported following spinal anaesthesia with lidocaine and other similar agents. The majority of cases have been associated with hyperbaric concentrations of lidocaine or prolonged spinal infusion.
Eye disordersBlurred vision, diplopia and transient amaurosis may be signs of lidocaine toxicity.Bilateral amaurosis may also be a consequence of accidental injection of the optic nerve sheath during ocular procedures. Orbital inflammation and diplopia have been reported following retro- or peribulbar anaesthesia (see section 4.4 Special warnings and precautions for use)
Ear and labyrinth disordersTinnitus, hyperacusis
Cardiac and vascular disordersCardiovascular reactions are depressant and may manifest as hypotension, bradycardia, myocardial depression, cardiac arrhythmias and possibly cardiac arrest or circulatory collapse.
Respiratory, thoracic or mediastinal disordersDyspnoea, bronchospasm, respiratory depression, respiratory arrest
Gastrointestinal disordersNausea, vomiting
Skin & subcutaneous tissue disordersRash, urticaria, oedema (including angioedema, face oedema)
Blood and the lymphatic system disordersMethaemoglobinaemia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Symptoms of acute systemic toxicityCentral nervous system toxicity presents with symptoms of increasing severity. Patients may present initially with circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors or muscle twitching are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercapnia occur rapidly following convulsions due to increased muscular activity, together with the interference with normal respiration and loss of the airway. In severe cases, apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.Effects on the cardiovascular system may be seen in severe cases. Hypotension, bradycardia, arrhythmia and cardiac arrest may occur as a result of high systemic concentrations, with potentially fatal outcome.Recovery occurs as a consequence of redistribution of the local anaesthetic drug from the central nervous system, and metabolism and may be rapid unless large amounts of the drug have been injected.
Treatment of acute toxicityIf signs of acute systemic toxicity appear, injection of the anaesthetic should be stopped immediately.Treatment will be required if convulsions and CNS depression occurs. The objectives of treatment are to maintain oxygenation, stop the convulsions and support the circulation.A patent airway should be established and oxygen should be administered, together with assisted ventilation (mask and bag) if necessary. The circulation should be maintained with infusions of plasma or intravenous fluids. Where further supportive treatment of circulatory depression is required, use of a vasopressor agent may be considered although this involves a risk of central nervous system excitation.If the convulsions do not stop spontaneously in 15-20 seconds, they may be controlled by the intravenous administration of diazepam or thiopentone sodium, bearing in mind that anti-convulsant drugs may also depress respiration and the circulation. Prolonged convulsions may jeopardise the patient's ventilation and oxygenation and early endotracheal intubation should be considered. If cardiac arrest should occur, standard cardiopulmonary resuscitation procedures should be instituted. Continual optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.