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BUPIVACAINE AND ADRENALINE (EPINEPHRINE) is a brand name for Bupivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bupivacaine 0.25% and 0.5% solutions are used for the production of local anaesthesia by percutaneous infiltration, peripheral nerve block(s) and central neural block (caudal or epidural), that is, for specialist use in areas where prolonged anaesthesia is indicated. Bupivacaine is particularly useful for pain relief…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Great care must be taken in order to prevent an accidental intravascular injection, always including careful aspirations. For epidural anaesthesia, a test dose of 3 - 5ml of Bupivacaine containing adrenaline should be administered, since an intravascular injection of adrenaline will be quickly recognised by an increase in heart rate.
Verbal contact and frequent measurements of the heart rate, preferably by electrographic (ECG) monitoring, should be maintained throughout a period of 5 minutes following the test dose. Aspiration should be repeated prior to the administration of the total dose.
, in incremental doses under constant contact with the patient. If mild toxic symptoms develop, the injection must be immediately stopped. The lowest dosage required to achieve effective anaesthesia should be given. However, the dose will vary and will be dependent on the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the technique of anaesthesia used.
For most indications, the duration of anaesthesia with bupivacaine solutions is such that a single dose is sufficient. The maximum dosage must be determined by evaluating the size and physical status of the patient and considering the usual rate of systemic absorption from a particular injection site.
Experience to-date indicates a single dose of up to 150mg bupivacaine hydrochloride. Doses of up to 50mg 2-hourly may subsequently be used. The dosages in the following table are recommended as a guide for use in the average adult. For young, elderly or debilitated patients, these doses should be reduced.
Each dose Motor block+Type of block % Conc. 50 Up to 60 10 to 20 6 to 12 6 to 12 15 to 30 Up to 150 50 to 100 30 to 60 15 to 30 75 to 150 - Moderate to complete Moderate to complete Minimal Moderate to complete Each dose Motor block+Type of block % Conc.
25 10 to 20 10 to 20 Up to 30 Up to 60 20 to 50 50 to 100 25 to 50 Up to 150 Up to 150 50 to 125 Moderate to complete Moderate Moderate to complete Slight to moderate - + With continuous (intermittent) techniques, repeat doses increase the degree of motor block.
5% may produce complete motor block for intra-abdominal surgery. 5% w/v, 1 in 200,000 in children aged < 12 years have not been established. Only limited data are available. Lower strengths may be more appropriate for administration to children aged 1 – 12 years.
The adverse reaction profile for Bupivacaine hydrochloride is similar to those for other long acting local anaesthetics. , epidural abscess) by needle puncture. Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia.
g. direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance, or an injection of a nonsterile solution. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control and paraplegia.
Occasionally these are permanent. The adverse reactions considered at least possibly related to treatment with Bupivacaine hydrochloride from clinical trials with related products and postmarketing experience are listed below by body system organ class and absolute frequency.
Frequencies are defined as very common ( 1/10), common ( 1/100, < 1/10), uncommon ( 1/1,000, < 1/100), rare ( 1/10,000, < 1/1,000) including isolated reports, or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data).
4) Nervous system disorders Common Paraesthesia, dizziness Following epidural injection of some local anaesthetic agents including bupivacaine, high sympathetic blockade may occasionally result in ocular and other symptoms similar to those seen in Horner’s syndrome.
These effects are encountered more commonly in pregnant women. 5) Respiratory, thoracic and mediastinal disorders Rare Respiratory depression Very Common NauseaGastrointestinal disorders Common Vomiting Renal and Common Urinary retention Hepatic dysfunction, with reversible increases of SGOT, SGPT, alkaline phosphates and bilirubin, has been observed following repeated injections or long-term infusions of bupivacaine.
Regional or local 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 whenever local or general anaesthesia is administered.
v. line inserted before the blocking procedure. The clinician responsible should take the necessary precautions to avoid overdose or intravascular injection, always including careful aspiration, and be appropriately trained and familiar with the diagnosis and treatment of side effects, systemic toxicity and other complications such as marked restlessness, twitching or convulsions followed by coma with apnoea and cardiovascular collapse.
Major peripheral nerve blocks may require the administration of a large volume of local anaesthetic in areas of high vascularity, often close to large vessels where there is an increased risk of intravascular injection and/or systemic absorption.
This may lead to high plasma concentrations. Small doses of local anaesthetics injected into the head and neck, including retrobulbar, dental and stellate ganglion blocks, may produce systemic toxicity due to inadvertent intra-arterial injection.
Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anaesthetic injection. Prior to retrobulbar block, necessary equipment, drugs and personnel should be immediately available as with all other regional procedures.
Like all local anaesthetic drugs, bupivacaine may cause acute toxicity effects on the central nervous and cardiovascular systems if utilized for local anaesthetic procedures resulting in high blood concentrations of the drug. Accidental intravascular injection of bupivacaine may lead to systemic toxicity which could result in: • Cerebral haemorrhage due to the sudden rise in blood pressure • Convulsions leading to cardiac arrest • Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death.
1 Bupivacaine hydrochloride solutions are contraindicated in patients with a known hypersensitivity to local anaesthetic agents of the amide group. Solutions of bupivacaine hydrochloride are contraindicated for intravenous regional anaesthesia (Bier's block).
Solutions containing adrenaline are contraindicated in patients with thyrotoxicosis or severe heart disease particularly when tachycardia is present. Solutions of bupivacaine containing adrenaline should not be used in connection with anaesthesia in areas of the body supplied by end arteries or otherwise having a compromised blood supply such as digits, nose, external ear or genitalia owing to the risk of tissue necrosis.
Epidural anaesthesia, regardless of the local anaesthetic used, has its own contraindications which include: Active disease of the central nervous system such as meningitis, poliomyelitis, intracranial haemorrhage, subacute combined degeneration of the cord due to pernicious anaemia and cerebral or spinal tumours.
Tuberculosis of the spine. Pyogenic infection of the skin at or adjacent to the site of lumbar puncture. Cardiogenic or hypovolaemic shock. Coagulation disorders or ongoing anticoagulant therapy. Epidural anaesthesia is contraindicated in patients with an expanding cerebral lesion, a tumour, cyst or abscess, which may, if the intracranial pressure is suddenly altered, cause obstruction to the cerebrospinal fluid or blood circulation (the pressure cone).
g. penile block, Oberst block) may cause ischemic tissue necrosis.
Note:
No specific contraindications were identified for paediatric patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Method of administration Epidural injection
If signs of hepatic dysfunction are observed during treatment with bupivacaine, the drug should be discontinued. Accidental sub-arachnoid injection can lead to very high spinal anaesthesia possibly with apnoea and severe hypotension.
Serious systemic adverse reactions are rare, but may occur in connection with overdosage or unintentional intravascular injection. Paediatric population Adverse drug reactions in children are similar to those in adults, however, in children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during sedation or general anaesthesia.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
1 Acute systemic toxicity Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system. 4). CNS reactions are similar for all amide local anaesthetics, while cardiac reactions are more dependent on the drug, both quantitatively and qualitatively.
Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are usually light-headedness, circumoral paraesthesia, numbness of the tongue, hyperacusis, tinnitus and visual disturbances.
Dysarthria, muscular twitching or tremors 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 hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with respiration Urinary disorders and possible loss of functional airways. In severe cases apnoea may occur.
Acidosis, hyperkalaemia and hypoxia increase and extend the toxic effects of local anaesthetics. Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion.
Recovery may be rapid unless large amounts of the drug have been injected. Cardiovascular system toxicity may be seen in severe cases and is generally preceded by signs of toxicity in the central nervous system. In patients under heavy sedation or receiving a general anaesthetic, prodromal CNS symptoms may be absent.
Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics, but in rare cases cardiac arrest has occurred without prodromal CNS effects. 2 Treatment of acute toxicity If signs […]
g. amiodarone) should be under close surveillance and ECG monitoring, since cardiac effects may be additive. Although regional anaesthesia is frequently the optimal anaesthetic technique, some patients require special attention in order to reduce the risk of dangerous side effects: • The elderly and patients in poor general condition should be given reduced doses commensurate with their physical status.
• Patients with partial or complete heart block – due to the fact that local anaesthetics may depress myocardial conduction. • Patients with advanced liver disease or severe renal dysfunction. • Patients in late stages of pregnancy There have been reports of cardiac arrest with difficult resuscitation or death during the use of bupivacaine for epidural anaesthesia in obstetrical patients.
Resuscitation has been difficult or impossible despite adequate preparation and appropriate management. Paracervical block may have a greater adverse effect on the foetus than any other nerve blocks used in obstetrics. Due to the systemic toxicity of bupivacaine, special care should be taken when using bupivacaine for paracervical block.
Injection of repeated doses of bupivacaine hydrochloride may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug. Tolerance varies with the status of the patient. Only in rare cases have amide local anaesthetics been associated with allergic reactions (with anaphylactic shock developing in most severe instances).
Patients allergic to ester type local anaesthetics such as procaine have not shown cross-sensitivity to amide-type agents such as bupivacaine. Bupivacaine with adrenaline solutions contain sodium metabisulphite, which can cause allergic-type reactions including anaphylaxis and life threatening or less severe asthmatic episodes in certain susceptible individuals.
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. Since bupivacaine is metabolised in the liver, it should be used cautiously in patients with liver disease or with reduced liver blood flow.
Local anaesthetics should be used with caution for epidural anaesthesia in the following situations: severe shock, hypovolaemia, dehydration, hypotension below 90mm systolic or a level less than 30% of their average systolic blood pressure, gross hypertension, marked obesity, senility, cerebral atheroma, myocardial degeneration, toxaemia and severe ischaemic heart disease, (especially with a history of recent infarction) because of the dangers of hypotension.
Similar caution is required in cases of impaired cardiovascular conduction, such as patients with a fixed cardiac output (severe valvular stenosis, heart block, beta-blocking therapy), resulting in decreased ability to respond to dilatation of the vascular bed or to compensate for functional changes associated with the prolongation of A-V conduction produced by local anaesthetics.
Epidural anaesthesia with any local anaesthetic can cause hypotension and bradycardia which should be anticipated and appropriate precautions taken. These may include preloading the circulation with crystalloid or colloid solution. g.
ephedrine 10 - 15mg intravenously in divided doses, intravenous infusions, atropine or glycopyrrolate in the presence of severe bradycardia, and oxygen. Severe hypotension may result from hypovolaemia due to haemorrhage or dehydration, or aorta-caval occlusion in patients with massive ascites, large abdominal tumours or late pregnancy.
Marked hypotension should be avoided in patients with cardiac decompensation. Epidural anaesthesia, properly performed, is generally well […]