Loading…
BUPIVACAINE HYDROCHLORIDE is a brand name for Bupivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bupivacaine Hydrochloride is 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 situations where prolonged anaesthesia is required. Because sensory nerve block is more marked than motor…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and children above 12 years of age The dosage varies and depends upon 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.
The lowest dosage needed to provide effective anaesthesia should be administered. 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 150 mg bupivacaine hydrochloride monohydrate. Doses of up to 50 mg 2-hourly may subsequently be used. A maximum dose of 2 mg/kg should not be exceeded in any four-hour period. The following table is a guide to dosage for the more commonly used techniques in the average adult.
The figures reflect the expected average dose range needed. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements. B. When prolonged blocks are used, either by continuous infusion or by repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing a local neural injury must be considered.
The clinician's experience and knowledge of the patient's physical status is important in calculating the required dose. The lowest dose required for adequate anaesthesia should be used. Individual variations in onset and duration occur.
g. g. g. 5 <60 <150 1-3 3-4 Notes: Dose includes test dose. 1) The dose for a major nerve block must be adjusted according to site of administration and patient status. 4. 2) In total <500 mg/24 h. 3) This solution is often used for epidural administration in combination with a suitable opioid for pain management.
In total <400 mg/24 h. 4) If additional bupivacaine is used by any other techniques in the same patient, an overall dose limit of 150 mg should not be exceeded. 5) There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics.
4). 6) Bupivacaine without adrenaline. g. epidural administration) requires the use of higher concentrations and doses. g. in the relief of labour pain), the use of a lower concentration is indicated. The volume of drug used will affect the extent of spread of anaesthesia.
Bupivacaine causes systemic toxicity similar to that observed with other local anaesthetic agents. It is caused by high plasma concentrations as a result of excessive dosage, rapid absorption or, most commonly, inadvertent intravascular injection.
Such reactions involve the central nervous system and the cardiovascular system. CNS reactions are characterised by numbness of the tongue, light-headedness, dizziness, blurred vision and muscle twitch, followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.
Cardiovascular reactions are depressant and are characterised by hypotension and myocardial depression. They may be the result of hypoxia due to convulsions and apnoea as well as a direct effect. Accidental sub-arachnoid injection can lead to very high spinal anaesthesia possibly with apnoea and severe hypotension.
The adverse reaction profile for Bupivacaine is similar to those for other long acting local anaesthetics. g. g. g. 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 non- sterile solution. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control and paraplegia.
Occasionally these are permanent. In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock). Tabulated list of adverse reactions The adverse reactions considered at least possibly related to treatment with Bupivacaine from clinical trials with related products and post-marketing experience are listed below by body system organ class and absolute frequency.
There have been reports of cardiac arrest or death during the use of bupivacaine for epidural anaesthesia or peripheral nerve blockade where resuscitative efforts have been difficult, and were required to be prolonged before the patient responded.
However, in some instances resuscitation has proven difficult or impossible despite apparently adequate preparation and appropriate management. Like all local anaesthetic drugs, bupivacaine may cause acute toxicity effects on the central nervous and cardiovascular systems if utilised for local anaesthetic procedures resulting in high blood concentrations of the drug.
This is especially the case after unintentional intravascular administration or injection into highly vascular areas. Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death have been reported in connection with high systemic concentrations of bupivacaine.
Adequate resuscitation equipment should be available whenever local or general anaesthesia is administered. Overdosage or accidental intravenous injection may give rise to toxic reactions with marked restlessness, twitching or convulsions followed by coma with apnoea and cardiovascular collapse.
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. v. line inserted before the blocking procedure.
9). 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. Overdosage or accidental intravenous injection may give rise to toxic reactions. 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.
1. Bupivacaine hydrochloride solutions are contra- indicated in patients with hypersensitivity to local anaesthetic agents of the amide type. Solutions of bupivacaine hydrochloride are contra-indicated for injection into inflamed or infected areas and for intravenous regional anaesthesia (Bier's-block) and obstetrical paracervical block.
Epidural anaesthesia, regardless of the local anaesthetic used, has its own contra- indications which include: Active diseases of the central nervous system such as meningitis, poliomyelitis and intracranial haemorrhage, sub-acute combined degeneration of the cord due to pernicious anaemia and cerebral and 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 anticoagulation treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bupivacaine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In order to avoid intravascular injection, aspiration should be repeated prior to and during administration of the main dose, which should be injected slowly or in incremental doses, at a rate of 25-50 mg/min, while closely observing the patient's vital functions and maintaining verbal contact.
When an epidural dose is to be injected, a preceding test dose of 3-5 ml bupivacaine containing adrenaline (epinephrine) is recommended. An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block.
1). Experience to date indicates that 400 mg administered over 24 hours is well tolerated in the average adult. Paediatric population 1 to 12 years of age Paediatric regional anaesthetic procedures should be performed by qualified clinicians who are familiar with this population and the technique.
The doses in the table should be regarded as guidelines for use in paediatrics. Individual variations occur. In children with a high body weight a gradual reduction of the dosage is often necessary and should be based on the ideal body weight.
Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements. The lowest dose required for adequate analgesia should be used. Table 2 Dosage recommendations for children 1 to 12 years of age Conc.
g […]
5) Respiratory, thoracic Rare Respiratory depression and mediastinal disorders Gastrointestinal disorders Very Common Nausea Common Vomiting Renal and urinary disorders 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.
If signs of hepatic dysfunction are observed during treatment with bupivacaine, the drug should be discontinued. 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. . Signs of toxicity in the central nervous system generally precede cardiovascular toxic effects, unless the patient is receiving a general anaesthetic or is heavily sedated with medicinal products such as benzodiazepine or barbiturate.
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 and possible loss of functional airways. In severe cases apnoea may occur. Acidosis, hyperkalaemia, hypocalcaemia 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.
Paediatric population Adverse drug reactions in children are similar to those […]
Tolerance varies with the status of the patient. 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 the late stages of pregnancy.
g. amiodarone) should be under close surveillance and ECG monitoring, since cardiac effects may be additive. ) have not shown cross-sensitivity to agents of the amide type such as bupivacaine. Certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used.
• Local anaesthetics should be used with caution for epidural anaesthesia in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.
• The physiological effects generated by a central neural blockade are more pronounced in the presence of hypotension. Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anaesthesia.
Epidural anaesthesia should therefore be avoided or used with caution in patients with untreated hypovolaemia or significantly impaired venous return. • Retrobulbar injections may very rarely reach the cranial subarachnoid space causing temporary blindness, cardiovascular collapse, apnoea, convulsions, etc.
These must be diagnosed and treated promptly. • Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles and/or nerves.
The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used.
• Vasoconstrictors may aggravate tissue reactions and should be used only when indicated. • 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.
• 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 bupivacaine solution for injection.
Hypotension and bradycardia may occur as normal physiological phenomena following sympathetic block with central neural blocks. Epidural anaesthesia and subarachnoid block may lead to hypotension and bradycardia. g. by injecting a […]