Bupivacaine hydrochloride

Source is the eMC SPC for Bupivacaine 2.5 mg/ml Solution for Injection (plain bupivacaine, no adrenaline; eMC product 11611). The dosage varies with the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the technique used - the lowest dosage needed to provide effective anaesthesia should be administered. 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 the particular injection site; doses should be reduced for young, elderly or debilitated patients. When prolonged blocks are used by continuous infusion or repeated bolus administration, the risk of reaching a toxic plasma concentration must be considered. To avoid intravascular injection, repeat aspiration before and during administration of the main dose, which should be injected slowly or in incremental doses at 25 to 50 mg/min while closely observing vital functions and maintaining verbal contact; stop the injection immediately if toxic symptoms occur. When an epidural dose is to be injected, a preceding test dose of 3 to 5 ml of bupivacaine containing adrenaline is recommended. Intra-articular block, for example a single injection after knee arthroscopy, up to 100 mg (up to 40 ml of 2.5 mg/ml); bupivacaine is not approved for continuous intra-articular infusion (post-marketing reports of chondrolysis). The dose for a major nerve block must be adjusted according to the site of administration and patient status; interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions. Special attention and reduced doses are required in older people and patients in poor general condition, patients with partial or complete heart block, patients with advanced liver disease or severe renal dysfunction, patients in late stages of pregnancy, and patients on class III antiarrhythmics such as amiodarone (close surveillance and ECG monitoring should be considered).

The SPC states a RANGE, not a single per-kg figure: 1.5 to 2 mg/kg using bupivacaine 2.5 mg/ml at a volume of 0.6 to 0.8 ml/kg for caudal, lumbar and thoracic epidural administration in children 1 to 12 years; no single value is asserted here. Field block and peripheral nerve blocks (e.g. ilioinguinal-iliohypogastric) are listed at concentrations 2.5 and 5.0 mg/ml with the volume (ml/kg) and dose (mg/kg) columns both printed as 0.5 to 2.0 - the fetched table is compressed at this row, so verify against the SPC. Other stated paediatric uses: peritonsillar infiltration in children above 2 years with 2.5 mg/ml at 7.5 to 12.5 mg per tonsil; ilioinguinal-iliohypogastric block in children aged 1 year or older with 2.5 mg/ml at 0.1 to 0.5 ml/kg (equivalent to 0.25 to 1.25 mg/kg), and children aged 5 years or older with 5 mg/ml at 1.25 to 2 mg/kg; penile block with 5 mg/ml at total doses of 0.2 to 0.5 ml/kg (equivalent to 1 to 2.5 mg/kg). In children with a high body weight a gradual reduction of the dosage is often necessary and should be based on ideal body weight; use the lowest dose required for adequate analgesia. Paediatric regional anaesthetic procedures should be performed by qualified clinicians familiar with this population and the technique, consulting standard textbooks. Safety and efficacy in children under 1 year of age have not been established, and safety and efficacy of intermittent epidural bolus injection or continuous infusion have not been established. Verify against a children's formulary before use.