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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.
The clinician's experience and knowledge of the patient's physical status are of importance in calculating the required dose. The lowest dose required for adequate anaesthesia should be used. Individual variations in onset and duration occur, and the extent of the spread of anaesthesia may be difficult to predict, but will be affected by the volume of the drug used, especially with isobaric (plain) solution.
Dosage recommendations: Intrathecal anaesthesia for surgery: 2-4mL (10-20 mg bupivacaine hydrochloride).
The dose should be reduced in elderly patients and patients in the late stages of pregnancy (see Precautions).
Paediatric population: Neonates, infants and children up to 40 kg: One of the differences between young children and adults is a relatively large volume of CSF in infants and neonates, requiring relatively higher dose/kg to produce the same level of nerve block as compared to adults.
Procedures of regional anaesthesia in children should be performed by qualified clinicians who are familiar with this population and techniques. The doses in the table 1 should be regarded as guidelines for use in paediatric patients. There are individual variations. Standard textbooks should be consulted for factors affecting specific block technique and for individual patient requirements. The lowest dose required for adequate anaesthesia should be used. (See Table 1.)
Click on icon to see table/diagram/imageThe spread of anaesthesia obtained with Bupivacaine Hydrochloride depends on several factors including the volume of solution and the position of the patient during and following the injection.
When injected at the L3-L4 intervertebral space, with the patient in the sitting position, 3 mL of Bupivacaine Hydrochloride spreads to the T7-T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spreads to T4-T7 spinal segments. It should be understood that the level of spinal anaesthesia achieved with any local anaesthetic can be unpredictable in a given patient. The recommended site of injection is below L3.
The effects of injections of Bupivacaine Hydrochloride exceeding 4 mL have not yet been studied and such volumes can therefore not be recommended.
Mode of administration: For intrathecal use.
Sergivell Iso: Adults and children above 12 years of age: The following Table 1 is a guide to dosage for the most 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.
N.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 are important in calculating the required dose. The lowest dose required for adequate anesthesia should be used. Individual variations in onset and duration occur.
Warning: There is a risk of systemic effects of adrenaline in the case of a case of administration of high volumes of solutions of anesthetic with adrenaline. (See Table 2.)
Click on icon to see table/diagram/imageIn general, surgical anesthesia (e.g. epidural administration) requires a higher concentration and dose of a local anesthetic. When a less intense nerve block is required (e.g.in the relief of labor pain), the use of a lower concentration of anesthetic is indicated. The volume of medicinal products will affect the extent of the spread of anesthesia.
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. An inadvertent intravascular injection may be recognized by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block. If toxic symptoms occur, the injection should be stopped immediately.
Current experience indicates that 400 mg of bupivacaine administered over 24 hours is well-tolerated dose in the average adult.
Pediatric population 1 to 12 years of age: Pediatric regional anesthetic techniques should be performed by a qualified physician who is familiar with this population and the technique.
The doses listed in Table 2 should be regarded as guidelines for use in pediatrics. There are individual variations. In children with a high body weight is often necessary to reduce the dose gradually working with the assumption of 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. (See Table 3.)
Click on icon to see table/diagram/imageThe dose required for children should be calculated on the basis of knowledge of body weight up to a dose of 2 mg/kg.
In order to avoid intravascular injection, aspiration should be repeated prior to and during the administration of the main dose. The dose should be injected slowly in incremental doses, particularly in the lumbar and thoracic epidural routes, constantly and closely observing the patient's vital functions.
Peritonsillar infiltration has been performed in children above 2 years of age with bupivacaine 2.5 mg/mL at a dose of 7.5-12.5 mg per tonsil.
Ilioinguinal-iliohypogastric blocks have been performed in children aged 1 year or older with bupivacaine 2.5 mg/mL at a dose of 0.1-0.5 mL/kg, equivalent to 0.25-1.25 mg/kg. In children aged 5 years or older bupivacaine 5 mg/mL was administered at a dose of 1.25-2 mg/kg.
For penile blocks bupivacaine 5 mg/mL has been used at a total dose of 0.2-0.5 mL/kg, equivalent to 1-2.5 mg/kg.
Safety and efficacy of this medicine with or without adrenaline in children aged up to 1 year have not been established. Only limited data are available.
Safety and efficacy of intermittent epidural bolus injections or continuous epidural infusion have not been established. Only limited data are available.
Mode of administration: For peripheral nerve block, caudal block, and lumbar epidural block.
