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LEVOBUPIVACAINE is a brand name for Levobupivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults and adolescents (≥ 12 years) Surgical anaesthesia - Major, e.g. epidural (including for caesarean section), intrathecal, perineural (peripheral nerve block). - Minor, e.g. infiltration (including peribulbar block in ophthalmic surgery). Pain management - Continuous epidural infusion, single or multiple bolus…
Verbatim from this product's MHRA label. Tap a section to expand.
Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience. Posology The table below is a guide to dosage for the more commonly used blocks. g. epidural administration for pain management), the lower concentrations and doses are recommended.
g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection. There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours.
4). Maximum dose The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur.
Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours. The recommended maximum single dose is 150 mg.
Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. 75 mg/hour. 3). The maximum recommended dose is 150 mg. 5 mg/hour.
25 mg/kg/side. The maximum dosage should be adjusted according to the size, body constitution and physical status of the patient/child. The safety and efficacy of levobupivacaine in children for other indications have not been established.
Special populations Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status. In the management of post-operative pain, the dose given during surgery must be taken into account.
2). 5 mg/ml solutions. 2 Spread over 5 minutes (see also text). 3 Given over 15-20 minutes. g. g. 25 mg/ml) is preferable. 5 The minimum recommended interval between intermittent injections is 15 minutes. 5 mg/ml solutions. 2 No data are available in paediatric population < 6 months of age.
5 mg/ml is indicated for epidural use, intrathecal use, perineural use(peripheral nerve blocks) and for infiltration (including peribulbar use) (see table of doses above). 5–30 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact.
The adverse drug reactions for levobupivacaine are consistent with those known for its respective class of medicinal products. The most commonly reported adverse drug reactions are hypotension, nausea, anaemia, vomiting, dizziness, headache, pyrexia, procedural pain, back pain and foetal distress syndrome in obstetric use (see table below).
Adverse reactions reported either spontaneously or observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data).
8 text below). 8 text below). Adverse reactions with local anaesthetics of the amide type are rare, but they may occur as a result of overdosage or unintentional intravascular injection and may be serious. 3). Accidental intrathecal injection of local anaesthetics can lead to very high spinal anaesthesia.
Cardiovascular effects are related to depression of the conduction system of the heart and a reduction in myocardial excitability and contractility. e. convulsions, but in rare cases, cardiac arrest may occur without prodromal CNS effects.
Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia. It may be due to 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.
Rarely, these may be permanent. There have been reports of prolonged weakness or sensory disturbance, some of which may have been permanent, in association with levobupivacaine therapy. It is difficult to determine whether the long-term effects where the result of medication toxicity or unrecognized trauma during surgery or other mechanical factors, such as catheter insertion and manipulation.
All forms of local and regional anaesthesia with levobupivacaine should be performed in well-equipped facilities and administered by staff trained and experienced in the required anaesthetic techniques and able to diagnose and treat any unwanted adverse effects that may occur.
8). g. 3). The introduction of local anesthetics via either intrathecal or epidural administration into the central nervous system in patients with preexisting CNS diseases may potentially exacerbate some of these disease states. Therefore, clinical judgment should be exercised when contemplating epidural or intrathecal anesthesia in such patients.
75%) should be administered in incremental doses of 3 to 5 ml with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Cases of severe bradycardia, hypotension and respiratory compromise with cardiac arrest (some of them fatal), have been reported in conjunction with local anesthetics, including levobupivacaine.
g. in epidural block, a test dose of 3-5 ml lidocaine with adrenaline is recommended. An inadvertent intravascular injection may then be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block.
Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given.
Epidural anaesthesia with any local anaesthetic may cause hypotension and bradycardia. All patients must have intravenous access established. 9). 8) temporally associated with the use of levobupivacaine for 24 hours or more for epidural analgesia.
General contraindications related to regional anaesthesia, regardless of the local anaesthetic used, should be taken into account. 8). Levobupivacaine solutions are contraindicated for intravenous regional anaesthesia (Bier's block).
Levobupivacaine solutions are contraindicated in patients with severe hypotension such as cardiogenic or hypovolaemic shock. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If toxic symptoms occur, the injection should be stopped immediately. 6.
Reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity paraesthesia, weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with levobupivacaine administration.
4). However, it cannot be determined whether these events are due to an effect of levobupivacaine, mechanical trauma to the spinal cord or spinal nerve roots, or blood collection at the base of the spine. There have also been reports of transient Horner’s syndrome (ptosis, miosis, enophthalmos, unilateral sweating and/or flushing) in association with use of regional anaesthetics, including levobupivacaine.
This event resolves with discontinuation of therapy. 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.
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These events were more severe and in some cases led to permanent sequelae when levobupivacaine was administered for more than 24 hours. Therefore, infusion of levobupivacaine for a period exceeding 24 hours should be considered carefully and only be used when benefit to the patient outweighs the risk.
It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both before the original dose and all subsequent doses, to avoid intravascular or intrathecal injection.
However, a negative aspiration does not ensure against intravascular or intrathecal injection. Levobupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, since the toxic effects of these drugs are additive.
V. fluids running via an indwelling catheter to assure a functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects.
The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. Use in Head and Neck Area Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.
The injection procedures require the utmost care. Reactions may be due to intraarterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain.
Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Use in Ophthalmic Surgery Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anaesthetic injection.
Prior to retrobulbar block, as with all other regional procedures, the immediate availability of equipment, drugs, and personnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation or depression should be assured.
As with other anesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions. Chondrolysis 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 levobupivacaine.
Special populations Debilitated, elderly or acutely ill patients: levobupivacaine should be used with caution in debilitated, elderly or acutely ill patients (see […]