Levobupivacaine injection 75mg/10ml
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection or concentrate for solution for infusion containing 75 mg/10 ml levobupivacaine
Local anaesthetic for epidurals
Local anaesthetic for peribulbar block in ophthalmic surgery
Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5 to 30 mg per minute, while closely observing the patient's vital functions and maintaining verbal contact.
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 to 15 minutes following epidural administration, with a time to regression in the range of 6 to 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.
Surgical Anaesthesia (moderate to complete block)
5.0 to 7.5 mg/ml concentration given by bolus injection over 5 minutes, total dose 50 to 150 mg (10 to 20 ml).
Ophthalmic peribulbar block
7.5 mg/ml concentration, total dose 37.5 to 112.5 mg (5 to 15 ml).
For epidural and peribulbar injection
Children under 18 years
Intravenous regional anaesthesia
Precautions and Warnings
Restricted sodium intake
Cardiac conduction defects
Central nervous system disorder
Sodium content of formulation may be significant
Treatment to be initiated and supervised by a specialist
Aspirate prior to injection to avoid intravascular administration
Discontinue immediately if toxic symptoms occur, especially in epidural use
Initial test dose should be given
Resuscitation facilities must be immediately available
Monitor patient closely if infusion therapy lasts longer than 24 hours
Reduce dose in debilitated patients
Reduce dose in elderly
Driving or operating machinery not advisable following treatment
Concentrated solutions (0.5 to 0.75%) should be administered in incremental doses of 3 to 5 ml. Sufficient time should be allowed between doses to detect toxic symptoms resulting from accidental intravascular or intrathecal injection.
When a large dose is to be injected, in a epidural block for example, a test dose of 3 to 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.
Aspiration should be repeated before and during administration of each injection in continuous catheter techniques. An intravascular injection is still possible despite negative aspirations for blood. During administration of epidural anaesthesia, a test dose should be administered and effects monitored before the full dose is given.
Epidural administration may cause hypotension and bradycardia, therefore all patients must have intravenous access established. Appropriate fluids, vasopressors, anaesthetics with anticonvulsant properties, myorelaxants, atropine, and resuscitation equipment must be immediately available.
Small doses into the head or neck area, including retrobulbar, dental and stellate ganglion blocks, can cause adverse reactions similar to those seen following accidental intravascular injection. There have been reports that respiratory arrest has occurred following local anaesthetic injection. Patients receiving these blocks should be constantly observed and circulatory and respiratory function should be monitored. Equipment and drugs to manage respiratory arrest or depression, convulsions and cardiac stimulation or depression should be immediately available.
Pregnancy and Lactation
Levobupivacaine is contraindicated in pregnancy.
Due to enhanced risk for cardiotoxic events and foetal bradycardia based on experience with bupivacaine, levobupivacaine solutions is contraindicated in obstetrics. At the time of writing there is limited published information regarding the use of levobupivacaine during pregnancy. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity at systemic exposure levels similar to those obtained in clinical use. The manufacturer suggests that levobupivacaine should be contraindicated in concentrations of 5.0 mg/ml and greater for obstetric use including caesarean sections. The potential risk for humans is unknown, therefore levobupivacaine should not be given during early pregnancy unless clearly necessary.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Levobupivacaine is considered safe for use in breastfeeding.
At the time of writing there is limited published information regarding the use of levobupivacaine during breastfeeding. It is not known if levobupivacaine or its metabolites are excreted in human breast milk, but it is likely if levobupivacaine is excreted into breast milk the amount would be too small to cause harm.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Cauda equina syndrome
Decreased cardiac output
Local pain (injection site)
Loss of sphincter control
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2017
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 30 September 2016.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 30 September 2016.
Summary of Product Characteristics: Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion. Abbott Laboratories Ltd. Revised August 2015.
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