Levobupivacaine epidural infusion 0.625mg/ml and 1.25mg/ml
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for infusion containing levobupivacaine.
Local anaesthetic for labour pain
Local anaesthetic for post-operative pain
Levobupivacaine infusion is for epidural use only. Levobupivacaine should be administered in well-equipped facilities. Administration should be by individuals who are trained/experienced in the required anaesthetic technique and who are able to diagnose/treat any adverse effects that may arise.
In the management of postoperative pain, the dose administered during surgery must be taken into account.
The size and physical status of the patient must be evaluated in order to determine the maximum dose. During a 24 hour period, the maximum dose must not exceed 400mg.
Management of postoperative pain
0.625mg/ml solution: 20 to 30ml/hour (12.5 to 18.75mg/hour) as an epidural infusion
1.25mg/ml solution: 10 to 15ml/hour (12.5 to 18.75mg/hour) as an epidural infusion
For postoperative pain management, the dose should not exceed 18.75mg/hour, however the accumulated dose for a 24 hour period should not exceed 400mg.
Analgesia during labour
0.625mg/ml solution: 8 to 20ml/hour (5 to 12.5mg/hour) as an epidural infusion
1.25mg/ml solution: 4 to 10ml/hour (5 to 12.5mg/hour) as an epidural infusion
For labour analgesia by epidural infusion, the dose should not exceed 12.5mg/hour.
Reduced doses should be administered in elderly patients depending on their physical status.
For epidural use only.
Before infusion, careful aspiration is recommended to prevent intravascular injection.
Children under 18 years
Obstetric paracervical anaesthesia
Precautions and Warnings
Restricted sodium intake
Cardiac conduction defects
Central nervous system disorder
First trimester of pregnancy
Second trimester of pregnancy
Sodium content of formulation may be significant
Aspirate prior to injection to avoid intravascular administration
Initial test dose should be given
Resuscitation facilities must be immediately available
Treatment to be administered by or under supervision of specialist
Monitor patient closely if infusion therapy lasts longer than 24 hours
Discontinue immediately on the first signs of toxicity
Discontinue if an intrathecal blockade occurs
Reduce dose in debilitated patients
Reduce dose in elderly
Driving or operating machinery not advisable following treatment
Pregnancy and Lactation
Levobupivacaine infusion is considered safe for use during labour as an epidural infusion. Use as a paracervical block is contraindicated. Caution is advised during other stages of pregnancy.
The manufacturer recommends levobupivacaine should not be used during early pregnancy unless clearly necessary. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity. The potential risk for humans during early pregnancy is unknown.
Clinical experience with bupivacaine during obstetric surgery is extensive and has not demonstrated any foetotoxic effects.
Breastfeeding may resume following administration with levobupivacaine.
The manufacturer states that it is not known if levobupivacaine is excreted in human breast milk. However, levobupivacaine is likely to be poorly transmitted into breast milk.
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: November 2019
Summary of Product Characteristics: Chirocaine 1.25mg/ml solution for infusion. AbbVie Limited. Revised June 2019.
Summary of Product Characteristics: Levobupivacaine 0.625mg/ml solution for infusion. Fresenius Kabi Limited. Revised May 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 30 October 2019
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