Levobupivacaine epidural infusion 0.625mg/ml and 1.25mg/ml
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for infusion containing levobupivacaine.
Drugs List
Therapeutic Indications
Uses
Local anaesthetic for labour pain
Local anaesthetic for post-operative pain
Dosage
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.
Adults
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.
Elderly
Reduced doses should be administered in elderly patients depending on their physical status.
Administration
For epidural use only.
Before infusion, careful aspiration is recommended to prevent intravascular injection.
Contraindications
Children under 18 years
Hypovolaemic shock
Atrioventricular block
Cardiogenic shock
Obstetric paracervical anaesthesia
Severe hypotension
Precautions and Warnings
Debilitation
Elderly
Restricted sodium intake
Alcoholism
Cardiac conduction defects
Cardiovascular disorder
Central nervous system disorder
Epileptic disorder
First trimester of pregnancy
Hepatic cirrhosis
Hepatic impairment
Myasthenia gravis
Respiratory impairment
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
Pregnancy
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.
Lactation
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.
Side Effects
Anaemia
Anaphylactic shock
Anaphylactoid reaction
Anaphylaxis
Angioedema
Angioneurotic oedema
Anhidrosis
Apnoea
Back pain
Bladder dysfunction
Blurred vision
Bradycardia
Cardiac arrest
Cauda equina syndrome
Convulsions
Decreased cardiac output
Dizziness
ECG changes
Enophthalmos
Erythema
Flushing
Foetal distress
Headache
Heart block
Hyperhidrosis
Hypersensitivity reactions
Hypotension
Laryngeal oedema
Local pain (injection site)
Loss of sphincter control
Miosis
Muscle twitch
Muscle weakness
Nausea
Neurological damage
Oral hypoaesthesia
Paraesthesia
Paralysis
Paraplegia
Priapism
Pruritus
Ptosis
Pyrexia
Respiratory arrest
Sneezing
Somnolence
Sweating
Syncope
Tachycardia
Unconsciousness
Urticaria
Ventricular tachyarrhythmias
Vomiting
Overdosage
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 ).
Further Information
Last Full Review Date: November 2019
Reference Sources
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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