levobupivacaine hydrochloride: clinical use

Prescribing considerations

• Use only where trained staff, monitoring and resuscitation facilities are immediately available.
• Review cardiovascular function, liver disease, pre-existing neurological disease, frailty and acute illness.
• Prevent unintended intravascular or intrathecal administration using appropriate technique.
• Prolonged epidural exposure needs careful benefit–risk assessment because reported neurological injury has been more severe with extended use.
• Consider sodium content in patients requiring sodium restriction.

Contraindications and cautions

• Hypersensitivity to levobupivacaine, another amide local anaesthetic or a formulation excipient
• Intravenous regional anaesthesia (Bier block)
• Severe hypotension, including cardiogenic or hypovolaemic shock
• Paracervical block in obstetrics
• General contraindications to the proposed regional anaesthetic technique

Monitoring

• Blood pressure, heart rate, ECG, oxygenation, ventilation and consciousness
• Sensory and motor block, pain control and signs of unintended high spinal block
• Neurological or cardiac features of local-anaesthetic systemic toxicity
• Neurological function and bladder or bowel symptoms during epidural use
• Catheter, pump and insertion site during epidural infusion

Clinical pharmacology

Levobupivacaine is the S-enantiomer of bupivacaine and a long-acting amide local anaesthetic. It predominantly inhibits voltage-gated sodium channels, with additional effects on potassium and calcium channels. It is highly protein-bound and extensively metabolised in the liver, principally through CYP3A4 and CYP1A2 pathways.

Formulation and product differences

• The selected 2.5 mg/ml ampoule is a clear, colourless solution for injection or infusion supporting surgical anaesthesia, epidural pain management and a specified paediatric nerve block.
• The selected 1.25 mg/ml bag is a clear, colourless solution for continuous epidural infusion only, licensed for postoperative pain and labour analgesia in adults.
• Both selected products contain sodium; the stated concentration differs slightly.
• Ampoules are single-use. Infusion bags are for single epidural use and should be used only if clear and intact.

Solution for infusion

Route: Intravenous

Strengths: 1.25 mg/mL

Injection

Route: Parenteral

Strengths: 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL, 25 mg/10 mL, 50 mg/10 mL, 75 mg/10 mL