bupivacaine hydrochloride: clinical use

Prescribing considerations

• Use only by clinicians trained in the proposed regional technique and management of local-anaesthetic systemic toxicity.
• Prevent intravascular administration through careful aspiration, appropriate test procedures and close patient contact during administration.
• Ensure intravenous access, resuscitation equipment and facilities for oxygenation, ventilation and circulatory support are immediately available.
• Use particular caution with impaired cardiac conduction, advanced liver disease, severe renal dysfunction, hypovolaemia, poor general health, older age and late pregnancy.
• Continuous epidural infusion requires a clearly identified epidural line, appropriate pump safeguards and ongoing assessment of block height, pain, sedation and cardiorespiratory observations.

Contraindications and cautions

• Hypersensitivity to bupivacaine, formulation excipients or amide local anaesthetics.
• Intravenous regional anaesthesia (Bier block).
• For epidural or spinal techniques: infection near the puncture site, relevant central nervous system disease, cardiogenic or hypovolaemic shock, coagulation disorder or ongoing anticoagulant therapy.
• Expanding intracranial lesions where an abrupt pressure change could obstruct cerebrospinal-fluid or cerebral blood flow.

Monitoring

• Observe for early neurological toxicity, hypotension, bradycardia, arrhythmia, respiratory impairment and progression of the block.
• For continuous epidural use, monitor cardiovascular observations, analgesia, sedation and segmental block level.
• Consider close surveillance and ECG monitoring with class III anti-arrhythmics.
• Investigate hepatic dysfunction if it develops during repeated or prolonged exposure.

Clinical pharmacology

Bupivacaine is a long-acting amide local anaesthetic that reduces nerve-cell membrane permeability to sodium ions, blocking nerve impulse generation and conduction. Systemic absorption varies with administration site and tissue vascularity. It is highly protein-bound, metabolised in the liver and excreted mainly as urinary metabolites.

Formulation and product differences

• The selected infusion product is a clear sterile solution in polypropylene bags licensed specifically for continuous epidural analgesia in labour and after surgery; it contains a clinically relevant amount of sodium.
• The selected injection product is a clear sterile solution in polypropylene ampoules for infiltration, peripheral nerve block, epidural and caudal use.
• Neither selected formulation should be mixed with other medicines unless compatibility is established; avoid prolonged contact with metal components.

Solution for infusion

Route: Intravenous

Strengths: 0.1% w/v, 0.125% w/v

Injection

Route: Parenteral

Strengths: 2.5 mg/mL, 5 mg/mL, 0.25% w/v, 0.5% w/v