ropivacaine hydrochloride monohydrate: clinical use

Prescribing considerations

• Use only in an appropriately staffed and equipped setting with monitoring and resuscitation immediately available.
• Take precautions against intravascular or intrathecal administration and stop administration immediately if toxicity develops.
• Exercise particular caution with major blocks, head and neck blocks, elderly or systemically unwell patients, conduction disorders, advanced hepatic disease and severe renal dysfunction with acidosis or reduced protein binding.
• Avoid continuous intra-articular infusion because it is unlicensed and has been associated with chondrolysis.
• Neonates require particular vigilance because metabolic immaturity and variable exposure may increase systemic toxicity risk.

Contraindications and cautions

• Hypersensitivity to ropivacaine or another amide local anaesthetic
• Contraindications relevant to the intended epidural or regional technique
• Intravenous regional anaesthesia
• Obstetric paracervical anaesthesia
• Hypovolaemia

Monitoring

• Observe cardiovascular and respiratory status, level of block and early neurological toxicity signs.
• Consider ECG monitoring with class III antiarrhythmics or significant cardiac disease.
• During prolonged administration, assess analgesia, motor block, catheter site and cumulative toxicity risk.
• In neonates, monitor for central nervous system toxicity, oxygen saturation, ECG changes and delayed neurological recovery.

Clinical pharmacology

Ropivacaine is the S-enantiomer of a long-acting amide local anaesthetic. It reversibly inhibits voltage-dependent sodium conductance, blocking nerve impulse propagation. Systemic exposure varies with administration site and vascularity; metabolism is mainly hepatic, with CYP1A2 contributing to its principal metabolite.

Formulation and product differences

• The selected injection product is a clear, colourless sodium-containing solution supplied in ampoules.
• The selected infusion product is a clear, colourless, preservative-free solution supplied in polypropylene bags for epidural infusion.
• Both are intended for single use; inspect the solution and container before use and discard unused contents.
• The infusion product contains more sodium as bag volume increases, which may matter when sodium restriction is clinically important.
• Ropivacaine may precipitate in alkaline solutions; compatibility should be confirmed before mixing.

Solution for infusion

Route: Intravenous

Strengths: 2 mg/mL

Injection

Route: Parenteral

Strengths: 2 mg/mL, 7.5 mg/mL, 10 mg/mL