ROPIBAM

What it is

Ropibam is ropivacaine hydrochloride, a solution for injection containing 2 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride per mL. Ropibam is a sterile, clear, colourless, isotonic, isobaric, aqueous solution of ropivacaine HCl in water for injections. The solution is preservative free.

Approved indications

— Epidural block for surgery including caesarean section in adults and children over 12 years of age. — Intrathecal anaesthesia in adults and children over 12 years of age. — Field block (minor nerve block and infiltration) for surgical anaesthesia in adults and children over 12 years of age. — Major nerve block for surgical anaesthesia in adults and children over 12 years of age. — Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain in adults and children over 12 years of age. — Continuous peripheral nerve block infusion or intermittent injections for post-operative pain management in adults and children over 12 years of age. — Continuous wound infusion for postoperative pain management in adults only. — Caudal epidural block in neonates (over 37 weeks gestation and over 2,500 g weight), infants and children up to and including 12 years for peri- and postoperative pain management. — Continuous epidural infusion in infants (over 30 days and over 2,500 g weight) and children up to and including 12 years for peri- and postoperative pain management. — Peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management.

Dosing overview

The lowest dosage that results in effective anaesthesia should be used and should be based on the status of the patient and the type of regional anaesthesia intended. In general, surgical anaesthesia requires the use of higher concentrations and doses than those required for analgesia. For surgical anaesthesia in adults and children over 12 years, dosing varies by procedure. For lumbar epidural administration in abdominal, pelvic and lower limb surgery, 0.75% (7.5 mg/mL) in volumes of 15–25 mL or 1% (10 mg/mL) in volumes of 15–20 mL are recommended. For caesarean section via lumbar epidural, 0.75% (7.5 mg/mL) in volumes of 15–20 mL is recommended. For thoracic epidural administration in upper abdominal and thoracic surgery, 0.75% (7.5 mg/mL) in volumes of 5–15 mL are recommended. For intrathecal anaesthesia, 0.5% (5 mg/mL) in volumes of 3–4 mL are recommended. For postoperative analgesia, epidural analgesia is maintained with Ropibam 0.2% (2 mg/mL) infusion, with infusion rates of 6–14 mL (12–28 mg) per hour providing adequate analgesia with only slight and non-progressive motor block in most cases of moderate to severe postoperative pain. For peripheral nerve block administered as continuous peripheral infusion or intermittent injections, dosages of 10–20 mg per hour (5–10 mL per hour) support use for up to 48 hours only.

Key safety warnings

Ropibam should only be used by or under the supervision of clinicians experienced in regional anaesthesia. Careful aspiration before and during injection is recommended to avoid intravascular injection. The main dose should be injected slowly at a rate of 25–50 mg per minute, while closely observing the patient's vital functions and maintaining verbal contact. Interscalene and supraclavicular brachial plexus blocks may be associated with higher frequency of serious adverse reactions regardless of the local anaesthetic used. When prolonged epidural blocks are used, either by continuous infusion or repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. There are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. Data for peripheral nerve block administered as continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only.

Regulatory history

Ropibam was first registered on the ARTG on 9 March 2012, with eight variants listed across 0.2%, 0.75% and 1% strengths in various presentations including ampoules and bags.