NAROPIN

What it is

NAROPIN is ropivacaine hydrochloride, supplied as injection solutions for the production of local or regional anaesthesia. It is not for intravenous administration under any circumstances. The pharmaceutical form is an injection solution presented as a clear colourless solution. Ropivacaine is the first long acting amide local anaesthetic developed as a pure enantiomer. Ropivacaine has both anaesthetic and analgesic effects; at higher doses it produces surgical anaesthesia with motor block, while at lower doses it produces a sensory block including analgesia with little motor block.

Approved indications **Surgical anaesthesia (adults and children over 12 years of age):** — Epidural block for surgery including caesarean section — Intrathecal anaesthesia — Field block (minor nerve block and infiltration) — Major nerve block

**Analgesia (adults and children over 12 years of age):** — Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain — Field block (minor nerve block and infiltration) — Continuous peripheral nerve block infusion or intermittent injections for post-operative pain management — Continuous wound infusion for postoperative pain management (adults only)

**Analgesia (children aged 0–12 years):** — Caudal epidural block in neonates (>37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years — Continuous epidural infusion in infants (>30 days and over 2500 g weight) and children up to and including 12 years — Peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management There are no safety or efficacy data to support the use of NAROPIN for analgesia for longer than 72 hours.

Dosing overview

The lowest dosage that results in effective anaesthesia should be used 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. The 1% (10 mg/mL) formulation is recommended for epidural anaesthesia in which a profound motor block is essential for surgery. For postoperative pain management, infusion rates of 6–14 mL (12–28 mg) per hour of NAROPIN 0.2% provide 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 a continuous peripheral infusion or intermittent injections, data support use for up to 48 hours only at dosages of 10–20 mg/hr (5–10 mL/hr). In paediatric patients, dosages should be regarded as guidelines; individual variations occur. In children with a high body weight a gradual reduction of the dosage is often necessary and should be based on the ideal body weight. The volume for single caudal epidural block and the volume for epidural bolus doses should not exceed 25 mL in any patient.

Key safety warnings

Resuscitative equipment and drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems. Because of the possibility of hypotension and bradycardia following major blocks, an intravenous cannula should be inserted before the local anaesthetic is injected. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects. There have been reports of cardiac arrest during the use of NAROPIN for epidural anaesthesia or peripheral nerve blockade, especially after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome. NAROPIN should not be used for post-operative intra-articular continuous infusion. When neuraxial anaesthesia is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters, traumatic or repeated epidural or spinal puncture, and the concomitant use of drugs affecting haemostasis such as NSAIDs, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment. Elderly, young or debilitated patients, including those with partial or complete heart conduction block, advanced liver disease or severe renal dysfunction, should be given reduced doses commensurate with their age and physical condition. NAROPIN is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available.

Contraindications

Allergy or hypersensitivity to amide type local anaesthetics. Intravenous administration. Local anaesthetics are contraindicated for epidural and spinal anaesthesia in patients with uncorrected hypotension. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection and/or in the presence of septicaemia. Intravenous regional anaesthesia (Bier's block) is contraindicated as unintentional passage of local anaesthetic into the systemic circulation, despite the use of a tourniquet, may cause systemic toxic reactions. The use of NAROPIN is not recommended for obstetric paracervical block.

Regulatory history

NAROPIN was first registered on the Australian Register of Therapeutic Goods on 30 January 1996, with multiple strengths and formulations listed including 0.2%, 0.5%, 0.75% and 1% concentrations supplied as injection ampoules and bags. Formulations combining NAROPIN 0.2% with fentanyl were listed from 23–24 May 2000.