Naropin Special Precautions

Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available.
Patients receiving major blocks should be in an optimal condition and have an i.v. line inserted before the blocking procedure. The clinician responsible should take the necessary precautions to avoid intravascular injection (see Dosage & Administration) and be appropriately trained and familiar with the diagnosis and treatment of side effects, systemic toxicity and other complications (see Adverse Reactions and Overdosage).
One complication is inadvertent subarachnoid injection which may produce a high spinal block with apnoea and hypotension.
Convulsions have occurred most often after brachial plexus block and epidural block. This is likely to be the result of either accidental intravascular injection or rapid absorption from the injection site.
Cardiovascular: Epidural and spinal anaesthesia may lead to hypotension and bradycardia. The risk of such effects can be reduced by injecting a vasopressor.
Hypotension should be treated promptly with a sympathomimetic intravenously, repeated as necessary.
Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
There have been rare 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.
Head and neck blocks: Certain local anaesthetic procedures such as injections in the head and neck regions may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used. Caution is required to prevent injections in inflamed areas.
Major peripheral nerve blocks: Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in highly vascularised areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations.
Hypersensitivity: A possible cross-hypersensitivity with other amide-type local anaesthetics should be taken into account.
Hypovolaemia: Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.
Patients in poor general health: Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention, although regional anaesthesia is frequently indicated in these patients.
Acute porphyria: Naropin solution for injection and infusion is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken in the case of vulnerable patients.
Chondrolysis: There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Naropin.
Excipients with recognised action/effect: This medicinal product contains maximum 3.7 mg sodium per mL. To be taken into consideration by patients on a controlled sodium diet.
Prolonged administration: Prolonged administration of ropivacaine should be avoided in patients treated with strong inhibitors of CYP1A2, (such as fluvoxamine and enoxacin) (see Interactions).
Effects on Ability to Drive and Use Machines: Besides the direct anaesthetic effect, local anaesthetics may have a minor influence on mental function and co-ordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.
Patients with hepatic and renal impairment: Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with severe liver disease; repeated doses may need to be reduced due to delayed elimination. Normally there is no need to modify the dose in patients with impaired renal function when used for single-dose or short-term treatment. Acidosis and reduced plasma protein concentration, frequently seen in patients with chronic renal failure, may increase the risk of systemic toxicity.
Use in Children: Neonates may need special attention due to immaturity of some organs and functions. This is especially important during continuous epidural infusion. Higher concentrations than 5 mg/mL have not been documented in children.