Special Warning : אזהרת שימוש

4.4.   Special warnings and precautions for use
There should be awareness that spinal anaesthesia can sometimes lead to major blockades with paralysis of intercostal muscles and the diaphragm, especially inpregnant women.

Caution should be exercised in patients with grade II or III AV block since local anaesthetic agents can decrease the conduction capacity of the myocardium.
The elderly and patients with severe hepatic disease, severely impaired renal function or whose general condition is impaired also require special attention.

Patients being treated with class III antiarrhythmic agents (e.g. amiodarone) should be closely monitored and ECG monitoring considered since the cardiac effects of bupivacaine and class III antiarrhythmic agents may be additive.

Intrathecal anaesthesia may lead to hypotension and bradycardia. The risk of such effects can be reduced, e.g., by injecting a vasopressor. Hypotension should be treated promptly with a sympathomimetic intravenously, repeated as necessary.

Like all local anaesthetic agents, bupivacaine may cause acute toxic effects on the central nervous system and cardiovascular system when its use leads to high blood concentrations. This applies especially after accidental intravascular administration or administration into highly vascularised areas.

Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death have been reported in connection with high systemic concentrations of bupivacaine.
However, high systemic concentrations are uncommon at the doses normally used in spinal anaesthesia.

One uncommon, but serious, side effect in spinal anaesthesia is extensive or total spinal blockade resulting in cardiovascular depression and respiratory depression. The cardiovascular depression is caused by extensive sympathetic blockade, which can result in hypotension and bradycardia, or even cardiac arrest. Respiratory depression may be caused by blockade of the innervation of the respiratory muscles, including thediaphragm.

There is an increased risk of extensive or total spinal blockade in elderly patients and patients in the late stages of pregnancy. Therefore, the dose should be reduced in these patients.
In rare cases, spinal anaesthesia may lead to neurological damage, which results in paraesthesia, anaesthesia, motor weakness and paralysis. Neurological disorders, such as multiple sclerosis, hemiplegia, paraplegia and neuromuscular disorders are not thought to be adversely affected by spinal anaesthesia, but caution should be exercised.

Effects on Driving

4.7      Effects on ability to drive and use machines
Depending on the dose and method of administration, bupivacaine may have a transient effect on mobility and coordination.