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Marcaine 0.5% Adrenaline

Marcaine 0.5% Adrenaline Special Precautions

Manufacturer:

Aspen

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Regional or local anaesthetic procedures, except those of the most trivial nature, should always be carried out in the proximity of resuscitation equipment. Before major blocks, an intravenous cannula should be inserted before the local anaesthetic is injected.
There have been reports of cardiac arrest or deaths in cases of use of bupivacaine for epidural anaesthesia or peripheral nerve block. In some cases, resuscitation has been difficult or impossible despite adequate treatment. Extensive peripheral nerve blocks can involve large volumes of local anaesthetics being administered to richly vascularised areas, often in the proximity of large blood vessels.
In these, cases there is an increased risk of intravascular injection and/or systemic absorption, which can lead to high plasma concentrations.
Like all local anaesthetic agents, bupivacaine can cause acute central nervous and cardiovascular toxic effects in cases of use leading to high concentrations in the blood. This applies particularly after inadvertent intravascular administration or injection into highly vascularised areas.
Some regional anaesthesia techniques may be associated with severe adverse reactions, as indicated as follows: Epidural anaesthesia can cause cardiovascular depression, especially in cases of concomitant hypovolaemia. Caution should therefore be exercised in patients with impaired cardiovascular function.
Retrobulbar injections can in rare cases reach the cranial subarachnoid space and cause e.g. temporary blindness, cardiovascular collapse, apnoea and convulsions. These symptoms must be treated immediately.
Retro- and peribulbar injections with local anaesthetics may involve some risk of persistent ocular muscle dysfunction.
The prime causes are traumatic nerve injury and/or local toxic effects on muscles and nerves by injected local anaesthetic. The extent of this tissue damage depends on the degree of trauma, the concentration of the local anaesthetic, and the duration of exposure to the local anaesthetic. For this reason, the lowest effective dose should be chosen. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated. Inadvertent intravascular injection in the head and neck regions can cause immediate cerebral symptoms even with low doses.
Paracervical block can sometimes cause bradycardia/tachycardia in the foetus, and the foetus's heart rhythm must be closely monitored.
Caution should be exercised in patients with degree II or III AV block since local anaesthetics can lower the conduction capacity of the myocardium. Elderly patients and patients with severe hepatic disease, severely impaired renal function or with generally reduced general condition also require special attention.
Patients treated with class III anti-arrhythmic drugs (e.g. amiodarone) should be closely observed and ECG monitoring should be considered, since the cardiac effects of bupivacaine and class III anti-arrhythmic drugs can be additive.
Epidural anaesthesia can lead to hypotension and bradycardia. The risk of such effects can be reduced e.g by injecting a vasopressor. Hypotension should be treated immediately with a sympathomimetic intravenously, repeated as necessary.
Adrenaline-containing solutions should be used with caution in patients with severe or untreated hypertension, poorly controlled thyrotoxicosis, ischaemic heart disease, AV block, cerebrovascular insufficiency, advanced diabetes, and other conditions that can be exacerbated by adrenaline. Caution should also be exercised in cases of use in peripheral parts of the body such as fingers, or parts of the body that for other reasons have a low blood supply. In cases of administration of high doses the risk of systemic effects of adrenaline should be taken into account.
Sodium metabisulfite (anti-oxidant) can in rare cases cause allergic reactions, e.g. asthma of varying severity and anaphylactic reactions.
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 Marcaine Adrenaline.
Hepatic dysfunction, with reversible increases of alanine aminotransferase (ALT), alkaline phosphates (AlkP) and bilirubin, has been observed following repeated injections or long-term infusions of bupivacaine. Association between bupivacaine use and the development of drug-induced liver injury (DILI) has been reported in a small number of literature reports especially with prolonged use. While the pathophysiology of this reaction remains unclear, immediate withdrawal of bupivacaine has shown rapid clinical improvement. If signs of hepatic dysfunction are observed during administration with bupivacaine, the medicinal product should be discontinued. (See Adverse Reactions.)
Effects on Ability to Drive and Use Machines: Depending on the dose and method of administration, bupivacaine can have a transient effect on movement and coordination.
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