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Marcain

Marcain Adverse Reactions

bupivacaine

Manufacturer:

Aspen Pharmacare Asia

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Adverse Reactions
Accidental sub-arachnoid injection can lead to very high spinal anaesthesia possibly with apnoea and severe hypotension.
The adverse reaction profile for Marcain is similar to those for other long acting local anaesthetics. Adverse reactions caused by the drug per se are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia), events caused directly (e.g. nerve trauma) or indirectly (e.g. epidural abscess) by needle puncture.
Neurological damage is a rare but well recognised consequence of regional and particularly epidural and spinal anaesthesia. It may be due to several causes, e.g. direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance, or an injection of a non-sterile solution. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control and paraplegia. Occasionally these are permanent.
The adverse reactions considered at least possibly related to treatment with Marcain from clinical trials with related products and post-marketing experience are listed below by body system organ class and absolute frequency. Frequencies are defined as very common (1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (1/10,000, <1/1,000) including isolated reports, or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data). (See Table 3.)

Click on icon to see table/diagram/image

Hepatic dysfunction, with reversible increases of SGOT, SGPT, alkaline phosphates and bilirubin, has been observed following repeated injections or long-term infusions of bupivacaine. If signs of hepatic dysfunction are observed during treatment with bupivacaine, the drug should be discontinued.
Paediatric population: Adverse drug reactions in children are similar to those in adults, however in children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.
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