Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa
BUPICAN is used as a peripheral nerve block, caudal or epidural block.
The area and vascularity of the tissue, the amount of neuronal segments to be blocked, the technique of anaesthesia as well as personal tolerance to BUPICAN are factors that need to be taken into account when administering BUPICAN.
The utmost care should be taken to prevent an accidental intravascular injection, always including careful aspiration.
When the correct dose of BUPICAN is administered, complete sensory blockage will occur; however, motor blockade depends on the dose of BUPICAN administered. The duration of anaesthesia is such that in most cases, a single dose will be sufficient.
The following dosages are recommended as a guide for use and have generally proved satisfactory in the average adult:
| Procedure | Dose | Additional Info | |
|---|---|---|---|
| mL | mg | ||
| Trigeminal block | 0,5 – 4 | 2,5 – 20 | |
| Axillary block | 15 – 30 | 75 – 150 | |
| Intercostal block | 3 – 5 | 15 – 25 | Dose indicated for every segment |
| Epidural anaesthesia | 10 – 20 | 50 – 100 | |
| Continuous epidural anaesthesia | Starting dose of 10 mL followed by 3 mL – 5 mL – 8 mL every 4 – 6 hours. The dose depends on the number of segments to be rendered analgesic and the patient’s age. | ||
| Caudal anaesthesia | 15 – 30 | 75 – 150 | |
BUPICAN is not recommended for children younger than 12 years.
The maximum recommended dose of BUPICAN in a single injection is 150 mg and should not be exceeded unless there are special considerations present. Where dosage is calculated on the patient’s mass, this should not exceed 2 mg/kg body mass up to a maximum of 150 mg. Patients treated with antidysrhythmic medicines class III (e.g. amiodarone) should be under close surveillance and ECG monitoring, since cardiac effects may be additive (see section 4.5).
Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic toxicity appears later (15–60 minutes after injection) due to the slower increase in local anaesthetic blood concentration.
Maintenance of the airways and ventilation with oxygen of the patient during respiratory distress. Treatment of milder symptoms of systemic toxicity may not be required but if convulsions occur, they can be controlled with oxygen and by rapid intravenous administration of a suitable benzodiazepine or a short-acting barbiturate e.g. thiopentone 100 mg–200 mg or diazepam 5 mg–10 mg.
During circulatory distress intravenous fluids, and when necessary, vasopressors can be administered.
Unopened vials: 36 months.
After first opening: Use immediately.
Store at or below 30°C.
Discard any unused portion.
Keep vials in outer carton until required for use in order to protect the contents from light.
10 mL tubular clear type I glass vials with a 20 mm grey bromobutyl rubber closure covered by an aluminium crimp with a plastic flip-off cap. 5 vials are packed in PVC/aluminium foil blisters and are placed in cardboard cartons.
For single use only.
The solution should be inspected visually before use.
Do not use if the solution is brown or contains a precipitate.
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