Bupivacaine Hydrochloride Infusion Solution BP 0.1% w/v Ref.[2579] Active ingredients: Bupivacaine

Route of Administration: Epidural infusion.

Bupivacaine Hydrochloride Infusion Solution should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia.

Every precaution should be taken to avoid accidental intravascular administration; careful aspiration is essential. Prior to commencing a continuous epidural infusion, satisfactory epidural block should be established with test and loading doses of local anaesthetic. A test dose containing adrenaline is recommended, since an intravascular injection of an adrenaline-containing solution may be recognised by an increase in heart rate. A test dose of 7.5mg of bupivacaine 0.25% (3ml) or 10mg of bupivacaine 0.5% (2ml) containing adrenaline may be used. Verbal contact with the patient and repeated measurements of heart rate (ECG) should be maintained following the test dose. Aspiration should be repeated prior to administration of the loading dose and before starting the infusion. Epidural block can usually be established with test and loading doses (total volume 8 – 12ml of bupivacaine 0.25%) and sufficient time should be allowed to confirm that a satisfactory block has been established before commencing the infusion. If symptoms of toxicity or signs of an intrathecal blockade occur, the infusion should be stopped immediately.

Following the start of an infusion a continuous review of the patient is required with adequate clinical monitoring, (a minimum being the recording of blood pressure/pulse pain and sedation assessments). Segmental testing of the level of the block is required at least at 2 hourly intervals throughout the time the infusion is administered. For obstetric analgesia the test level T5/T6 should be clearly marked, for postoperative analgesia the level of block should be determined relative to the site of surgery. Appropriate monitoring should be carried out to detect progressive spread of the block or an increasing density of block.

Adequate filtering should be an integral part of the infusion line. The infusion line should be clearly marked to avoid confusion with intravenous lines. Also to avoid confusion, consideration should be given to using a different brand of proprietary pump to that used for IV infusions. In addition, the following pump specifications should be considered:

• accurate infusion rates down to 1ml/hour should be able to be set.
• positive pressure drive, (not gravity feed), should be present.
• a back-up battery should be present.
• an automatic infusion shut-off should be present in case power is lost or the front of the pump is accidentally opened.

The lowest dose required to provide adequate analgesia should be given. A maximum dose of bupivacaine 2mg/kg should not be exceeded in any 4 hour period. The total dose of bupivacaine over 24 hours should not exceed 400mg.

The length of continuous epidural infusions given post-operatively should be minimised, due to the increased risks of reaching a toxic plasma concentration, inducing local neural injury or local infection. Administration of bupivacaine epidural infusion has not been adequately studied for more than 72 hours.

The dosages in the following table are recommended as a guide for use in healthy adults during labour and in the post operative period. It should not be necessary to exceed an infusion dosage of bupivacaine 20mg/hour. The dosage should be titrated to meet the individual requirements and the lowest effective dosage should be used.

In the management of post-operative pain, the dose given during surgery should be taken into account.

It may be possible to reduce the dose of bupivacaine when epidural opioids are co-administered.

Children: Not recommended.

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. (See sections 4.8.1 & 4.8.2).

2 years.

Do not store above 25°C.

100ml or 250ml polypropylene infusion bags in packs of 10, 20 or 50.

The infusion is for single patient use and should be used immediately after opening. Any unused portion should be discarded.
Bupivacaine Hydrochloride Infusion Solution has been demonstrated to be compatible with fentanyl 2 micrograms/ml, 5 micrograms/ml and 10 micrograms/ml for 48 hours at 25°C and 2 – 8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8°C, unless dilution has taken place in controlled and validated aseptic conditions.