Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marcain Heavy 0.5% solution for injection is indicated in adults and children of all ages for intrathecal (subarachnoid) spinal anaesthesia for surgery (urological and lower limb surgery lasting 2–3 hours, abdominal surgery lasting 45–60 minutes).
Bupivacaine is a long-acting anaesthetic agent of the amide type. Marcain Heavy has a rapid onset of action and long duration. The duration of analgesia in the T10–T12 segments is 2–3 hours.
Marcain Heavy produces a moderate muscular relaxation of the lower extremities lasting 2–2.5 hours. The motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 45–60 minutes. The duration of the motor blockade does not exceed the duration of analgesia. The cardiovascular effects of Marcain Heavy are similar or less than those seen with other spinal agents. Bupivacaine 5 mg/ml with glucose 80 mg/ml is exceptionally well tolerated by all tissues with which it comes in contact.
The doses recommended below should be regarded as a guide for use in the average adult.
The figures reflect the expected average dose range needed. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.
The clinician’s experience and knowledge of the patient’s physical status are of importance in calculating the required dose. The lowest dose required for adequate anaesthesia should be used. Individual variations in onset and duration occur, and the extent of the spread of anaesthesia may be difficult to predict, but will be affected by the volume of the drug used, especially with the isobaric (plain) solution.
Intrathecal anaesthesia for surgery:
2-4 ml (10-20 mg bupivacaine hydrochloride).
The dose should be reduced in the elderly and in patients in the late stages of pregnancy, see Section 4.4.
Marcain Heavy may be used in children.
One of the differences between small children and adults is a relatively high CSF volume in infants and neonates, requiring a relatively larger dose/kg to produce the same level of block as compared to adults.
Paediatric regional anaesthesia procedures should be performed by qualified clinicians who are familiar with this population and the techniques.
The doses in the table should be regarded as guidelines for use in paediatric patients. Individual variations occur. Standard textbooks should be consulted for factors affecting specific block technique and for individual patient requirements. The lowest dose required for adequate anaesthesia should be used.
Dosage recommendations in neonates, infants and children:
| Body weight (kg) | Dose (mg/kg) |
|---|---|
| <5 | 0.40-0.50 mg/kg |
| 5 to 15 | 0.30-0.40 mg/kg |
| 15 to 40 | 0.25-0.30 mg/kg |
The spread of anaesthesia obtained with Marcain Heavy depends on several factors including the volume of solution and the position of the patient during and following the injection.
When injected at the L3–L4 intervertebral space, with the patient in the sitting position, 3 ml of Marcain Heavy spreads to the T7–T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spreads to T4–T7 spinal segments. It should be understood that the level of spinal anaesthesia achieved with any local anaesthetic can be unpredictable in a given patient.
The recommended site of injection is below L3.
The effects of injections of Marcain Heavy exceeding 4 ml have not yet been studied and such volumes can therefore not be recommended.
Route of administration: For intrathecal injection.
Marcain Heavy, used as recommended, is not likely to cause blood levels high enough to cause systemic toxicity. However, if other local anaesthetics are concomitantly administered, toxic effects are additive and may cause systemic toxic reactions. (See section 4.8.2 and 4.8.3).
3 years.
Do not store above 25°C.
4 ml sterile wrapped glass ampoules or One Point Cut ampoules. Not all pack sizes may be marketed.
The solution should be used immediately after opening of the ampoule. Any remaining solution should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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