PANCURONIUM BROMIDE Solution for injection Ref.[9354] Active ingredients: Pancuronium

Posology

The use of a peripheral nerve stimulator is recommended for monitoring the neuromuscular block and recovery.

Adult

Initial dose: 50-80 micrograms/kg (intubation accomplished within 150-120 seconds) or 80-100 micrograms/kg (intubation accomplished within 120-90 seconds).

Incremental doses: 10-20 micrograms/kg.

Paediatric

Initial dose: 60-100 micrograms/kg.

Incremental doses: 10-20 micrograms/kg.

Neonates

Doses of pancuronium bromide in neonates up to one month of age must be carefully individualised since neonates are particularly sensitive to non-depolarising neuromuscular blocking agents.

Dosage 30-40 micrograms/kg initially I/V followed by 10-20 micrograms/kg thereafter.

If succinylcholine is used for intubation the administration of pancuronium bromide should be delayed until the patient has clinically recovered from the neuromuscular block induced by succinylcholine.

Following the administration of suxamethonium the dosage of pancuronium bromide may be considerably reduced:

Adults:

Initial dose: 20-60 micrograms/kg.

Incremental doses 10-20 micrograms/kg.

Children:

Initial dose: 20-60 micrograms/kg.

Incremental doses 10-20 micrograms/kg.

Elderly:

The neuromuscular blocking activity of pancuronium bromide is prolonged in the elderly and lower doses may be necessary.

Obesity

In obese patients doses of pancuronium bromide based on a mg/kg basis may lead to over dosage. Dosage must be adjusted according to response.

Intensive care

Pancuronium bromide is longer acting in the intensive care patient, and an intravenous dose of 60 micrograms/kg every one to one and a half hours, or even less frequently is usually adequate.

Impaired liver and renal function

Care must be exercised in patients with impaired liver or renal function. See section 4.4.

Hyperdiuresis may result in a decreased neuromuscular blocking effect.

In the control of tetanus, duration of pancuronium bromide relaxation probably depends upon the severity of the spasm, therefore duration of effect can be variable.

The duration of action depends upon the clinical condition of the patient and the dose administered, but in normal subjects receiving perioperative muscle relaxant doses the duration of action is usually 45-60 minutes.

Pancuronium bromide should not be mixed with other agents in the same syringe, or with solutions for intravenous infusions as a change in pH may cause precipitation.

Discard any unused solution.

Method of administration

Pancuronium bromide should be administered intravenously. It is not recommended to be given by infusion.

The dosage should be individualised as there is a wide variation in individual response to muscle relaxants. When determining the dose, the method of anaesthesia, expected duration of surgery, potential interaction with other drugs that are administered before and during anaesthesia and the condition of the patient should be taken into account.

Clinical features

The symptoms are those of prolonged apnoea, respiratory depression and/or muscle weakness. Death may follow acute respiratory failure.

Management

Neostigmine at a dose of 2.5mg and Atropine at a dose of 1.2mg can be administered to reverse the neuromuscular block whilst ventilation is continued. When administration of the cholinesterase inhibiting agent fails to reverse the neuromuscular blocking effects of pancuronium bromide ventilation must continue until spontaneous breathing is restored. Repeated dosage of cholinesterase inhibitor can be dangerous.

Shelf life: 2 years.

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the ampoule in the outer carton in order to protect from light.

2ml Type I clear glass ampoules.

Pack sizes of 5, 10 and 50.

Not all pack sizes may be marketed.

For single use only. Discard any unused contents. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.