INFORMATION FOR HEALTH PROFESSIONALS
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Injection 2 mg/mL: a clear, colourless, particle-free solution containing 2 mg/mL Pancuronium bromide.
Pancuronium is a non-depolarising neuromuscular blocking agent of medium duration, blocking transmission of motor nerve impulses to striated muscle receptors. It also increases heart rate by a direct blocking effect on acetylcholine receptors in the heart, but this effect is small with therapeutic doses. It does not cause histamine release or ganglion blockade and therefore does not cause hypertension or bronchospasm.
With an initial dose of Pancuronium of 0.06 mg/kg IV, muscle relaxation reaches a level suitable for endotracheal intubation within 2 to 3 minutes, and the effects of the agent begin to subside in about 35 to 45 minutes (these data are approximations since muscle relaxant response may be variable). Onset and duration of action of Pancuronium is dose dependent. Supplemental incremental doses, following the initial dose, slightly increase the magnitude of blockade, and significantly increase the duration of blockade alone or following suxamethonium.
An adjunct to surgical anaesthesia to induce skeletal muscle relaxation to facilitate operative manipulations. The necessary conditions for intubation can be achieved with Pancuronium alone or following suxamethonium.
Pancuronium is also indicated to promote mechanical ventilation by reducing or eliminating spontaneous breathing effort in intensive care patients.
Pancuronium bromide injection BP is administered intravenously. The dosage must be individualised in each case and take into account the potential effect of the anaesthetic or any other concomitant drug, clinical state of the patient and the anticipated duration of the neuromuscular block. The following dosage information is a guide only.
In heavy or obese patients calculations based on mg/kg may lead to overdosage.
Adults and children older than 1 month
Initial dose: 0.04 to 0.1 mg/kg. This usually provides rapid satisfactory muscle relaxation for ease of intubation within 2 to 3 minutes. Duration of action of the initial dose may average approximately 45 minutes but can vary widely (30 to 150 minutes or longer).
Maintenance dose: Additional doses of 0.01 to 0.02 mg/kg may be administered at 25 to 60 minute intervals to maintain skeletal muscle relaxation during prolonged surgery. Doses of 0.015 mg/kg may be used to maintain relaxation for controlled respiration.
Neonates and children less than 1 month: Dosage must be carefully individualised, since neonates are particularly sensitive to nondepolarising neuromuscular blocking agents. An initial test dose of 0.02 mg/kg has been suggested to determine responsiveness.
After Suxamethonium for Intubation
A reduction in the initial dosage of PANCURONIUM is recommended when it is given following administration of suxamethonium. For adults and children older than 1 month, the initial dose should be reduced by approximately a third to 0.02 to 0.06 mg/kg and the incremental doses should be 25 to 33% of the initial dose.
Do not mix Pancuronium bromide with other solutions in the same syringe, since possible changes in pH may induce precipitation. Any unused contents should be discarded.
Known hypersensitivity to Pancuronium bromide or to the bromide ion.
Extreme caution should be exercised and reductions in dosage made when administering pancuronium to patients with myasthenia gravis, myasthenic syndrome, prior poliomyelitis or myopathia as small doses may have profound effects.
Pancuronium should not be used in patients with pre-existing tachycardia or in patients in whom even a minor elevation in heart rate is undesirable. It should be used with caution in patients with a tendency to hypertension including hypertension associated with phaeochromocytoma or renal disease.
Individual cases of prolonged paralysis, disuse atrophy and areflexia have been reported in association with prolonged use of pancuronium to assist mechanical ventilation. It is unclear whether the motor dysfunction was due to the duration of neurological blockade (usually greater than 7 days), prolonged bedrest, underlying clinical condition, intervention of synergistic drugs or a combination of such factors. Improvement was seen after 2-5 months in some but not all cases.
Careful monitoring of motor function is therefore particularly important when prolonged pancuronium-induced neurological blockade is necessary.
Pancuronium should only be used in hospitals equipped with suitable equipment for anaesthesia and/or resuscitation and administered only by a qualified anaesthetist or a physician experienced in anaesthetics. All patients receiving Pancuronium should be intubated and given artificial respiration until spontaneous respiration returns.
Prior administration of suxamethonium has been reported to increase the intensity and duration of neuromuscular blockade produced by Pancuronium and a reduction in Pancuronium dosage is recommended. Administration of depolarising agents such as suxamethonium following Pancuronium is not recommended.
Electrolyte balance and dehydration should be corrected if possible before the administration of Pancuronium. Hypokalaemia, hypermagnesesaemia, hypocalcaemia, dehydration, acidosis, hypoproteinaemia and hypercapnoea can increase the neuromuscular blocking activity of PANCURONIUM.
Hypothermia reduces the intensity of neuromuscular blockade and increased doses of Pancuronium may be required. Hyperthermia has the opposite effect. When hypothermia techniques are used during surgery, the reduction in neuromuscular blockade is reversed when the patient is rewarmed.
Pancuronium is antagonised by acetylcholine, anticholinesterases and potassium ions. The action of Pancuronium may also be altered by concomitant administration of various medicines such as neuromuscular blocking agents, some antibiotics and certain anaesthetics (see Interactions).
Although a prolonged duration of action may be expected, a higher initial dose may be necessary to induce neuromuscular blockage in patients with hepatic impairment.
Prolonged neuromuscular blockade may occur in patients with poor renal perfusion or severe renal disease; reduction of maintenance doses may be necessary. Pancuronium should be avoided in patients with a GFR of less than 10 mL per minute; recurarisation might occur up to 24 hours after administration.
Neonates are particularly sensitive to pancuronium and nondepolarising neuromuscular blocking agents in general. Dosage must be individualised (see Dosage and Administration) and further reductions may be necessary in prematurity, acidosis, hypothermia and during antibiotic therapy.
Plasma concentrations have been reported to decline at a decreased rate in the elderly. Dosage reduction, however, was not indicated.
The safe use of Pancuronium has not been established with respect to possible adverse effects upon foetal development. Therefore, it should not be used in women in pregnancy or in those likely to become pregnant unless the potential benefits outweigh the unknown hazards.
Pancuronium may be used in operative obstetrics (caesarian section) but reversal of medicine effects may be unsatisfactory in patients receiving magnesium sulphate for toxaemia of pregnancy. Magnesium salts enhance neuromuscular blockade; therefore a reduced dosage of Pancuronium is indicated.
Pancuronium has been found to cross the placenta in small amounts.
Complications are rare and usually associated with overdosage. This may result in prolonged apnoea or respiratory depression. After administration approximately 10% of patients may exhibit mild to moderate increases in blood pressure and/or pulse rate.
Pancuronium decreases intraocular pressure and induces miosis. A few cases of local reactions manifested by pain and burning at the site of injection have been reported.
Other adverse experiences reported during use of Pancuronium included excessive salivation, transient rashes and wheezing. Hypersensitivity reactions occur rarely.
Certain anaesthesic agents may influence the neuromuscular blocking activity of Pancuronium. Halothane, diethylether, enflurane, isoflurane, methoxyflurane, cyclopropane, thiopentone, methohexitone may increase neuromuscular blocking activity while neurolept analgesia may decrease activity.
Concomitant neomycin, streptomycin, kanamycin, gentamicin, bacitracin, diazepam, propranolol, thiamine (high dose), IV lignocaine (high dose), magnesium sulphate, lithium carbonate, monoamine oxidase inhibitors, quinine, quinidine or protamine may potentiate the neuromuscular blocking effects of Pancuronium.
Neostigmine, edrophonium, high dose cortiscosteroid, adrenaline, azathioprine, theophylline (high dose), potassium chloride, sodium chloride and calcium chloride may decrease the activity of Pancuronium.
Prior administration of suxamethonium can increase the intensity of neuromuscular blockade due to Pancuronium. (See Warnings and Precautions and Dosage and Administration).
A precipitate may form if Pancuronium is mixed with barbituates in the same syringe.
Pancuronium bromide is stable for up to 48 hours in the following solutions: 5% dextrose, 0.9% sodium chloride, lactated Ringer's or 5% dextrose and 0.45 or 0.9% sodium chloride.
Symptoms of overdose are prolonged apnoea, respiratory depression and/or persistent muscle weakness. Incremental doses of neostigmine in conjunction with atropine should be administered within the prescribed therapeutic range and assisted ventilation should continue until recovery is complete.
Should be refrigerated at 2-8°C until use.
Do Not Freeze.
Pancuronium need not be refrigerated during normal periods of use in operating theatres.
Prescription Medicine.
Injection 2 mg/mL, 50 x 2 ml polyamp, Duo Fit.
Nil.
AstraZeneca Limited
303 Manukau Road
Epsom
AUCKLAND
Telephone 09 623 6300
3 May 1999
(Aust PI 29-01-96)