INFORMATION FOR HEALTH PROFESSIONALS
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Pancuronium Bromide Injection B.P. is a sterile solution containing in each mL: Pancuronium Bromide 2mg, Sodium Acetate 2mg, Sodium Chloride 8mg in Water for Injections B.P.
Pancuronium, a bis-quaternary ammonium steroid, is a non-depolarizing neuromuscular blocking agent that competes with acetylcholine for cholino- ceptive sites at the postjunctional membrane and thereby blocks competitively the transmitter action of acetylcholine resulting in muscle paralysis. Clinical studies have shown that pancuronium is approximately fives times as potent as d-tubocurarine as a competitive neuromuscular blocker. Pancuronium causes moderate increases in heart rate with an attendant increase in cardiac output and blood pressure; there does not appear to be any measurable effect on systemic vascular resistance. Pancuronium causes little or no histamine release and no ganglionic blockade, and therefore does not cause hypotension or bronchospasm. Despite its steroid structure, the drug exhibits no hormonal activity. Cholinesterase inhibitors such as pyridostigmine and neostigmine reverse the action of pancuronium.
I.V. administration of 0.1mg/kg of pancuronium normally produces muscular relaxation within 45-90 seconds, a peak effect at about 4-1/2 minutes and an average duration of effect of 45 minutes. However, it should be remembered that there is wide variation in individual patient responses to muscle relaxants.
Plasma concentrations of pancuronium appear to decline in a triphasic manner. In patients with normal renal and hepatic function the half-life in the terminal phase is about 2 hours. Since a large fraction of pancuronium is excreted in the urine the duration of neuromuscular blockade is prolonged in patients with renal failure and the dose should be reduced. In patients with impaired hepatic function, prolonged distribution and elimination half-lives result in a higher initial dose to be given and longer duration of action respectively.
Pancuronium is indicated as an aid to anaesthesia, to act as a muscle relaxant in certain surgical operations such as abdominal, anal, open chest and ophthalmic surgery. It is also used as a relaxant in orthopaedic manipulations such as the correction and setting of dislocations and fractures. The onset and duration of action are dose dependent.
Pancuronium is contraindicated in patients who are hypersensitive to it or to the bromide ion.
Patients with myasthenia gravis: small doses of pancuronium in these patients may have profound effects and therefore it should be used with extreme care and in small doses.
As with other non-depolarising muscle relaxants pancuronium should be used with care in patients with pre-existing pulmonary, hepatic or renal disease and with particular care in patients with muscular dystrophies or the myasthenic syndrome of disseminated carcinomatosis. (Eaton-Lambert Syndrome). The action of pancuronium may be prolonged in patients with dehydration, electrolyte disturbances or altered pH; these disturbances should, if possible be corrected prior to pancuronium administration.
Pancuronium should be used cautiously in patients with a tendency to hypertension, e.g. phaeochromocytoma or hypertension associated with renal disease.
In operations employing hypothermic techniques the neuromuscular blocking effect of non-depolarising drugs is decreased and increased by rewarming the patient.
Pancuronium should be administered in carefully adjusted dosage by or under the supervision of a fully qualified anaesthetist. The drug should not be administered unless facilities for intubation, artificial respiration, oxygen therapy and reversal agents are immediately available. The anaesthetist must be prepared to assist or control respiration.
Administration of depolarising drugs (e.g. suxamethonium) following a non- depolarising drug (pancuronium) is not advised.
Do not mix other solutions in the same syringe as a change in pH may cause precipitation.
Category B2.
Category B = Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Group B2 = Studies in animals are inadequate and may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Pancuronium may be used for Caesarian section but reversal of pancuronium may be unsatisfactory in patients receiving magnesium sulphate for toxaemia of pregnancy because magnesium salts enhance neuromuscular blockade.
It is not known whether pancuronium is excreted in breast milk or whether it has any harmful effect on the newborn. Therefore it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
Cardiovascular: Increased pulse rate and cardiac output is frequently noted. Blood pressure may rise. Dysrhythmias may occasionally occur.
Gastrointestinal: Salivation is sometimes noted during anaesthesia.
Hypersensitivity: An occasional transient rash has been noted with pancuronium use.
Injection site reactions: Pain or a local skin response has been noted in a few patients at the injection site.
Respiratory: Bronchospasm has been reported.
Serious or life-threatening reactions: Severe anaphylactoid reactions have been reported uncommonly.
Pancuronium is given by intravenous administration. It is not recommended to be given by intravenous infusion. The dosage should be individualised for each patient as there is wide variation in individual response to muscle relaxants.
Since potent inhalation agents or prior administration of suxamethonium enhance the intensity of blockade and duration of action of pancuronium, these factors should be considered when selecting initial and incremental dosage.
Adult: Initial dose range is 0.04 to 0.15mg per kg body weight depending on surgical procedure. Incremental doses 0.01- 0.02mg/kg.
For endotracheal intubation when pancuronium is given in a dose range of 0.05-0.15mg/kg conditions satisfactory for intubation are usually present within 2-3 minutes.
In heavy or obese patients doses of pancuronium based on mg/kg may lead to overdosage.
Paediatric: 0.06-0.08mg/kg initially I.V. followed by increments of 0.03-0.04mg/kg thereafter.
Neonates: Dosage of pancuronium in neonates up to one month of age must be carefully individualised, since neonates are particularly sensitive to non-depolarising neuromuscular blocking agents.
Dosage: 0.03-0.04mg/kg initially I.V. followed by 0.015- 0.02mg/kg thereafter.
With impaired hepatic function: In patients with cirrhosis of the liver the distribution half-life and elimination half-life are significantly prolonged. Thus, the initial dose of pancuronium necessary to achieve effective muscle relaxation is increased and the rate of disappearance from the plasma is slower.
With impaired renal function: The effect of pancuronium may be prolonged as the drug is excreted partly unchanged in the urine.
Clinical features: The symptoms are those of prolonged apnoea, respiratory depression and/or persistent muscle weakness. Death may follow acute respiratory failure.
Management: The patient should remain under artificial respiration with intermittent positive pressure ventilation. At the same time the neuromuscular action of pancuronium may be reversed by the administration of atropine and neostigmine.
Store at 2°C - 8°C
Refrigerate. Do not freeze.
| CODE | STRENGTH | PACK SIZE |
|---|---|---|
| 4970B | 4mg/2mL | 5 x 2mL ampoules |
| 4970G | 4mg/2mL | 50 x 2mL ampoules |
Baxter Healthcare Ltd
18 Allright Place
Mt Wellington
AUCKLAND
6 May 1999