Medicinal Products

PAVULON 4 mg / 2 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Pancuronium bromide
laboratory: Schering SA

IV injectable solution
Box of 25 ampoules of 2 ml
All forms

Indication

Adjuvant of general anesthesia to induce muscle relaxation and facilitate tracheal intubation during surgical procedures lasting more than two hours or when controlled ventilation is continued after the procedure.

Dosage PAVULON 4 mg / 2 ml Solution for injection IV Box of 25 ampoules of 2 ml

Administration mode :
- Pancuronium bromide should be given intravenously only as a bolus in the tubing of an infusion. Continuous infusion of pancuronium is not recommended due to accumulation of the active ingredient.
Pancuronium should only be administered by anesthetists or practitioners familiar with the use and action of curare patients, or under their control.
- Tracheal intubation equipment, respiratory support and adequate arterial oxygenation should be available.
Pancuronium should be used under control of an instrumental method (monitor of curarization) estimating the degree of muscular relaxation during the injection but also at the end of the treatment in order to evaluate the level of decurarization (recovery) in the aim in particular to pose the possible indication of a pharmacological decurarization by neostigmine.
Dosage:
- As with all other curarisers, the dosage of pancuronium bromide should be adapted to each patient. It depends on the method of associated anesthesia (with or without halogenated agent), the type of surgery (level of neuromuscular blocking desired), the presumed duration of the intervention, any interactions with other drugs administered before or during anesthesia and the pathological status of the patient (renal and / or hepatic insufficiency in particular).
The use of an appropriate neuromuscular blocking technique is recommended during neuromuscular blocking and decurarization (see section on warnings and precautions for use).
Volatile anesthetics potentiate the action of pancuronium bromide. This potentiation only becomes clinically significant during anesthesia when volatile anesthetics have reached a certain tissue concentration. It is therefore advisable to adjust pancuronium bromide doses by lowering maintenance doses and by spacing intervals of administration during surgical procedures where such anesthetics are used (see section on interactions).
- In adults, the following dosages are proposed for information only. They give the doses of pancuronium bromide to be injected for tracheal intubation and to obtain muscular relaxation in surgery of predictable duration greater than two hours. They must be adapted to each patient according to the data provided by the instrumental monitoring of the curarization.
. Tracheal intubation :
The recommended intubation dose is two DA95s, 0.1 to 0.12 mg / kg.
Good clinical conditions of intubation are obtained between 180 and 300 seconds after the injection of 0.08 to 0.1 mg / kg.
The amplitude of the muscle contractions reaches 25% of its initial value approximately 75 minutes after the intravenous injection of 0.08 mg / kg of pancuronium bromide and approximately 100 minutes after the injection of a dose of 0.1 mg / kg.
If suxamethonium is used for intubation, the administration of pancuronium bromide should be delayed until clinical decontamination of suxamethonium-induced neuromuscular blockade is observed and it is recommended that doses be reduced (0.04 to 0.06 mg / kg) of pancuronium when suxamethonium has been previously injected.
. Dose of maintenance :
The recommended maintenance dose is 0.01 to 0.02 mg pancuronium bromide per kg. To minimize cumulative effects, it is best to administer these maintenance doses when the muscle response to single nerve stimulation ("single twitch") has returned to 25% of its control response to adductor pollicis. ("control twitch").
. Use in intensive care :
The use of pancuronium bromide in intensive care units is not recommended. Repeated administration results in the accumulation of an active metabolite. In addition, there is a higher incidence of renal and / or hepatic dysfunction in resuscitation, which prolongs the duration of action of pancuronium.
- Use in pediatrics:
The use in pediatrics is not adapted because of its long duration of action.
Clinical studies have shown that the required doses in neonates (0-1 months) and infants (1-12 months) are comparable to those required in adults. Due to varying sensitivity to non-depolarizing muscle relaxants, a newborn dose of 0.01-0.02 mg / kg is recommended. Children (1-14 years) require higher doses (about 25%).
- Use in the overweight or obese patient:
In patients with overweight or obese patients (body weight greater than 30% or more in relation to the ideal weight), pancuronium bromide doses should be reduced by taking into account the ideal weight.

Against indications

- This medicine is contraindicated in case:
a history of anaphylactic / anaphylactoid reactions to pancuronium bromide or bromide ion, or hypersensitivity to any of the excipients.
- Breast-feeding: In the absence of data on the passage into breast milk, it is recommended to suspend breastfeeding for 12 hours following the administration of pancuronium bromide.

Pavulon side effects

The following adverse effects of pancuronium bromide have been reported during post-marketing surveillance; they are very rare, that is, they occur at a frequency of less than 1 per 10, 000.
- Extended neuromuscular block:
The most common adverse effect of non-depolarizing muscle relaxants is residual curarization. This can range from striated muscle weakness to deep, prolonged neuromuscular block leading to respiratory failure or apnea by obstruction of the upper airways.
- Anaphylactic reactions:
Although very rare, severe anaphylactic reactions have been reported for all muscle relaxants, including pancuronium bromide. These anaphylactic / anaphylactoid reactions include bronchospasm, cardiovascular changes (eg hypotension, tachycardia, collapse / circulatory shock) and skin manifestations (eg, angioedema, urticaria). These reactions have been in some cases fatal. Because of their severity, it is necessary to evoke their eventual occurrence and to take the appropriate precautions.
- Histamine release and histaminoid reactions:
. Muscle relaxants can induce histamine release, both at the local and systemic levels. As a result, it is possible that pruritus and erythematous reactions occur at the injection site and / or that systemic histaminoid (anaphylactoid) reactions such as bronchospasm and cardiovascular disorders occur after administration of these products.
. Experimental studies of pancuronium bromide by intradermal injection have shown that this drug induces only a weak local release of histamine. Controlled studies in humans have not revealed a significant increase in plasma histamine levels after intravenous administration of pancuronium bromide.
- Ophthalmic:
Although this has not been reported in post-marketing surveillance, the literature indicates that pancuronium bromide causes a significant decrease in intraocular pressure for a few minutes, whether it is normal or excessive and miosis.
- Cardiovascular:
The cardiovascular effects of pancuronium bromide are minor: moderate increase in heart rate and mean arterial pressure with increased cardiac output.
These effects are due to the mild cardioselective vagolytic action of the drug and should be considered in three situations:
. in the severe coronary patient where the occurrence of myocardial ischemia has been described during the administration of this drug in combination with certain opioid analgesics,
. if the recommended doses are exceeded,
. when fixing the dosage and / or the use of vagolytics for the premedication or induction of anesthesia.
Because of its vagolytic action, pancuronium bromide counteracts the cardiodepressant effect of certain volatile anesthetics. It also helps to correct the bradycardia caused by some powerful anesthetics and analgesics.

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