Arduan (pіpekuronіy bromid) lyophilisate for solution for injections 4 mg. vial №25

Description

Ingredients

1 vial contains pipecuronium bromide 4 mg

1 ampoule with solvent: sodium chloride 18.0 mg, water for injection up to 2 ml.

Release form

Lyophilizate for the preparation of a solution for intravenous administration of white or almost white color; the applied solvent is a colorless transparent solution.

pharmachologic effect

Long-acting non-depolarizing peripheral muscle relaxant. Due to competitive binding to n-cholinergic receptors located on the end plate of the neuromuscular synapse of skeletal muscles, it blocks signal transmission from nerve endings to muscle fibers.

Does not cause muscle fasciculation, does not have a hormonal effect.

Even at doses several times higher than its effective dose required for a 90% decrease in muscle contractility (ED90), it does not have ganglioblocking, m-anticholinergic and sympathomimetic activity.

According to studies, with balanced anesthesia, the doses of ED50 and ED90 of pipecuronium bromide are 30-50 µg/kg of body weight, respectively.

A dose of 50 mcg/kg of body weight provides 40-50 minutes of muscle relaxation during various operations.

The maximum effect of pipecuronium bromide depends on the dose and develops after 1.5-5 minutes. The effect develops most rapidly at doses of 70-80 mcg/kg. A further increase in the dose of the drug reduces the time required for the development of the effect, and significantly increases the duration of the drug.

Indication for use

Endotracheal intubation and relaxation of skeletal muscles under general anesthesia during various surgical operations requiring more than 20-30 minutes of muscle relaxation and under mechanical ventilation.

Dosage and Administration

As with other non-depolarizing myorelaxants, the dose of Arduan (pipecuronium bromide) is selected for each patient individually, taking into account the type of anesthesia, the expected duration of the surgical intervention, possible interactions with other drugs used before or during anesthesia, concomitant diseases and the general condition of the patient. To control neuromuscular blockade, the use of a peripheral nerve stimulator is recommended.

Apply only in / in. Immediately before administration, the contents of the vial (4 mg of dry matter) are diluted with the supplied solvent. Only freshly prepared solution should be used.

Contraindications

• severe liver failure;
• children’s age up to 3 months;
• hypersensitivity to pipecuronium and / or bromine.

special instructions

Arduan (pipecuronium bromide) should be used only in a specialized hospital with appropriate equipment for artificial respiration and in the presence of a specialist in artificial respiration, due to the effect of the drug on the respiratory muscles.

It is necessary to carefully monitor and maintain vital functions during surgery and in the early postoperative period until full recovery of muscle contractility.

When calculating the dose, one should take into account the anesthesia technique used, possible interactions with other drugs administered before or during anesthesia, the condition and individual sensitivity of the patient to the drug.

The medical literature describes cases of anaphylactic and anaphylactoid reactions with the use of muscle relaxants. Despite the absence of reports of such an action of Arduan, the drug can be used only in conditions that allow immediate treatment of such conditions.

Greater caution should be exercised when using Arduan in patients with a history of anaphylactic reactions caused by muscle relaxants, due to the possible development of cross-allergy.

Arduan (pipecuronium bromide) in doses that cause muscle relaxation does not have a significant cardiovascular effect and in the vast majority of cases does not cause bradycardia.

The use and dose of m-anticholinergics for the purpose of premedication is subject to careful preliminary evaluation; one should also take into account the stimulating effect on n. vagus of other concomitantly used drugs, as well as the type of operation.

To prevent a relative overdose of the drug and to ensure adequate control of the recovery of muscle activity, it is recommended to use a peripheral nerve stimulator.

Patients with neuromuscular transmission disorders, obesity, renal insufficiency, diseases of the liver and / or biliary tract, with indications of a history of poliomyelitis, it is necessary to prescribe the drug in lower doses.

In the case of liver disease, the use of Arduan (pipecuronium bromide) is possible only in cases where the intended benefit to the patient outweighs the potential risk. In this case, the drug should be used in the minimum effective dose.

Some conditions (hypokalemia, digitalization, hypermagnesemia, diuretics, hypocalcemia, hypoproteinemia, dehydration, acidosis, hypercapnia, cachexia, hypothermia) may increase the intensity or duration of the effect. As in the case of other muscle relaxants, before using Arduan, electrolyte balance, acid-base balance should be normalized and dehydration should be eliminated.

Like other muscle relaxants, Arduan may reduce aPTT and prothrombin time.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature of 2° to 8°C.