Vero-pipecuronium (Lyophilisate) Instructions for Use

ATC Code

M03AC06 (Pipecuronium bromide)

Active Substance

Pipecuronium bromide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Peripherally acting non-depolarizing competitive-type muscle relaxant

Pharmacotherapeutic Group

Non-depolarizing peripheral-acting muscle relaxant

Pharmacological Action

A peripherally acting non-depolarizing competitive-type muscle relaxant. It is a bis-quaternary ammonium compound of steroid structure. It blocks the n-cholinergic receptors of skeletal muscles and prevents the depolarizing action of acetylcholine.

The muscle relaxant effect after intravenous administration of pipecuronium bromide develops within 2-3 minutes and lasts for 30-120 minutes depending on the dose.

Muscle relaxation is not accompanied by fasciculations and postoperative muscle pain. Pipecuronium bromide does not cause histamine release from mast cells, in therapeutic doses it has little effect on the cardiovascular system, and in high doses it has some ganglion-blocking activity.

Pharmacokinetics

After intravenous administration, a rapid initial distribution phase and a slow elimination phase are noted. It is not metabolized. T_1/2 is 60-120 minutes. More than 75% of the administered dose is excreted in the urine, the remainder, apparently, in the bile.

Indications

For skeletal muscle relaxation during general anesthesia for surgical procedures and artificial ventilation.

ICD codes

Dosage Regimen

Administer the lyophilisate intravenously only. Determine the dose individually based on body weight, type of anesthesia, expected surgical duration, and patient condition.

For adults, the typical initial dose range is 20 to 85 mcg/kg. The onset of action occurs within 2 to 3 minutes. The duration of effect varies from 30 to 120 minutes, depending on the administered dose.

For prolonged procedures, administer supplemental doses of one-quarter of the initial dose to extend the duration of neuromuscular blockade.

Use reduced doses in patients with renal impairment or hepatic impairment due to altered drug elimination. Adjust dosage for patients with obesity, electrolyte imbalances, or dehydration.

Administer with extreme caution and at significantly reduced doses to patients with myasthenia gravis or myasthenic syndrome. Exercise caution in elderly patients and those with chronic heart failure.

Continuously monitor neuromuscular function using a peripheral nerve stimulator throughout administration to guide dosing and assess recovery. Ensure adequate sedation and analgesia are maintained.

Have facilities for controlled ventilation and airway management immediately available until full neuromuscular function is restored. Maintain reversal agents (e.g., anticholinesterases) on hand.

Adverse Reactions

From the cardiovascular system moderate bradycardia, some decrease in blood pressure are possible.

From the blood coagulation system a decrease in partial thromboplastin time and prothrombin time has been described.

Allergic reactions rarely – anaphylactoid reactions.

Contraindications

Severe myasthenia gravis, hypersensitivity to pipecuronium bromide.

Use in Pregnancy and Lactation

In pregnant women who have received magnesium salts (which can potentiate neuromuscular blockade) for the treatment of toxemia, Pipecuronium bromide should be used in reduced doses. There are no data on the excretion of pipecuronium bromide in breast milk.

Use in Hepatic Impairment

In patients with liver diseases, Pipecuronium bromide should be used in lower doses.

Use in Renal Impairment

In patients with renal failure, Pipecuronium bromide should be used in lower doses.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Pipecuronium bromide should be used only in specialized hospital settings with equipment for artificial ventilation by anesthesiologists.

Before the start of anesthesia, the electrolyte balance, acid-base balance should be normalized, and dehydration should be eliminated.

In patients with impaired neuromuscular transmission, obesity, renal failure, liver and biliary tract diseases, and with a history of polio, Pipecuronium bromide should be used in lower doses.

Use with caution in patients with chronic heart failure, and in elderly persons.

Pipecuronium bromide, like other neuromuscular blocking agents, should be used with particular caution in patients with myasthenia gravis or myasthenic syndrome.

The effect of pipecuronium bromide is enhanced in hypokalemia, hypocalcemia, hypermagnesemia, hypoproteinemia, dehydration, under conditions of acidosis, hypercapnia, cachexia.

Drug Interactions

Enhancement and/or prolongation of the action of pipecuronium bromide is possible with simultaneous use with agents for inhalation anesthesia (halothane, methoxyflurane, diethyl ether), agents for intravenous anesthesia (ketamine, propanidid, barbiturates), other non-depolarizing muscle relaxants, aminoglycoside antibiotics, tetracyclines, imidazole, metronidazole, diuretics, beta-blockers, thiamine, MAO inhibitors, guanidine, protamine, phenytoin, alpha-blockers, calcium channel blockers, lidocaine (with intravenous administration).

When corticosteroids, neostigmine, norepinephrine, theophylline, potassium chloride, sodium chloride, calcium chloride are used before surgery, a weakening of the effect of pipecuronium bromide is possible.

Depolarizing muscle relaxants can either enhance or weaken the action of pipecuronium bromide; this depends on the dose, time of administration, and individual sensitivity to the drugs.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.