Esmeron (rocuronium bromide) solution for injections 10 mg/ml. 5 ml. (50 mg.) vial №10

Description

Esmeron Storage
active substance: rocuronium bromide;

1 ml of solution contains 10 mg of rocuronium bromide;

Esmeron Excipients:

sodium acetate, sodium chloride, glacial acetic acid, water for injections.

Dosage form
Solution for injection.

Main physical and chemical properties: clear aqueous solution from colorless to light brown.

Esmeron Pharmacotherapeutic group
Muscle relaxants with a peripheral mechanism of action.

Code ATX M0ZA C09.

Pharmacological properties

Pharmacodynamics.

Mechanism of action

Esmeron® (rocuronium bromide) is a fast-acting, medium-acting, non-depolarizing muscle relaxant that has all the pharmacological effects characteristic of this class of drugs (curare-like). It blocks the nicotine cholinoreceptors of the end plate of the motor nerve of the skeletal muscle. Antagonists of this action are acetylcholinesterase inhibitors, such as neostigmine, endorphony and pyridostigmine.

Pharmacodynamic effects

ED90 (the dose of rocuronium bromide required to 90% inhibit the contractile response of the thumb muscle to ulnar nerve stimulation) is approximately 0.3 mg / kg under intravenous anesthesia. ED95 in infants is lower than in adults and children (0.25, 0.35 and 0.4 mg / kg, respectively).

The clinical duration of action (time to spontaneous recovery of skeletal muscle contractility up to 25% of the control level) at a dose of rocuronium bromide 0.6 mg / kg body weight is 30-40 minutes. The total duration (time to spontaneous recovery of skeletal muscle contractility up to 90% of the control level) is 50 minutes. The average time of spontaneous recovery of contractility from 25% to 75% of the control level (recovery index) after a bolus dose of 0.6 mg / kg body weight is 14 minutes.

When using the drug in lower doses – 0.3-0.45 mg / kg body weight (1-1½ × ED90) – the onset of action occurs later and the duration of action is shorter. At high doses – 2 mg / kg body weight – the clinical duration is 110 minutes.

Indication
Esmeron® is indicated for adults and children (infants to adolescents 0 to <18 years of age) as an adjunct to general anesthesia to facilitate tracheal intubation during routine sequential induction of anesthesia and to provide skeletal muscle relaxation during surgery. In adults, Esmeron® is also indicated to facilitate tracheal intubation during rapid sequential induction of anesthesia and as an adjunct to artificial lung ventilation in intensive care units.

Contraindication
Hypersensitivity to rocuronium, bromides or to any of the excipients.

Interaction with other medicinal products and other forms of interaction
Drugs that affect the strength and / or duration of action of non-depolarizing muscle relaxants:

Enhancing the effect

Halogenated volatile anesthetics increase the neuromuscular blockade caused by Esmeron®. This effect becomes noticeable only with the introduction of maintenance doses (see section “Method and Dosage”). Restoration of neuromuscular conduction with acetylcholinesterase inhibitors may be delayed.
After intubation with suxamethonium (see section “Peculiarities”).
Prolonged concomitant use of corticosteroids and Esmeron® in the intensive care unit may lead to an increase in the duration of neuromuscular blockade or to myopathy (see sections “Special warnings and special precautions for use” and “Adverse reactions”).