Index of drugs

Helpful under general anesthesia to facilitate endotracheal intubation during routine and rapid induction of anesthesia and to achieve skeletal muscle relaxation during surgery. Supplementary in intensive care units to facilitate intubation and mechanical ventilation.

1 ml of solution contains 10 mg rocuronium bromide.

Non-depolarizing neuromuscular blocking agent with an average duration of action, possessing all the pharmacological properties characteristic of drugs belonging to the group of crescine derivatives. Works competitively with acetylcholine at the nicotine receptor level in the muscle fiber end-plate. This effect is antagonized by acetylcholinesterase inhibitors such as neostigmine, edrofonium and pyridostigmine. ED dose₉₀ (required up to 90% inhibition of the thumb systolic response to ulnar nerve stimulation) during intravenous anesthesia is about 0.3 mg / kg. Clinical duration of action of the drug (25% recovery of normal systolic response to stimulus) at a dose of 0.6 mg / kg rocuronium bromide is 30 to 40 minutes. The total duration of action (the time required for 90% recovery of the correct response to the stimulus) is 50 minutes. Mean time for spontaneous recovery from 25% to 75% of the response to the stimulus (rate of return of conductivity) after administration of 0.6 mg / kg. in a quick intravenous injection is 14 minutes. After administration of lower doses of 0.3 to 0.45 mg / kg (1-1.5 x ED₉₀rururonium bromide, the onset of action is prolonged and the duration of action of the drug is reduced. After a high dose of 2 mg / kg, the clinical duration of action is 110 minutes. It is excreted in urine (47%) and faeces (43%), and 50% in unchanged form. T_0,5 is 73 min. In patients with impaired liver function, plasma clearance of rocuronium bromide is reduced and T_0,5 extended by 30 minutes.

Hypersensitivity to rocuronium, bromide ion or other components of the preparation.

Due to the fact that rocuronium bromide causes relaxation of the respiratory muscles, it is necessary to use mechanical ventilation in patients to whom it is administered, until the return of its own respiratory function. In addition, it is important to anticipate possible difficulties with intubation, especially when used in the induction of anesthesia in emergency situations. After administration of rocuronium bromide the phenomenon of residual neuromuscular block was described - it is recommended to extubate patients only when the neuromuscular blockade passes. Other factors that may cause residual neuromuscular blockade after extubating during the postoperative period (eg drug interactions or patients' condition) should also be considered. If the drug is not used as part of standard clinical practice, the use of a reversing agent should be considered, especially in the case of an increased risk of residual neuromuscular blockade. Use with caution in patients with a history of anaphylactic reactions to neuromuscular blocking agents; with clinically significant liver and / or biliary problems and / or renal insufficiency (these patients had prolonged exposure to rocuronium bromide at a dose of 0.6 mg / kg); and with neuromuscular diseases or after inflammation of the gray matter of the spinal cord. In patients with myasthenia gravis or Eaton-Lambert myasthenic syndrome, even small doses of rocuronium bromide can cause deep flabbiness, so the dose should be adjusted according to the clinical response. The effect of the drug may be delayed in states associated with slowing blood flow, e.g. in cardiovascular diseases, in elderly patients and in edema states that increase the volume of distribution. When performing surgical procedures at a reduced temperature, the action blocking the neuromuscular conductivity of the preparation is increased and the period of action is prolonged. The preparation may prolong the duration of the blocking action of the neuromuscular junction and the time of spontaneous recovery of the conductivity in obese patients, if the doses have been determined based on the actual body weight.In patients with burns, resistance to non-depolarizing neuromuscular blocking agents develops - it is recommended to adjust the dosage to the clinical response. The effects of rocuronium bromide may be increased by: hypokalaemia, hypermalaemia, hypocalcaemia, hypoproteinaemia, dehydration, acidosis, hypercapnia, emaciation - severe electrolyte disturbances, altered blood pH or dehydration should be corrected.

There are no adequate data from the use of rocuronium bromide during pregnancy. Caution should be exercised when using rocuronium bromide in pregnant women. The use of rocuronium bromide at a dose of 0.6 mg / kg during caesarean section, the Apgar score, fetal muscle tone, and cardiovascular and respiratory system alignment are not affected. Based on the analysis of umbilical cord blood samples, it was shown that rocuronium bromide only penetrates the placental barrier only to a small extent and does not cause clinically significant adverse reactions in newborns. There are no data on the use of rocuronium bromide during breastfeeding. It can be given to breast-feeding women only if the doctor thinks that the potential benefits outweigh the risks.

Uncommon or rare: tachycardia, hypotension, decreased drug effect / therapeutic response, increased drug / therapeutic response, pain at the injection site, injection site reaction, prolonged neuromuscular block, delayed recovery from anesthesia. Very rare: hypersensitivity, anaphylactic reaction, anaphylactoid reaction, anaphylactic shock, anaphylactoid shock, flaccid paralysis, circulatory collapse and shock, redness, bronchospasm, angioneurotic edema, urticaria, rash, erythematous rash, muscle weakness, steroidal myopathy, facial edema, complications anesthesia related to the airways.

Doses should be selected individually depending on the method of anesthesia, the expected duration of the surgery, sleep methods, the expected duration of mechanical ventilation, possible interactions with other drugs and the patient's condition. During long (over one hour) anesthesia with inhalation medication, the roxuronium bromide dosage should be adjusted by administering lower maintenance doses at longer intervals or reducing the rate of drug delivery. Surgical procedures. Adults. Endotracheal intubation: 0.6 mg / kg body weight, adequate intubation conditions are achieved within 60 s of drug administration; in emergency situations: 1 mg / kg body weight, appropriate conditions for intubation are achieved within 60 s of the drug administration, if an emergency dose of 0.6 mg / kg is used. Patient intubation is recommended after 90 s. If higher doses are required for individual patients during surgery, initial doses of up to 2 mg / kg are given. rocuronium bromide, without side effects affecting the heart and vessels. The use of higher doses of rocuronium bromide shortens the time of occurrence of the onset of action of the drug and extends the period of its therapeutic effect. The recommended maintenance dose is 0.15 mg / kg. During long-term inhalation anesthesia, the dose of rocuronium bromide should be reduced to 0.075-0.1 mg / kg. Maintenance doses should be used until the systolic response to stimulation returns to 25% of the control value or 2 to 3 responses to stimulation with a 4-pulse train. Continuous infusion: an initial dose of 0.6 mg / kg is recommended, and when the neuromuscular block begins to subside, the infusion should be started; the infusion rate should be chosen so that the systolic response to the stimulus is 10% of the control value or to maintain 1 to 2 responses to 4 pulses. During intravenous anesthesia, the infusion rate required to maintain the neuromuscular block at this level is 0.3-0.6 mg / kg / h, and during inhalation anesthesia 0.3-0.4 mg / kg / h. Pregnant patients: for patients undergoing cesarean section only 0.6 mg / kg is recommended. Reversal of the neuromuscular block may be inhibited or unsatisfactory in patients treated with Magnesium salts due to pregnancy poisoning, because magnesium salts intensify the neuromuscular block - smaller doses of rocuronium bromide should be used and selected depending on the systolic response to stimulation.Infants, children and adolescents: intubation doses during routine anesthesia and maintenance doses are similar to those in adults; in children it may be necessary to increase the rate of infusion - it is recommended to use the initial infusion rate the same as in adults, then choose to maintain a systolic response of 10% of the control value or to maintain 1 to 2 responses to stimulation with 4 pulses, while surgery. The use of rocuronium bromide to facilitate endotracheal intubation during rapid induction of anesthesia is not recommended. Elderly patients with impaired liver function and / or biliary and / or renal function: 0.6 mg / kg for intubation, maintenance dose 0.075-0.1 mg / kg / body, with the continuous infusion i.v. 0.3-0.4 mg / kg / h; in overweight and obese patients, the dosage should be reduced, taking into account lean body mass. Procedures performed in intensive care units. Intubation of endotracheal - the same doses described above are used. Mechanical ventilation - a starting dose of 0.6 mg / kg is recommended, and if the systolic response to the stimulus returns to 10% of the initial value or one to two responses to a series of 4 pulses occurs, a continuous intravenous infusion should be started; the recommended initial infusion rate for maintenance of the neuromuscular block at 80 to 90% in adult patients is 0.3 to 0.6 mg / kg / h. at the first hour of administration; during the Next 6 to 12 hours, the infusion rate should be reduced according to the patient's individual needs, then individual needs remain relatively constant. The use of rocuronium bromide is not recommended to facilitate mechanical ventilation in intensive care units in children and elderly patients due to a lack of data on efficacy and safety. Rocuronium bromide can be combined with 0.9% NaCl and 5% Glucose for infusion.