Rocuronium Kabi (Solution) Instructions for Use

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Hameln Pharmaceuticals, GmbH (Germany)

Or

Fresenius Kabi Austria, GmbH (Austria)

ATC Code

M03AC09 (Rocuronium bromide)

Active Substance

Rocuronium bromide (Rec.INN registered by WHO)

Dosage Form

Rocuronium Kabi

Solution for intravenous administration 10 mg/1 ml: 5 ml or 10 ml fl. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration colorless or brownish-yellow, transparent.

Excipients: sodium chloride – 3.3 mg, sodium acetate trihydrate – 2 mg, glacial acetic acid – 7.139-8.725 mg (for pH adjustment), water for injections – up to 1 ml.

5 ml – colorless glass vials (5) – cardboard packs.
5 ml – colorless glass vials (10) – cardboard packs.
10 ml – colorless glass vials (5) – cardboard packs.
10 ml – colorless glass vials (10) – cardboard packs.

Solution for intravenous administration colorless or brownish-yellow, transparent.

Excipients: sodium chloride – 3.3 mg, sodium acetate trihydrate – 2 mg, glacial acetic acid – 7.139-8.725 mg (for pH adjustment), water for injections – up to 1 ml.

5 ml – colorless glass vials (5) – cardboard packs.
5 ml – colorless glass vials (10) – cardboard packs.
10 ml – colorless glass vials (5) – cardboard packs.
10 ml – colorless glass vials (10) – cardboard packs.

Clinical-Pharmacological Group

Peripherally acting non-depolarizing competitive-type muscle relaxant

Pharmacotherapeutic Group

Muscle relaxants; peripherally acting muscle relaxants; other quaternary ammonium compounds

Pharmacological Action

Rocuronium Kabi (Rocuronium bromide) is a non-depolarizing muscle relaxant with a short (closer to intermediate) duration of action, possessing all the pharmacological effects (curare-like) characteristic of this class of medicinal substances. It competitively blocks nicotinic cholinergic receptors at motor endplates. The antagonists of this effect are cholinesterase inhibitors, such as neostigmine methylsulfate, edrophonium chloride, and pyridostigmine bromide. The ED₉₀ (the dose required to suppress 90% of the reflex thumb movement in response to ulnar nerve stimulation) under balanced anesthesia is approximately 0.3 mg/kg body weight.

Within 60 seconds after intravenous administration of rocuronium bromide at a dose of 0.6 mg/kg body weight (2 × ED₉₀ under balanced anesthesia), adequate conditions for intubation are achieved in almost all patients. In 80% of cases, these conditions are optimal. Within 2 minutes, general myoplegia develops, allowing for any interventions. The duration of clinical action of the drug (until spontaneous recovery of muscle contractions to 25% of the control level) after administration of this dose is 30-40 minutes. The total duration of action (time until recovery of muscle contractions to 90% of the control level) is 50 minutes. The average time for spontaneous recovery of muscle contractions from 25% to 75% of the control level (recovery index) after administration of rocuronium bromide as a bolus of 0.6 mg/kg body weight is 14 minutes.

When rocuronium bromide is administered in lower doses of 0.3-0.45 mg/kg (1-1.5 (ED₉₀)), the onset of action is slower and its duration is reduced (13-26 minutes). After administration of rocuronium bromide at a dose of 0.45 mg/kg body weight, adequate conditions for intubation are achieved within 90 seconds.

During rapid induction of anesthesia with propofol or fentanyl/sodium thiopental, adequate conditions for intubation after administration of rocuronium bromide at a dose of 1.0 mg/kg are achieved within 60 seconds in 93% and 96% of patients, respectively. In 70% of cases, these conditions are optimal. The duration of clinical action of this dose reaches 1 hour. By this time, neuromuscular blockade can be safely reversed. After administration of rocuronium bromide at a dose of 0.6 mg/kg, adequate conditions for intubation are achieved within 60 seconds in 81% and 75% of patients who received propofol or fentanyl/sodium thiopental for anesthesia induction, respectively.

Using rocuronium bromide in doses greater than 1.0 mg/kg body weight does not lead to a significant improvement in intubation conditions, but the duration of action increases. Doses greater than 4 × ED₉₀ have not been studied.

For patient management in intensive care units, Rocuronium bromide is prescribed at a dose of 0.6 mg/kg, followed by a maintenance continuous infusion at a rate of 0.2-0.5 mg/kg/h during the first hour, when muscle contractions recover to 10% of the control level or 1-2 responses appear during monitoring in the train-of-four (TOF) stimulation mode. Doses are titrated individually; subsequently, they must be reduced under constant TOF monitoring. The duration of use is 7 days.

This dosing regimen leads to adequate muscle relaxation; however, significant variability in the infusion rate and an increase in the duration of blockade are noted.

The time to recovery of TOF to 0.7 does not significantly depend on the total duration of rocuronium bromide administration. After continuous infusion for 20 hours or more, the median (range) time between the appearance of the second response to TOF stimulation and recovery of the TOF ratio to 0.7 is from 0.9 to 12 hours in patients without multiple organ failure and 1.2-25.5 hours in patients with multiple organ failure.

In neonates and children, the average onset time of a 0.6 mg/kg dose is faster than in adults. The duration of action of the drug in children is shorter than in adults. The duration of action of maintenance doses of rocuronium bromide 0.15 mg/kg may be slightly prolonged under enflurane and isoflurane anesthesia in elderly patients and patients with liver or kidney diseases (approximately 20 minutes) compared to that in patients without impaired liver and kidney function during intravenous anesthesia (approximately 13 minutes).

With subsequent administration of recommended maintenance doses, no cumulation effect (progressive increase in duration of action) is noted. During cardiovascular surgery, the most frequent changes observed in patients during the development of maximum blockade after administration of 0.6-0.9 mg/kg body weight are small and clinically insignificant increases in heart rate (by 9%) and an increase in mean arterial pressure (by 16%) compared to control values.

Pharmacokinetics

It binds to plasma proteins by 30%. Penetrates the placental barrier.

After a single bolus administration of rocuronium bromide, the dependence of its plasma concentration on time was exponential and consisted of three phases. In healthy adults, the mean T_1/2 (95% CI) is 73 (66-80) minutes, the apparent volume of distribution at steady state is 203 (193-214) ml/kg, and plasma clearance is 3.7 (3.5-3.9) ml/kg/min.

Plasma clearance in elderly patients and patients with impaired renal function is somewhat reduced compared to that in younger individuals with normal renal function. In patients with liver diseases, the mean T_1/2 is 30 minutes longer, and the mean plasma clearance is reduced by 1 ml/kg/min.

The volume of distribution in infants (3-12 months) is higher than in older children (1-8 years) and adults.

In children aged 3-8 years, clearance is higher and T_1/2 is approximately 20 minutes shorter than in adults and children under 3 years of age.

During continuous infusion for 20 hours or more during artificial ventilation, the mean T_1/2 and the mean volume of distribution at steady state increase.

High interindividual variability is noted, associated with the nature and degree of multiple organ failure and individual patient characteristics. In patients with multiple organ failure, the mean T_1/2 (±SD) was 21.5 (±3.3) hours, the volume of distribution at steady state was 1.5 (±0.8) L/kg, and plasma clearance was 2.1 (±0.8) ml/kg/min. Rocuronium bromide is excreted in urine and bile.

The degree of urinary excretion reaches 40% within 12-24 hours, 47% is excreted in feces. Approximately 50% of the dose is excreted as rocuronium bromide. Metabolites were not detected in plasma.

Indications

Used in adults and children over 3 months

• During general anesthesia, to facilitate tracheal intubation during standard and rapid sequence induction of anesthesia;
• For muscle relaxation during surgical interventions.

In intensive care units (ICU) for short-term muscle relaxation (e.g., to facilitate intubation).

ICD codes

Dosage Regimen

Intravenously as a bolus or continuous infusion.

The dose of rocuronium bromide, like other muscle relaxants, should be selected individually.

When choosing the dose, the method of general anesthesia and the expected duration of surgery, the method of sedation and the expected duration of artificial ventilation, the possibility of interaction with other drugs, and the patient’s condition should be taken into account. Instrumental monitoring methods are recommended for assessing neuromuscular blockade and recovery of neuromuscular transmission.

Inhalation anesthetics enhance the muscle relaxant effect of rocuronium bromide. This effect is clinically significant during inhalation anesthesia when a certain concentration of volatile substances is reached in the tissues. Accordingly, during prolonged inhalation anesthesia (more than 1 hour), smaller maintenance doses of rocuronium bromide should be administered at longer intervals or the infusion rate of the drug should be reduced.

Below are general recommendations for the dosing regimen of rocuronium bromide for tracheal intubation and muscle relaxation during short and long surgical interventions and in intensive care units.

Rocuronium bromide is intended for single use only.

Surgical Interventions

Tracheal Intubation

The standard dose of rocuronium bromide for routine anesthesia is 0.6 mg/kg body weight. This dose provides adequate conditions for intubation within 60 seconds in almost all patients.

For rapid sequence induction of anesthesia, the use of rocuronium bromide at a dose of 1.0 mg/kg body weight is recommended.

After administration of the specified dose, adequate conditions for intubation are also achieved within 60 seconds in almost all patients. If Rocuronium bromide is prescribed at a dose of 0.6 mg/kg during rapid sequence induction of anesthesia, then intubation should be performed 90 seconds after drug administration.

Maintenance Doses

The recommended maintenance dose of rocuronium bromide is 0.15 mg/kg body weight. During prolonged inhalation anesthesia, it should be reduced to 0.075-0.1 mg/kg body weight. The maintenance dose is best administered at the moment when muscle contractions recover to 25% of the control level or when 2-3 responses appear during monitoring in the train-of-four (TOF) stimulation mode.

Continuous Infusion

Drip administration of rocuronium bromide is recommended to start with a loading dose of 0.6 mg/kg body weight.

When neuromuscular blockade begins to recover, a continuous infusion of the drug is started. The infusion rate is adjusted to maintain muscle contractions at 10% of the control value or to maintain 1-2 responses during TOF monitoring.

During intravenous anesthesia in adult patients, the infusion rate required to maintain neuromuscular blockade at the specified level is 0.3-0.6 mg/kg/h.

During inhalation anesthesia, the infusion rate is 0.3-0.4 mg/kg/h.

The degree of neuromuscular blockade should be constantly monitored, as the required infusion rate differs among patients and depends on the anesthesia method.

Dosage regimen in children

In children over 3 months of age, the recommended doses of rocuronium bromide for intubation during inhalation anesthesia and maintenance doses are similar to those in adults and amount to 0.3-0.6 mg/kg/h, and during inhalation anesthesia – 0.3-0.4 mg/kg/h. The rate of continuous infusion in adolescents is the same as in adults, but children may require a higher infusion rate.

In children, the infusion is started at the same rate as in adults. Subsequently, the infusion rate is adjusted to maintain muscle contractions at 10% of the control value or to maintain 1-2 responses during monitoring in the train-of-four (TOF) stimulation mode.

Experience with the use of rocuronium bromide in children for rapid sequence induction of anesthesia is limited. In this regard, Rocuronium bromide is not recommended for use in children to facilitate tracheal intubation during rapid induction of anesthesia. There are no data on the use of rocuronium bromide in neonates under 1 month of age.

Dosage regimen in elderly patients and patients with liver, biliary tract diseases and/or renal failure

The standard intubation dose of rocuronium bromide for inhalation anesthesia in elderly patients and patients with liver, biliary tract diseases and/or renal failure is 0.6 mg/kg body weight. For rapid sequence induction of anesthesia in patients with prolonged drug action, the dose can also be 0.6 mg/kg; however, adequate conditions for intubation may be achieved only 90 seconds after administration of rocuronium bromide. Regardless of the method of general anesthesia, the recommended maintenance dose of rocuronium bromide is 0.075-0.1 mg/kg, and the infusion rate is 0.3-0.4 mg/kg/h.

Dosage regimen in obese patients

In obese patients (body weight exceeding the ideal by 30% or more), the dose should be reduced taking into account lean body mass.

Intensive Care

Tracheal Intubation

For tracheal intubation, rocuronium bromide is used in the same doses as for surgical interventions.

Dosage for maintaining artificial ventilation

It is recommended to start with a dose of 0.6 mg/kg body weight, and when neuromuscular conduction recovers to 10% or 1-2 responses are obtained during TOF stimulation, begin intravenous administration as a bolus or continuous infusion. Doses of rocuronium bromide should be selected individually. The recommended administration rate in adult patients is 0.3-0.6 mg/kg/h during the first hour, after which, over 6-12 hours, the administration rate should be reduced according to the individual patient response.

Rocuronium Kabi contains less than 1 mmol sodium (23 mg) in one dose, i.e., a negligible amount of sodium.

Adverse Reactions

By frequency, adverse effects are divided into the following categories

The main adverse effects are pain/reaction at the injection site, changes in vital signs, and prolonged neuromuscular blockade.

Immune system disorders

Very rare: anaphylactic reaction, e.g., anaphylactic shock, anaphylactoid reactions*, hypersensitivity.

Nervous system disorders

Very rare: paralysis.

Cardiac and vascular disorders

Very rare: tachycardia, decreased blood pressure, collapse and shock.

Respiratory, thoracic and mediastinal disorders

Very rare: bronchospasm.

Frequency not known: apnea, respiratory failure

Skin and subcutaneous tissue disorders

Very rare: rash, erythematous rash, angioedema, urticaria, pruritus, exanthema.

Musculoskeletal and connective tissue disorders

Frequency not known: skeletal muscle weakness, steroid myopathy*.

Local reactions

Very common: pain/reaction at the injection site*

Investigations

Very rare: increased histamine content*

Injury, poisoning and procedural complications

Very rare: prolonged neuromuscular blockade*

*Additional information on adverse reactions:

Anaphylactic reactions

Severe anaphylactic reactions caused by muscle relaxants have in some cases resulted in death.

Given the potential severity of such reactions, the risk of their development must always be considered and appropriate precautions taken.

Reactions at the injection site

Pain at the injection site was observed during rapid induction of anesthesia, especially in cases where the patient had not completely lost consciousness and propofol was used for anesthesia induction. In clinical studies, pain at the injection site was noted in 16% of patients who underwent rapid induction of anesthesia with propofol, and in less than 0.5% of patients who received fentanyl and sodium thiopental for this purpose.

Increased histamine content

Muscle relaxants can cause local and systemic release of histamine; therefore, when using these drugs, the possibility of pruritus and the development of an erythematous reaction at the injection site and/or generalized anaphylactoid reactions, such as bronchospasm and changes in the cardiovascular system (arterial hypotension and bradycardia), should be considered. In patients receiving Rocuronium bromide, rash, exanthema, urticaria, bronchospasm, and arterial hypotension were very rarely observed.

In clinical studies, after rapid bolus administration of rocuronium bromide 0.3-0.9 mg/kg body weight, a slight increase in plasma histamine levels was noted.

Prolonged neuromuscular blockade

The most common side effect of the entire class of non-depolarizing muscle relaxants is an undesirable increase in the duration of action, ranging from skeletal muscle weakness to pronounced and prolonged paralysis leading to respiratory failure and apnea.

Contraindications

• History of anaphylactic reactions to rocuronium or bromine;
• Children under 3 months of age.

Use in Pregnancy and Lactation

Experience with the use of rocuronium bromide during pregnancy is limited. Rocuronium bromide should be prescribed to pregnant women only in cases of extreme necessity, if the physician believes that the benefit of its use outweighs the potential risk.

During cesarean section, Rocuronium bromide is recommended to be administered at a dose of 0.6 mg/kg, as the 1.0 mg/kg dose has not been studied in pregnant women.

The use of rocuronium bromide at a dose of 0.6 mg/kg during cesarean section does not affect the Apgar score, the muscle tone of the newborn, or the adaptation of the cardiovascular and respiratory systems.

Magnesium salts, used to treat toxemia in pregnant women, enhance the neuromuscular blockade and may inhibit the recovery of neuromuscular transmission after the use of muscle relaxants. Accordingly, in such cases, the dose of rocuronium bromide should be reduced and titrated based on the degree of muscle contractions. Rocuronium bromide crosses the placenta to a limited extent, which does not lead to adverse reactions in newborns.

There is no experience with the use of rocuronium bromide in breastfeeding women. Other drugs in this class are excreted in small amounts in breast milk and are absorbed by the breastfed newborn.

The decision on the advisability of discontinuing breastfeeding should be made taking into account the importance of breastfeeding and the potential risk to the child.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Contraindicated in children under 3 months of age.

In children over 3 months of age, the recommended doses of rocuronium bromide for intubation during inhalation anesthesia and maintenance doses are similar to those in adults and amount to 0.3-0.6 mg/kg/h, and during inhalation anesthesia – 0.3-0.4 mg/kg/h. The rate of continuous infusion in adolescents is the same as in adults, but children may require a higher infusion rate.

In children, the infusion is started at the same rate as in adults. Subsequently, the infusion rate is adjusted to maintain the degree of muscle contractions at 10% of the control value or to maintain 1-2 responses when monitoring in the train-of-four (TOF) mode.

Experience with the use of rocuronium bromide in children for rapid sequence induction of anesthesia is limited. In this regard, Rocuronium bromide is not recommended for use in children to facilitate tracheal intubation during rapid induction of anesthesia. There are no data on the use of rocuronium bromide in newborns under 1 month of age.

Geriatric Use

Use with caution in the elderly.

Special Precautions

Rocuronium bromide should be administered by physicians experienced in the use of muscle relaxants. It is necessary to have means for tracheal intubation and artificial lung ventilation ready.

Rocuronium bromide causes paralysis of the respiratory muscles, so when using it, artificial lung ventilation should be performed until spontaneous breathing is restored.

As with the use of other muscle relaxants, it is important to anticipate possible difficulties with intubation, especially during rapid sequence induction of anesthesia. After administration of rocuronium bromide, as with other muscle relaxants, residual curarization is observed. To avoid complications associated with residual curarization, it is recommended to discontinue intubation only after adequate recovery of neuromuscular transmission.

Other factors that may cause residual curarization after extubation in the postoperative period (e.g., interaction with other drugs or the patient’s condition) should also be taken into account. In this situation, the possibility of using drugs that restore neuromuscular transmission should be considered, especially in cases where the likelihood of residual curarization is increased. Before transporting the patient after recovery from anesthesia, it is necessary to ensure that spontaneous, deep, and regular breathing has been restored. Anaphylactic reactions may develop after the administration of muscle relaxants. In this regard, precautionary measures should always be taken, especially if anaphylactic reactions have occurred previously with the administration of other drugs in this group, taking into account the possibility of cross-reactivity.

Rocuronium bromide at a dose of more than 0.9 mg/kg may cause an increase in heart rate. This effect may counteract bradycardia developing under the influence of anesthetic agents or vagus nerve stimulation.

After prolonged use of muscle relaxants in intensive care units, the development of paralysis and/or skeletal muscle weakness has been observed. To avoid possible prolongation of neuromuscular blockade and/or overdose, it is strongly recommended to monitor neuromuscular transmission when using muscle relaxants. Furthermore, adequate analgesia and sedation must be ensured. Doses of muscle relaxants should be individually selected under the supervision of experienced physicians based on neuromuscular transmission monitoring.

Rocuronium bromide is always used in combination with other medicinal products.

Given the possibility of malignant hyperthermia developing during anesthesia even in the absence of known triggers, physicians should be aware of its early signs, methods of diagnosis and treatment.

Myopathy has been observed with prolonged use of non-depolarizing muscle relaxants and corticosteroids; thus, combination therapy should be prescribed for the shortest possible duration.

Rocuronium bromide can only be administered after complete recovery from the neuromuscular blockade caused by suxamethonium.

Instructions for preparation and administration

• The solution should be administered immediately after opening the vial.
• The solution should be inspected before administration. Only a clear solution free of mechanical inclusions should be administered.
• Compatibility of rocuronium bromide with 0.9% sodium chloride solution and 5% dextrose solution for intravenous administration has been established.
  After dilution, the 5 mg/ml and 0.1 mg/ml solution (diluted with 0.9% sodium chloride solution or 5% dextrose solution) is chemically and physically stable for 24 hours at room temperature in glass vials and polyethylene or polyvinyl chloride bags.
• If Rocuronium bromide and other medicinal products are administered through the same infusion system, it must be flushed (e.g., with 0.9% sodium chloride solution) between drug administrations. This is necessary in cases where Rocuronium bromide and other drugs are incompatible, or their compatibility has not been established.
• Residual solution and other waste should be disposed of in accordance with current requirements.

If the solution is prepared under aseptic conditions, it can be stored for no more than 24 hours at a temperature of 2 to 8°C (46.4°F).

Precautions for use

Liver and biliary tract diseases and renal failure

Since Rocuronium bromide is excreted in urine and bile, it should be used with caution in patients with severe liver and biliary tract diseases and/or renal failure. In such patients, an increase in the duration of action of rocuronium bromide at a dose of 0.6 mg/kg is observed.

Increased circulation time

Conditions accompanied by slowed circulation, such as cardiovascular disease, old age, and edematous syndrome, cause an increase in the volume of distribution, which may lead to a delayed onset of action.

Neuromuscular diseases

As with other muscle relaxants, Rocuronium bromide should be used with extreme caution in patients with neuromuscular diseases or after poliomyelitis, as the response to neuromuscular blockade may be significantly altered in such cases. The severity and direction of these changes vary widely. In patients with myasthenia gravis or myasthenic syndrome (Eaton-Lambert syndrome), Rocuronium bromide may cause a pronounced effect at low doses, so its dose should be individually selected.

Hypothermia

During surgical interventions under hypothermia, the neuromuscular blocking effect of rocuronium bromide is enhanced, and its duration of action is increased.

Obesity

If the dose of rocuronium bromide, as with other muscle relaxants, in obese patients is calculated based on actual body weight, an increase in its duration of action and delayed recovery of neuromuscular transmission are possible. Therefore, the dose is calculated based on ideal body weight.

Burns

In patients with burns, resistance to non-depolarizing muscle relaxants may develop. The dose is recommended to be individually selected taking into account the patient’s response.

Conditions that may enhance the effect of rocuronium bromide

Hypokalemia (e.g., after severe vomiting, diarrhea, or diuretic therapy), hypermagnesemia, hypocalcemia (after massive transfusions), hypoproteinemia, dehydration, acidosis, hypercapnia, and cachexia.

Whenever possible, correction of severe electrolyte disturbances, changes in blood pH, and dehydration should be achieved.

Effect on ability to drive vehicles and operate machinery

Rocuronium bromide has a significant effect on the ability to drive a car and operate complex machinery.

During the first 24 hours after complete recovery from the neuromuscular blockade caused by rocuronium bromide, it is not recommended to drive a car or operate complex machinery.

Overdose

In case of overdose and prolonged neuromuscular blockade, lung ventilation and sedation should be continued. When spontaneous recovery of neuromuscular transmission begins, an acetylcholinesterase inhibitor (e.g., neostigmine, edrophonium, pyridostigmine) should be administered in an adequate dose.

If the administration of an acetylcholinesterase inhibitor does not lead to the elimination of the effect of rocuronium bromide, artificial lung ventilation should be continued until spontaneous breathing is restored. Repeated administration of an acetylcholinesterase inhibitor may be dangerous.

Drug Interactions

The following medicinal products have influenced the degree and/or duration of action of non-depolarizing muscle relaxants

Enhanced effect

• Inhalational anesthetics: halothane, diethyl ether, enflurane, isoflurane, methoxyflurane, cyclopropane
• Non-inhalational anesthetics: high doses of sodium thiopental, methohexital, ketamine, fentanyl, sodium oxybate, etomidate and propofol
• Other non-depolarizing muscle relaxants
• Previous use of suxamethonium
• Long-term treatment with corticosteroids and rocuronium bromide in intensive care units (ICU) may lead to an increase in the duration of neuromuscular blockade or myopathy
• Drugs of other groups: antibiotics (aminoglycosides, lincosamides (lincomycin and clindamycin), polypeptide antibiotics, acylaminopenicillins, tetracyclines), high doses of metronidazole, diuretics, thiamine, monoamine oxidase inhibitors, quinidine, quinine, protamine sulfate, beta-blockers, magnesium salts, slow calcium channel blockers, lithium salts, and local anesthetics (lidocaine intravenously, epidural administration of bupivacaine).

Weakened effect

• Neostigmine, edrophonium, pyridostigmine, aminopyridine derivatives
• Previous therapy with corticosteroids, phenytoin or carbamazepine
• Norepinephrine, azathioprine (only transient and limited effect), theophylline, calcium chloride, potassium chloride
• HIV protease inhibitors

Variable effect

The use of other non-depolarizing muscle relaxants in combination with rocuronium bromide may lead to a weakening or enhancement of the neuromuscular blockade depending on the order of their administration and the type of muscle relaxant.

The use of suxamethonium prior to the administration of rocuronium bromide may lead to an enhancement or suppression of the muscle relaxant effect of rocuronium bromide.

Effect of rocuronium bromide on the effects of other drugs:

Rocuronium bromide may accelerate the onset of action of lidocaine.

Recurarization has been reported against the background of postoperative use of aminoglycosides, lincosamides, polypeptides and acylaminopenicillins, quinidine, quinine and magnesium salts.

Pharmaceutical interactions

Incompatibility

Physical incompatibility of rocuronium bromide with solutions containing the following medicinal products has been established: amphotericin B, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, sodium thiopental, trimethoprim and vancomycin.

Compatibility when mixed with other medicinal products

Rocuronium bromide in nominal concentrations of 0.5 mg/ml and 2.0 mg/ml is compatible with 0.9% sodium chloride solution, 5% dextrose in 0.9% sodium chloride solution, water for injections, Ringer’s solution. Administration must be started immediately after mixing and completed within 24 hours. Unused solutions should be discarded.

Rocuronium bromide can be administered through an intravenous infusion system together with solutions of the following drugs for intravenous administration: epinephrine, alcuronium chloride, alfentanil, aminophylline, atracurium besylate, atropine, ceftazidime, cefuroxime, cimetidine, clemastine, clindamycin, clobetasol, clonazepam, clonidine, danaparoid sodium, dobutamine, dopamine, droperidol, ephedrine, ergotamine, esmolol, etomidate, fentanyl, flucytosine, gallamine triiodide, gentamicin, 40% dextrose solution, glycopyrronium bromide, heparin, isoprenaline, ketamine, labetalol, lidocaine, 20% mannitol solution, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, morphine, nifedipine, nimodipine, nitroglycerin, norepinephrine, oxytocin, pancuronium bromide, pipecuronium bromide, potassium chloride, promethazine, propranolol, ranitidine, salbutamol, sodium nitroprusside, sufentanil, suxamethonium, vecuronium bromide, verapamil.

Storage Conditions

Store at a temperature of 2 to 8°C (46.4°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Storage at temperatures up to 30°C (86°F) for 12 weeks is allowed, after which the drug must not be used!

Unused solution must be disposed of in accordance with the current requirements for drug disposal adopted in the given hospital.

Dispensing Status

For hospitals.

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.