Rocuronium (Solution) Instructions for Use
ATC Code
M03AC09 (Rocuronium bromide)
Active Substance
Rocuronium bromide (Rec.INN registered by WHO)
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
A non-depolarizing muscle relaxant with a short (closer to intermediate) duration of action. It is a competitive antagonist of acetylcholine at the n-cholinergic receptors of the neuromuscular synapses of skeletal muscles. It has practically no ganglion-blocking and m-cholinoblocking action, and has a minor effect on histamine release. It can cause tachycardia (in 30% of cases); its effect on heart rate is less pronounced than that of pancuronium bromide and greater than that of vecuronium bromide.
The ED90 (the dose required to suppress 90% of the thumb muscle’s contractile response to ulnar nerve stimulation) under intravenous general anesthesia is approximately 0.3 mg/kg of body weight. After intravenous administration of a dose of 0.6 mg/kg (2 × ED90), complete neuromuscular blockade is achieved within 60-70 seconds; total skeletal muscle relaxation adequate for any surgical intervention occurs within 2 minutes; the clinical duration of action (time until spontaneous recovery of skeletal muscle contractility to 25% of the control level) is 30-40 minutes; the average time for spontaneous recovery of contractility from 25% to 75% of the control level (recovery index) is 14 minutes; the total duration (time until spontaneous recovery of skeletal muscle contractility to 90% of the control level) is 50 minutes.
The time to achieve the maximum effect depends on the dose, age, and the choice of the type of anesthetic.
Pharmacokinetics
Plasma protein binding is 30%. Distribution is biphasic. The half-life in the rapid phase is 1-2 minutes, in the slow phase it is 14-18 minutes. Vd is 0.26 L/kg; in hepatic insufficiency – 0.53 L/kg; in patients with a kidney transplant – 0.34 L/kg; in children 3-12 months – 0.3 L/kg, 1-3 years – 0.26 L/kg, 3-8 years – 0.21 L/kg. It crosses the placental barrier in small amounts. It is metabolized in the liver to form a weakly active metabolite – 17-deacetyl-rocuronium. It is eliminated by the liver and kidneys. Within the first 12 hours, 13-30.8% of the total administered dose is excreted by the kidneys unchanged. In hepatic insufficiency, clearance increases 2-fold. During anesthesia with opioids and nitrous oxide, the T1/2 is 1.4 hours; with isoflurane and normal liver function – 2.4 hours; with hepatic insufficiency – 4.3 hours; with a kidney transplant – 2.4 hours; with halothane, the T1/2 in children 3-12 months is 1.3 hours, 1-3 years – 1.1 hours, 3-8 years – 0.8 hours. A cumulative effect with repeated administration of maintenance doses was not observed.
Indications
For short-term muscle relaxation (to facilitate endotracheal intubation and mechanical ventilation).
ICD codes
| ICD-10 code | Indication |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer intravenously only. Individualize the dose based on patient factors and clinical requirements.
For routine endotracheal intubation in adults, use an initial bolus dose of 0.6 mg/kg. For rapid sequence induction, administer a dose of 0.9 mg/kg to achieve conditions for intubation within 60 seconds.
In adult patients, the maintenance dose for prolonged surgical relaxation is 0.15 mg/kg. Administer maintenance doses upon reappearance of T2 in response to train-of-four (TOF) nerve stimulation.
For continuous infusion in adults, initiate only after early evidence of spontaneous recovery from an initial bolus dose. Use an initial infusion rate of 0.3-0.6 mg/kg/h. Adjust the infusion rate according to the response to peripheral nerve stimulation, typically maintaining 1-2 twitches in the TOF response.
In pediatric patients (over 3 months), for routine intubation, use a dose of 0.6 mg/kg. For maintenance during prolonged procedures, administer 0.15 mg/kg. Continuous infusion can be used in children; titrate carefully based on monitoring.
In patients with significant hepatic impairment or biliary tract disease, expect a prolonged duration of action. Use the standard intubating dose but anticipate a reduced maintenance dose requirement and a longer recovery time.
In patients with renal impairment, use standard dosing. Exercise caution as altered pharmacokinetics may occur.
In obese patients, base the dose on ideal body weight (IBW), not total body weight, to avoid overdose and prolonged blockade.
For electroconvulsive therapy (ECT), use a dose of 0.3-0.6 mg/kg to achieve adequate muscle relaxation.
Monitor neuromuscular function throughout administration using a peripheral nerve stimulator. Do not extubate until the patient has fully recovered neuromuscular function, as evidenced by a sustained head lift for 5 seconds, a train-of-four ratio >0.9, or vital capacity >15-20 mL/kg.
Have reversal agents (e.g., sugammadex, neostigmine with an anticholinergic) and equipment for ventilatory support immediately available.
Adverse Reactions
From the cardiovascular system less frequently – decrease or increase in blood pressure; rarely – arrhythmia (including tachycardia).
From the digestive system: rarely – hiccups, nausea, vomiting.
Allergic reactions: rarely – angioedema, skin rash, bronchospasm, shortness of breath.
Local reactions: swelling and pain at the injection site (in case of extravasation).
Contraindications
Infant age (under 3 months), hypersensitivity to rocuronium chloride.
Use in Pregnancy and Lactation
The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or breastfed infant.
Use in Hepatic Impairment
Use with caution in hepatic insufficiency.
Use in Renal Impairment
Use with caution in renal insufficiency.
Pediatric Use
Contraindicated in infant age (under 3 months). In children over 3 months of age, use is possible according to the dosing regimen.
Geriatric Use
Use with caution in the elderly.
Special Precautions
Use with caution: acid-base balance and electrolyte imbalances, burns, cachexia, severe chronic heart failure, neuromuscular transmission disorders (including myasthenia gravis), pulmonary hypertension, heart defects, hepatic and/or renal insufficiency, old age, pregnancy, lactation period.
Overdose manifests as excessive decrease in blood pressure, collapse, prolonged muscle relaxation, apnea, shock. Treatment of overdose: mechanical ventilation, administration of muscle relaxant antagonists (neostigmine, pyridostigmine), symptomatic therapy.
The effect is enhanced by hypokalemia (e.g., after severe vomiting, diarrhea, digitalization, diuretic therapy), hypermagnesemia, hypocalcemia (e.g., after massive blood transfusions), hypoproteinemia, dehydration, acidosis, hypercapnia, cachexia.
Before use, it is necessary to correct blood pH changes, severe electrolyte disturbances, and dehydration.
When used in a dose of more than 0.9 mg/kg body weight, an increase in heart rate is possible, which may counteract bradycardia caused by other anesthetics or occurring during vagus nerve stimulation.
It should be borne in mind that during general anesthesia, even in the absence of known triggering agents, malignant hyperthermia may develop, so specialists should carefully monitor for early signs confirming the diagnosis of malignant hyperthermia. Experimental studies have shown that Rocuronium bromide is a factor that triggers the development of malignant hyperthermia.
Since the drug causes paralysis of the respiratory muscles, mechanical ventilation must be performed until adequate spontaneous breathing is restored.
Effect on the ability to drive vehicles and operate machinery
Within 24 hours after complete restoration of neuromuscular conduction, it is not recommended to drive vehicles or engage in potentially hazardous activities that require increased attention and rapid psychomotor reactions.
Drug Interactions
The effect of rocuronium bromide is enhanced by general anesthetics (it is recommended to reduce their infusion rate by 40%), other non-depolarizing muscle relaxants, aminoglycosides, polymyxin, tetracycline, vancomycin, bacitracin, colistin, quinidine, metronidazole (in high doses), diuretics, alpha-blockers, beta-blockers, thiamine, MAO inhibitors, protamine sulfate, magnesium salts, succinylcholine, corticosteroids, mineralocorticoids.
Rocuronium bromide exhibits properties of an antagonist of anticholinesterase agents (including proserin, neostigmine, pyridostigmine). Aminophylline, theophylline, norepinephrine, azathioprine, calcium chloride, aminopyridine derivatives, phenytoin, carbamazepine reduce the effect.
Atropine, hyoscyamine and other anticholinergic agents increase the risk of tachycardia.
Phenylephrine in nasal drops increases the risk of tachycardia, increased blood pressure and resistance to muscle relaxants in children.
Pharmaceutically incompatible with amphotericin, amoxicillin, azathioprine, cefazolin, dexamethasone, diazepam, erythromycin, famotidine, furosemide, hydrocortisone, insulin, methylprednisolone, prednisolone, trimethoprim, vancomycin, intralipid.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 5 or 10 pcs.
Marketing Authorization Holder
B-PHARM, LLC (Russia)
Manufactured By
Bryntsalov-A, JSC (Russia)
Dosage Form
 |
Rocuronium | Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous administration transparent, from colorless to light brown.
| 1 ml | |
| Rocuronium bromide | 10 mg |
Excipients : sodium acetate trihydrate – 2 mg, sodium chloride – 3.3 mg, glacial acetic acid – to pH 3.8-4.2, water for injections – to 1 ml.
5 ml – vials (1) – cardboard package.
5 ml – vials (5) – cardboard package.
5 ml – vials (10) – cardboard package.
10 ml – vials (1) – cardboard package.
10 ml – vials (5) – cardboard package.
10 ml – vials (10) – cardboard package.
Solution for intravenous administration 10 mg/ml: 5 ml amp. 5 pcs.
Marketing Authorization Holder
Ecofarmplus, JSC (Russia)
Dosage Form
|
Rocuronium | Solution for intravenous administration 10 mg/ml: 5 ml amp. 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous administration transparent, from colorless to slightly brownish-yellow.
| 1 ml | |
| Rocuronium bromide | 10 mg |
Excipients : sodium acetate – 2 mg, sodium chloride – 3.3 mg, glacial acetic acid – to pH 4.0, water for injections – to 1 ml.
5 ml – ampoules (5) – blister packs (1) – cardboard packs.
Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 1, 5, or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Rocuronium bromide | Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 1, 5, or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous administration in the form of a transparent liquid from colorless to light brown, with a characteristic odor.
| 1 ml | |
| Rocuronium bromide | 10 mg |
Excipients : sodium acetate trihydrate – 2 mg, sodium chloride – 3.3 mg, glacial acetic acid – to pH 3.8-4.2, water for injections – to 1 ml.
5 ml – vials – cardboard packs.
5 ml – vials (5) – cardboard packs.
5 ml – vials (10) – cardboard packs.
5 ml – vials (50) – cardboard boxes (for hospitals).
10 ml – vials – cardboard packs.
10 ml – vials (5) – cardboard packs.
10 ml – vials (10) – cardboard packs.
10 ml – vials (50) – cardboard boxes (for hospitals).
Solution for intravenous administration 10 mg/ml
Marketing Authorization Holder
Velpharm-M, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Or
Velpharm-M, LLC (Russia)
Dosage Form
|
Rocuronium bromide Velpharm | Solution for intravenous administration 10 mg/ml |
Dosage Form, Packaging, and Composition
Solution for intravenous administration
| 1 ml | |
| Rocuronium bromide | 10 mg |
10 ml – ampoules – cardboard packs – Prescription only
10 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (100 pcs.) – cardboard boxes – for hospitals
10 ml – ampoules (12 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (15 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (16 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (2 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (20 pcs.) – cardboard boxes – for hospitals
10 ml – ampoules (20 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (3 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (4 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
10 ml – ampoules (50 pcs.) – cardboard boxes – for hospitals
10 ml – ampoules (8 pcs.) – cardboard packs – Prescription only
10 ml – vials – cardboard packs – Prescription only
10 ml – vials (10 pcs.) – cardboard packs – Prescription only
10 ml – vials (100 pcs.) – cardboard boxes – for hospitals
10 ml – vials (12 pcs.) – cardboard packs – Prescription only
10 ml – vials (15 pcs.) – cardboard packs – Prescription only
10 ml – vials (16 pcs.) – cardboard packs – Prescription only
10 ml – vials (2 pcs.) – cardboard packs – Prescription only
10 ml – vials (20 pcs.) – cardboard boxes – for hospitals
10 ml – vials (20 pcs.) – cardboard packs – Prescription only
10 ml – vials (3 pcs.) – cardboard packs – Prescription only
10 ml – vials (4 pcs.) – cardboard packs – Prescription only
10 ml – vials (5 pcs.) – cardboard packs – Prescription only
10 ml – vials (50 pcs.) – cardboard boxes – for hospitals
10 ml – vials (8 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules – cardboard packs – Prescription only
2.5 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (100 pcs.) – cardboard boxes – for hospitals
2.5 ml – ampoules (12 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (15 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (16 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (2 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (20 pcs.) – cardboard boxes – for hospitals
2.5 ml – ampoules (20 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (3 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (4 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
2.5 ml – ampoules (50 pcs.) – cardboard boxes – for hospitals
2.5 ml – ampoules (8 pcs.) – cardboard packs – Prescription only
2.5 ml – vials – cardboard packs – Prescription only
2.5 ml – vials (10 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (100 pcs.) – cardboard boxes – for hospitals
2.5 ml – vials (12 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (15 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (16 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (2 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (20 pcs.) – cardboard boxes – for hospitals
2.5 ml – vials (20 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (3 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (4 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (5 pcs.) – cardboard packs – Prescription only
2.5 ml – vials (50 pcs.) – cardboard boxes – for hospitals
2.5 ml – vials (8 pcs.) – cardboard packs – Prescription only
5 ml – ampoules – cardboard packs – Prescription only
5 ml – ampoules (10 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (100 pcs.) – cardboard boxes – for hospitals
5 ml – ampoules (12 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (15 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (16 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (2 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (20 pcs.) – cardboard boxes – for hospitals
5 ml – ampoules (20 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (3 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (4 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (5 pcs.) – cardboard packs – Prescription only
5 ml – ampoules (50 pcs.) – cardboard boxes – for hospitals
5 ml – ampoules (8 pcs.) – cardboard packs – Prescription only
5 ml – vials – cardboard packs – Prescription only
5 ml – vials (10 pcs.) – cardboard packs – Prescription only
5 ml – vials (100 pcs.) – cardboard boxes – for hospitals
5 ml – vials (12 pcs.) – cardboard packs – Prescription only
5 ml – vials (15 pcs.) – cardboard packs – Prescription only
5 ml – vials (16 pcs.) – cardboard packs – Prescription only
5 ml – vials (2 pcs.) – cardboard packs – Prescription only
5 ml – vials (20 pcs.) – cardboard boxes – for hospitals
5 ml – vials (20 pcs.) – cardboard packs – Prescription only
5 ml – vials (3 pcs.) – cardboard packs – Prescription only
5 ml – vials (4 pcs.) – cardboard packs – Prescription only
5 ml – vials (5 pcs.) – cardboard packs – Prescription only
5 ml – vials (50 pcs.) – cardboard boxes – for hospitals
5 ml – vials (8 pcs.) – cardboard packs – Prescription only
Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 1, 5, 10, 12, 20, 50 or 100 pcs.
Marketing Authorization Holder
Binergia JSC (Russia)
Manufactured By
Kursk Biopharmaceutical Plant – Firm “Biok”, FKP (Russia)
Dosage Form
|
Rocuronium-Binergy | Solution for intravenous administration 10 mg/ml: 5 ml or 10 ml fl. 1, 5, 10, 12, 20, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous administration transparent, from colorless to light brown in color, with a characteristic odor.
| 1 ml | |
| Rocuronium bromide | 10 mg |
Excipients : sodium acetate trihydrate, sodium chloride, acetic acid, water for injections.
5 ml – vials (5) – contour cell packs (1) – cardboard packs (for hospitals).
5 ml – vials (5) – contour cell packs (2) – cardboard packs (for hospitals).
5 ml – vials (1) – cardboard packs (for hospitals).
5 ml – vials (5) – cardboard packs (for hospitals).
5 ml – vials (10) – cardboard packs (for hospitals).
5 ml – vials (12) – cardboard packs (for hospitals).
5 ml – vials (20) – cardboard packs (for hospitals).
5 ml – vials (50) – cardboard packs (for hospitals).
5 ml – vials (100) – cardboard packs (for hospitals).
10 ml – vials (5) – contour cell packs (1) – cardboard packs (for hospitals).
10 ml – vials (5) – contour cell packs (2) – cardboard packs (for hospitals).
10 ml – vials (1) – cardboard packs (for hospitals).
10 ml – vials (5) – cardboard packs (for hospitals).
10 ml – vials (10) – cardboard packs (for hospitals).
10 ml – vials (12) – cardboard packs (for hospitals).
10 ml – vials (20) – cardboard packs (for hospitals).
10 ml – vials (50) – cardboard packs (for hospitals).
10 ml – vials (100) – cardboard packs (for hospitals).
![Rocuronium [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Rocuronium [Solution] 2")