Rocuronium Bromide

Trade Names:
Zemuron
- Injection 10 mg/mL

Pharmacology

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Binds competitively to cholinergic receptors on motor end-plate to antagonize action of acetylcholine, resulting in block of neuromuscular transmission.

Pharmacokinetics

Distribution

Rapid distribution half-life is 1 to 2 min and the slower distribution half-life is 14 to 18 min. Plasma protein binding is approximately 30%.

Special Populations

Because of the limited role of the kidney in rocuronium elimination, follow usual dosing guidelines.

Because rocuronium is primarily excreted by the liver, use with caution in patients with clinically significant hepatic impairment.

Observed pharmacokinetic effects for patients 65 yr of age and older were similar to other adult patients. Onset time and duration of action are slightly longer in elderly patients.

Indications and Usage

As an adjunct to general anesthesia for inpatients and outpatients to facilitate both rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Contraindications

Standard considerations.

Dosage and Administration

Use of a peripheral nerve stimulator is recommended to monitor drug response and determine the need for additional relaxant and adequacy of spontaneous recovery or antagonism.

IV 0.01 to 0.012 mg/kg per min initiated only after early evidence of spontaneous recovery from the intubating dose.

IV 0.45 to 0.6 mg/kg, depending on anesthetic technique and age of the patient. The infusion must be individualized for each patient. Adjust the rate of administration according to the patients twitch response as monitored with the use of a peripheral nerve stimulator.

When used for general anesthesia, patients ranging from 3 mo of age through adolescence administered rocuronium maintenance dose of 0.075 to 0.125 mg/kg administered upon return of T ₁ to 0.25%, halothane can provide clinical relaxation for 7 to 10 min. Alternatively, a continuous infusion of rocuronium initiated at a rate of 12 mcg/kg/min upon return of T ₁ to 10% (1 twitch present in train-of-four), may also be used to maintain neuromuscular blockade in children. With sevoflurane induction, doses of rocuronium 0.45 mg/kg and 0.6 mg/kg, in general, produce excellent to good intubating conditions within 75 sec. When halothane is used, a 0.6 mg/kg dose of rocuronium resulted in excellent to good intubating conditions within 60 sec. When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of rocuronium 0.15 mg/kg can be administered as bolus doses at reappearance of T ₃ in all pediatric age groups. Maintenance dosing at a rate of 7 to 10 mcg/kg/min can be administered at the reappearance of T ₂ with the lowest dose requirement for neonates (ie, birth to younger than 28 days of age) and the highest dose requirement for children (ie, older than 2 yr of age up to 11 yr of age).

IV Exhibited slightly prolonged median clinical duration under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively.

0.1 to 0.15 mg/kg administered at 25% recovery of T ₁ .

IV 0.1, 0.15, and 0.2 mg/kg administered at 25% recovery of control T ₁ (defined as 3 twitches of train-of-four).

IV 0.6 to 1.2 mg/kg provides excellent to good intubating conditions in most patients in less than 2 min.

IV 0.6 mg/kg as a recommended initial dose. Good intubation conditions usually occur within 2 min.

General Advice

• Rocuronium is physically incompatible when mixed with amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, ketorolac, lorazepam, methohexital, methylprednisolone, thiopental, trimethoprim, and vancomycin.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. May be removed from refrigerator and stored at controlled room temperature (less than 77°F), but injection must be used within 60 days. Once vial has been opened, use within 30 days. Use within 24 h of mixing.

Drug Interactions

May enhance the neuromuscular blocking action of rocuronium.

Resistance to neuromuscular blocking action of rocuronium may occur.

QT interval may be prolonged.

May prolong the clinically effective duration of action of initial and maintenance doses of rocuronium and decrease the required infusion rate.

Time of onset of max block following rocuronium may be faster with prior administration of succinylcholine.

Incompatibility

Should not be mixed with alkaline solutions (eg, barbiturates) in the same syringe or administered simultaneously during IV infusion through the same needle.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Increased pulmonary vascular resistance (24%); abnormal ECG, arrhythmia, hypertension, hypotension, tachycardia (less than 1%).

Dermatologic

Pruritus, rash (less than 1%).

GI

Nausea, vomiting (less than 1%).

Hypersensitivity

Severe allergic reactions, including life-threatening and fatal anaphylactoid and anaphylactic reactions and shock (postmarketing).

Local

Injection-site edema (less than 1%).

Musculoskeletal

Myopathy; residual paralysis.

Respiratory

Asthma (bronchospasm, rhonchi, wheezing), hiccup (less than 1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Sevoflurane induction has been studied in neonates and children up to 17 yr of age. Rocuronium is not recommended for rapid sequence intubation in children. Use in children younger than 3 mo of age or older than 14 yr of age under halothane anesthesia has not been studied.

Hypersensitivity

Rare, severe, or life-threatening anaphylactic reactions have been reported.

Hepatic Function

Use with caution.

Special Risk Patients

May have profound effect in patients with neuromuscular disease (eg, myasthenia gravis). Patients with burns, hemiparesis, or paraparesis may have resistance to rocuronium. Severe acid-base and/or electrolyte abnormalities may potentiate or cause resistance.

Administration

Under the supervision of experienced clinicians who are familiar with rocuronium action and complications. Personnel and facilities for resuscitation and life support and an antagonist of rocuronium should be immediately available.

Malignant hyperthermia

May occur.

Onset time

May be delayed in patients with slower circulation time (eg, CV disease).

Pulmonary hypertension

Because rocuronium may be associated with increased pulmonary vascular resistance, use with caution in patients with pulmonary hypertension or valvular heart disease.

Residual paralysis

In order to prevent complications resulting from residual paralysis, it is recommended to extubate only after patient recovers sufficiently from neuromuscular block.

Tolerance

Tolerance may develop during chronic administration in the intensive care unit.

Overdosage

Symptoms

Prolonged neuromuscular block.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Reassure patient, family, or caregiver that breathing will be closely monitored and supported while medication is being administered and that breathing and muscle function will return to normal after medication has been discontinued.

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