Rocuronium Bromide

Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )

• Rocuronium Bromide Injection is for intravenous use only
• Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents
• Individualize the dose for each patient
• Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery
• Store Rocuronium Bromide Injection with tamper evidence cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product
• Tracheal intubation : Recommended initial dose is 0.6 mg/kg
• Rapid sequence intubation : 0.6 mg/kg to 1.2 mg/kg
• Maintenance doses : Guided by response to prior dose, not administered until recovery is evident
• Continuous infusion : Initial rate of 10 mcg/kg/min to 12 mcg/kg/min
• Start only after early evidence of spontaneous recovery from an intubating dose
• Important Dosing and Administration Information Rocuronium Bromide Injection is for intravenous use only
• Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. …

Rocuronium Bromide Injection is a clear, colorless to yellow/orange solution, free from visible particulate matter available as: 50 mg/5 mL (10 mg/mL), single-dose vials 100 mg/10 mL (10 mg/mL), single-dose vials 50 mg/5 mL (10 mg/mL), single-dose prefilled syringes Injection: 50 mg/5 mL (10 mg/mL), single-dose vial and single-dose prefilled syringe. …

• Obtain information about your patient's medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents
• If applicable, inform your patients that certain medical conditions and medications might influence how Rocuronium Bromide Injection works [see Warnings and Precautions , Drug Interactions ]
• In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported. …

• Rocuronium Bromide Injection is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions ]
• Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents

Succinylcholine : Use before succinylcholine has not been studied. ( 7.11 ) Nondepolarizing muscle relaxants : Interactions have been observed. ( 7.7 ) Enhanced Rocuronium Bromide Injection activity possible : Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible : Anticonvulsants. …

Appropriate Administration and Monitorin g: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. ( 5.1 ) Anaphylaxis : Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents. ( 5.2 ) Risk of Death due to Medication Errors : Accidental administration can cause death. ( 5.3 ) Need for Adequate Anesthesia : Must be accompanied by adequate anesthesia or sedation. ( 5.4 ) Residual Paralysis : Consider using a reversal agent in cases where residual paralysis is more likely to occur. …

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions ( 5.2 )] Residual paralysis [see Warnings and Precautions ( 5.5 )] Myopathy [see Warnings and Precautions ( 5.6 )] Increased pulmonary vascular resistance [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (2%) are transient hypotension and hypertension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Available data from controlled trials and case series and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ). …

Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.