A Nondepolarizing Neuromuscular Blocking (NMB) Agent

Transcription

1 DOSING GUIDE A Nondepolarizing Neuromuscular Blocking (NMB) Agent Easy to remember dosing for the 0.20 mg/kg adult intubating doses of NIMBEX 1 *: For every 10 kg, give 1 ml of NIMBEX (2 mg/ml concentration) Example, a 70 kg patient = 7 ml of NIMBEX (2 mg/ml concentration) for a total dose of 14 mg * There are two recommended adult intubating doses for NIMBEX 0.15 mg/kg (3 x ED95) and 0.20 mg/kg (4 x ED95). Indication 1 NIMBEX (cisatracurium besylate) is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU. Safety Considerations 1 NIMBEX is contraindicated in patients with known hypersensitivity to the product and its components. Severe anaphylactic reactions to neuromuscular blocking agents, including NIMBEX, have been reported. The 10-mL multiple-dose vials of NIMBEX contain benzyl alcohol, which is contraindicated for use in premature infants and is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity and there have been rare reports of deaths, primarily in preterm infants. NIMBEX is not recommended for rapid sequence endotracheal intubation, will not counteract bradycardia, and requires individualized dosing for conditions causing potentiation of or resistance to neuromuscular block. Certain drugs may potentiate the neuromuscular blocking action of the drug. 1

2 NIMBEX Infusion Dosing for Adults and Children 1 Initial Infusion Rate Maintenance Rate a 3 mcg/kg/min 1 to 2 mcg/kg/min A diluted solution of NIMBEX can be administered by continuous infusion in adults and children 2 years old during extended surgical procedures. Infusion of NIMBEX should be initiated only after early evidence of spontaneous recovery from the initial bolus dose. It is recommended that a peripheral nerve stimulator be used during the administration of NIMBEX to monitor drug effect. NIMBEX Injection is not compatible with propofol injection or ketorolac injection for Y-site administration. NIMBEX Injection should not be diluted with Lactated Ringer s Injection, USP, due to chemical instability. a A rate of 1 to 2 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under opioid/n 2 O/O 2 anesthesia. NIMBEX Infusion in the Intensive Care Unit (ICU) 1 Infusion Rate Range ~3 mcg/kg/min 0.5 to 10.2 mcg/kg/min NIMBEX infusion in the ICU can be administered to adult patients to provide neuromuscular block. There may be wide interpatient variability in dosage requirements and these may increase or decrease with time. Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion. The amount of infusion solution required per minute will depend upon the concentration of NIMBEX in the infusion solution, the desired dose of NIMBEX, and the patient s weight. Long-term infusion (up to 6 days) of NIMBEX during mechanical ventilation in the ICU has been safely used in two studies. Use in the ICU for longer than 6 days has not been studied. Adverse experiences were uncommon among the 68 ICU patients who received NIMBEX in conjunction with other drugs in US and European clinical studies. One out of 68 patients experienced bronchospasm. In one study, there were 2 reports of prolonged recovery among 28 patients administered NIMBEX compared with 13 reports among 30 patients administered vecuronium. Dosing should be individualized. This is a guide only. For additional information about NIMBEX, contact your local sales representative or call

3 A Nondepolarizing Neuromuscular Blocking Agent Intubation Dosing 1 Maintenance Dosing 1 ADULTS CHILDREN (2-12 yrs) INFANTS a (1-23 mos) ADULTS kg Total Dose (mg) kg Total Dose (mg) kg Total Dose (mg) kg Total Dose (mg) The presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. The onset, duration of action, and recovery profiles of NIMBEX during propofol/o 2 or propofol/n 2 O/O 2 anesthesia are similar to those during opioid/n 2 O/O 2 anesthesia. a The 10-mL multiple-dose vial is contraindicated for use in premature infants because it contains benzyl alcohol. NIMBEX has an intermediate onset of action and is not recommended for rapid sequence endotracheal intubation. 3

4 NIMBEX Profiles for Onset and Duration of Action 1 Time to Onset a (sec) Time to 90% Block (min) ADULTS 0.15 mg/kg c,d 120 d,e 2.6 (range: ) 0.20 mg/kg c 90 d,e 2.4 (range: ) CHILDREN (2-12 yrs) 0.10 mg/kg c 1.7 (range: ) 0.15 mg/kg f 2.1 (range: ) Time to Maximum Block (min) 3.5 (range: ) 2.9 (range: ) 2.8 (range: ) 3.0 (range: ) Clinical Duration b (min) 55 (range: 44-74) 65 (range: ) 28 (range: 21-38) 36 (range: 29-46) INFANTS g (1-23 mos) 0.15 mg/kg f 1.5 (range: ) 2.0 (range: ) 43 (range: 34-58) The presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. The onset, duration of action, and recovery profiles of NIMBEX during propofol/o 2 or propofol/n 2 O/O 2 anesthesia are similar to those during opioid/n 2 O/O 2 anesthesia. Adult Maintenance Bolus Dose Clinical Duration 0.03 mg/kg 20 minutes a In a study at a dose of 0.1 mg/kg, time to maximum block was approximately 1 minute slower in elderly patients ( 65 years) than in healthy young adults; onset time was approximately 1 minute faster in patients with end-stage liver disease and time to 90% block was approximately 1 minute slower in patients with renal disease than in healthy adult control patients. b Time to 25% spontaneous recovery. c Opioid/N 2 O/O 2 anesthesia. d Propofol/N 2 O/O 2 anesthesia. e Co-induction agents: midazolam and fentanyl. f Thiopentone/alfentanil/N 2 O/O 2 anesthesia. g The 10-mL multiple-dose vial is contraindicated for use in premature infants because it contains benzyl alcohol. NIMBEX has an intermediate onset of action and is not recommended for rapid sequence endotracheal intubation. 4

5 Indication 1 NIMBEX (cisatracurium besylate) is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU. Important Safety Information 1 NIMBEX is contraindicated in patients with known hypersensitivity to the product and its components. The 10-mL multiple-dose vials of NIMBEX are contraindicated for use in premature infants because the formulation contains benzyl alcohol. Severe anaphylactic reactions to neuromuscular blocking agents, including NIMBEX, have been reported. These reactions have in some cases been life-threatening and fatal. Precaution should be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents. NIMBEX should only be administered intravenously in carefully adjusted dosage by or under the supervision of experienced clinicians familiar with the drug s actions and possible complications. It is recommended that a peripheral nerve stimulator be used during the administration of NIMBEX to monitor drug effect, determine the need for additional doses, and confirm recovery from neuromuscular block. NIMBEX has no known effect on consciousness, pain threshold, or cerebration. The 10-mL multiple-dose vials of NIMBEX contain benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity, particularly in preterm infants and neonates, and there have been rare reports of deaths, primarily in preterm infants. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The practitioner must consider the daily metabolic load of benzyl alcohol from medications containing this preservative. Single-use vials (5-mL and 20-mL) of NIMBEX do not contain benzyl alcohol. NIMBEX has not been studied in pediatric patients below the age of 1 month. NIMBEX has an intermediate onset of action and is not recommended for rapid sequence endotracheal intubation. NIMBEX will not counteract the bradycardia produced by many anesthetic agents or by vagal stimulation. Doses should be individualized for conditions causing potentiation of or resistance to neuromuscular block, such as in patients with neuromuscular diseases, burns, hemiparesis or paraparesis, acid-base and/or serum electrolyte abnormalities, and in patients receiving chronic treatment with phenytoin or carbamazepine. Long-term infusion (up to 6 days) of NIMBEX during mechanical ventilation in the ICU has been safely used in 2 studies. Use in the ICU for longer than 6 days has not been studied. Dosage requirements may increase or decrease with time. Whenever the use of NIMBEX in the ICU is contemplated, it is recommended that neuromuscular function be monitored during administration with a nerve stimulator. Additional doses of NIMBEX or any other neuromuscular blocking agent should not be given before there is a definite response to nerve stimulation. If no response is elicited, infusion administration should be discontinued until a response returns. The time to onset of maximum block following NIMBEX is approximately 2 minutes faster with prior administration of succinylcholine. Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC may prolong the clinically effective duration of action and decrease the required infusion rate of NIMBEX. Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as NIMBEX include certain antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistemethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine. No adverse event was reported by >1% of the surgical patients treated with NIMBEX during clinical trials; <1% of patients reported bradycardia, hypotension, flushing, bronchospasm, and/or rash. Adverse experiences were uncommon among the 68 ICU patients who received NIMBEX in conjunction with other drugs in US and European clinical studies. One out of 68 patients experienced bronchospasm. In one study, there were 2 reports of prolonged recovery among 28 patients administered NIMBEX compared with 13 reports among 30 patients administered vecuronium. Reference: 1. NIMBEX [package insert] AbbVie Inc. North Chicago, IL January