NIMBEX PRESERVATIVE FREE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NIMBEX PRESERVATIVE FREE (NIMBEX PRESERVATIVE FREE).
Competitive antagonist at nicotinic acetylcholine receptors at the neuromuscular junction, blocking acetylcholine binding and inhibiting neuromuscular transmission, resulting in skeletal muscle paralysis.
| Metabolism | Primarily via Hofmann elimination (pH/temperature-dependent chemical degradation) and ester hydrolysis by plasma esterases, independent of renal or hepatic function. |
| Excretion | Primarily via Hofmann elimination (approximately 80%) and ester hydrolysis by nonspecific plasma esterases; renal excretion of unchanged drug accounts for less than 5% of the dose, and biliary/fecal elimination is minimal (less than 1%). |
| Half-life | Terminal elimination half-life is approximately 20-30 minutes (mean 24 minutes) in patients with normal renal and hepatic function; clinically, this short half-life supports rapid recovery after discontinuation and suitability for continuous infusion. |
| Protein binding | Approximately 50-60% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution at steady state (Vdss) is approximately 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid; higher Vd may be seen in elderly or obese patients. |
| Bioavailability | Intravenous administration only; no oral or other routes are clinically relevant. Bioavailability is 100% by IV route. |
| Onset of Action | Following intravenous bolus: 1.5-3 minutes for good to excellent intubating conditions; maximum neuromuscular blockade occurs at 3-5 minutes. |
| Duration of Action | Clinical duration (time to 25% recovery of T1) is approximately 20-35 minutes after a 0.15-0.2 mg/kg bolus in adults; duration is dose-dependent and prolonged with higher doses. Recovery index (time from 25% to 75% recovery) is about 10-15 minutes. |
0.15-0.2 mg/kg IV bolus for intubation; maintenance: 1.5-2 mcg/kg/min IV infusion
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for GFR >30 mL/min; for GFR 15-30 mL/min, reduce infusion rate by 20-30% and monitor; for GFR <15 mL/min, reduce infusion rate by 50% and monitor |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce infusion rate by 20-30%; Child-Pugh C: reduce infusion rate by 50% and monitor recovery |
| Pediatric use | Infants and children: 0.15-0.2 mg/kg IV bolus; maintenance infusion: 1-2 mcg/kg/min (titrate to effect) |
| Geriatric use | Consider lower initial doses (0.1-0.15 mg/kg) and slower infusion rates (1-1.5 mcg/kg/min); monitor for prolonged recovery |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NIMBEX PRESERVATIVE FREE (NIMBEX PRESERVATIVE FREE).
| Breastfeeding | It is not known whether cisatracurium is excreted in human milk. Caution should be exercised when administered to a nursing woman. M/P ratio: not available. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal studies have not revealed evidence of teratogenicity. In first trimester, risk cannot be excluded; use only if clearly needed. In second and third trimesters, no known fetal risk based on limited human data. |
| Fetal Monitoring |
■ FDA Black Box Warning
Requires immediate availability of resuscitative equipment, trained personnel, and ability to reverse neuromuscular blockade due to risk of prolonged apnea and respiratory paralysis.
| Serious Effects |
Known hypersensitivity to cisatracurium or other neuromuscular blocking agents.
| Precautions | May cause histamine release; monitor for anaphylaxis. Prolonged recovery in patients with electrolyte disturbances, hypothermia, or acidosis. Use with caution in neuromuscular diseases (e.g., myasthenia gravis) and burns. |
Loading safety data…
| Monitor maternal vital signs (heart rate, blood pressure, oxygen saturation), depth of neuromuscular blockade using peripheral nerve stimulator, and fetal heart rate during prolonged use near delivery. |
| Fertility Effects | No human data on fertility effects. Animal studies have not been conducted to evaluate effects on fertility. |