TRACRIUM PRESERVATIVE FREE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRACRIUM PRESERVATIVE FREE (TRACRIUM PRESERVATIVE FREE).
Competitive antagonist of nicotinic acetylcholine receptors at the neuromuscular junction, blocking depolarization and preventing muscle contraction.
| Metabolism | Hofmann elimination (non-enzymatic degradation at physiological pH and temperature) and ester hydrolysis (by nonspecific esterases) to form laudanosine and other metabolites. |
| Excretion | Renal: 10-20% unchanged; biliary/fecal: 50-60% as metabolites and parent drug; Hofmann elimination (non-enzymatic) accounts for ~45% of clearance. |
| Half-life | Terminal elimination half-life: 20-30 minutes (healthy adults). Clinically, recovery is rapid due to redistribution and Hofmann elimination; prolonged in hypothermia or acidosis. |
| Protein binding | ~80% bound to plasma proteins (mainly albumin and immunoglobulins). |
| Volume of Distribution | Vd: 0.15-0.27 L/kg; approximates extracellular fluid volume. |
| Bioavailability | IM: not recommended due to tissue irritation and unpredictable absorption; IV: 100%. |
| Onset of Action | IV: 2-3 minutes (intubating dose 0.5-0.6 mg/kg); onset may be slightly slower than succinylcholine. |
| Duration of Action | IV: 20-35 minutes (clinical duration to 25% recovery of twitch height); prolonged with volatile anesthetics or renal/hepatic impairment. |
Initial dose 0.4-0.5 mg/kg IV bolus for intubation; maintenance 0.08-0.1 mg/kg IV every 20-45 minutes as needed or continuous infusion 5-10 mcg/kg/min
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for GFR > 10 mL/min; for GFR < 10 mL/min, consider prolonged effect, no specific dose reduction needed but monitor recovery |
| Liver impairment | In Child-Pugh Class A, no adjustment; Child-Pugh B and C: consider reduced initial dose (0.3 mg/kg) and prolonged duration; monitor closely |
| Pediatric use | Neonates: 0.3-0.4 mg/kg IV; Infants 1-12 months: 0.3-0.4 mg/kg IV; Children 1-12 years: 0.4-0.5 mg/kg IV; maintenance 0.05-0.1 mg/kg every 20-45 min or infusion 5-9 mcg/kg/min |
| Geriatric use | Elderly patients: initial dose 0.4-0.5 mg/kg IV; may have prolonged duration; infusion rate 5-7 mcg/kg/min; monitor recovery time |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRACRIUM PRESERVATIVE FREE (TRACRIUM PRESERVATIVE FREE).
| Breastfeeding | Atracurium is unlikely to be excreted in breast milk due to its high molecular weight and ionization. The M/P ratio is unknown. It is rapidly cleared from maternal plasma. Breastfeeding is considered safe after clinical effect has worn off. |
| Teratogenic Risk | Atracurium (Tracrium) is a nondepolarizing neuromuscular blocker. Animal studies have not shown teratogenicity at doses up to 0.15 mg/kg. There are no adequate well-controlled studies in pregnant women. Use only if clearly needed. First trimester: theoretical risk; avoid if possible. Second/third trimester: may be used for maternal surgery or Cesarean section; no known fetal harm. However, fetal muscle relaxation may occur, requiring monitoring. |
■ FDA Black Box Warning
Not for use in patients with known hypersensitivity to cisatracurium or other bisbenzylisoquinolinium agents. Should be administered by experienced clinicians prepared for resuscitation.
| Serious Effects |
Known hypersensitivity to TRACRIUM or any component of the formulation. Not recommended for use in neonates or for rapid sequence intubation in children.
| Precautions | Risk of histamine release, especially with rapid bolus doses, leading to hypotension and tachycardia. May cause bronchospasm in asthmatics. Monitor for residual neuromuscular block. Use caution in patients with neuromuscular diseases (e.g., myasthenia gravis), electrolyte imbalances, or hepatic/renal impairment. |
Loading safety data…
| Fetal Monitoring | Monitor maternal vital signs (heart rate, blood pressure, oxygen saturation). Continuous fetal heart rate monitoring if used during Cesarean section. Assess neuromuscular transmission (train-of-four) to avoid excessive blockade. Have resuscitation equipment available. |
| Fertility Effects | Atracurium has no known direct effects on fertility. No human studies available. Animal studies show no significant reproductive toxicity. |