MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER (MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER).
Competitive antagonist at nicotinic acetylcholine receptors at the neuromuscular junction, preventing acetylcholine-mediated depolarization and muscle contraction.
| Metabolism | Hydrolyzed by plasma esterases (pseudocholinesterase); minimally metabolized by the liver. |
| Excretion | Renal excretion of unchanged drug and metabolites accounts for approximately 50% of the dose; biliary/fecal elimination accounts for the remainder, primarily as metabolites via the liver. |
| Half-life | Terminal elimination half-life is approximately 2-3 minutes (0.03-0.05 h) due to rapid hydrolysis by plasma esterases; clinical duration is short, with recovery of neuromuscular function beginning within 5-10 minutes after bolus dose. |
| Protein binding | Mivacronium is approximately 30-40% 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. |
| Bioavailability | Mivacronium is administered intravenously; bioavailability is 100% by this route as it is a direct IV drug; oral bioavailability is negligible due to rapid hydrolysis in the gastrointestinal tract. |
| Onset of Action | After intravenous bolus, onset of neuromuscular blockade occurs within 1-3 minutes; for continuous infusion, effect onset is dose-dependent but similarly rapid. |
| Duration of Action | Duration of clinical neuromuscular blockade (time to 25% recovery of twitch height) is approximately 15-25 minutes after a single intubating dose; prolonged with higher doses or in patients with reduced esterase activity. |
Initial IV bolus of 0.15-0.2 mg/kg (following succinylcholine) or 0.25 mg/kg (without succinylcholine) over 30-60 seconds. Maintenance infusion: 8-10 mcg/kg/min for continuous neuromuscular blockade during anesthesia.
| Dosage form | INJECTABLE |
| Renal impairment | In renal impairment (CrCl <30 mL/min), reduce dose by 50-75% due to prolonged duration of action. Consider monitoring with train-of-four stimulation. |
| Liver impairment | In severe hepatic impairment (Child-Pugh Class C), reduce dose by 50% due to altered clearance. Avoid use in cholestasis. |
| Pediatric use | Children 2-12 years: Initial IV bolus 0.25 mg/kg. Maintenance infusion 14 mcg/kg/min initial, then titrate. Infants 1-23 months: 0.2 mg/kg bolus and 15 mcg/kg/min infusion. Neonate: Not recommended. |
| Geriatric use | Elderly patients: Reduce initial bolus by 25-50% (e.g., 0.1-0.15 mg/kg) due to increased sensitivity. Infusion rates typically lower (5-7 mcg/kg/min). Cautious titration with neuromuscular monitoring. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER (MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Not known if mivacurium is excreted in human milk. M/P ratio not available. Caution advised; discontinue breastfeeding or drug based on importance of drug to mother. |
| Teratogenic Risk | Mivacron (mivacurium) is a nondepolarizing neuromuscular blocker. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use only if clearly needed. First trimester: Risk cannot be ruled out (Category C). Second trimester: Insufficient data; potential fetal effects from maternal hypoxia or acidosis. Third trimester: Risk of neonatal neuromuscular blockade if administered near delivery; prolonged weakness in neonates possible. |
■ FDA Black Box Warning
Not recommended for prolonged use in ICU settings due to risk of prolonged paralysis and neuromuscular weakness; has been associated with anaphylactic reactions.
| Serious Effects |
Known hypersensitivity to mivacurium or any component; patients with known or suspected susceptibility to malignant hyperthermia.
| Precautions | Risk of histamine release causing hypotension and flushing; may cause malignant hyperthermia; caution in patients with renal or hepatic impairment; monitor neuromuscular function; have resuscitation equipment available. |
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| Fetal Monitoring | Monitor maternal vital signs (heart rate, blood pressure, oxygen saturation) and neuromuscular function with train-of-four (TOF) monitoring. Fetal heart rate monitoring during prolonged use near delivery. Assess for neonatal respiratory depression or muscle weakness after delivery. |
| Fertility Effects | No human data on fertility. Animal studies not conducted; no expected direct effect on fertility, but indirect effects from maternal illness or surgery may occur. |