"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
There has been limited experience with overdosage of TRACRIUM (atracurium besylate) . The possibility of iatrogenic overdosage can be minimized by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of TRACRIUM (atracurium besylate) can be expected to produce enhanced pharmacological effects. Overdosage may increase the risk of histamine release and cardiovascular effects, especially hypotension. If cardiovascular support is necessary, this should include proper positioning, fluid administration, and the use of vasopressor agents if necessary. The patient†s airway should be assured, with manual or mechanical ventilation maintained as necessary. A longer duration of neuromuscular block may result from overdosage and a peripheral nerve stimulator should be used to monitor recovery. Recovery may be facilitated by administration of an anticholinesterase reversing agent such as neostigmine, edrophonium, or pyridostigmine, in conjunction with an anticholinergic agent such as atropine or glycopyrrolate. The appropriate package inserts should be consulted for prescribing information.
Three pediatric patients (3 weeks, 4 and 5 months of age) unintentionally received doses of 0.8 mg/kg to 1.0 mg/kg of TRACRIUM (atracurium besylate) . The time to 25% recovery (50 to 55 minutes) following these doses, which were 5 to 6 times the ED95 dose, was moderately longer than the corresponding time observed following doses 2.0 to 2.5 times the TRACRIUM (atracurium besylate) ED95 dose in infants (22 to 36 minutes). Cardiovascular changes were minimal. Nonetheless the possibility of cardiovascular changes must be considered in the case of overdose.
An adult patient (17 years of age) unintentionally received an initial dose of 1.3 mg/kg of TRACRIUM (atracurium besylate) . The time from injection to 25% recovery (83 minutes) was approximately twice that observed following maximum recommended doses in adults (35 to 45 minutes). The patient experienced moderate hemodynamic changes (13% increase in mean arterial pressure and 27% increase in heart rate) which persisted for 40 minutes and did not require treatment.
The intravenous LD50s determined in nonventilated male and female albino mice and male Wistar rats were 1.9, 2.01, and 1.31 mg/kg, respectively. Deaths occurred within 2 minutes and were caused by respiratory paralysis. The subcutaneous LD50 determined in nonventilated male Wistar rats was 282.8 mg/kg. Tremors, ptosis, loss of reflexes, and respiratory failure preceded death which occurred 45 to 120 minutes after injection.
TRACRIUM (atracurium besylate) is contraindicated in patients known to have a hypersensitivity to it. Use of TRACRIUM (atracurium besylate) from multiple-dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Tracrium Information
- Tracrium Drug Interactions Center: atracurium iv
- Tracrium Side Effects Center
- Tracrium FDA Approved Prescribing Information including Dosage
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