"The US Food and Drug Administration (FDA) has approved an expanded indication for onabotulinum toxin A (Botox, Actavis) for the treatment of adults with upper limb spasticity, according to a company news release.
The expanded i"...
Observed in Clinical Trials of Surgical Patients
Adverse experiences were uncommon among the 945 surgical patients who received NIMBEX (cisatracurium besylate) in conjunction with other drugs in US and European clinical studies in the course of a wide variety of procedures in patients receiving opioid, propofol, or inhalation anesthesia. The following adverse experiences were judged by investigators during the clinical trials to have a possible causal relationship to administration of NIMBEX (cisatracurium besylate) :
Incidence Greater than 1%
Incidence Less than 1%
Observed in Clinical Trials of Intensive Care Unit Patients
Adverse experiences were uncommon among the 68 ICU patients who received NIMBEX (cisatracurium besylate) in conjunction with other drugs in US and European clinical studies. One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (167 and 270 minutes) among 28 patients administered NIMBEX (cisatracurium besylate) and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisatracurium besylate.
Histamine release, hypersensitivity reactions including anaphylactic or anaphylactoid reactions which in some cases have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS). There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of NIMBEX (cisatracurium besylate) in children. These reported adverse events were not serious and their etiology could not be established with certainty.
Prolonged neuromuscular block, inadequate neuromuscular block, muscle weakness, and myopathy.
Read the Nimbex (cisatracurium besylate) Side Effects Center for a complete guide to possible side effects
NIMBEX (cisatracurium besylate) has been used safely following varying degrees of recovery from succinylcholine-induced neuromuscular block. Administration of 0.1 mg/kg (2 × ED95) NIMBEX (cisatracurium besylate) at 10% or 95% recovery following an intubating dose of succinylcholine (1 mg/kg) produced ≥ 95% neuromuscular block. The time to onset of maximum block following NIMBEX (cisatracurium besylate) is approximately 2 minutes faster with prior administration of succinylcholine. Prior administration of succinylcholine had no effect on the duration of neuromuscular block following initial or maintenance bolus doses of NIMBEX (cisatracurium besylate) . Infusion requirements of NIMBEX (cisatracurium besylate) in patients administered succinylcholine prior to infusions of NIMBEX (cisatracurium besylate) were comparable to or slightly greater than when succinylcholine was not administered.
The use of NIMBEX (cisatracurium besylate) before succinylcholine to attenuate some of the side effects of succinylcholine has not been studied.
Although not studied systematically in clinical trials, no drug interactions were observed when vecuronium, pancuronium, or atracurium were administered following varying degrees of recovery from single doses or infusions of NIMBEX (cisatracurium besylate) .
Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC [Minimum Alveolar Concentration] may prolong the clinically effective duration of action of initial and maintenance doses of NIMBEX (cisatracurium besylate) and decrease the required infusion rate of NIMBEX (cisatracurium besylate) . The magnitude of these effects may depend on the duration of administration of the volatile agents. Fifteen to 30 minutes of exposure to 1.25 MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of NIMBEX (cisatracurium besylate) and therefore, no adjustment to the initial dose should be necessary when NIMBEX (cisatracurium besylate) is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing, lower maintenance doses, or reduced infusion rates of NIMBEX (cisatracurium besylate) may be necessary. The average infusion rate requirement may be decreased by as much as 30% to 40%.
In clinical studies propofol had no effect on the duration of action or dosing requirements for NIMBEX (cisatracurium besylate) .
Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as NIMBEX (cisatracurium besylate) include certain antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistemethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine.
Resistance to the neuromuscular blocking action of nondepolarizing neuromuscular blocking agents has been demonstrated in patients chronically administered phenytoin or carbamazepine. While the effects of chronic phenytoin or carbamazepine therapy on the action of NIMBEX (cisatracurium besylate) are unknown, slightly shorter durations of neuromuscular block may be anticipated and infusion rate requirements may be higher.
Drug/Laboratory Test Interactions
Read the Nimbex Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/4/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Nimbex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.