The most frequent adverse effect of nondepolarizing blocking agents as a class consists of an extension of the pharmacological action beyond the time needed for surgery and anesthesia. This effect may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency and apnea which require manual or mechanical ventilation until recovery is judged to be clinically adequate (see OVERDOSAGE). Inadequate reversal of neuromuscular block from NUROMAX is possible, as with all nondepolarizing agents. Prolonged neuromuscular block and inadequate reversal may lead to postoperative complications.

Observed in Clinical Trials

Adverse experiences were uncommon among the 1034 surgical patients and volunteers who received NUROMAX and other drugs in US clinical studies in the course of a wide variety of procedures conducted during balanced or inhalational anesthesia. The following adverse experiences were reported in patients administered NUROMAX (all events judged by investigators during the clinical trials to have a possible causal relationship):

Incidence Greater than 1%: None

Incidence Less than 1%:

Cardiovascular:* Hypotension , flushing , ventricular fibrillation, myocardial infarction

Respiratory: Bronchospasm, wheezing

Dermatological: Urticaria, injection site reaction

Special Senses: Diplopia

Nonspecific: Difficult neuromuscular block reversal, prolonged drug effect, fever

* Reports of ventricular fibrillation (n = 1) and myocardial infarction (n = 1) were limited to ASA Class 3-4 patients undergoing cardiac surgery (n = 142).

  0.3% incidence. All other reactions unmarked were £ 0.1%.

Prior administration of succinylcholine has no clinically important effect on the neuromuscular blocking action of NUROMAX.

The use of NUROMAX before succinylcholine to attenuate some of the side effects of succinylcholine has not been studied.

There are no clinical data on concomitant use of NUROMAX and other nondepolarizing neuromuscular blocking agents.

Isoflurane, enflurane, and halothane decrease the ED₅₀ of NUROMAX by 30% to 45%. These agents may also prolong the clinically effective duration of action by up to 25%.

Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as NUROMAX include certain antibiotics (e. g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistimethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine.

As with some other nondepolarizing neuromuscular blocking agents, the time of onset of neuromuscular block induced by NUROMAX is lengthened and the duration of block is shortened in patients receiving phenytoin or carbamazepine.

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