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warnings
WARNINGS Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including NUROMAX, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs. Administration NUROMAX SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH THE DRUG'S ACTIONS AND THE POSSIBLE COMPLICATIONS OF ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND AN ANTAGONIST ARE WITHIN IMMEDIATE REACH. IT IS RECOMMENDED THAT CLINICIANS ADMINISTERING LONG-ACTING NEUROMUSCULAR BLOCKING AGENTS SUCH AS NUROMAX EMPLOY A PERIPHERAL NERVE STIMULATOR TO MONITOR DRUG RESPONSE, NEED FOR ADDITIONAL RELAXANTS, AND ADEQUACY OF SPONTANEOUS RECOVERY OR ANTAGONISM. NUROMAX HAS NO KNOWN EFFECT ON CONSCIOUSNESS, PAIN THRESHOLD, OR CEREBRATION. TO AVOID DISTRESS TO THE PATIENT, NEUROMUSCULAR BLOCK SHOULD NOT BE INDUCED BEFORE UNCONSCIOUSNESS. NUROMAX Injection is acidic (pH 3.9 to 5.0) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). NUROMAX Injection contains benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see WARNINGS and PRECAUTIONS - Pediatric Use ).
ADVERSE REACTIONS 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%. Observed During Clinical Practice There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) with the use of neuromuscular blocking agents of which NUROMAX is a member. These reactions, 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 ).