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warnings
WARNINGS MIVACURIUM CHLORIDE 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 PERSONNEL AND FACILITIES FOR RESUSCITATION AND LIFE SUPPORT (TRACHEAL INTUBATION, ARTIFICIAL VENTILATION, OXYGEN THERAPY), AND AN ANTAGONIST OF MIVACURIUM CHLORIDE ARE IMMEDIATEDLY AVAILABLE. IT IS RECOMMENDED THAT A PERIPHERAL NERVE STIMULATOR BE USED TO MEASURE NEUROMUSCULAR FUNCTION DURING THE ADMINISTRATION OF MIVACURIUM CHLORIDE IN ORDER TO MONITOR DRUG EFFECT, DETERMINE THE NEED FOR ADDITIONAL DRUG, AND CONFIRM RECOVERY FROM NEUROMUSCULAR BLOCK. MIVACURIUM CHLORIDE HAS NO KNOWN EFFECT ON CONSCIOUSNESS, PAIN THRESHOLD, OR CEREBRATION. TO AVOID DISTRESS TO THE PATIENT, NEUROMUSCULAR BLOCK SHOULD NOT BE INDUCED BEFORE UNCONSCIOUSNESS. MIVACURIUM CHLORIDE IS METABOLIZED BY PLASMA CHOLINESTERASE AND SHOULD BE USED WITH GREAT CAUTION, IF AT ALL, IN PATIENTS KNOWN TO BE OR SUSPECTED OF BEING HOMOZYGOUS FOR THE ATYPICAL PLASMA CHOLINESTERASE GENE. Mivacurium chloride injection is acidic (pH 3.5 to 5.0) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions).
ADVERSE REACTIONS Observed in Clinical Trials Mivacurium chloride (a mixture of three stereoisomers) was well tolerated during extensive clinical trials in inpatients and outpatients. Prolonged neuromuscular block, which is an important adverse experience associated with neuromuscular blocking agents as a class, was reported as an adverse experience in three of 2074 patients administered mivacurium chloride. The most commonly reported adverse experience following the administration of mivacurium chloride was transient, dose-dependent cutaneous flushing about the face, neck, and/or chest. Flushing was most frequently noted after the initial dose of mivacurium and was reported in about 25% of adult patients who received 0.15 mg/kg mivacurium over 5 to 15 seconds. When present, flushing typically began within 1 to 2 minutes after the dose of mivacurium and lasted for 3 to 5 minutes. Of 105 patients who experienced flushing after 0.15 mg/kg mivacurium, two patients also experienced mild hypotension that was not treated, and one patient experienced moderate wheezing that was successfully treated. Overall, hypotension was infrequently reported as an adverse experience in the clinical trials of mivacurium. One of 332 (0.3%) healthy adults who received 0.15 mg/kg mivacurium over 5 to 15 seconds and none of 37 cardiac surgery patients who received 0.15 mg/kg mivacurium over 60 seconds were treated for a decrease in blood pressure in association with the administration of mivacurium. One to two percent of healthy adults given ≥0.20 mg/kg mivacurium over 5 to 15 seconds, 2% to 3% of healthy adults given 0.20 mg/kg over 30 seconds, none of 100 healthy adults given 0.25 mg/kg as a divided dose (0.15 mg/kg followed in 30 seconds by 0.10 mg/kg), and 2% to 4% of cardiac surgery patients given ≥0.20 mg/kg over 60 seconds were treated for a decrease in blood pressure. None of the 63 children who received the recommended dose of 0.20 mg/kg mivacurium was treated for a decrease in blood pressure in association with the administration of mivacurium. The following adverse experiences were reported in patients administered mivacurium (all events judged by investigators during the clinical trials to have a possible causal relationship): Incidence Greater Than 1%- Cardiovascular: Flushing (16%) Incidence Less Than 1%- Cardiovascular: Hypotension, tachycardia, bradycardia, cardiac arrhythmia, phlebitis Respiratory: Bronchospasm, wheezing, hypoxemia Dermatological: Rash, urticaria, erythema, injection site reaction Nonspecific: Prolonged drug effect Neurologic: Dizziness Musculoskeletal: Muscle spasms Observed in Clinical Practice Based on initial clinical practice experience in patients who received mivacurium chloride, spontaneously reported adverse events are uncommon. Some of these events occurred at recommended doses and required treatment. Anaphylaxis/Anaphylactoid Reaction From post-marketing surveillance, mivacurium has been associated with reports of anaphylactic/anaphylactoid reactions. In some of these reports, sensitivity to mivacurium chloride was confirmed using skin test procedures. Other adverse reaction data from clinical practice are insufficient to establish a casual relationship or to support an estimate of their incidence. These adverse events include: Musculoskeletal: Diminished drug effect, prolonged drug effect Cardiovascular: Hypotension (rarely severe), flushing Respiratory: Bronchospasm Integumentary: Rash