Bhi Restore

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• Medinatura Inc
  

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  Bhi Restore | Auromedics Pharma Llc

  

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  To avoid distress to the patient, atracurium should not be administered before unconsciousness has been induced. Atracurium should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g., barbiturate solutions).
  
  Atracurium besylate should be administered intravenously. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. Intramuscular administration of atracurium besylate may result in tissue irritation and there are no clinical data to support this route of administration.
  
  As with other neuromuscular blocking agents, the use of a peripheral nerve stimulator will permit the most advantageous use of atracurium besylate, minimizing the possibility of overdosage or underdosage, and assist in the evaluation of recovery.
  
  Bolus Doses for Intubation and Maintenance of Neuromuscular Block
  
  Adults
  
  An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED95), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection.
  
  Atracurium is potentiated by isoflurane or enflurane anesthesia. The same initial atracurium besylate dose of 0.4 to 0.5 mg/kg may be used for intubation prior to administration of these inhalation agents; however, if atracurium is first administered under steady-state of isoflurane or enflurane, the initial atracurium besylate dose should be reduced by approximately one-third, i.e., to 0.25 to 0.35 mg/kg, to adjust for the potentiating effects of these anesthetic agents. With halothane, which has only a marginal (approximately 20%) potentiating effect on atracurium, smaller dosage reductions may be considered.
  
  Atracurium besylate doses of 0.08 to 0.1 mg/kg are recommended for maintenance of neuromuscular block during prolonged surgical procedures. The first maintenance dose will generally be required 20 to 45 minutes after the initial atracurium besylate injection, but the need for maintenance doses should be determined by clinical criteria. Because atracurium lacks cumulative effects, maintenance doses may be administered at relatively regular intervals for each patient, ranging approximately from 15 to 25 minutes under balanced anesthesia, slightly longer under isoflurane or enflurane. Higher atracurium doses (up to 0.2 mg/kg) permit maintenance dosing at longer intervals.
  
  Pediatric Patients
  
  No atracurium dosage adjustments are required for pediatric patients two years of age or older. An atracurium besylate dose of 0.3 to 0.4 mg/kg is recommended as the initial dose for infants (1 month to 2 years of age) under halothane anesthesia. Maintenance doses may be required with slightly greater frequency in infants and children than in adults.
  
  Special Considerations
  
  An initial atracurium besylate dose of 0.3 to 0.4 mg/kg, given slowly or in divided doses over one minute, is recommended for adults, children, or infants with significant cardiovascular disease and for adults, children, or infants with any history (e.g., severe anaphylactoid reactions or asthma) suggesting a greater risk of histamine release.
  
  Dosage reductions must be considered also in patients with neuromuscular disease, severe electrolyte disorders, or carcinomatosis in which potentiation of neuromuscular block or difficulties with reversal have been demonstrated. There has been no clinical experience with atracurium in these patients, and no specific dosage adjustments can be recommended. No atracurium dosage adjustments are required for patients with renal disease.
  
  An initial atracurium besylate dose of 0.3 to 0.4 mg/kg is recommended for adults following the use of succinylcholine for intubation under balanced anesthesia. Further reductions may be desirable with the use of potent inhalation anesthetics. The patient should be permitted to recover from the effects of succinylcholine prior to atracurium administration. Insufficient data are available for recommendation of a specific initial atracurium dose for administration following the use of succinylcholine in children and infants.
  
  Use by Continuous Infusion
  
  Infusion in the Operating Room (OR)
  
  After administration of a recommended initial bolus dose of atracurium besylate injection (0.3 to 0.5 mg/kg), a diluted solution of atracurium besylate can be administered by continuous infusion to adults and pediatric patients aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures.
  
  Infusion of atracurium should be individualized for each patient. The rate of administration should be adjusted according to the patient’s response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.
  
  Infusion of atracurium should be initiated only after early evidence of spontaneous recovery from the bolus dose. An initial infusion rate of 9 to 10 mcg/kg/min may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 5 to 9 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under balanced anesthesia. Occasional patients may require infusion rates as low as 2 mcg/kg/min or as high as 15 mcg/kg/min.
  
  The neuromuscular blocking effect of atracurium administered by infusion is potentiated by enflurane or isoflurane and, to a lesser extent, by halothane. Reduction in the infusion rate of atracurium should, therefore, be considered for patients receiving inhalation anesthesia. The rate of atracurium infusion should be reduced by approximately one-third in the presence of steady-state enflurane or isoflurane anesthesia; smaller reductions should be considered in the presence of halothane.
  
  In patients undergoing cardiopulmonary bypass with induced hypothermia, the rate of infusion of atracurium required to maintain adequate surgical relaxation during hypothermia (25° to 28°C) has been shown to be approximately half the rate required during normothermia.
  
  Spontaneous recovery from neuromuscular block following discontinuation of atracurium infusion may be expected to proceed at a rate comparable to that following administration of a single bolus dose.
  
  Infusion in the Intensive Care Unit (ICU)
  
  The principles for infusion of atracurium in the OR are also applicable to use in the ICU.
  
  An infusion rate of 11 to 13 mcg/kg/min (range: 4.5 to 29.5) should provide adequate neuromuscular block in adult patients in an ICU. Limited information suggests that infusion rates required for pediatric patients in the ICU may be higher than in adult patients. There may be wide interpatient variability in dosage requirements and these requirements may increase or decrease with time (see PRECAUTIONS: Long-Term Use in Intensive Care Unit (ICU)). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.
  
  Infusion Rate Tables
  
  The amount of infusion solution required per minute will depend upon the concentration of atracurium in the infusion solution, the desired dose of atracurium, and the patient’s weight. The following tables provide guidelines for delivery, in mL/hr (equivalent to microdrops/min when 60 microdrops = 1 mL), of atracurium solutions in concentrations of 0.2 mg/mL (20 mg in 100 mL) or 0.5 mg/mL (50 mg in 100 mL) with an infusion pump or a gravity flow device. 

  
  Table 3: Atracurium Besylate Infusion Rates for a Concentration of 0.2 mg/mL Patient
  Weight
  (kg)
  Drug Delivery Rate (mcg/kg/min)
  5
  6
  7
  8
  9
  10
  11
  12
  13
  Infusion Delivery Rate (mL/hr)
  30
  45
  54
  63
  72
  81
  90
  99
  108
  117
  35
  53
  63
  74
  84
  95
  105
  116
  126
  137
  40
  60
  72
  84
  96
  108
  120
  132
  144
  156
  45
  68
  81
  95
  108
  122
  135
  149
  162
  176
  50
  75
  90
  105
  120
  135
  150
  165
  180
  195
  55
  83
  99
  116
  132
  149
  165
  182
  198
  215
  60
  90
  108
  126
  144
  162
  180
  198
  216
  234
  65
  98
  117
  137
  156
  176
  195
  215
  234
  254
  70
  105
  126
  147
  168
  189
  210
  231
  252
  273
  75
  113
  135
  158
  180
  203
  225
  248
  270
  293
  80
  120
  144
  168
  192
  216
  240
  264
  288
  312
  90
  135
  162
  189
  216
  243
  270
  297
  324
  351
  100
  150
  180
  210
  240
  270
  300
  330
  360
  390
  
  Table 4: Atracurium Besylate Infusion Rates for a Concentration of 0.5 mg/mL Patient
  Weight
  (kg)
  Drug Delivery Rate (mcg/kg/min)
  5
  6
  7
  8
  9
  10
  11
  12
  13
  Infusion Delivery Rate (mL/hr)
  30
  18
  22
  25
  29
  32
  36
  40
  43
  47
  35
  21
  25
  29
  34
  38
  42
  46
  50
  55
  40
  24
  29
  34
  38
  43
  48
  53
  58
  62
  45
  27
  32
  38
  43
  49
  54
  59
  65
  70
  50
  30
  36
  42
  48
  54
  60
  66
  72
  78
  55
  33
  40
  46
  53
  59
  66
  73
  79
  86
  60
  36
  43
  50
  58
  65
  72
  79
  86
  94
  65
  39
  47
  55
  62
  70
  78
  86
  94
  101
  70
  42
  50
  59
  67
  76
  84
  92
  101
  109
  75
  45
  54
  63
  72
  81
  90
  99
  108
  117
  80
  48
  58
  67
  77
  86
  96
  106
  115
  125
  90
  54
  65
  76
  86
  97
  108
  119
  130
  140
  100
  60
  72
  84
  96
  108
  120
  132
  144
  156
  

  Compatibility and Admixtures
  
  Atracurium besylate infusion solutions may be prepared by admixing atracurium besylate injection with an appropriate diluent such as 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection. Infusion solutions should be used within 24 hours of preparation. Unused solutions should be discarded. Solutions containing 0.2 mg/mL or 0.5 mg/mL atracurium besylate in the above diluents may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Care should be taken during admixture to prevent inadvertent contamination. Visually inspect prior to administration.
  
  Spontaneous degradation of atracurium besylate has been demonstrated to occur more rapidly in Lactated Ringer’s solution than in 0.9% sodium chloride solution. Therefore, it is recommended that Lactated Ringer’s Injection not be used as a diluent in preparing solutions of atracurium besylate injection for infusion.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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