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Tracrium

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Tracrium

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(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

TRACRIUM (atracurium besylate) is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

DOSAGE AND ADMINISTRATION

To avoid distress to the patient, TRACRIUM (atracurium besylate) should not be administered before unconsciousness has been induced. TRACRIUM (atracurium besylate) should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g., barbiturate solutions).

TRACRIUM (atracurium besylate) should be administered intravenously. DO NOT GIVE TRACRIUM (atracurium besylate) BY INTRAMUSCULAR ADMINISTRATION. Intramuscular administration of TRACRIUM (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 TRACRIUM (atracurium besylate) , minimizing the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Bolus Doses for Intubation and Maintenance of Neuromuscular Block

Adults: A dose of TRACRIUM (atracurium besylate) 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.

TRACRIUM (atracurium besylate) is potentiated by isoflurane or enflurane anesthesia. The same initial dose of TRACRIUM (atracurium besylate) of 0.4 to 0.5 mg/kg may be used for intubation prior to administration of these inhalation agents; however, if TRACRIUM (atracurium besylate) is first administered under steady state of isoflurane or enflurane, the initial dose of TRACRIUM (atracurium besylate) 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 TRACRIUM (atracurium besylate) , smaller dosage reductions may be considered.

Doses of TRACRIUM (atracurium besylate) of 0.08 to 0.10 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 injection of TRACRIUM (atracurium besylate) , but the need for maintenance doses should be determined by clinical criteria. Because TRACRIUM (atracurium besylate) 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 doses of TRACRIUM (atracurium besylate) (up to 0.2 mg/kg) permit maintenance dosing at longer intervals.

Pediatric Patients: No dosage adjustments of TRACRIUM (atracurium besylate) are required for pediatric patients 2 years of age or older. A dose of TRACRIUM (atracurium besylate) 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 dose of TRACRIUM (atracurium besylate) of 0.3 to 0.4 mg/kg, given slowly or in divided doses over 1 minute, is recommended for adults, adolescents, children, or infants with significant cardiovascular disease and for adults, adolescents, 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 TRACRIUM (atracurium besylate) in these patients, and no specific dosage adjustments can be recommended. No dosage adjustments of TRACRIUM (atracurium besylate) are required for patients with renal disease.

An initial dose of TRACRIUM (atracurium besylate) 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 administration of TRACRIUM (atracurium besylate) . Insufficient data are available for recommendation of a specific initial dose of TRACRIUM (atracurium besylate) 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 TRACRIUM (atracurium besylate) (0.3 to 0.5 mg/kg), a diluted solution of TRACRIUM (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 TRACRIUM (atracurium besylate) 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 TRACRIUM (atracurium besylate) should be initiated only after early evidence of spontaneous recovery from the bolus dose. An initial infusion rate of 9 to 10 mcg/kg per minute may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 5 to 9 mcg/kg per minute 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 per minute or as high as 15 mcg/kg per minute.

The neuromuscular blocking effect of TRACRIUM (atracurium besylate) administered by infusion is potentiated by enflurane or isoflurane and to a lesser extent, by halothane. Reduction in the infusion rate of TRACRIUM (atracurium besylate) should, therefore, be considered for patients receiving inhalation anesthesia. The infusion rate of TRACRIUM (atracurium besylate) 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 TRACRIUM (atracurium besylate) 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 infusion of TRACRIUM (atracurium besylate) 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 TRACRIUM (atracurium besylate) in the OR are also applicable to use in the ICU.

An infusion rate of 11 to 13 mcg/kg per minute (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 TRACRIUM (atracurium besylate) in the infusion solution, the desired dose of TRACRIUM (atracurium besylate) , 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 solutions of TRACRIUM (atracurium besylate) 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: Infusion Rates of TRACRIUM (atracurium besylate) for a Concentration of 0.2 mg/mL

Patient

Weight

(kg)

Drug Delivery Rate (mcg/kg per minute)

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: Infusion Rates of TRACRIUM (atracurium besylate) for a Concentration of 0.5 mg/mL

Patient

Weight

(kg)

Drug Delivery Rate (mcg/kg per minute)

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

Infusion solutions of TRACRIUM (atracurium besylate) may be prepared by admixing TRACRIUM (atracurium besylate) Injection with an appropriate diluent such as 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP. 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 TRACRIUM (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 TRACRIUM (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, USP not be used as a diluent in preparing solutions of TRACRIUM (atracurium besylate) for infusion.

HOW SUPPLIED

TRACRIUM Injection, 10 mg atracurium besylate in each mL.

5-mL Single-Use Vial (50 mg atracurium besylate per vial). Tray of 10 (NDC 0173-0940-44).

10-mL Multiple-Dose Vial (100 mg atracurium besylate per vial). Contains benzyl alcohol (see WARNINGS). Tray of 10 (NDC 0173-0545-00).

STORAGE: TRACRIUM (atracurium besylate) Injection should be refrigerated at 2° to 8° C (36° to 46° F) to preserve potency. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25° C / 77° F), use TRACRIUM (atracurium besylate) Injection within 14 days even if rerefrigerated.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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