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| U.S. Brand
Names |
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| Sufenta®
Injection |

|
|
| Generic
Available |
|
|
No |

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| Synonyms |
|
|
Sufentanil Citrate |

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|
| Pharmacological Index |
|
|
Analgesic, Narcotic; General Anesthetic |

|
|
| Use |
|
|
Analgesic supplement in maintenance of balanced general
anesthesia |

|
|
| Restrictions |
|
|
C-II |

|
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| Pregnancy Risk
Factor |
|
|
C |

|
|
| Contraindications |
|
|
Hypersensitivity to sufentanil or any component |

|
|
| Warnings/Precautions |
|
|
Sufentanil can cause severely compromised respiratory depression; use with
caution in patients with head injuries, hepatic or renal impairment or with
pulmonary disease; sufentanil shares the toxic potential of opiate agonists,
precaution of opiate agonist therapy should be observed; rapid I.V. infusion may
result in skeletal muscle and chest wall rigidity
impaired ventilation
respiratory distress/arrest;
inject slowly over 3-5 minutes; nondepolarizing skeletal muscle relaxant may be
required |

|
|
| Adverse
Reactions |
|
|
>10%:
Cardiovascular: Bradycardia, hypotension
Central nervous system: Drowsiness
Gastrointestinal: Nausea, vomiting
Respiratory: Respiratory depression
1% to 10%:
Cardiovascular: Cardiac arrhythmias, orthostatic hypotension
Central nervous system: Confusion, CNS depression
Gastrointestinal: Biliary tract spasm
Ocular: Blurred vision
<1%: Circulatory depression, convulsions, dysesthesia, paradoxical CNS
excitation or delirium; mental depression, dizziness, rash, urticaria, itching,
urinary tract spasm, laryngospasm, bronchospasm; cold, clammy skin; physical and
psychological dependence with prolonged use |

|
|
| Overdosage/Toxicology |
|
|
Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as
necessary up to a total of 10 mg; supportive care includes establishment of
respiratory change; naloxone may be used to treat respiratory depression;
muscular rigidity may also respond to opiate antagonist therapy or to
neuromuscular blocking agents |

|
|
| Drug
Interactions |
|
|
CYP3A3/4 enzyme substrate |

|
|
| Mechanism of
Action |
|
|
Binds with stereospecific receptors at many sites within the CNS, increases
pain threshold, alters pain reception, inhibits ascending pain pathways; ultra
short-acting narcotic |

|
|
| Pharmacodynamics/Kinetics |
|
|
Onset of action: 1-3 minutes
Duration: Dose dependent
Metabolism: Primarily by the liver |

|
|
| Usual Dosage |
|
|
Children <12 years: 10-25 mcg/kg with 100% O2, maintenance:
25-50 mcg as needed
Adults: Dose should be based on body weight. Note: In obese patients
(ie, >20% above ideal body weight), use lean body weight to determine dosage.
1-2 mcg/kg with N2O/O2 for endotracheal intubation;
maintenance: 10-25 mcg as needed
2-8 mcg/kg with N2O/O2 more complicated major surgical
procedures; maintenance: 10-50 mcg as needed
8-30 mcg/kg with 100% O2 and muscle relaxant produces sleep; at
doses greater than or equal to 8 mcg/kg maintains a deep level of anesthesia;
maintenance: 10-50 mcg as needed |

|
|
| Administration |
|
|
Parenteral: I.V.: Slow I.V. injection or by infusion |

|
|
| Mental Health: Effects
on Mental Status |
|
|
Drowsiness is common; may cause confusion; may rarely cause delirium or
depression |

|
|
| Mental Health:
Effects on Psychiatric
Treatment |
|
|
Concurrent use with psychotropics may produce additive
sedation |

|
|
| Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
|
No information available to require special precautions |

|
|
| Dental Health:
Effects on Dental Treatment |
|
|
No effects or complications reported |

|
|
| Patient
Information |
|
|
Do not drive for 24 hours after receiving this
medication |

|
|
| Nursing
Implications |
|
|
Patient may develop rebound respiratory depression
postoperatively |

|
|
| Dosage Forms |
|
|
Injection, as citrate: 50 mcg/mL (1 mL, 2 mL, 5 mL) |

|
|
| References |
|
|
Bovill JG, Sebel PS, Blackburn CL, et al,
"The Pharmacokinetics of Sufentanil in Surgical Patients,"
Anesthesiology, 1984, 61(5):502-6.
Bowdle TA, "Myoclonus Following Sufentanil Without EEG Seizure Activity,"
Anesthesiology, 1987, 67(4):593-5.
Guay J, Gaudreault P, Tang A, et al,
"Pharmacokinetics of Sufentanil in Normal Children," Can J Anaesth, 1992,
39(1):14-20.
Gust R and Böhrer H,
"Stiff-Man Syndrome Associated With Continuous Sufentanil Administration,"
Anaesthesia, 1995, 50(6):575.
Rosow CE,
"Sufentanil Citrate: A New Opioid Analgesic for Use in Anaesthesia,"
Pharmacotherapy, 1984, 4(1):11-9.
Scholz J, Steinfath M, and Schulz M,
"Clinical Pharmacokinetics of Alfentanil, Fentanyl, and Sufentanil. An Update,"
Clin Pharmacokinet, 1996, 31(4):275-92.
Seguin JH, Erenberg A, and Leff RD,
"Safety and Efficacy of Sufentanil Therapy in the Ventilated Infant,"
Neonatal Netw, 1994, 13(4):37-40.
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