Sufentanil Citrate (Page 3 of 5)

Neuromuscular Blocking Agents

The hemodynamic effects and degree of skeletal muscle relaxation required should be considered in the selection of a neuromuscular blocking agent. High doses of pancuronium may produce increases in heart rate during sufentanil-oxygen anesthesia. Bradycardia and hypotension have been reported with other muscle relaxants during sufentanil-oxygen anesthesia; this effect may be more pronounced in the presence of calcium channel and/or beta blockers. Muscle relaxants with no clinically significant effect on heart rate (at recommended doses) would not counteract the vagotonic effect of sufentanil; therefore, a lower heart rate would be expected. Rare reports of bradycardia associated with the concomitant use of succinylcholine and sufentanil have been reported.

Interaction With Calcium Channel And Beta Blockers

The incidence and degree of bradycardia and hypotension during induction with sufentanil may be greater in patients on chronic calcium channel and beta blocker therapy. (See Neuromuscular Blocking Agents.)

Interaction With Other Central Nervous System Depressants

Both the magnitude and duration of central nervous system and cardiovascular effects may be enhanced when sufentanil is administered to patients receiving barbiturates, tranquilizers, other opioids, general anesthetics or other CNS depressants. In such cases of combined treatment, the dose of sufentanil and/or these agents should be reduced.

The use of benzodiazepines with sufentanil during induction may result in a decrease in mean arterial pressure and systemic vascular resistance.

Head Injuries

Sufentanil may obscure the clinical course of patients with head injuries.

Impaired Respiration

Sufentanil should be used with caution in patients with pulmonary disease, decreased respiratory reserve or potentially compromised respiration. In such patients, opioids may additionally decrease respiratory drive and increase airway resistance. During anesthesia, this can be managed by assisted or controlled respiration.

Impaired Hepatic Or Renal Function

In patients with liver or kidney dysfunction, sufentanil citrate should be administered with caution due to the importance of these organs in the metabolism and excretion of sufentanil.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies of sufentanil have been performed to evaluate carcinogenic potential. The micronucleus test in female rats revealed that single intravenous doses of sufentanil as high as 80 mcg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations. The AmesSalmonella typhimurium metabolic activating test also revealed no mutagenic activity. See Animal Toxicology for reproduction studies in rats and rabbits.


Teratogenic Effects—Pregnancy Category C.

Sufentanil has been shown to have an embryocidal effect in rats and rabbits when given in doses 2.5 times the upper human intravenous dose for a period of 10 days to over 30 days. These effects were most probably due to maternal toxicity (decreased food consumption with increased mortality) following prolonged administration of the drug.

No evidence of teratogenic effects have been observed after administration of sufentanil citrate in rats or rabbits.

Labor and Delivery

The use of epidurally administered sufentanil in combination with bupivacaine 0.125% with or without epinephrine is indicated for labor and delivery. (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.) Sufentanil is not recommended for intravenous use or for use of larger epidural doses during labor and delivery because of potential risks to the newborn infant after delivery. In clinical trials, one case of severe fetal bradycardia associated with maternal hypotension was reported within 8 minutes of maternal administration of sufentanil 15 mcg plus bupivacaine 0.125% (10 mL total volume).

Nursing Mothers

It is not known whether sufentanil is excreted in human milk. Because fentanyl analogs are excreted in human milk, caution should be exercised when sufentanil citrate is administered to a nursing woman.

Pediatric Use

The safety and efficacy of intravenous sufentanil in pediatric patients as young as 1 day old undergoing cardiovascular surgery have been documented in a limited number of cases. The clearance of sufentanil in healthy neonates is approximately one-half that in adults and children. The clearance rate of sufentanil can be further reduced by up to a third in neonates with cardiovascular disease, resulting in an increase in the elimination half-life of the drug.

Animal Toxicology

The intravenous LD50 of sufentanil is 16.8 to 18.0 mg/kg in mice, 11.8 to 13.0 mg/kg in guinea pigs and 10.1 to 19.5 mg/kg in dogs. Reproduction studies performed in rats and rabbits given doses up to 2.5 times the upper human intravenous dose for a period of 10 to over 30 days revealed high maternal mortality rates due to decreased food consumption and anoxia, which preclude any meaningful interpretation of the results. Epidural and intrathecal injections of sufentanil in dogs and epidural injections in rats were not associated with neurotoxicity.


The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. Sufentanil may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See CLINICAL PHARMACOLOGY,WARNINGS and PRECAUTIONS on the management of respiratory depression and skeletal muscle rigidity. Urinary retention has been associated with the use of epidural opioids but was not reported in the clinical trials of epidurally administered sufentanil due to the use of indwelling catheters. The incidence of urinary retention in patients without urinary catheters receiving epidural sufentanil is unknown; return of normal bladder activity may be delayed.

The following adverse reaction information is derived from controlled clinical trials in 320 patients who received intravenous sufentanil during surgical anesthesia and in 340 patients who received epidural sufentanil plus bupivacaine 0.125% for analgesia during labor. Based on the observed frequency, none of the reactions occurring with an incidence less than 1% were observed during clinical trials of epidural sufentanil used during labor and delivery (N=340).

In general, cardiovascular and musculoskeletal adverse experiences were not observed in clinical trials of epidural sufentanil. Hypotension was observed 7 times more frequently in intravenous trials than in epidural trials. The incidence of central nervous system, dermatological and gastrointestinal adverse experiences was approximately 4 to 25 times higher in studies of epidural use in labor and delivery.

Probably Causally Related: Incidence greater than 1% – Derived from clinical trials

(See preceding paragraph)

Cardiovascular – bradycardia*, hypertension*, hypotension*

Musculoskeletal – chest wall rigidity*

Central Nervous System – somnolence*

Dermatological – pruritus (25%)

Gastrointestinal – nausea*, vomiting*

*Incidence 3% to 9%

Probably Causally Related: Incidence less than 1% – Derived from clinical trials

(Adverse events reported in post-marketing surveillance, not seen in clinical trials, are italicized)

Body as a whole – anaphylaxis

Cardiovascular – arrhythmia*, tachycardia*, cardiac arrest

Central Nervous System – chills*

Dermatological – erythema*

Musculoskeletal – skeletal muscle rigidity of neck and extremities

Respiratory – apnea*, bronchospasm*, postoperative respiratory depression*

Miscellaneous – intraoperative muscle movement*

*Incidence 0.3 to 1%

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