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SUFENTA
Overview
What is SUFENTA?
SUFENTA (sufentanil citrate) is a potent opioid analgesic chemically designated as N-[4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide:2-hydroxy-1,2,3-propanetricarboxylate (1:1) with a molecular weight of 578.68. The structural formula of SUFENTA is:
SUFENTA is a sterile, preservative free, aqueous solution containing sufentanil citrate equivalent to 50 mcg per mL of sufentanil base for intravenous and epidural injection. The solution has a pH range of 3.5 to 6.0.
What does SUFENTA look like?
What are the available doses of SUFENTA?
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What should I talk to my health care provider before I take SUFENTA?
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How should I use SUFENTA?
SUFENTA (sufentanil citrate) is indicated for intravenous administration
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
SUFENTA (sufentanil citrate) is indicated for epidural administration as an analgesic combined with low dose bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery.
SEE SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTA.
The dosage of SUFENTA should be individualized in each case according to body weight, physical status, underlying pathological condition, use of other drugs, and type of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of SUFENTA should be determined on the basis of lean body weight. Dosage should be reduced in elderly and debilitated patients (see ).
Vital signs should be monitored routinely.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because the clearance of SUFENTA is reduced in neonates, especially those with cardiovascular disease, the dose of SUFENTA should be reduced accordingly (see ).
What interacts with SUFENTA?
SUFENTA is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
What are the warnings of SUFENTA?
When ganglion blockers or other potent antihypertensive drugs are discontinued suddenly, hypertensive levels return. In patients with malignant hypertension and others, this may occur abruptly and may cause fatal cerebral vascular accidents or acute congestive heart failure. When INVERSINE is withdrawn, this should be done gradually and other antihypertensive therapy usually must be substituted. On the other hand, the effects of INVERSINE sometimes may last from hours to days after therapy is discontinued.
SUFENTA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS AND EPIDURAL ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
PRIOR TO CATHETER INSERTION, THE PHYSICIAN SHOULD BE FAMILIAR WITH PATIENT CONDITIONS (SUCH AS INFECTION AT THE INJECTION SITE, BLEEDING DIATHESIS, ANTICOAGULANT THERAPY, ETC.) WHICH CALL FOR SPECIAL EVALUATION OF THE BENEFIT VERSUS RISK POTENTIAL.
Intravenous use
Intravenous administration or unintentional intravascular injection during epidural administration of SUFENTA may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is dose related. Administration of SUFENTA may produce muscular rigidity with a more rapid onset of action than that seen with fentanyl. SUFENTA may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. As with fentanyl, muscular rigidity has been reported to occur or recur infrequently in the extended postoperative period. The incidence of muscular rigidity associated with intravenous SUFENTA can be reduced by: 1) administration of up to 1/4 of the full paralyzing dose of a non-depolarizing neuromuscular blocking agent just prior to administration of SUFENTA at dosages of up to 8 mcg/kg, 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of consciousness when SUFENTA is used in anesthetic dosages (above 8 mcg/kg) titrated by slow intravenous infusion, or, 3) simultaneous administration of SUFENTA and a full paralyzing dose of a neuromuscular blocking agent when SUFENTA is used in rapidly administered anesthetic dosages (above 8 mcg/kg).
The neuromuscular blocking agents used should be compatible with the patient's cardiovascular status. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered SUFENTA. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
What are the precautions of SUFENTA?
General
The initial dose of SUFENTA should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining supplemental doses.
Vital signs should be monitored routinely.
Nitrous oxide may produce cardiovascular depression when given with high doses of SUFENTA (see ).
Bradycardia has been reported infrequently with SUFENTA-oxygen anesthesia and has been responsive to atropine.
Respiratory depression caused by opioid analgesics can be reversed by opioid antagonists such as naloxone. Because the duration of respiratory depression produced by SUFENTA may last longer than the duration of the opioid antagonist action, appropriate surveillance should be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression and diminished sensitivity to CO stimulation which may persist into or recur in the postoperative period. Respiratory depression may be enhanced when SUFENTA is administered in combination with volatile inhalational agents and/or other central nervous system depressants such as barbiturates, tranquilizers, and other opioids. Appropriate postoperative monitoring should be employed to ensure that adequate spontaneous breathing is established and maintained prior to discharging the patient from the recovery area. Respiration should be closely monitored following each administration of an epidural injection of SUFENTA.
Proper placement of the needle or catheter in the epidural space should be verified before SUFENTA is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of SUFENTA could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full sufentanil/bupivacaine epidural doses and volume could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery. If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications. SUFENTA should be administered epidurally by slow injection.
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 SUFENTA-oxygen anesthesia. Bradycardia and hypotension have been reported with other muscle relaxants during SUFENTA-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 SUFENTA, therefore a lower heart rate would be expected. Rare reports of bradycardia associated with the concomitant use of succinylcholine and SUFENTA have been reported.
The incidence and degree of bradycardia and hypotension during induction with SUFENTA may be greater in patients on chronic calcium channel and beta blocker therapy. (See .)
Both the magnitude and duration of central nervous system and cardiovascular effects may be enhanced when SUFENTA is administered to patients receiving barbiturates, tranquilizers, other opioids, general anesthetic or other CNS depressants. In such cases of combined treatment, the dose of SUFENTA and/or these agents should be reduced.
The use of benzodiazepines with SUFENTA during induction may result in a decrease in mean arterial pressure and systemic vascular resistance.
SUFENTA may obscure the clinical course of patients with head injuries.
SUFENTA 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.
In patients with liver or kidney dysfunction, SUFENTA should be administered with caution due to the importance of these organs in the metabolism and excretion of SUFENTA.
Carcinogenesis, Mutagenesis and Impairment of Fertility
No long-term animal studies of SUFENTA have been performed to evaluate carcinogenic potential. The micronucleus test in female rats revealed that single intravenous doses of SUFENTA as high as 80 mcg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations. The Ames metabolic activating test also revealed no mutagenic activity. See for reproduction studies in rats and rabbits.
Pregnancy Category C
SUFENTA 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 SUFENTA in rats or rabbits.
Labor and Delivery
The use of epidurally administered SUFENTA in combination with bupivacaine 0.125% with or without epinephrine is indicated for labor and delivery. (See and sections.) SUFENTA 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 SUFENTA is administered to a nursing woman.
Pediatric Use
The safety and efficacy of intravenous SUFENTA in pediatric patients as young as 1 day old undergoing cardiovascular surgery have been documented in a limited number of cases. The clearance of SUFENTA in healthy neonates is approximately one-half that in adults and children. The clearance rate of SUFENTA 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 LD of SUFENTA 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 of 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.
What are the side effects of SUFENTA?
The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. SUFENTA may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See , and 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 and is presented below. 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.
Probably Causally Related: Incidence Less than 1% - Derived from clinical trials
italicized
Body as a whole: anaphylaxis.
Cardiovascular: arrhythmia, tachycardia, .
Central Nervous System: chills.
Dermatological: erythema.
Musculoskeletal: skeletal muscle rigidity of neck and extremities.
Respiratory: apnea, bronchospasm, postoperative respiratory depression.
Miscellaneous: intraoperative muscle movement.
What should I look out for while using SUFENTA?
SUFENTA is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
SUFENTA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS AND EPIDURAL ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
PRIOR TO CATHETER INSERTION, THE PHYSICIAN SHOULD BE FAMILIAR WITH PATIENT CONDITIONS (SUCH AS INFECTION AT THE INJECTION SITE, BLEEDING DIATHESIS, ANTICOAGULANT THERAPY, ETC.) WHICH CALL FOR SPECIAL EVALUATION OF THE BENEFIT VERSUS RISK POTENTIAL.
What might happen if I take too much SUFENTA?
Overdosage is manifested by an extension of the pharmacological actions of SUFENTA (see ) as with other potent opioid analgesics. The most serious and significant effect of overdose for both intravenous and epidural administration of SUFENTA is respiratory depression. Intravenous administration of an opioid antagonist such as naloxone should be employed as a specific antidote to manage respiratory depression. The duration of respiratory depression following overdosage with SUFENTA may be longer than the duration of action of the opioid antagonist. Administration of an opioid antagonist should not preclude more immediate countermeasures. In the event of overdosage, oxygen should be administered and ventilation assisted or controlled as indicated for hypoventilation or apnea. A patent airway must be maintained, and a nasopharyngeal airway or endotracheal tube may be indicated. If depressed respiration is associated with muscular rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed.
How should I store and handle SUFENTA?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArraySUFENTA (Sufentanil Citrate Injection, USP) is supplied as a sterile aqueous preservative-free solution for intravenous and epidural use as:NDC 11098-050-01 50 mcg/mL sufentanil base, 1 mL ampules in packages of 10 NDC 11098-050-02 50 mcg/mL sufentanil base, 2 mL ampules in packages of 10 NDC 11098-050-05 50 mcg/mL sufentanil base, 5 mL ampules in packages of 10 SUFENTA (Sufentanil Citrate Injection, USP) is supplied as a sterile aqueous preservative-free solution for intravenous and epidural use as:NDC 11098-050-01 50 mcg/mL sufentanil base, 1 mL ampules in packages of 10 NDC 11098-050-02 50 mcg/mL sufentanil base, 2 mL ampules in packages of 10 NDC 11098-050-05 50 mcg/mL sufentanil base, 5 mL ampules in packages of 10
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
SUFENTA is an opioid analgesic. When used in balanced general anesthesia, SUFENTA has been reported to be as much as 10 times as potent as fentanyl. When administered intravenously as a primary anesthetic agent with 100% oxygen, SUFENTA is approximately 5 to 7 times as potent as fentanyl.
Assays of histamine in patients administered SUFENTA have shown no elevation in plasma histamine levels and no indication of histamine release.
(See for more complete information on the intravenous use of SUFENTA.)
Non-Clinical Toxicology
SUFENTA is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.SUFENTA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS AND EPIDURAL ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
PRIOR TO CATHETER INSERTION, THE PHYSICIAN SHOULD BE FAMILIAR WITH PATIENT CONDITIONS (SUCH AS INFECTION AT THE INJECTION SITE, BLEEDING DIATHESIS, ANTICOAGULANT THERAPY, ETC.) WHICH CALL FOR SPECIAL EVALUATION OF THE BENEFIT VERSUS RISK POTENTIAL.
Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
The initial dose of SUFENTA should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining supplemental doses.
Vital signs should be monitored routinely.
Nitrous oxide may produce cardiovascular depression when given with high doses of SUFENTA (see ).
Bradycardia has been reported infrequently with SUFENTA-oxygen anesthesia and has been responsive to atropine.
Respiratory depression caused by opioid analgesics can be reversed by opioid antagonists such as naloxone. Because the duration of respiratory depression produced by SUFENTA may last longer than the duration of the opioid antagonist action, appropriate surveillance should be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression and diminished sensitivity to CO stimulation which may persist into or recur in the postoperative period. Respiratory depression may be enhanced when SUFENTA is administered in combination with volatile inhalational agents and/or other central nervous system depressants such as barbiturates, tranquilizers, and other opioids. Appropriate postoperative monitoring should be employed to ensure that adequate spontaneous breathing is established and maintained prior to discharging the patient from the recovery area. Respiration should be closely monitored following each administration of an epidural injection of SUFENTA.
Proper placement of the needle or catheter in the epidural space should be verified before SUFENTA is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of SUFENTA could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full sufentanil/bupivacaine epidural doses and volume could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery. If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications. SUFENTA should be administered epidurally by slow injection.
The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. SUFENTA may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See , and 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 and is presented below. 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.
Probably Causally Related: Incidence Less than 1% - Derived from clinical trials
italicized
Body as a whole: anaphylaxis.
Cardiovascular: arrhythmia, tachycardia, .
Central Nervous System: chills.
Dermatological: erythema.
Musculoskeletal: skeletal muscle rigidity of neck and extremities.
Respiratory: apnea, bronchospasm, postoperative respiratory depression.
Miscellaneous: intraoperative muscle movement.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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