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Sufenta

Sufenta(sufentanil citrate) – Akorn

THERAPEUTIC CLASS

Opioid analgesic

INDICATIONS

Analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. Primary anesthetic agent of the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures who are intubated or 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. For epidural administrations an analgesic combined with low dose bupivacaine, usually 12.5mg per administration during labor and vaginal delivery.

ADULT DOSAGE

Adults: Individualize dose. Premedication: Based on patients needs. Analgesic: Total Dose: 1-8mcg/kg. Maint: Incremental: 10-50mcg. Infusion: Based on induction dose not to exceed 1mcg/kg/hr. Anesthetic: Total Dose: 8-30mcg/kg. Maint: Incremental 0.5-10mcg/kg. Infusion: Based on induction dose not to exceed 30mcg/kg. Epidural: 10-15mcg with 10mL bupivacaine 0.125% with or without epinephrine. May repeat for a total of 3 doses in not less than 1 hour intervals.

PEDIATRIC DOSAGE

Pediatrics: Individualize dose. ≥12 yrs: Use same dose as adults. <12 yrs: 10-25mcg/kg with 100% oxygen. Maint: 25-50mcg supplemental doses.

HOW SUPPLIED

Inj: 50mcg/mL

WARNINGS/PRECAUTIONS

Should only be administered by persons specifically trained in the use of IV 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, anticoagulation therapy) which call for special evaluation of the benefit versus risk potential. May cause muscle rigidity of the neck and extremities. Adequate facilities should be available for postoperative monitoring and ventilation. Monitor vital signs routinely. Reduce dose for elderly and debilitated patients. Caution with pulmonary disease, decreased respiratory reserve, liver and kidney dysfunction, cardiac bradyarrhythmias. Reports of bradycardia responsive to atropine. May obscure clinical course of patients with head injuries.

ADVERSE REACTIONS

Respiratory depression, skeletal muscle rigidity, bradycardia, HTN, hypotension, chest wall rigidity, somnolence, pruritus, N/V.

DRUG INTERACTIONS

Reports of cardiovascular depression with nitrous oxide. High doses of pancuronium may produce increase in HR. Reports of bradycardia and hypotension with other muscle relaxants. Greater incidence and degree of bradycardia and hypotension with chronic CCB and β-blocker therapy. Additive or potentiating effects with other CNS depressants (eg, barbiturates, tranquilizers, narcotics, general anesthetics). Reduce dose of either agent. Decrease in mean arterial pressure and systemic vascular resistance with benzodiazepines.

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

An opioid analgesic.

PHARMACOKINETICS

Distribution: Plasma protein binding (healthy males: 93%, mothers: 91%, neonates: 79%). Elimination: T1/2=164 min (adults), 97 min (neonates).

ASSESSMENT

Assess for pulmonary disease, decreased respiratory reserve, hepatic/renal dysfunction, cardiac bradyarrhythmias, head injury, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for cardiovascular depression (eg, bradycardia and hypotension), respiratory depression, muscle rigidity of the neck and extremities, N/V, chills, arrhythmias, chest wall rigidity. Monitor vital signs routinely. Appropriate postoperative monitoring should ensure that adequate spontaneous breathing is established and maintained prior to discharging patient.

PATIENT COUNSELING

Counsel about side effects of drug and abuse potential.

ADMINISTRATION/STORAGE

Absorption: IV and epidural route. Storage: 20-25°C (68-77°F). Protect from light.


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    Sufenta

    Sufenta

    Generic Name: Sufentanil citrate

    Dosage Form: injection

    For ProfessionalsSide EffectsInteractionsMore…

    Sufenta® (SufentaNIL CITRATE INJECTION, USP)

    CII

    50 mcg/mL Sufentanil base

    Rx only

    Sufenta Description

    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.

    Sufenta – Clinical Pharmacology

    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 dosage chart for more complete information on the intravenous use of Sufenta.)

    Pharmacodynamics

    Intravenous use At intravenous doses of up to 8 mcg/kg, Sufenta is an analgesic component of general anesthesia; at intravenous doses ≥8 mcg/kg, Sufenta produces a deep level of anesthesia. Sufenta produces a dose related attenuation of catecholamine release, particularly norepinephrine.

    At intravenous dosages of ≥8 mcg/kg, Sufenta produces hypnosis and anesthesia without the use of additional anesthetic agents. A deep level of anesthesia is maintained at these dosages, as demonstrated by EEG patterns. Dosages of up to 25 mcg/kg attenuate the sympathetic response to surgical stress. The catecholamine response, particularly norepinephrine, is further attenuated at doses of Sufenta of 25 to 30 mcg/kg, with hemodynamic stability and preservation of favorable myocardial oxygen balance.

    Sufenta has an immediate onset of action, with relatively limited accumulation. Rapid elimination from tissue storage sites allows for relatively more rapid recovery as compared with equipotent dosages of fentanyl. At dosages of 1 to 2 mcg/kg, recovery times are comparable to those observed with fentanyl; at dosages of >2 to 6 mcg/kg, recovery times are comparable to enflurane, isoflurane and fentanyl. Within the anesthetic dosage range of 8 to 30 mcg/kg of Sufenta, recovery times are more rapid compared to equipotent fentanyl dosages.

    The vagolytic effects of pancuronium may produce a dose dependent elevation in heart rate during Sufenta-oxygen anesthesia. The use of moderate doses of pancuronium or of a less vagolytic neuromuscular blocking agent may be used to maintain a stable lower heart rate and blood pressure during Sufenta-oxygen anesthesia. The vagolytic effects of pancuronium may be reduced in patients administered nitrous oxide with Sufenta.

    Preliminary data suggest that in patients administered high doses of Sufenta, initial dosage requirements for neuromuscular blocking agents are generally lower as compared to patients given fentanyl or halothane, and comparable to patients given enflurane.

    Bradycardia is infrequently seen in patients administered Sufenta-oxygen anesthesia. The use of nitrous oxide with high doses of Sufenta may decrease mean arterial pressure, heart rate and cardiac output.

    Sufenta at 20 mcg/kg has been shown to provide more adequate reduction in intracranial volume than equivalent doses of fentanyl, based upon requirements for furosemide and anesthesia supplementation in one study of patients undergoing craniotomy. During carotid endarterectomy, Sufenta-nitrous oxide/oxygen produced reductions in cerebral blood flow comparable to those of enflurane-nitrous oxide/oxygen. During cardiovascular surgery, Sufenta-oxygen produced EEG patterns similar to fentanyl-oxygen; these EEG changes were judged to be compatible with adequate general anesthesia.

    The intraoperative use of Sufenta at anesthetic dosages maintains cardiac output, with a slight reduction in systemic vascular resistance during the initial postoperative period. The incidence of postoperative hypertension, need for vasoactive agents and requirements for postoperative analgesics are generally reduced in patients administered moderate or high doses of Sufenta as compared to patients given inhalation agents.

    Skeletal muscle rigidity is related to the dose and speed of administration of Sufenta. This muscular rigidity may occur unless preventative measures are taken (see WARNINGS).

    Decreased respiratory drive and increased airway resistance occur with Sufenta. The duration and degree of respiratory depression are dose related when Sufenta is used at sub-anesthetic dosages. At high doses, a pronounced decrease in pulmonary exchange and apnea may be produced.

    Epidural use in Labor and Delivery Onset of analgesic effect occurs within approximately 10 minutes of administration of epidural doses of Sufenta and bupivacaine. Duration of analgesia following a single epidural injection of 10 to 15 mcg Sufenta and bupivacaine 0.125% averaged 1.7 hours.

    During labor and vaginal delivery, the addition of 10 to 15 mcg Sufenta to 10 mL 0.125% bupivacaine provides an increase in the duration of analgesia compared to bupivacaine without an opioid. Analgesia from 15 mcg Sufenta plus 10 mL 0.125% bupivacaine is comparable to analgesia from 10 mL of 0.25% bupivacaine alone. Apgar scores of neonates following epidural administration of both drugs to women in labor were comparable to neonates whose mothers received bupivacaine without an opioid epidurally.

    Pharmacokinetics

    Intravenous use The pharmacokinetics of intravenous Sufenta can be described as a three-compartment model, with a distribution time of 1.4 minutes, redistribution of 17.1 minutes and elimination half-life of 164 minutes in adults. The elimination half-life of Sufenta is shorter (e.g. 97 +/- 42 minutes) in infants and children, and longer in neonates (e.g. 434 +/- 160 minutes) compared to that of adolescents and adults. The liver and small intestine are the major sites of biotransformation. Approximately 80% of the administered dose is excreted within 24 hours and only 2% of the dose is eliminated as unchanged drug. Plasma protein binding of Sufentanil, related to the alpha acid glycoprotein concentration, was approximately 93% in healthy males, 91% in mothers and 79% in neonates.

    Epidural use in Labor and Delivery After epidural administration of incremental doses totaling 5 to 40 mcg Sufenta during labor and delivery, maternal and neonatal Sufentanil plasma concentrations were at or near the 0.05 to 0.1 ng/mL limit of detection, and were slightly higher in mothers than in their infants.

    Clinical Studies

    Epidural use in Labor and Delivery

    Epidural Sufentanil was tested in 340 patients in two (one single-center and one multicenter) double-blind, parallel studies. Doses ranged from 10 to 15 mcg Sufentanil and were delivered in a 10 mL volume of 0.125% bupivacaine with and without epinephrine 1:200,000. In all cases Sufentanil was administered following a dose of local anesthetic to test proper catheter placement. Since epidural opioids and local anesthetics potentiate each other, these results may not reflect the dose or efficacy of epidural Sufentanil by itself.

    Individual doses of 10 to 15 mcg Sufenta plus bupivacaine 0.125% with epinephrine provided analgesia during the first stage of labor with a duration of 1 to 2 hours. Onset was rapid (within 10 minutes). Subsequent doses (equal dose) tended to have shorter duration. Analgesia was profound (complete pain relief) in 80% to 100% of patients and a 25% incidence of pruritus was observed. The duration of initial doses of Sufenta plus bupivacaine with epinephrine is approximately 95 minutes, and of subsequent doses, 70 minutes.

    There are insufficient data to critically evaluate neonatal neuromuscular and adaptive capacity following recommended doses of maternally administered epidural Sufentanil with bupivacaine. However, if larger than recommended doses are used for combined local and systemic analgesia, e.g. after administration of a single dose of 50 mcg epidural Sufentanil during delivery, then impaired neonatal adaption to sound and light can be detected for 1 to 4 hours and if a dose of 80 mcg is used impaired neuromuscular coordination can be detected for more than 4 hours.

    Indications and Usage for Sufenta

    Sufenta (Sufentanil citrate) is indicated for intravenous administration in adults and pediatric patients:

    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 DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF Sufenta.

    Contraindications

    Sufenta is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.

    Warnings

    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.

    Precautions

    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 CLINICAL PHARMACOLOGY).

    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 CO2 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.

    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 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.

    Interaction with Calcium Channel and Beta Blockers 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 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 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.

    Head Injuries Sufenta may obscure the clinical course of patients with head injuries.

    Impaired Respiration 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.

    Impaired Hepatic or Renal Function 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 Salmonella typhimurium metabolic activating test also revealed no mutagenic activity. See ANIMAL TOXICOLOGY 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 INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION 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 LD50 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.

    Adverse Reactions

    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 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 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: bradycardia1, hypertension1, hypotension1.

    Musculoskeletal: chest wall rigidity1.

    Central Nervous System: somnolence1.

    Dermatological: pruritus (25%).

    Gastrointestinal: nausea1, vomiting1.

    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: arrhythmia2, tachycardia2, cardiac arrest.

    Central Nervous System: chills2.

    Dermatological: erythema2.

    Musculoskeletal: skeletal muscle rigidity of neck and extremities.

    Respiratory: apnea2, bronchospasm2, postoperative respiratory depression2.

    Miscellaneous: intraoperative muscle movement2.

    1
    Incidence 3% to 9%
    2
    Incidence 0.3% to 1%

    Drug Abuse and Dependence

    Sufenta (Sufentanil citrate) is a Schedule II controlled drug product that can produce drug dependence of the morphine type and therefore has the potential for being abused.

    Overdosage

    Overdosage is manifested by an extension of the pharmacological actions of Sufenta (see CLINICAL PHARMACOLOGY) 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.

    Sufenta Dosage and Administration

    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 PRECAUTIONS).

    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 PRECAUTIONS).

    Intravenous use

    Sufenta may be administered intravenously by slow injection or infusion 1) in doses of up to 8 mcg/kg as an analgesic adjunct to general anesthesia, and 2) in doses ≥8 mcg/kg as a primary anesthetic agent for induction and maintenance of anesthesia (see Dosage Range Chart). If benzodiazepines, barbiturates, inhalation agents, other opioids or other central nervous system depressants are used concomitantly, the dose of Sufenta and/or these agents should be reduced (see PRECAUTIONS). In all cases dosage should be titrated to individual patient response.

    Usage in Children For induction and maintenance of anesthesia in children less than 12 years of age undergoing cardiovascular surgery, an anesthetic dose of 10 to 25 mcg/kg administered with 100% oxygen is generally recommended. Supplemental dosages of up to 25 to 50 mcg are recommended for maintenance, based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.

    Premedication The selection of preanesthetic medications should be based upon the needs of the individual patient.

    Neuromuscular Blocking Agents The neuromuscular blocking agent selected should be compatible with the patient’s condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS).

    ADULT DOSAGE RANGE CHART for Intravenous use
    ANALGESIC COMPONENT TO GENERAL ANESTHESIA

    •TOTAL DOSAGE REQUIREMENTS OF 1 MCG/KG/HR OR LESS ARE RECOMMENDED

    TOTAL DOSAGE MAINTENANCE DOSAGE
    ANALGESIC DOSAGES
    Incremental or Infusion: 1 to 2 mcg/kg (expected duration of anesthesia 1 to 2 hours). Approximately 75% or more of total Sufenta dosage may be administered prior to intubation by either slow injection or infusion titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. Incremental: 10 to 25 mcg (0.2 to 0.5 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to remaining operative time anticipated.

    Infusion: Sufenta may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of Sufenta so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated.

    ANALGESIC DOSAGES
    Incremental or Infusion: 2 to 8 mcg/kg (expected duration of anesthesia 2 to 8 hours). Approximately 75% or less of the total calculated Sufenta dosage may be administered by slow injection or infusion prior to intubation, titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing more complicated major surgical procedures in which endotracheal intubation and mechanical ventilation are required. At dosages in this range, Sufenta has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery. Incremental: 10 to 50 mcg (0.2 to 1 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to the remaining operative time anticipated.

    Infusion: Sufenta may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In the absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of Sufenta so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated.

    ANESTHETIC DOSAGES
    Incremental or Infusion: 8 to 30 mcg/kg (anesthetic doses). At this anesthetic dosage range Sufenta is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. Sufenta with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages ≥8 mcg/kg and to maintain a deep level of anesthesia without the use of additional anesthetic agents. The addition of N2O to these dosages will reduce systolic blood pressure. At dosages in this range of up to 25 mcg/kg, catecholamine release is attenuated. Dosages of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release. High doses are indicated in patients undergoing major surgical procedures, in which endotracheal intubation and mechanical ventilation are required, such as cardiovascular surgery and neurosurgery in the sitting position with maintenance of favorable myocardial and cerebral oxygen balance. Postoperative observation is essential and postoperative mechanical ventilation may be required at the higher dosage range due to extended postoperative respiratory depression. Dosage should be titrated to individual patient response. Incremental: Depending on the initial dose, maintenance doses of 0.5 to 10 mcg/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass.

    Infusion: Sufenta may be administered by continuous or intermittent infusion as needed in response to signs of lightening of anesthesia. In the absence of lightening of anesthesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. The maintenance infusion rate for Sufenta should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg.

    In patients administered high doses of Sufenta, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.

    Also see WARNINGS and PRECAUTIONS sections.

    For purposes of administering small volumes of Sufenta accurately, the use of a tuberculin syringe or equivalent is recommended.

    Epidural use in Labor and Delivery
    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 by slow injection. Respiration should be closely monitored following each administration of an epidural injection of Sufenta.
    Dosage for Labor and Delivery: The recommended dosage is Sufenta 10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine. Sufenta and bupivacaine should be mixed together before administration. Doses can be repeated twice (for a total of three doses) at not less than one-hour intervals until delivery.

    How is Sufenta Supplied

    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

    STORAGE

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.

    U.S. Patent No. 3,998,834

    MAY 1995, SEPTEMBER 1995

    TAYLOR PHARMACEUTICALS

    AN AKORN COMPANY

    Decatur, IL 62522

    SFA0N

    Rev. 07/07

    Sufenta 

    Sufentanil citrate solution

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11098-050
    Route of Administration INTRAVENOUS DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sufentanil citrate (Sufentanil) Sufentanil 50 ug  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Packaging
    # Item Code Package Description
    1 NDC:11098-050-01 10 AMPULE (10 AMPULE) in 1 CARTON
    1 1 mL (1 MILLILITER) in 1 AMPULE
    2 NDC:11098-050-02 10 AMPULE (10 AMPULE) in 1 CARTON
    2 2 mL (2 MILLILITER) in 1 AMPULE
    3 NDC:11098-050-05 10 AMPULE (10 AMPULE) in 1 CARTON
    3 5 mL (5 MILLILITER) in 1 AMPULE
    Labeler - Taylor Pharmaceuticals

    Revised: 07/2008   Taylor Pharmaceuticals

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    Sufenta

    Sufenta

    Generic Name: sufentanil (soo-FEN-ta-nil)

    Brand Name: Sufenta

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Sufenta is used for:

    Producing anesthesia for surgery. It may also be used with other medicines as part of epidural anesthesia during labor and delivery to decrease pain.

    Sufenta is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.

    Do NOT use Sufenta if:

    • you are allergic to any ingredient in Sufenta or any related medicine (eg, sufentanil)

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Sufenta:

    Some medical conditions may interact with Sufenta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have diabetes, asthma or other breathing problems, fever, increased pressure or unusual growths in the brain, heart problems, liver or kidney disease, pancreatitis, or a recent head injury
    • if you have a history of slow or irregular heartbeat or blood pressure problems

    Some MEDICINES MAY INTERACT with Sufenta. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Naltrexone because the effectiveness of Sufenta may be decreased
    • Amiodarone, azole antifungals (eg, fluconazole), beta-blockers (eg, propranolol), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), sibutramine, or sodium oxybate (GHB) because the risk of side effects may be increased
    • Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), sibutramine, or sodium oxybate (GHB) because actions and side effects of these medicines may be increased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Sufenta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Sufenta:

    Use Sufenta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Sufenta is usually administered as an injection at your doctor’s office, hospital, or clinic.
    • If Sufenta contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
    • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
    • If you miss a dose of Sufenta, contact your doctor immediately.

    Ask your health care provider any questions you may have about how to use Sufenta.

    Important safety information:

    • Sufenta may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sufenta. Using Sufenta alone, with certain other medicines or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
    • Avoid drinking alcohol while taking Sufenta.
    • Use Sufenta with caution in the ELDERLY because they may be more sensitive to its effects.
    • Use Sufenta with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Sufenta during pregnancy. Sufenta is excreted in breast milk. If you are or will be breast-feeding while you are using Sufenta, check with your doctor to discuss the risk to your baby.

    When used for long periods of time or at high doses, some people develop a need to continue taking Sufenta. This is known as DEPENDENCE or “addiction.”

    Possible side effects of Sufenta:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

    Proper storage of Sufenta: Sufenta is usually handled and stored by a health care provider. If you are using Sufenta at home, store Sufenta as directed by your pharmacist or health care provider. Keep Sufenta out of the reach of children and away from pets.

    General information:

    • If you have any questions about Sufenta, please talk with your doctor, pharmacist, or other health care provider.
    • Sufenta is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Sufenta or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sufenta. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sufenta. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Sufenta.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Sufenta

    Sufenta

    Generic Name: Sufentanil Citrate
    Class: Opiate Agonists

    VA Class: CN101

    Chemical Name: N – [4 - (Methoxymethyl) - 1 - [2 - (2 - thieyl)ethyl] – 4 – piperidinyl] – N – phenylpropanamide2 – hydroxy – 1,2,3 – propanetricarboxylate (1:1)

    Molecular Formula: C22H30N2O2S•O6H8O7

    CAS Number: 60561-17-3

    For ProfessionalsSide EffectsInteractionsMore…

    Introduction

    Opiate agonist; synthetic phenylpiperidine derivative.1 3 4 5

    Uses for Sufenta

    Anesthesia

    As the analgesic component in the maintenance of balanced anesthesia (e.g., IV hypnotic and/or inhalation anesthetic, analgesic, skeletal muscle relaxant).1 17 34 36 41 46

    As the primary anesthetic agent for induction and maintenance of general anesthesia when used in conjunction with 100% oxygen and a skeletal muscle relaxant (e.g., pancuronium bromide, succinylcholine chloride).1 10 11 12 13 15 16 18 35 37 38 39 43 44 45

    Particularly useful when postoperative ventilation is anticipated and in providing favorable myocardial and cerebral oxygen balance.1 11 19 40 41 46

    Cardiovascular parameters generally are more stable intraoperatively with use of sufentanil compared with inhalation agents.36 41 Incidence of postoperative hypertension and requirements for vasoactive agents or postoperative analgesics generally are decreased following use of moderate or high doses of sufentanil as compared with use of inhalation agents.1 36 38 41

    Pain

    Obstetric analgesia during labor and vaginal delivery.1 88

    Sufenta Dosage and Administration

    General

    Premedication

    • Selection of preanesthetic medication(s) should be based on the individual needs of the patient.1

    Administration

    Administer by IV injection, intermittent or continuous IV infusion, or epidural injection.1 4 7 8 10 11 12 13 19

    IV Administration

    For solution and drug compatibility information, see Compatibility under Stability.

    Administration of small volumes may require use of a tuberculin syringe or equivalent.1

    Rate of Administration

    Administer by slow injection or intermittent or continuous infusion; individualize rate based on patient’s needs.1

    Concomitant Administration of a Neuromuscular Blocking Agent

    Risk of muscular rigidity (particularly of the truncal muscles) is related to the dose and rate of the infusion; however, administration of a neuromuscular blocking agent prior to sufentanil therapy can reduce the risk.1

    The neuromuscular blocking agent used should be compatible with the patient’s condition, taking into account the hemodynamic effects of the drug, the cardiovascular status of the patient, existing drug therapy (e.g., preoperative use of β-adrenergic blocking agents), and the degree of skeletal muscle relaxation required.1

    Administration of a Neuromuscular Blocking Agent with Sufentanil1
    Sufentanil Dosage

    Neuromuscular Blocking Agent Dosage

    <8 mcg/kg

    Administer up to 25% of the full paralyzing dose just prior to sufentanil1

    >8 mcg/kg (titrated by slow IV infusion)

    Administer a full paralyzing dose following loss of consciousness (e.g., loss of eyelash reflex, loss of response to voice command)1 61

    >8 mcg/kg (rapidly administered anesthetic doses)

    Administer a full paralyzing dose simultaneously with sufentanil1 or immediately after loss of consciousness61

    Epidural Administration

    For drug compatibility information, see Compatibility under Stability.

    Specialized techniques are required for epidural administration; administration should be performed only by qualified individuals familiar with the techniques of administration, dosages, and special patient management problems associated with epidural administration.1

    Dosage

    Available as sufentanil citrate; dosage expressed in terms of sufentanil.1

    Adjust dosage carefully according to body weight, individual requirements and response, physical status and underlying pathologic condition, premedication or concomitant medication(s), the anesthetic(s) being used, and the nature and duration of the surgery.1

    Administer additional doses when patient movement and/or changes in vital signs indicate surgical stress or lightening of analgesia, and adjust according to individual requirements, response, and the anticipated remaining duration of the surgical procedure.1

    Pediatric Patients

    Anesthesia
    General Anesthesia (as sole anesthetic agent) for Cardiovascular Surgery

    IV Children <12 years of age: Initially, 10–25 mcg/kg in conjunction with 100% oxygen and a skeletal muscle relaxant.1 8 61 Additional doses of up to 25–50 mcg each (or, alternatively, 1–2 mcg/kg each)61 may be given as needed based on response to the initial dose and as determined by changes in vital signs that indicate surgical stress or lightening of anesthesia.1

    Neonates: Reduce dosage, especially in those with cardiovascular disease, according to the decrease in clearance.89 (See Pediatric Use under Cautions.)

    Adults

    Anesthesia
    Analgesic Component of General Anesthesia

    IV Minor surgical procedures (expected duration of anesthesia is 1–2 hours): Total dosage of 1–2 mcg/kg in conjunction with nitrous oxide and oxygen; ≥75% of the total dosage may be given by slow injection or infusion prior to intubation.1 88 May administer supplemental doses of 10–25 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.1 88

    Major surgical procedures (expected duration of anesthesia is 2–8 hours): Total dosage of 2–8 mcg/kg in conjunction with nitrous oxide and oxygen; ≤75% of the total dosage may be given by slow injection or infusion prior to intubation.1 88 May administer supplemental doses of 10–50 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.1 88

    General Anesthesia (as sole anesthetic agent)

    IV Total dosage of 8–30 mcg/kg (by slow injection, infusion, or injection followed by infusion) in conjunction with oxygen and a skeletal muscle relaxant.1 88 Depending on the initial dose, may administer additional incremental doses of 0.5–10 mcg/kg by slow injection in anticipation of surgical stress (e.g., incision, sternotomy, cardiopulmonary bypass).1 88 Alternatively, may administer intermittent or continuous maintenance infusions as necessary as determined by changes in vital signs that indicate surgical stress and lightening of anesthesia; adjust maintenance infusion rate so that total dosage for the procedure does not exceed 30 mcg/kg.1 88

    Pain
    Obstetric Analgesia

    Epidural 10–15 mcg (in combination with 10 mL of bupivacaine 0.125% with or without epinephrine).1 88 Doses may be repeated twice (for a total of 3 doses) at ≥1-hour intervals until delivery.1 88

    Prescribing Limits

    Adults

    Anesthesia
    Analgesic Component of General Anesthesia

    IV Minor or major surgical procedures: Total dose of ≤1 mcg/kg per hour of expected surgical time.1

    General Anesthesia (as sole anesthetic agent)

    IV Total dose for procedure: ≤ 30 mcg/kg.1

    Special Populations

    Hepatic Impairment

    Adjust dosage carefully; elimination of the drug may be decreased.1 60

    Renal Impairment

    Adjust dosage carefully; elimination of the drug may be decreased.1 60

    Geriatric and Debilitated Patients

    Reduce initial dosage;1 adjust additional doses according to the initial response and desired effect.1 61

    Obese Patients

    Base dosage on an estimate of ideal (lean) body weight if body weight exceeds ideal weight by >20%.1

    Cautions for Sufenta

    Contraindications

    • Known hypersensitivity to sufentanil or intolerance to other opiate agonists.1

    Warnings/Precautions

    Warnings

    Shares the toxic potentials of the opiate agonists; observe the usual precautions of opiate agonist therapy.1 4

    Respiratory Depression

    Respiratory function can be severely compromised.1

    Consider the possibility of a recurrence of respiratory depression during recovery.4 A secondary rise in plasma concentrations may occur during the recovery period as blood perfusion to peripheral tissues increases and drug redistribution occurs.4

    Administration of an opiate antagonist (e.g., naloxone) can reverse respiratory depression.1 The duration of respiratory depression produced by sufentanil may be longer than the duration of the opiate antagonist; therefore, continue appropriate patient monitoring following apparent initial reversal.1

    Supervised Administration

    Should be administered only by individuals experienced in the use of parenteral anesthetics and in the maintenance of an adequate airway and respiratory support.1

    Opiate antagonist (e.g., naloxone) and facilities for intubation, administration of oxygen, and assisted or controlled respiration should be immediately available.1

    Monitor vital signs routinely during administration; facilities for postoperative monitoring and assisted or controlled respiration should be available following administration of anesthetic doses of the drug (i.e., ≥8 mcg/kg).1

    Major Toxicities

    Musculoskeletal Effects

    Possible skeletal muscle rigidity (e.g., of the truncal muscles); onset may be more rapid than with fentanyl.1 Administration of a neuromuscular blocking agent may be necessary.1 (See Concomitant Administration of a Neuromuscular Blocking Agent under Dosage and Administration.)

    General Precautions

    CNS Effects

    Caution in patients with head injuries; sufentanil may obscure the clinical course.1

    Impaired Respiration

    Caution in patients with pulmonary disease, decreased respiratory reserve, or potentially compromised respiratory function.1 Further decreases in respiratory function and increases in airway resistance may occur.1

    Cardiovascular Effects

    Generally produces few cardiovascular effects.4 8 13 17 39 Possible hypotension1 8 10 34 36 39 40 or hypertension.1 8 10 18 35 37 38 40 41 42 Bradycardia occurs infrequently during anesthesia and may be corrected by administration of atropine.1

    Specific Populations

    Pregnancy

    Category C.1

    Used epidurally for analgesia during labor and delivery.1 88 Not recommended for IV use during labor and delivery; avoid epidural dosages in excess of the recommended dosage.1

    Lactation

    Not known whether sufentanil is distributed into milk.1 Caution if used in nursing women.1

    Pediatric Use

    Safety and efficacy documented in a limited number of children ≥1 day of age undergoing cardiovascular surgery.1 8 89

    Use with caution in neonates because decreased clearance may result in increased blood concentrations of the drug.89 Clearance in healthy neonates is approximately one-half that reported in adults and children; may be further reduced by up to one-third in neonates with cardiovascular disease.89

    Geriatric Use

    Consider dosage reduction.1 61 (See Geriatric and Debilitated Patients under Dosage and Administration.)

    Hepatic Impairment

    Use with caution, since the drug undergoes metabolism in the liver.1

    Renal Impairment

    Use with caution, since the drug and its metabolites are eliminated mainly by the kidneys.1

    Common Adverse Effects

    Respiratory depression,1 38 skeletal muscle rigidity (e.g., truncal muscles, neck, extremities).1 4 13 38

    Interactions for Sufenta

    Specific Drugs

    Drug

    Interaction

    Comments

    β-Adrenergic blocking agents

    Possible increased incidence and degree of bradycardia and hypotension during sufentanil induction in patients receiving chronic β-blocker therapy1

    Patients with CAD receiving chronic preoperative β-blocker therapy appear to require lower initial and fewer supplemental doses of sufentanil during CABG surgery than do patients who have not received preoperative β-blocker therapy10

    Calcium-channel blocking agents

    Increased incidence and degree of bradycardia and hypotension during sufentanil induction in patients receiving chronic calcium-channel blocker therapy1

    CNS depressants (e.g., opiate agonists, general anesthetics, tranquilizers, sedatives, hypnotics)

    Potentiation of CNS and cardiovascular effects1

    Use with caution; reduce dosage of at least one of the drugs when used concomitantly1

    Nitrous oxide

    Possible cardiovascular depression, manifested by bradycardia and decreases in mean arterial pressure and cardiac output, following concomitant administration of nitrous oxide with high doses of sufentanil1

    Neuromuscular blocking agents

    Possible tachycardia following administration of high doses of pancuronium during anesthesia with sufentanil and oxygen;1 4 38 hypertension and an increase in cardiac index may occur4

    Bradycardia and hypotension reported during anesthesia during concomitant administration of neuromuscular blocking agents with sufentanil and oxygen; effects may be increased in patients also receiving calcium-channel blockers or β-blockers;1 bradycardia reported rarely following concomitant administration of sufentanil with succinylcholine1

    To maintain a stable, lower HR and BP during anesthesia, use moderate doses of pancuronium or use a neuromuscular blocking agent with a lesser inhibitory effect on the vagus nerve 1

    Sufenta Pharmacokinetics

    Absorption

    Onset

    Following IV administration, the onset of action as determined by time to unconsciousness (i.e., loss of response to voice command) is 1.2–3 minutes.4 10 13 15 16 18

    Following epidural administration of 10–15 mcg and 0.125% bupivacaine with epinephrine 1:200,000 during the first stage of labor, the onset of action occurs within 10 minutes.1 88

    Duration

    The mean duration of anesthesia is 40 minutes following initial IV dose of 0.4 mcg/kg and 41–44 minutes following additional doses of 0.1 mcg/kg.20 Following administration of anesthetic doses (about 13–19 mcg/kg total), patient response to verbal command4 13 15 and adequate ventilation4 15 occurs at 0.6–1.8 and 5.6 hours, respectively.

    Following IM administration of single doses of 0.15, 0.3, or 0.5 mcg/kg in patients with pain, the approximate duration of detectable analgesia was 2.3, 3.7, and 3.8 hours, respectively.21

    Following epidural administration of 10–15 mcg and 0.125% bupivacaine with epinephrine 1:200,000 during the first stage of labor, the duration of action was 1–2 hours.1 88

    Distribution

    Extent

    Distribution into human body tissues and fluids has not been fully characterized;14 however, the drug is highly lipophilic and is rapidly and extensively distributed in animals.4

    Not known whether sufentanil crosses the placenta2 or distributes into milk.1 2

    Plasma Protein Binding

    Approximately 93% bound at plasma pH 7.41 4 6 14 (mainly to albumin; α-, α1-, β-, and γ-globulins; and α1-acid glycoprotein).6 14

    Because a large portion of the drug appears to be bound to α1-acid glycoprotein, binding may be affected by disease states in which this protein is altered.4 6 14 24

    Binding in plasma is independent of plasma drug concentration within the therapeutic range (i.e., 0.1–10 ng/mL);4 6 however, binding is affected by changes in plasma pH.4 6 14 Increases in plasma pH from 7.4 to 7.8 increase sufentanil binding by about 30%; decreases in plasma pH from 7.4 to 7 decrease binding by about 30%.6

    Elimination

    Metabolism

    Appears to be metabolized mainly in the liver and small intestine1 2 via N-dealkylation and O-demethylation.4

    The O-demethylated metabolite appears to have about 10% of the analgesic activity of the unchanged drug.4

    Elimination Route

    Excreted principally in urine and also in feces via biliary elimination;1 2 60 only 2% of a dose is excreted unchanged in urine and feces.1 2

    Half-life

    Triphasic; plasma concentrations decline rapidly secondary to redistribution.1 2 4 5 14 22

    In adults with normal renal and hepatic function, the plasma half-life averages 0.72–1.2 minutes in the initial (distribution) phase, 13.7–17 minutes in the second (redistribution) phase, and 140–158 minutes in the terminal (elimination) phase.1 2 4 5 14 22 23

    Elimination half-life is longer (434 minutes) in neonates but shorter in infants and children (97 minutes), compared with adults and adolescents.89

    Stability

    Storage

    Parenteral

    Injection

    15–25°C; protect from light.1

    Compatibility

    For information on systemic interactions resulting from concomitant use, see Interactions.

    Parenteral

    Sufentanil citrate is hydrolyzed in acidic solutions.60

    Solution Compatibilitya
    Compatible

    Dextrose 5% in water

    Variable

    Sodium chloride 0.9%

    Drug Compatibility
    Admixture Compatibilitya
    Compatible

    Bupivacaine HCl

    Y-Site Compatibilitya
    Compatible

    Amphotericin B cholesteryl sulfate complex

    Atropine sulfate

    Dexamethasone sodium phosphate

    Diazepam

    Diphenhydramine HCl

    Etomidate

    Gatifloxacin

    Haloperidol lactate

    Hetastarch in lactated electrolyte injection (Hextend)

    Hydroxyzine HCl

    Ketorolac tromethamine

    Linezolid

    Metoclopramide HCl

    Midazolam HCl

    Phenobarbital sodium

    Prochlorperazine edisylate

    Propofol

    Remifentanil HCl

    Scopolamine HBr

    Incompatible

    Lorazepam

    Phenytoin sodium

    Thiopental sodium

    Actions

    • A potent analgesic;1 shares the actions of the opiate agonists.1 4 29

    • Precise mechanism of action has not been fully elucidated; opiate agonists act at several CNS sites, involving several neurotransmitter systems to produce analgesia.b
    • Pain perception is altered in the spinal cord and higher CNS levels (e.g., substantia gelatinosa, spinal trigeminal nucleus, periaqueductal gray, periventricular gray, medullary raphe nuclei, hypothalamus).26 b
    • Opiate agonists do not alter the threshold or responsiveness of afferent nerve endings to noxious stimuli, nor peripheral nerve impulse conduction.26
    • Opiate agonists act at specific receptor binding sites in the CNS and other tissues; opiate receptors are concentrated in the limbic system, thalamus, striatum, hypothalamus, midbrain, and spinal cord.b
    • High affinity and selectivity for the μ-opiate receptor in the CNS; reportedly is more selective and binds more tightly to this receptor than does fentanyl.4 9 12 25 49 52
    • Produces dose-related analgesia;1 2 4 at doses up to 8 mcg/kg, the drug has a potent analgesic effect, but higher doses usually produce substantial CNS depression resulting in hypnosis and anesthesia.1 2 4 9 10 11 12 13 19
    • Analgesic potency appears to be 5–12 times that of fentanyl on a weight basis.1 12 23 39 40 47 48 50
    • Appears to have little effect on histamine release.1 7 53 54 61
    • May have a centrally mediated vagal effect.4 60 61

    Advice to Patients

    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
    • Importance of informing patients of other important precautionary information.1 (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.1

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Sufentanil Citrate
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Parenteral

    Injection

    50 mcg (of sufentanil) per mL*

    Sufenta (C-II; preservative-free)

    Akorn

    Sufentanil Citrate Injection (C-II; preservative-free)

    Baxter, Hospira

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions October 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    References

    1. Taylor Pharmaceuticals. Sufenta injection prescribing information. Decatur, IL: 1998 Aug.

    2. Janssen Pharmaceutica. Product information form for American Hospital Formulary Service on Sufenta. Piscataway, NJ; 1984 Apr 5.

    3. Windholz M, ed. The Merck index. 10th ed. Rahway, NJ: Merck & Co., Inc.; 1983:APP-3.

    4. Rosow CE. Sufentanil citrate: a new opioid analgesic for use in anesthesia. Pharmacotherapy. 1984; 4:11-9. [IDIS 393492] [PubMed 6230606]

    5. Michiels M, Hendriks R, Heykants J. Radioimmunoassay of the new opiate analgesics alfentanil and sufentanil. Preliminary pharmacokinetic profile in man. J Pharm Pharmacol. 1983; 35:86-93. [IDIS 165823] [PubMed 6131992]

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