DRUGS & SUPPLEMENTS
When are you taking this medicine?
Sufentil Citrate Injection, USP 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.
Sufentil Citrate Injection, USP 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 Sufentil.
Sufentil Citrate Injection is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
Sufentil CITRATE INJECTION 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 WHICH CALL FOR SPECIAL EVALUATION OF THE BENEFIT VERSUS RISK POTENTIAL.
Intravenous administration or unintentional intravascular injection during epidural administration of Sufentil citrate may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is dose related. Administration of Sufentil citrate may produce muscular rigidity with a more rapid onset of action than that seen with fentanyl. Sufentil 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 Sufentil 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 Sufentil citrate 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 Sufentil is used in anesthetic dosages (above 8 mcg/kg) titrated by slow intravenous infusion, or, 3) simultaneous administration of Sufentil and a full paralyzing dose of a neuromuscular blocking agent when Sufentil 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 Sufentil. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
The initial dose of Sufentil 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 Sufentil.
Bradycardia has been reported infrequently with sufentanil-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 Sufentil 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 Sufentil 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 Sufentil.
Proper placement of the needle or catheter in the epidural space should be verified before Sufentil is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of Sufentil 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. Sufentil 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 sufentanil-oxygen anesthesia. Bradycardia and hypotension have been reported with other muscle relaxants during sufentanil-oxygen anesthesia; this effect may be more pronounced in the presence of calcium channel and/or beta blockers. Muscle relaxants with no clinically significant effect on heart rate (at recommended doses) would not counteract the vagotonic effect of Sufentil, therefore a lower heart rate would be expected. Rare reports of bradycardia associated with the concomitant use of succinylcholine and Sufentil have been reported.
The incidence and degree of bradycardia and hypotension during induction with Sufentil may be greater in patients on chronic calcium channel and beta blocker therapy..
Both the magnitude and duration of central nervous system and cardiovascular effects may be enhanced when Sufentil is administered to patients receiving barbiturates, tranquilizers, other opioids, general anesthetics or other CNS depressants. In such cases of combined treatment, the dose of Sufentil and/or these agents should be reduced.
The use of benzodiazepines with Sufentil during induction may result in a decrease in mean arterial pressure and systemic vascular resistance.
Sufentil may obscure the clinical course of patients with head injuries.
Sufentil 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, Sufentil citrate should be administered with caution due to the importance of these organs in the metabolism and excretion of Sufentil.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Sufentil.
Sufentil was not genotoxic in the in vitro bacterial reverse mutation assay or in the in vivo rat bone marrow micronucleous assay.
Fertility and early embryonic development studies were conducted in male and female rats treated with 0.005, 0.02 or 0.08 mg/kg Sufentil IV for 56 days and 14 days prior to mating through gestation respectively. Increased mortality was noted in all treatment groups. Lower pregnancy rates were noted following treatment of males at doses of 0.02 and 0.08 mg/kg (0.1 and 0.4 times the maximum human total procedural dose of 30 mcg/kg IV, based on a body surface area comparison), suggesting the potential for an adverse effect on fertility in males. Increased resorption of fetuses and reduced litter size was noted in the high dose females (0.4 times the maximum human total procedural dose of 30 mcg/kg IV, based on a body surface area comparison) suggesting the potential for fetotoxicity, likely due to maternal toxicity.
There are no adequate and well-controlled trials of Sufentil in pregnant women. Sufentil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Embryolethality and maternal toxicity were noted in rabbits treated from Gestation Day 6 to 18 with 0.08 mg/kg Sufentil IV.
No teratogenic effects were observed in either rats or rabbits at these exposures.
In a pre- and post-natal development study in rats, Sufentil doses of 0.02 and 0.08 mg/kg decreased pup weight and survival at maternally toxic doses (0.1 and 0.4 times the maximum human total procedural dose of 30 mcg/kg IV, based on a body surface area comparison).
The use of epidurally administered Sufentil 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.) Sufentil 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 Sufentil 15 mcg plus bupivacaine 0.125% (10 mL total volume).
It is not known whether Sufentil is excreted in human milk. Because fentanyl analogs are excreted in human milk, caution should be exercised when Sufentil citrate is administered to a nursing woman.
The safety and efficacy of intravenous Sufentil citrate in pediatric patients as young as 1 day old undergoing cardiovascular surgery have been documented in a limited number of cases. The clearance of Sufentil in healthy neonates is approximately one-half that in adults and children. The clearance rate of Sufentil 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.
The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. Sufentil 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 Sufentil due to the use of indwelling catheters. The incidence of urinary retention in patients without urinary catheters receiving epidural Sufentil 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 Sufentil during surgical anesthesia and in 340 patients who received epidural Sufentil 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 Sufentil used during labor and delivery (N=340).
In general, cardiovascular and musculoskeletal adverse experiences were not observed in clinical trials of epidural Sufentil. 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
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.)
Sufentil Citrate Injection is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore has the potential for being abused.
Overdosage is manifested by an extension of the pharmacological actions of Sufentil (see CLINICAL PHARMACOLOGY ) as with other potent opioid analgesics. The most serious and significant effect of overdose for both intravenous and epidural administration of Sufentil 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 Sufentil 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.
The dosage of Sufentil 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, the dosage of Sufentil citrate 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 Sufentil is reduced in neonates, especially those with cardiovascular disease, the dose of Sufentil should be reduced accordingly (see PRECAUTIONS ).
Sufentil Citrate 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.
If benzodiazepines, barbiturates, inhalation agents, other opioids or other central nervous system depressants are used concomitantly, the dose of Sufentil and/or these agents should be reduced (see PRECAUTIONS ). In all cases dosage should be titrated to individual patient response.
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.
The selection of preanesthetic medications should be based upon the needs of the individual patient.
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.
|Total Dosage||Maintenance Dosage|
|Incremental or Infusion:||Incremental:|
|1 to 2 mcg/kg (expected duration of anesthesia 1 to 2 hours). Approximately 75% or more of total Sufentil 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.||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.|
|Sufentil 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 Sufentil 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.|
|Incremental or Infusion:||Incremental:|
|2 to 8 mcg/kg (expected duration of anesthesia 2 to 8 hours). Approximately 75% or less of the total calculated Sufentil 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, Sufentil has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery.||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.|
|Sufentil 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 Sufentil 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.|
|Incremental or Infusion:||Incremental:|
|8 to 30 mcg/kg (anesthetic doses). At this anesthetic dosage range Sufentil is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. Sufentil 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.||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.|
|Sufentil 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 Sufentil 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 Sufentil citrate, 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 Sufentil citrate injection accurately, the use of a tuberculin syringe or equivalent is recommended.
Proper placement of the needle or catheter in the epidural space should be verified before Sufentil is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of Sufentil could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full Sufentil, 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. Sufentil should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of Sufentil.
The recommended dosage is Sufentil 10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine. Sufentil 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.
Sufentil Citrate Injection, USP equivalent to 50 mcg/mL Sufentil is supplied in the following single-use containers:
|NDC Number||Container||Container Size||Total Sufentil |
|0409-3380-31||Ampul||1 mL fill in 1 mL||50 mcg|
|0409-3380-32||Ampul||2 mL fill in 2 mL||100 mcg|
|0409-3380-35||Ampul||5 mL fill in 5 mL||250 mcg|
|0409-3382-21||Fliptop Vial||1 mL fill in 2 mL||50 mcg|
|0409-3382-22||Fliptop Vial||2 mL fill in 2 mL||100 mcg|
|0409-3382-25||Fliptop Vial||5 mL fill in 5 mL||250 mcg|
Protect from light. Retain in carton until time of use.
Store at 20 to 25°C (68 to 77°F).
Hospira, Inc., Lake Forest, IL 60045 USA
Sufentil CITRATE Inj., USP
WARNING: May be habit forming.
For I.V. and Epidural Use.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
CITRATE Inj., USP
WARNING: May be habit forming.
For I.V. and Epidural Use
Protect from light.
Retain in carton until time of use.
Hospira, Inc., Lake Forest, IL 60045 USA
Depending on the reaction of the Sufentil after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sufentil not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Sufentil addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology