Sufentanil

Name: Sufentanil

Warnings

Black Box Warnings

Therapy exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death; assess each patient’s risk prior to prescribing therapy, and monitor all patients regularly for the development of these behaviors and conditions

Contraindications

Relative: hepatic function impairment

Cautions

Use caution in bradycardia, compromised cardiac reserve, head injury, hypothyroidism, increased intracranial pressure, intracranial lesions, renal function impairment, respiratory impairment

Concurrent administration of benzodiazepine or neuromuscular blocker will decrease chest wall rigidity

In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

May cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely

Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

Muscle rigidity occurring during induction of can be treated by decreasing rate or discontinuing infusion of drug or by administering a neuromuscular blocking agent; neuromuscular blocking agents used should be compatible with patient's cardiovascular status

Not to be administered into same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products

Proper placement of needle or catheter in epidural space should be verified before drug is injected to assure that unintentional intravascular or intrathecal administration does not occur; unintentional intravascular injection of sufentanil could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea; unintentional intrathecal injection of sufentanil/bupivacaine epidural doses and volume could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery; if analgesia is inadequate, placement and integrity of catheter should be verified prior to administration of any additional epidural medications; administer epidurally by slow injection

Bradycardia may occur; monitor heart rate during dosage initiation and titration; responsive to ephedrine or anticholinergic drugs

Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock

Sufentanil and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

SUFentanil falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. SUFentanil should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. SUFentanil should be given to a pregnant woman only if clearly needed.

What are some other side effects of Sufentanil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Feeling sleepy.
  • Itching.
  • Muscle stiffness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about sufentanil, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 sufentanil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using sufentanil.

Review Date: October 4, 2017

Indications and Usage for Sufentanil

Sufentanil 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.

Sufentanil 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 Sufentanil.

Rl-0762

Sufentanil CITRATE 
Sufentanil citrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-3380
Route of Administration EPIDURAL, 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  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0409-3380-31 10 AMPULE in 1 CONTAINER
1 1 mL in 1 AMPULE
2 NDC:0409-3380-32 10 AMPULE in 1 CONTAINER
2 2 mL in 1 AMPULE
3 NDC:0409-3380-35 10 AMPULE in 1 CONTAINER
3 5 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074534 09/07/2005
Sufentanil CITRATE 
Sufentanil citrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-3382
Route of Administration EPIDURAL, 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  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0409-3382-21 10 VIAL, SINGLE-USE in 1 CARTON
1 1 mL in 1 VIAL, SINGLE-USE
2 NDC:0409-3382-22 10 VIAL, SINGLE-USE in 1 CARTON
2 2 mL in 1 VIAL, SINGLE-USE
3 NDC:0409-3382-25 10 VIAL, SINGLE-USE in 1 CARTON
3 5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074534 07/26/2005
Labeler - Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS(0409-3380, 0409-3382), LABEL(0409-3380, 0409-3382), MANUFACTURE(0409-3380, 0409-3382), PACK(0409-3380, 0409-3382)
Revised: 04/2017   Hospira, Inc.

Index Terms

  • Sufentanil Citrate

Contraindications

Hypersensitivity (eg, anaphylaxis) to sufentanil or any component of the formulation

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing Geriatric

Refer to adult dosing. Use with caution and titrate slowly; monitor closely for signs of CNS and respiratory depression.

Dosing Pediatric

Surgical anesthesia (cardiovascular surgery): IV: Children <12 years: Induction: 10 to 25 mcg/kg with 100% O2; maintenance: up to 25 to 50 mcg based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution and reduce dose as needed; titrate slowly and closely monitor for signs of CNS and respiratory depression.

Administration

Intermittent doses may be administered IV as either a slow injection (eg, over at least 2 minutes [Sebel 1982] or a range of 2 to 10 minutes [Miller 2010]) or as an infusion. May also be administered as a continuous infusion.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, fatigue, itching, or muscle rigidity. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), noisy breathing, angina, tachycardia, severe dizziness, passing out, confusion, difficulty breathing, slow breathing, shallow breathing, seizures, bradycardia, sexual dysfunction (males), amenorrhea, decreased libido, or infertility (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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