General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Sufentanil Citrate
SUFENTANIL CITRATE
1 INDICATIONS AND USAGE Sufentanil Citrate Injection 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 proced...
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Brand names:Sufentanil Citrate
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- SUFENTANIL CITRATE
- Medicine class
- General Medicine
- Brand names
- Sufentanil Citrate
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life is 164 minutes in adults
- FDA approved
- Yes
What Is Sufentanil Citrate?
1 INDICATIONS AND USAGE Sufentanil Citrate Injection 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 proced...
Sufentanil Citrate (SUFENTANIL CITRATE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Sufentanil Citrate. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Sufentanil Citrate with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Sufentanil Citrate is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE Sufentanil Citrate Injection 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 is indicated for epidural administration: • as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
Sufentanil Citrate Injection is an opioid agonist indicated: ( 1 ) • 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.
• for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION • Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. • Ensure that an opioid overdose reversal agent, resuscitative and intubation equipment, and oxygen are readily available. ( 2.1 ) • Individualize dosing based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. ( 2.1 ) • Initiate analgesic treatment with 1 to 2 mcg/kg intravenously. ( 2.2 ) • Initiate epidural injection for labor and delivery at 10 to 15 mcg of Sufentanil administered with 10 mL bupivacaine 0.125% with or without epinephrine. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous or epidural anesthetics and manag
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Skeletal Muscle Rigidity and Skeletal Muscle Movement [see Warnings and Precautions (5.5) ] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Severe Cardiovascular Depression [see Warnings and Precautions (5.6) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] • Serotonin Syndrome [see Warnings and Precautions (5.8) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11) ] • Seizures [see Warnings and Precautions (5.12) ] Most common adverse reactions were apnea, rigidity, and bradycardia.
- ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc.
- at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- 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,
- In all cases sufentanil was administered following a dose of local anesthetic to test proper catheter placement.
Serious
- 5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration.
- ( 5.2 ) • Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement : Manage with neuromuscular blocking agent.
- See full prescribing information for more detail on managing these risks.
- ( 5.5 ) • Severe Cardiovascular Depression : Monitor during dosage initiation and titration.
- ( 5.6 ) • Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. ( 5.2 ) • Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement : Manage with neuromuscular blocking agent. See full prescribing information for more detail on mana
How Sufentanil Citrate Works
12.1 Mechanism of Action Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil 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, sufentanil is approximately 5 to 7 times as potent as fentanyl.
Pharmacokinetics
Absorption
Absorption After epidural administration of incremental doses totaling 5 to 40 mcg sufentanil during labor and delivery, maternal and neonatal sufentanil plasma concentrations were at or near the 0
Half-Life
half-life is 164 minutes in adults
Metabolism
Metabolism The liver and small intestine are the major sites of biotransformation
Excretion
Excretion Approximately 80% of the administered dose is excreted within 24 hours and only 2% of the dose is eliminated as unchanged drug
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Sufentanil Citratewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Protect from light. Retain in carton until time of use. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
Frequently Asked Questions
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Sufentanil Citrate dosage guide
Adult, pediatric, renal, and hepatic dosing for Sufentanil Citrate
- Detail
Sufentanil Citrate side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Sufentanil Citrate
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.