Remifentanil B. Braun
Ultra-short-acting opioid analgesic for anesthesia and ICU sedation
Remifentanil B. Braun is an ultra-short-acting opioid analgesic used exclusively in hospital settings for pain relief during surgery (general anesthesia) and for analgesia in mechanically ventilated adults in intensive care units (ICU). Its unique metabolism by non-specific blood and tissue esterases gives it a remarkably rapid onset and offset of action, making it one of the most precisely controllable opioids available. This medication is always administered intravenously by trained anesthesiologists or intensivists.
Quick Facts
Key Takeaways
- Remifentanil is an ultra-short-acting opioid with a context-sensitive half-time of approximately 3–4 minutes, regardless of infusion duration, making recovery predictable and rapid.
- It must only be administered in fully equipped medical facilities by physicians trained in anesthetic drug use, with continuous monitoring of respiratory and cardiovascular function.
- The most common side effects include muscle rigidity, nausea, vomiting, and low blood pressure; serious effects include respiratory arrest and severe allergic reactions.
- Remifentanil must never be injected into the spinal canal (intrathecally or epidurally) or used as the sole agent to induce anesthesia.
- Abrupt discontinuation after prolonged use (more than 3 days) may cause withdrawal symptoms including rapid heartbeat, high blood pressure, and agitation.
What Is Remifentanil B. Braun and What Is It Used For?
Remifentanil belongs to the pharmacological group of opioid analgesics, specifically the phenylpiperidine derivatives related to fentanyl. However, it differs fundamentally from other opioids in this class due to its unique ester linkage, which allows it to be rapidly hydrolyzed by non-specific blood and tissue esterases. This metabolic pathway is independent of hepatic or renal function, giving remifentanil its hallmark characteristic: an ultra-short duration of action with a context-sensitive half-time of approximately 3 to 4 minutes.
This rapid metabolism means that regardless of how long remifentanil has been infused, its effects wear off within minutes of stopping the infusion. This property makes it particularly valuable in clinical anesthesiology, where precise control over the depth and duration of analgesia is critical for patient safety and optimal surgical conditions.
Primary Clinical Indications
Remifentanil B. Braun is approved for use in two main clinical settings:
- General anesthesia: As an analgesic component during the induction and maintenance of general anesthesia in surgical procedures. It is used in combination with other anesthetic agents (such as propofol, sevoflurane, or isoflurane) to provide balanced anesthesia with predictable recovery times.
- ICU analgesia: For pain management in mechanically ventilated adult patients (aged 18 years and older) in intensive care units. Its rapid offset allows for periodic neurological assessments, which is a significant advantage over longer-acting opioids in the critical care setting.
The drug is manufactured by B. Braun Melsungen AG, a German healthcare company, and is marketed in numerous countries across the European Economic Area. It is also available under the brand name Ultiva from other manufacturers. Remifentanil was first approved for clinical use in the late 1990s and has since become a cornerstone of modern anesthetic practice, particularly in procedures where rapid recovery and early extubation are desired.
It is important to note that remifentanil provides no residual analgesia after discontinuation. Therefore, when postoperative pain is anticipated, alternative analgesics must be administered before or at the time of discontinuing remifentanil to prevent acute postoperative pain and the risk of opioid-induced hyperalgesia.
What Should You Know Before Taking Remifentanil B. Braun?
Contraindications
Remifentanil B. Braun must not be administered in the following situations:
- You are allergic (hypersensitive) to remifentanil, any of the excipients (glycine, hydrochloric acid), or to fentanyl derivatives (such as alfentanil, fentanyl, or sufentanil). Signs of allergy include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
- It would be administered by injection into the spinal canal (intrathecal or epidural administration), as the formulation contains glycine which is not suitable for neuraxial use.
- It would be used as the sole agent for induction of anesthesia, as this carries an unacceptable risk of muscle rigidity and respiratory depression without adequate airway management.
Warnings and Precautions
Before receiving remifentanil, inform your physician if any of the following apply to you:
- You have previously experienced adverse reactions during any surgical procedure or anesthesia.
- You have a known or suspected allergy to any medication used during surgery, or to opioid medications such as morphine, fentanyl, pethidine (meperidine), or codeine.
- You have impaired lung function or chronic respiratory conditions, as you may be more susceptible to respiratory depression.
- You have liver disease, as you may be more sensitive to the respiratory depressant effects of opioids.
- You or a family member has a history of substance abuse, including alcohol, prescription medications, or illicit drugs.
- You smoke tobacco.
- You have ever experienced mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental health conditions.
Remifentanil contains an opioid active substance. Repeated use of opioid pain medications can lead to reduced effectiveness (tolerance) and may also lead to dependence and substance use disorder, with risk of life-threatening overdose. If you are concerned that you may be developing dependence on remifentanil, it is essential to discuss this with your physician.
Withdrawal reactions: Withdrawal symptoms, including tachycardia (rapid heartbeat), hypertension (high blood pressure), and agitation, have occasionally been reported following abrupt discontinuation of remifentanil, particularly when treatment has continued for more than three days. In such cases, your physician may reinstitute the drug and gradually taper the dose to minimize withdrawal effects.
Special Populations
Elderly patients: The initial dose of remifentanil should be reduced in elderly patients when used for surgery under general anesthesia. Elderly and debilitated patients, particularly those with decreased blood volume or low blood pressure, are more susceptible to cardiovascular side effects including bradycardia and hypotension.
Children: Remifentanil is not recommended for use in neonates and infants under one year of age. In children aged 1 to 12 years, it may be used for anesthesia with appropriate dose adjustments. Experience with remifentanil in pediatric ICU settings is limited.
Pregnancy and Breastfeeding
Remifentanil B. Braun should not be given to pregnant women unless the clinical benefit clearly outweighs the potential risk. It is not recommended during labor or for cesarean delivery. If administered during active labor or near the time of delivery, remifentanil may affect the newborn's breathing. Both mother and baby will be closely monitored for signs of excessive sedation and respiratory difficulty.
It is recommended that breastfeeding be discontinued for 24 hours after administration of remifentanil. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your physician before receiving this medication.
Driving and Operating Machinery
Remifentanil is administered exclusively in hospital settings. If you are discharged shortly after receiving remifentanil, you must not drive a vehicle, operate machinery, or work in hazardous conditions. You should not travel home unaccompanied. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness.
How Does Remifentanil B. Braun Interact with Other Drugs?
Inform your physician about all medications you are taking, have recently taken, or might take. Drug interactions are especially important to consider in the perioperative and ICU setting, as patients often receive multiple medications simultaneously. The following table summarizes key drug interactions with remifentanil:
Major Interactions
| Drug / Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Beta-blockers (e.g., atenolol, metoprolol) | Potentiation of cardiovascular effects | Can cause significant bradycardia and hypotension. Dose adjustment of remifentanil may be necessary. |
| Calcium channel blockers (e.g., verapamil, diltiazem) | Potentiation of cardiovascular effects | Can lower blood pressure and heart rate. Enhanced monitoring required during co-administration. |
| MAO inhibitors | Serotonin syndrome risk | Co-administration is not recommended due to the risk of serotonin syndrome, a potentially life-threatening condition. |
| SSRIs (e.g., fluoxetine, sertraline) | Serotonin syndrome risk | Co-administration is not recommended. Risk of hyperthermia, rigidity, myoclonus, and autonomic instability. |
| SNRIs (e.g., venlafaxine, duloxetine) | Serotonin syndrome risk | Co-administration is not recommended. Similar risk profile to SSRIs. |
| Gabapentin / Pregabalin | Enhanced respiratory depression | Concomitant use increases the risk of opioid overdose, respiratory depression, and may be life-threatening. |
Other Interactions
| Drug / Class | Type of Interaction | Clinical Note |
|---|---|---|
| Benzodiazepines (e.g., midazolam, diazepam) | Enhanced sedation and respiratory depression | Dose adjustment of benzodiazepines is required when co-administered with remifentanil. This is standard practice in balanced anesthesia. |
| Propofol | Compatible co-administration | Remifentanil is compatible with propofol when administered through a running IV catheter. This is one of the most common anesthetic combinations. |
| Alcohol | Enhanced CNS depression | Do not consume alcohol until you have fully recovered from anesthesia. |
Your physician will assess all potential drug interactions and determine whether remifentanil can be safely administered to you. It is essential to provide a complete medication history, including over-the-counter drugs, herbal supplements, and recreational substances, as these may also interact with remifentanil.
What Is the Correct Dosage of Remifentanil B. Braun?
Remifentanil must only be administered under carefully controlled conditions with resuscitation equipment immediately available. It is given by or under the supervision of a physician experienced in the use of anesthetic drugs. You will never be expected to administer this medication yourself. The dose and duration of infusion are determined by your anesthesiologist and may vary based on several factors including your body weight, age, physical condition, other medications you are receiving, and the nature of your surgical procedure.
- Remifentanil may only be given by intravenous injection or infusion directly into a vein.
- The injection/infusion time must not be less than 30 seconds.
- It must NEVER be injected into the spinal canal (intrathecal or epidural).
- It must not be used without further dilution after reconstitution.
Adults
Standard Adult Dosage
For most adult patients, infusion rates between 0.1 and 2 micrograms per kilogram of body weight per minute are sufficient to achieve adequate analgesia during general anesthesia. Your anesthesiologist may increase or decrease the dose based on your clinical response and hemodynamic stability.
For ICU analgesia in mechanically ventilated patients, similar infusion rates are used, with careful titration to achieve the desired level of pain relief while maintaining adequate respiratory drive (though mechanical ventilation support is in place).
Children (1 to 12 Years)
Pediatric Dosage
For most children aged 1 to 12 years, infusion rates between 0.05 and 1.3 micrograms per kilogram per minute are sufficient to maintain anesthesia during surgical procedures. The dose may be adjusted by the anesthesiologist and can be as high as 3 micrograms per kilogram per minute if clinically indicated.
Note: Remifentanil is not recommended for use in neonates and infants under 1 year of age. Experience with pediatric ICU use is limited.
Elderly Patients
Elderly Dosage Adjustments
When remifentanil is used for surgery under general anesthesia, the initial dose should be appropriately reduced in elderly patients. Elderly patients are typically more sensitive to the pharmacological effects of opioids and may experience more pronounced cardiovascular effects (bradycardia and hypotension). Careful titration with close hemodynamic monitoring is essential.
Special Patient Groups
Obese, Critically Ill, and Organ Impairment
For significantly overweight patients, the initial dose is adjusted based on ideal body weight rather than total body weight, and titrated to clinical response.
For critically ill patients, the initial dose is reduced and carefully titrated upward based on response.
For patients with impaired liver or kidney function, a dose reduction is generally not necessary due to remifentanil's unique metabolism by plasma esterases, which is independent of hepatic and renal clearance.
For patients undergoing neurosurgery, dose reduction is not required.
Overdose
Since remifentanil is administered by trained medical professionals under continuously monitored conditions, overdose is unlikely. However, if overdose is suspected or occurs, the medical team will immediately take appropriate measures. Due to remifentanil's ultra-short duration of action, the effects of an overdose will resolve rapidly upon discontinuation of the infusion. Symptoms of overdose would typically include profound respiratory depression, muscle rigidity, and severe bradycardia and hypotension.
Missed Dose
Since remifentanil is administered as a continuous infusion by medical professionals, the concept of a missed dose does not apply in the traditional sense. If the infusion is interrupted, the medical team will resume it as clinically appropriate.
What Are the Side Effects of Remifentanil B. Braun?
Not all patients will experience side effects. The likelihood and severity of side effects depend on the dose administered, the duration of infusion, the patient's overall health, and concomitant medications. The following categorization uses standard frequency definitions:
Very Common
- Muscle rigidity (skeletal muscle stiffness)
- Nausea
- Vomiting
- Low blood pressure (hypotension)
Common
- Slow heart rate (bradycardia)
- Shallow breathing (respiratory depression)
- Respiratory arrest (apnea)
- Itching (pruritus)
- Post-operative shivering
- Post-operative high blood pressure (hypertension)
- Cough
Uncommon
- Constipation
- Post-operative pain
- Low oxygen levels (hypoxia)
Rare
- Drowsiness during recovery
- Severe allergic reactions including anaphylactic shock
- Cardiovascular collapse and cardiac arrest (when co-administered with other anesthetic agents)
- Slow heart rate progressing to heart block (when co-administered with other anesthetic agents)
Not Known
- Seizures (convulsions)
- Heart block (atrioventricular block)
- Irregular heart rhythm (arrhythmia)
- Tolerance (reduced effectiveness with repeated use)
- Withdrawal syndrome (rapid heartbeat, high blood pressure, agitation, nausea, vomiting, diarrhea, anxiety, chills, tremors, sweating)
An important clinical phenomenon associated with remifentanil is opioid-induced hyperalgesia (OIH), where patients may paradoxically experience increased pain sensitivity following remifentanil exposure. This is thought to be related to the activation of NMDA receptors during rapid opioid offset. Clinicians typically manage this by transitioning to longer-acting analgesics before discontinuing remifentanil and, in some protocols, by administering low-dose ketamine as an NMDA receptor antagonist.
As with other opioid medications, prolonged use of remifentanil can lead to physical dependence. Consult your physician if you have concerns about this. If you experience any side effects, including those not listed here, inform your healthcare team immediately.
How Should You Store Remifentanil B. Braun?
Remifentanil B. Braun must be stored and handled by trained healthcare professionals in accordance with hospital pharmacy protocols. The following storage conditions apply to the unreconstituted powder:
- Store at or below 25°C (77°F).
- Protect from cold. Do not freeze.
- Keep out of the sight and reach of children.
- Do not use after the expiry date printed on the carton and label.
- Do not use if the reconstituted solution is not clear and free from visible particles, or if the container is damaged.
After reconstitution with an appropriate diluent, the solution demonstrates chemical and physical stability for 24 hours at up to 25°C. However, from a microbiological standpoint, it should be used immediately. If not used immediately, storage should not normally exceed 24 hours at 2–8°C, unless reconstitution has been performed under controlled and validated aseptic conditions.
Remifentanil B. Braun is for single use only. Any unused solution must be discarded in accordance with local regulations for the disposal of pharmaceutical waste. Do not dispose of medications via household waste or wastewater.
What Does Remifentanil B. Braun Contain?
Remifentanil B. Braun is supplied as a white to off-white or yellowish powder for concentrate for solution for injection or infusion. It is presented in colorless glass vials.
Active Ingredient
Each vial contains remifentanil (as remifentanil hydrochloride):
- Remifentanil B. Braun 1 mg: 1 mg remifentanil per vial
- Remifentanil B. Braun 2 mg: 2 mg remifentanil per vial
- Remifentanil B. Braun 5 mg: 5 mg remifentanil per vial
After reconstitution according to instructions, each milliliter contains approximately 1 mg of remifentanil.
Inactive Ingredients (Excipients)
- Glycine – used as a stabilizer and bulking agent in the lyophilized formulation. Note: the presence of glycine is the reason remifentanil must not be administered intrathecally or epidurally, as glycine can cause neurotoxicity when injected into the central nervous system.
- Hydrochloric acid – used for pH adjustment.
Reconstitution and Dilution
For reconstitution, an appropriate volume of diluent is added to achieve a concentration of approximately 1 mg/mL:
| Vial Strength | Diluent Volume | Final Concentration |
|---|---|---|
| 1 mg | 1 mL | 1 mg/mL |
| 2 mg | 2 mL | 1 mg/mL |
| 5 mg | 5 mL | 1 mg/mL |
After reconstitution, the solution may be further diluted to concentrations of 20 to 250 micrograms/mL (recommended: 50 micrograms/mL for adults, 20–25 micrograms/mL for children from 1 year of age). Compatible diluents include water for injection, 5% glucose solution, 0.9% sodium chloride solution, 0.45% sodium chloride solution, and 5% glucose in 0.9% sodium chloride solution. Ringer's lactate solution and Ringer's lactate with 5% glucose may also be used for co-administration through a running IV line. Remifentanil is compatible with propofol for co-administration through a running IV catheter.
Manufacturer
Marketing Authorization Holder: B. Braun Melsungen AG, Carl-Braun-Strasse 1, 34212 Melsungen, Germany.
Manufacturer: hameln rds s.r.o., Horná 36, 900 01 Modra, Slovakia.
Remifentanil B. Braun is approved and marketed in multiple countries across the European Economic Area, including Germany, France, the United Kingdom, the Netherlands, Portugal, Denmark, Poland, Finland, the Czech Republic, and Slovakia.
Frequently Asked Questions About Remifentanil
Medical References
The information in this article is based on the following peer-reviewed sources and international pharmaceutical guidelines:
- European Medicines Agency (EMA). Remifentanil – Summary of Product Characteristics. EMA product database. Available from: www.ema.europa.eu
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: World Health Organization; 2023.
- Patel SS, Spencer CM. Remifentanil. Drugs. 1996;52(3):417–427. doi:10.2165/00003495-199652030-00009
- Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. Anesthesiology. 1997;86(1):10–23. doi:10.1097/00000542-199701000-00004
- Egan TD. Remifentanil pharmacokinetics and pharmacodynamics: a preliminary appraisal. Clinical Pharmacokinetics. 1995;29(2):80–94.
- British National Formulary (BNF). Remifentanil. National Institute for Health and Care Excellence (NICE). bnf.nice.org.uk
- Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. British Journal of Anaesthesia. 2014;112(6):991–1004. doi:10.1093/bja/aeu137
- U.S. Food and Drug Administration (FDA). Ultiva (remifentanil hydrochloride) prescribing information. FDA Drug Labels. www.fda.gov
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