Remifentanil Orion

Ultra-short-acting opioid analgesic for anesthesia and ICU sedation

Rx - Prescription Only Opioid Analgesic ATC: N01AH06
Active Ingredient
Remifentanil (as hydrochloride)
Available Forms
Powder for concentrate for solution for injection/infusion
Available Strengths
1 mg per vial
Known Brands
Remifentanil Orion
Reviewed by iMedic Medical Board
Evidence Level 1A

Remifentanil Orion 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). Manufactured by Orion Corporation of Finland, it contains remifentanil hydrochloride as its active ingredient. 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

Active Ingredient
Remifentanil
Drug Class
Opioid Analgesic
ATC Code
N01AH06
Common Uses
Anesthesia & ICU
Available Forms
IV Powder 1 mg
Prescription Status
Rx Only

Key Takeaways

  • Remifentanil Orion 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 Orion 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 Orion and What Is It Used For?

Quick Answer: Remifentanil Orion is a potent, ultra-short-acting opioid analgesic administered intravenously to provide pain relief during surgical procedures and to facilitate analgesia in mechanically ventilated ICU patients aged 18 years and older.

Remifentanil Orion 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 Orion 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. The drug's effect peaks within 1 to 3 minutes of the start of infusion, providing rapid establishment of analgesic effect during the intense stimulus of surgical incision or laryngoscopy.

Remifentanil is approximately 20 to 30 times more potent than alfentanil and exhibits a similar analgesic profile to fentanyl, but with a significantly shorter duration. Because the drug is metabolized to a virtually inactive carboxylic acid metabolite (GR90291), there is no meaningful accumulation even after prolonged infusions, distinguishing it from other opioids which may accumulate substantially over time.

Primary Clinical Indications

Remifentanil Orion 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.

Remifentanil Orion is manufactured by Orion Corporation, a Finnish pharmaceutical company headquartered in Espoo, Finland. Orion has a long tradition of producing high-quality injectable medicines for European healthcare systems. The product is marketed in multiple countries across the European Economic Area as a generic equivalent to the originator brand Ultiva. As a generic, Remifentanil Orion has demonstrated bioequivalence to the reference product and meets the same regulatory standards for quality, safety, and efficacy.

It is important to note that Remifentanil Orion provides no residual analgesia after discontinuation. Therefore, when postoperative pain is anticipated, alternative analgesics (such as paracetamol, non-steroidal anti-inflammatory drugs, or longer-acting opioids) must be administered before or at the time of discontinuing remifentanil to prevent acute postoperative pain and the phenomenon of opioid-induced hyperalgesia, in which patients paradoxically experience heightened pain sensitivity following rapid opioid offset.

What Should You Know Before Taking Remifentanil Orion?

Quick Answer: Remifentanil Orion must not be used if you are allergic to remifentanil or fentanyl derivatives. It must never be injected into the spinal canal or used as the sole agent for anesthesia induction. Special caution is required in elderly patients, those with impaired lung function, and patients with a history of substance abuse.

Before Remifentanil Orion is administered, your anesthesiologist or ICU physician will carefully review your medical history, current medications, and any known allergies. Because this medication is given under highly controlled conditions in a hospital setting, it is essential that the medical team has a complete picture of your health. The pre-anesthetic assessment is a critical safety step and must not be skipped.

Contraindications

Remifentanil Orion must not be administered in the following situations:

Warnings and Precautions

Before receiving Remifentanil Orion, 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 such as chronic obstructive pulmonary disease (COPD) or severe asthma, 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, even though remifentanil itself does not depend on liver metabolism.
  • You have kidney disease (renal impairment), although dose adjustment is typically not required because remifentanil clearance is independent of renal function.
  • You or a family member has a history of substance abuse, including alcohol, prescription medications, or illicit drugs.
  • You smoke tobacco, as chronic smoking may increase the risk of postoperative respiratory complications.
  • You have ever experienced mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental health conditions.
  • You are taking any central nervous system depressants, antidepressants, or seizure medications.
Important Information About Opioid Dependence

Remifentanil Orion 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. Tolerance may develop with continuous infusion for more than 24 hours, occasionally requiring dose escalation to maintain adequate analgesia.

Muscle rigidity: Opioid-induced muscle rigidity, particularly of the chest wall and abdominal muscles, can develop rapidly with remifentanil, especially when administered as a bolus or at high infusion rates. This rigidity can interfere with ventilation and is managed by slowing administration, administering neuromuscular blocking agents, or by discontinuing the drug.

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, or transition to an alternative opioid with a longer duration of action to minimize withdrawal effects.

Hemodynamic effects: Remifentanil can cause dose-dependent decreases in blood pressure and heart rate, particularly in elderly or hypovolemic patients and those with significant cardiovascular comorbidity. These effects are usually managed with fluid administration, vasoactive medications, or dose reduction. Full resuscitation equipment must always be immediately available.

Special Populations

Elderly patients: The initial dose of Remifentanil Orion 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. A starting dose reduction of 50% is often recommended in patients over 65 years of age, with subsequent titration to clinical effect.

Children: Remifentanil Orion 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, and use in this population should be based on individual clinical judgment by experienced pediatric anesthesiologists or intensivists.

Obese patients: For significantly overweight patients, the initial dose is adjusted based on ideal body weight rather than total body weight, because the drug distributes primarily into lean body mass. This prevents inadvertent overdosing.

Pregnancy and Breastfeeding

Remifentanil Orion 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. The neonatal team should be prepared to provide respiratory support if needed.

It is recommended that breastfeeding be discontinued for 24 hours after administration of remifentanil. Because remifentanil has a very short half-life, most of the drug will have been eliminated from the mother's system within hours; however, the 24-hour precaution provides an additional safety margin. Expressed milk from this period should be discarded. 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 Orion 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 for at least 24 hours. You should not travel home unaccompanied. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness. Even after the direct effects have worn off, residual fatigue and cognitive impairment from the anesthetic experience may persist.

How Does Remifentanil Orion Interact with Other Drugs?

Quick Answer: Remifentanil Orion interacts significantly with cardiovascular medications (beta-blockers, calcium channel blockers), sedatives (benzodiazepines), antidepressants (SSRIs, SNRIs, MAO inhibitors), and gabapentinoids. These interactions can potentiate cardiovascular depression, respiratory depression, or increase the risk of serotonin syndrome.

Inform your physician about all medications you are taking, have recently taken, or might take, including prescription medications, over-the-counter drugs, herbal supplements, and recreational substances. Drug interactions are especially important to consider in the perioperative and ICU setting, as patients often receive multiple medications simultaneously. Remifentanil is not metabolized by cytochrome P450 enzymes, so it is generally free from the P450-based metabolic interactions that complicate other opioids; however, pharmacodynamic interactions remain clinically significant.

The following tables summarize key drug interactions with Remifentanil Orion:

Major Interactions

Major Drug Interactions with Remifentanil Orion
Drug / Class Type of Interaction Clinical Significance
Beta-blockers (e.g., atenolol, metoprolol, bisoprolol) Potentiation of cardiovascular effects Can cause significant bradycardia and hypotension. Dose adjustment of remifentanil may be necessary and careful hemodynamic monitoring is essential.
Calcium channel blockers (e.g., verapamil, diltiazem, amlodipine) Potentiation of cardiovascular effects Can lower blood pressure and heart rate. Enhanced monitoring is required during co-administration, particularly in elderly patients.
MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide) Serotonin syndrome risk Co-administration is not recommended due to the risk of serotonin syndrome, a potentially life-threatening condition. A washout period of at least 14 days is typically recommended.
SSRIs (e.g., fluoxetine, sertraline, citalopram, escitalopram) Serotonin syndrome risk Co-administration is not recommended. Risk of hyperthermia, rigidity, myoclonus, and autonomic instability. Symptoms require immediate medical attention.
SNRIs (e.g., venlafaxine, duloxetine) Serotonin syndrome risk Co-administration is not recommended. Similar risk profile to SSRIs. Monitor for agitation, hyperreflexia, and autonomic instability.
Gabapentin / Pregabalin Enhanced respiratory depression Concomitant use increases the risk of opioid overdose, respiratory depression, and may be life-threatening. Particularly concerning in elderly patients or those with respiratory impairment.
Other opioids (e.g., morphine, oxycodone, tramadol) Additive CNS and respiratory depression Dose of either agent may need to be reduced. Total opioid load must be carefully considered to prevent respiratory compromise.

Other Interactions

Other Drug Interactions with Remifentanil Orion
Drug / Class Type of Interaction Clinical Note
Benzodiazepines (e.g., midazolam, diazepam, lorazepam) 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 with synergistic effect Remifentanil is compatible with propofol when administered through a running IV catheter. This is one of the most common anesthetic combinations (total intravenous anesthesia, TIVA). Propofol doses should typically be reduced by 25%.
Volatile anesthetics (e.g., sevoflurane, isoflurane, desflurane) Synergistic anesthetic effect Minimum alveolar concentration (MAC) of inhaled agents may be reduced by up to 50% when co-administered with remifentanil. Adjust dosing accordingly.
Alcohol Enhanced CNS depression Do not consume alcohol until you have fully recovered from anesthesia (typically at least 24 hours).
Neuromuscular blocking agents No significant pharmacokinetic interaction Remifentanil does not affect the duration or intensity of neuromuscular blockade. Standard dosing of neuromuscular blockers can generally be used.

Your anesthesiologist will assess all potential drug interactions and determine whether Remifentanil Orion can be safely administered to you. It is essential to provide a complete medication history, including over-the-counter drugs, herbal supplements (such as St John's Wort, which can increase serotonin levels), and recreational substances, as these may also interact with remifentanil. If you are on long-term antidepressants, do not stop them without consulting your physician, but ensure the anesthesia team is fully aware of your regimen.

What Is the Correct Dosage of Remifentanil Orion?

Quick Answer: Remifentanil Orion is administered by intravenous infusion only, with dosing individually tailored by the anesthesiologist based on body weight, age, physical condition, concomitant medications, and the type of surgery. Typical adult infusion rates range from 0.1 to 2 micrograms per kilogram per minute. The injection time must not be less than 30 seconds.

Remifentanil Orion 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.

Adults

Standard Adult Dosage for General Anesthesia

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.

Induction phase: A typical induction infusion rate is 0.5 to 1 microgram per kilogram per minute, often combined with a slow bolus over 30 to 60 seconds. The bolus dose is typically 0.5 to 1 microgram per kilogram.

Maintenance phase: Infusion rates are titrated between 0.05 and 2 micrograms per kilogram per minute, adjusted to surgical stimulus. Rate changes of 25 to 100% can be made every 2 to 5 minutes based on analgesic requirements.

Standard Adult Dosage for ICU Analgesia

For ICU analgesia in mechanically ventilated adult patients (aged 18 years and older), the recommended starting infusion rate is 0.1 microgram per kilogram per minute, with subsequent titration in increments of 0.025 microgram/kg/min. Typical infusion rates range from 0.006 to 0.74 microgram/kg/min. The target is adequate sedation and analgesia while maintaining the ability to perform neurological assessments.

Note: Remifentanil infusions in the ICU should not typically exceed 3 days due to the risk of tolerance development and withdrawal on discontinuation.

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 Orion is not recommended for use in neonates and infants under 1 year of age. Experience with pediatric ICU use is limited, and should only be undertaken by anesthesiologists experienced in pediatric care.

Elderly Patients

Elderly Dosage Adjustments

When Remifentanil Orion 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). A dose reduction of approximately 50% is often recommended for patients over 65 years of age. 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 (lean body mass) rather than total body weight, and titrated to clinical response. This approach prevents unintended overdose.

For critically ill patients, the initial dose is reduced and carefully titrated upward based on response. Hemodynamically unstable patients may require significantly lower infusion rates.

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. However, the inactive metabolite GR90291 accumulates in severe renal impairment, although its clinical relevance is minimal.

For patients undergoing neurosurgery, dose reduction is not required. The drug's rapid offset is particularly valuable in these procedures, allowing immediate postoperative neurological assessment.

For patients with cardiac surgery, remifentanil is frequently used at higher infusion rates (up to 1 microgram/kg/min) due to the intense surgical stimulation, but must be carefully titrated against hemodynamic effects.

Overdose

Since Remifentanil Orion 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, which may include stopping the infusion, supporting ventilation, administering fluids and vasoactive medications, and using the opioid antagonist naloxone if clinically indicated. Due to remifentanil's ultra-short duration of action, the effects of an overdose will typically resolve within 5 to 10 minutes of discontinuation of the infusion. Symptoms of overdose would typically include profound respiratory depression, apnea, muscle rigidity, severe bradycardia, and hypotension.

Missed Dose

Since Remifentanil Orion 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 (for example, due to an IV line disconnection or pump failure), the medical team will resume it as clinically appropriate. Due to the drug's ultra-short half-life, even brief interruptions can result in rapid loss of analgesic effect, so the medical team will be vigilant to maintain continuous administration during critical phases of anesthesia.

What Are the Side Effects of Remifentanil Orion?

Quick Answer: Like all opioids, Remifentanil Orion can cause side effects. The most common effects (affecting more than 1 in 10 patients) are muscle rigidity, nausea, vomiting, and low blood pressure. Serious but rare effects include respiratory arrest, severe allergic reactions (including anaphylactic shock), and cardiac arrest.

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. Many side effects are short-lived due to the drug's rapid metabolism and resolve within minutes of stopping the infusion. The following categorization uses standard frequency definitions as defined by the Council for International Organizations of Medical Sciences (CIOMS):

Very Common

May affect more than 1 in 10 patients
  • Muscle rigidity (skeletal muscle stiffness, particularly of the chest wall)
  • Nausea
  • Vomiting
  • Low blood pressure (hypotension)

Common

May affect up to 1 in 10 patients
  • Slow heart rate (bradycardia)
  • Shallow breathing (respiratory depression)
  • Respiratory arrest (apnea)
  • Itching (pruritus)
  • Post-operative shivering
  • Post-operative high blood pressure (hypertension)
  • Cough

Uncommon

May affect up to 1 in 100 patients
  • Constipation
  • Post-operative pain
  • Low oxygen levels (hypoxia)
  • Dry mouth
  • Reflux (gastroesophageal regurgitation)

Rare

May affect up to 1 in 1,000 patients
  • 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)
  • Asystole (complete heart stop)

Not Known

Frequency cannot be estimated from available data
  • 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)
  • Opioid-induced hyperalgesia (paradoxical increased pain sensitivity)
Opioid-Induced Hyperalgesia

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 to attenuate hyperalgesia. Multimodal analgesia including paracetamol and NSAIDs (when not contraindicated) can also reduce the need for high-dose remifentanil and subsequent OIH.

Cardiovascular Side Effects

The hypotension and bradycardia caused by remifentanil are usually mild to moderate and resolve rapidly on dose reduction or discontinuation. However, they can become clinically significant in patients with reduced cardiovascular reserve. Prophylactic administration of an anticholinergic agent (such as glycopyrrolate) or vasopressor can mitigate these effects when necessary. Severe bradycardia occasionally progresses to asystole in rare cases, particularly in patients on beta-blockers.

As with other opioid medications, prolonged use of Remifentanil Orion 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. Patients and healthcare professionals are also encouraged to report suspected adverse reactions to their national pharmacovigilance authority (for example, the MHRA Yellow Card scheme in the UK, or FDA MedWatch in the United States).

How Should You Store Remifentanil Orion?

Quick Answer: Store below 25°C, protected from cold. Do not freeze. Keep out of the sight and reach of children. Do not use after the expiry date or if the solution is not clear and free of particles.

Remifentanil Orion must be stored and handled by trained healthcare professionals in accordance with hospital pharmacy protocols. As a controlled substance (opioid), its storage, dispensing, and disposal are also governed by national drug control regulations, which require secure storage in a locked cabinet and accurate record-keeping of all doses used. The following storage conditions apply to the unreconstituted powder:

  • Store at or below 25°C (77°F).
  • Protect from cold. Do not freeze.
  • Keep the vial in the outer carton to protect it from light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the carton and label (EXP). The expiry date refers to the last day of that month.
  • 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, the solution 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 Orion is for single use only. Any unused solution must be discarded in accordance with local regulations for the disposal of pharmaceutical waste and controlled substances. Do not dispose of medications via household waste or wastewater. Hospital pharmacies typically maintain dedicated protocols for controlled substance disposal, including documentation and witness requirements.

What Does Remifentanil Orion Contain?

Quick Answer: The active substance is remifentanil (as hydrochloride). Each vial of Remifentanil Orion contains 1 mg of remifentanil. The inactive ingredients are glycine and hydrochloric acid.

Remifentanil Orion 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 with a rubber stopper and aluminum seal with a flip-off cap.

Active Ingredient

Each vial of Remifentanil Orion contains 1 mg of remifentanil (as remifentanil hydrochloride):

  • Remifentanil Orion 1 mg: 1 mg of remifentanil base per vial, supplied as 1.1 mg remifentanil hydrochloride (after accounting for the salt).

After reconstitution according to instructions, each milliliter contains approximately 1 mg of remifentanil. The reconstituted solution must be further diluted before administration to obtain a final concentration suitable for infusion (typically 20 to 250 micrograms/mL).

Inactive Ingredients (Excipients)

  • Glycine – used as a stabilizer and bulking agent in the lyophilized (freeze-dried) formulation. Note: the presence of glycine is the specific reason Remifentanil Orion 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 during manufacturing to ensure stability and compatibility with blood.

Reconstitution and Dilution

For reconstitution, an appropriate volume of diluent is added to the Remifentanil Orion 1 mg vial to achieve a concentration of approximately 1 mg/mL:

Reconstitution Guide for Remifentanil Orion
Vial Strength Diluent Volume Final Concentration
1 mg 1 mL 1 mg/mL

After reconstitution, the solution may be further diluted to concentrations of 20 to 250 micrograms/mL. Recommended target concentrations are 50 micrograms/mL for adults and 20–25 micrograms/mL for children from 1 year of age. Compatible diluents include:

  • Water for injection
  • Glucose 5% solution
  • Sodium chloride 0.9% solution
  • Sodium chloride 0.45% solution
  • Glucose 5% in sodium chloride 0.9% solution

Ringer's lactate solution and Ringer's lactate with glucose 5% may also be used for co-administration through a running IV line. Remifentanil Orion is compatible with propofol for co-administration through a running IV catheter, enabling the total intravenous anesthesia (TIVA) technique.

Manufacturer

Marketing Authorization Holder: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland.

Manufacturer: Orion Corporation, Orion Pharma, Tengströminkatu 8, FI-20360 Turku, Finland.

Remifentanil Orion is approved and marketed in multiple countries across the European Economic Area. Orion Corporation is one of the Nordic region's leading pharmaceutical companies, with a particular focus on hospital-administered medicines and complex injectables. The product complies with all relevant European Medicines Agency (EMA) standards for generic bioequivalence and pharmaceutical quality.

Frequently Asked Questions About Remifentanil Orion

Medical References

The information in this article is based on the following peer-reviewed sources and international pharmaceutical guidelines:

  1. European Medicines Agency (EMA). Remifentanil – Summary of Product Characteristics. EMA product database. Available from: www.ema.europa.eu
  2. World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: World Health Organization; 2023.
  3. Patel SS, Spencer CM. Remifentanil. Drugs. 1996;52(3):417–427. doi:10.2165/00003495-199652030-00009
  4. Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. Anesthesiology. 1997;86(1):10–23. doi:10.1097/00000542-199701000-00004
  5. Egan TD. Remifentanil pharmacokinetics and pharmacodynamics: a preliminary appraisal. Clinical Pharmacokinetics. 1995;29(2):80–94.
  6. British National Formulary (BNF). Remifentanil. National Institute for Health and Care Excellence (NICE). bnf.nice.org.uk
  7. 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
  8. U.S. Food and Drug Administration (FDA). Ultiva (remifentanil hydrochloride) prescribing information. FDA Drug Labels. www.fda.gov
  9. Komatsu R, Turan A, Orhan-Sungur M, McGuire J, Radke OC, Apfel CC. Remifentanil for general anaesthesia: a systematic review. Anaesthesia. 2007;62(12):1266–1280. doi:10.1111/j.1365-2044.2007.05221.x
  10. Beers R, Camporesi E. Remifentanil update: clinical science and utility. CNS Drugs. 2004;18(15):1085–1104.

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