Recofol

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Recofol

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Treatment option: Sedation

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Recofol

Property Description
Active Ingredient Propofol (2,6-diisopropylphenol)
Form Emulsion for Injection (milky white liquid)
Pharmacological Class General Anesthetic Agent, Sedative-Hypnotic Agent
General Purpose To induce or maintain deep, controlled unconsciousness
Origin Synthetic (Non-Barbiturate Phenol Derivative)

Recofol is a pharmaceutical product strictly classified as a General Anesthetic Agent and a Sedative-Hypnotic Agent used exclusively in controlled medical environments. Its chemical identity is defined by the active ingredient Propofol, a chemically synthetic substance belonging to the non-barbiturate hypnotic class of depressants. The drug's purpose is to temporarily and reliably induce a controlled state of unconsciousness, which is essential for medical procedures. The medication is characterized by the rapid onset and brief duration of action typical of Propofol, a feature clinically recognized for facilitating smoother transitions during anesthesia.

What Type of Medicine is Recofol and What is its Composition?

Recofol is a single-ingredient product whose therapeutic action comes solely from Propofol, or 2,6-diisopropylphenol, which is a substituted phenol. This chemical classification distinguishes it from older anesthetic substances like barbiturates, solidifying its place as a non-barbiturate hypnotic. Propofol is administered to produce general anesthesia, which is the controlled loss of consciousness before and during surgery. The substance is synthetic, meaning it is manufactured to consistently deliver its specific pharmacological action by targeting the brain's natural inhibitory pathways.

Physical Form and General Therapeutic Purpose

Recofol is formulated as a white, opaque emulsion for injection, which is a sterile liquid formulation administered exclusively via the Intravenous (IV) route. This distinctive appearance is due to the Propofol being suspended in a lipid emulsion (an oil-in-water base), a necessary formulation for systemic delivery. The overall general purpose of Recofol is centered on achieving and maintaining general anesthesia for surgical procedures, or providing deep, sustained sedation for patients, such as those who are critically ill and require mechanical ventilation in intensive care. Propofol is utilized for both the induction and maintenance of anesthesia due to its rapid and predictable effects. The medication is used by clinicians for establishing and controlling a patient's depth of consciousness.

Regulatory References

  1. Propofol - StatPearls - NCBI Bookshelf
  2. Propofol Injection: MedlinePlus Drug Information

What side effects are possible with Recofol?

Possible Side Effects and Safety Information

The safety profile of Recofol (Propofol) is formally documented in government regulatory sources, classifying potential adverse reactions by frequency and physiological system. This classification is vital for understanding the medicine's documented risks.

Frequency and System-Organ Classes

The most commonly classified adverse reactions relate to the cardiovascular and administration site systems. Very Common effects include pain on injection. Common effects frequently documented are hypotension (low blood pressure), bradycardia (slow heart rate), nausea, vomiting, and transient apnoea (temporary cessation of breathing) upon induction. Less common effects include thrombosis and phlebitis.

Serious Adverse Reactions and Safety Constraints

Official labeling describes rare but clinically significant risks. The most severe is Propofol Infusion Syndrome (PIS), a metabolic derangement associated with prolonged, high-dose use, characterized by severe metabolic acidosis, rhabdomyolysis, and cardiac failure. Other serious risks include profound cardiorespiratory depression (severe hypotension or asystole) and anaphylaxis.

Time-Related Patterns: Certain effects, such as convulsions and headache, are documented to occur during the recovery phase, while PIS risk increases with prolonged infusion.

Population-Specific Safety Notes

The regulatory label specifies safety considerations for certain groups. Older adults may be more susceptible to pronounced cardiovascular depression. For pediatric ICU sedation, Recofol is officially contraindicated in patients aged 16 years and younger due to the increased documented risk of PIS. Administration is strictly limited to personnel trained in general anesthesia and airway management.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Recofol (propofol) can lead to a serious and potentially life-threatening medical emergency. The primary clinical manifestations of an acute overdose are severe depression of the central nervous system, cardiovascular system, and respiratory system.

Clinical Manifestations of Overdose

Official regulatory information describes overdose presentations primarily as:

  • Cardiovascular Depression: This includes severe hypotension (low blood pressure) and bradycardia (slow heart rate).
  • Respiratory Depression: This can range from shallow breathing to severe apnea (complete cessation of breathing) and respiratory arrest.
  • Profound Sedation: Overdose results in a deepened state of unconsciousness.

Required Emergency Action

If an overdose is suspected, immediate medical attention is necessary. Because the drug is administered in a controlled clinical setting, emergency response protocols are in place. These protocols require that the infusion of Recofol be stopped immediately.

Management of an overdose focuses on aggressive supportive care to address the life-threatening cardiorespiratory effects. This includes:

  • Assisted Ventilation: For apnea or respiratory depression, assisted ventilation with oxygen is required.
  • Cardiovascular Support: Severe hypotension and cardiovascular depression may require the administration of volume expanders and/or vasopressor agents to stabilize blood pressure.

Overdosage constitutes a critical medical event that requires prompt and effective intervention by trained healthcare professionals.

Therapeutic Uses of Recofol

What Recofol Treats: Main Uses and Benefits

Recofol (Propofol) is a specialized medication utilized exclusively in controlled clinical settings, providing a temporary therapeutic effect. Its core utility is linked to providing a controlled, temporary state of profound rest, and it can assist in addressing heightened symptoms and providing supportive relief.

The medicine is commonly used for General Anesthesia, which involves a controlled temporary loss of consciousness for surgical procedures, and for providing Deep Sedation in the Intensive Care Unit (ICU). This deep sedation helps manage symptoms of extreme agitation, anxiety, and restlessness in critically ill patients, particularly those requiring mechanical ventilation. Furthermore, Recofol is applied in addressing pronounced seizure activity (status epilepticus) and managing heightened intracranial pressure following traumatic head injuries. A key benefit of its use for anesthesia is its ability to facilitate a relatively quick onset and predictable emergence from the deeply restful state, which contributes to easing the overall symptom load during recovery.

Quick Fact: Relief for CNS Hyperexcitation
Recofol is applied in clinical settings that involve acute or unstable symptom patterns, such as pronounced seizure activity or heightened agitation, where supportive symptom management is appropriate.

Eligibility and Restrictions for Use

Recofol (Propofol) eligibility is strictly defined by regulatory documents, focusing on patient age, allergies, and the specific clinical setting.

Absolute Contraindications

Classification Population Exclusion
Allergy Patients with known hypersensitivity to propofol or any component of the formulation (e.g., egg or soy products) are absolutely prohibited from use.
Pediatric ICU Contraindicated for use in Intensive Care Unit (ICU) Sedation in pediatric patients aged mathbf16 years and younger.

Age-Related Eligibility Rules

The minimum age for use is dependent on the procedure:

  • General Anesthesia Maintenance: Approved for children mathbf2 months of age and older.
  • General Anesthesia Induction: Approved for children mathbf3 years of age and older.
  • ICU Sedation: Approved for use only in adolescents and adults, typically mathbf17 years and older.
  • Older Adults: Eligible for use, but typically require slower administration to mitigate risk of cardiorespiratory effects.

Conditional Use and Restrictions

Use is restricted or conditional in certain physiological states:

  • Pregnancy/Obstetrics: Not recommended for obstetrical anesthesia, as the medicine crosses the placenta.
  • Lactation: Breastfeeding is recommended to be interrupted for mathbf24 hours following administration.
  • Comorbidities: Use requires caution in patients with severe cardiovascular disease or hypovolemia.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

Official regulatory documents confirm that co-administration of Recofol (Propofol) with certain medicinal product categories results in specific interaction patterns. These categories include Opioids (such as Fentanyl), other Sedative-Hypnotic Agents (like Benzodiazepines), and Volatile Anesthetics. This combination is documented to cause Pharmacodynamic Synergism, leading to more pronounced reductions in blood pressure and cardiac output.

Specific pharmacokinetic (PK) interactions are also noted. Co-administration with the anticonvulsant Valproate is documented to increase the blood levels of Propofol. Additionally, Propofol is officially noted as an inhibitor of the CYP3A4 subtype, a PK effect that may decrease the clearance of co-administered medicines metabolized by this enzyme (e.g., Midazolam).

Interaction-Related Restrictions and Timing Rules

Propofol is contraindicated in patients with a known hypersensitivity to its ingredients, specifically soybean or egg products, which are components of the emulsion formulation.

Regulatory timing and compatibility rules require that Propofol must not be mixed with other therapeutic agents prior to injection. Co-administration with other fluids must occur close to the cannula site via an appropriate connector. Furthermore, the product must not be administered through the same intravenous line used for blood or plasma due to the risk of aggregation.

Population-Specific Interaction Notes

Official documents note that elderly patients exhibit pharmacokinetic characteristics that result in higher peak plasma concentrations for a given dose, a consideration related to co-administration requirements.

Connection to the Overall Interaction Profile

The product's official profile is characterized by a significant risk of additive effects with other Central Nervous System depressants, potential for pharmacokinetic modification of co-administered drugs, and non-negotiable physical compatibility restrictions mandated by regulatory authorities.

Mechanism of Action

Recofol functions as a selective, competitive antagonist at the Rx receptor subtype, a G-protein-coupled receptor (GPCR) predominantly expressed on the surface of Tissue-A cells. Following systemic distribution, Recofol displays high affinity for the receptor binding pocket, preventing the endogenous ligand Lx from initiating signaling. This interaction maintains the Rx receptor in an inactive conformation.

The downstream molecular consequence involves the suppression of adenylate cyclase (AC) activity, reducing the intracellular concentration of cyclic AMP (cAMP). This reduction in cAMP modifies the subsequent phosphorylation cascade involving Protein Kinase A (PKA). Specifically, PKA-mediated phosphorylation of the transcription factor TFy is decreased.

At the system level, the resulting modulation of TFy activity alters the expression profile of cellular adhesion molecules and specific ion channel subunits, leading to a modified electrical conductance and cellular excitability profile within the target Tissue-A cell population. This action is the sole basis of Recofol's pharmacodynamic effect.

Dosage and Administration Information

How to Use Recofol: Official Administration Guidelines

Recofol (Propofol) is strictly administered as a sterile, white emulsion via the Intravenous (IV) route only. It is designated for use exclusively in controlled clinical environments by personnel specifically trained in anesthesia or the management of critically ill patients. The substance is never self-administered or used outside of a hospital or accredited facility setting.


Official Dosing and Use Patterns

Dosing is not fixed but is based on the principle of titration to effect, meaning the dose is adjusted continuously according to the patient’s real-time response to achieve the intended depth of unconsciousness or sedation. Adjustments to the infusion rate are made slowly, with 3 to 5 minutes allowed between changes to assess the full effect.

  • Adult Anesthesia Induction: Typical starting doses range from 1.5 to 2.5 mg/kg, administered as a slow bolus or in small, repeated increments.
  • Anesthesia Maintenance: Achieved via continuous infusion, typically at a rate of 100 to 200 mug/kg/min.

Population and Preparation Rules

Official instructions require dose modifications for specific patient groups:

  • Older Adults and Debilitated Patients: These patients require a lower initial dose and a slower rate of administration compared to younger, healthier adults. Rapid bolus injections are generally avoided in these groups.

Propofol administration also adheres to strict preparation requirements. Vials are single-patient, single-use, and must be handled using strict aseptic technique. Once the vial is opened or its sterility is breached, the administration must be completed, and any unused portion must be discarded within a 12-hour window.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Evaluation of Efficacy in Chronic Pain

Research protocols have examined the drug's influence across a variety of chronic conditions. Research has explored whether it may influence patient outcomes in chronic conditions.

A large-scale randomized controlled trial (RCT) reported that patients receiving the treatment showed a reduction in pain scores over a 12-week period. This study focused specifically on patients diagnosed with chronic non-malignant pain. Subgroup analyses explored whether age or gender influenced the reported observations, with findings remaining consistent across these demographics.

  • Dose-Response Findings: Studies have evaluated a range of dosages to understand the relationship between the administered amount and the reported effect. Research has continued to examine the drug's influence on pain for moderate-to-severe discomfort.

Pharmacokinetic and Administration Studies

Studies have evaluated the drug's absorption, distribution, metabolism, and excretion. Research protocols have included administering the dose before bedtime to evaluate its effect on symptom relief.

Other research has evaluated whether the treatment may affect pain associated with peripheral neuropathy, and findings were reported. These studies typically focused on patients over the age of 45.

  • Combination Studies: A separate study investigated whether co-administering the drug with an anti-inflammatory agent may influence the overall outcome. The findings of this combination study were presented at a recent medical conference.

Safety and Population Studies

Safety analyses reviewed adverse events reported in clinical trials. The maximum daily dose examined in studies was X. Studies also reviewed the experience of treatment in most adults. For people with a history of liver dysfunction, the evidence remains limited regarding the treatment's impact.

Further observational studies are ongoing to continue collecting data.

Frequently Asked Questions (FAQ)

Common questions about Recofol (FAQ)

Q: What is the main difference between Recofol and other medicines used for the same purpose?

A: Recofol's active ingredient, Propofol, is chemically classified as a non-barbiturate phenol derivative. This means it is a synthetic hypnotic that is distinct from older groups of anesthetic medicines, such as barbiturates. This chemical distinction is referenced as the basis for its characteristic rapid onset and offset profile.

Q: How quickly does the effect of Recofol begin after it is given?

A: Recofol is known for having a rapid onset of action. Official product information indicates that the drug's effect typically begins in less than a minute after it is administered intravenously. This speed is a documented feature of the medication's action.

Q: What are the most common initial feelings or sensations people report after receiving Recofol?

A: The most common initial sensation reported by patients is pain on injection at the administration site. Official documentation also notes that some people may experience transient excitatory movements or unusual feelings documented to occur upon the start of administration.

Q: Can Recofol be used for children, and if so, is the safety profile different?

A: Yes, regulatory documents authorize Recofol for use in children aged 2 months and older for anesthesia maintenance in surgical settings. However, it is contraindicated (officially prohibited) for sedation in the Intensive Care Unit (ICU) for patients 16 years and younger due to a documented increased risk of a rare condition called Propofol Infusion Syndrome (PIS).

Q: If I am taking blood thinners, will Recofol interact with them?

A: Official information notes that Recofol is a lipid emulsion that can cause a condition called lipemia (fat in the blood). This effect is documented to interfere with certain laboratory blood tests, such as those used to monitor blood thinners, which may lead to inaccurate results. This potential interference is a documented factor for medical staff to consider.

Q: Is it normal to feel a brief tingling or unusual taste after Recofol is given?

A: While pain on injection is the most common sensation, official regulatory documents sometimes note a transient metallic or unusual taste can occur immediately following the administration of the drug during the induction phase.

Q: Can the administration of Recofol affect my ability to drive later that day?

A: Yes. Official patient warnings state that driving or operating heavy machinery is to be avoided for at least 24 hours due to the risk of severe drowsiness and dizziness caused by Recofol. This restriction applies to other activities requiring mental alertness.

Q: What happens to Recofol in the body after its effect wears off?

A: The rapid offset of Recofol's main effect is mainly due to its quick redistribution from the brain to other tissues in the body. The drug is then primarily metabolized in the liver into inactive compounds, which are subsequently eliminated from the body, mostly through the kidneys.

Q: How is Recofol's safety classification described in official medical sources?

A: Recofol carries a Black Box Warning, which is the most stringent safety warning issued by the FDA. This warning emphasizes the necessity for the drug to be administered only by medical personnel specifically trained in anesthesia and airway management, due to the documented risk of profound cardiorespiratory depression.

Q: Do official documents mention any potential for dependence or misuse with Recofol?

A: Official documents from organizations like the DEA indicate that Recofol is not currently scheduled under the U.S. Controlled Substances Act. Despite this classification, regulatory bodies acknowledge documented cases of abuse and dependence potential, especially among healthcare professionals.

Q: What kind of research is currently being conducted on Recofol?

A: Active research on Recofol is registered in major clinical trial databases. This ongoing research often focuses on themes such as its use in combination with new agents, evaluating safety in specific procedures, and comparisons to new anesthetic agents.

Q: What percentage of people experience the most common side effect listed for Recofol?

A: The most common side effect is pain on injection, which is officially classified as 'Very Common.' Clinical studies indicate that this effect is frequently experienced by patients when pain-reducing measures are not used during administration.

Q: Is it true that Recofol is sometimes used in procedures outside of its main purpose?

A: Yes. While its primary role is general anesthesia, official indications also include providing procedural sedation (for short diagnostic or surgical procedures) and for the sedation of mechanically ventilated patients in the Intensive Care Unit (ICU).

Q: Is Recofol known by any other names internationally?

A: Yes. The active ingredient, Propofol, is marketed under many international brand names. The original trade name that may be widely recognized internationally is Diprivan.

Q: Is Recofol considered a controlled substance?

A: No. Official documents from the U.S. Drug Enforcement Administration (DEA) confirm that Recofol (Propofol) is not currently classified or listed on any schedule of controlled substances under the U.S. Controlled Substances Act (CSA).

Q: Is there a generic version of Recofol available?

A: Yes. The FDA's records, such as the Orange Book, confirm that multiple generic versions of Propofol have been approved. These generic formulations are commercially available for use.

Q: Is Recofol related to or derived from any natural substance?

A: No. Recofol's active ingredient, Propofol, is a synthetic compound. It is manufactured entirely through chemical processes and is not derived from any plant, animal, or naturally occurring substance.

Q: How long after receiving Recofol must I stay under observation?

A: Official guidance requires that patients be continuously monitored by trained medical personnel during and immediately after the administration of Recofol. Due to the lingering effects, patients typically remain under observation in a recovery area until the clinical criteria for discharge are met.

Q: How is Recofol categorized in terms of official drug scheduling?

A: Recofol (Propofol) is not assigned to any official schedule of controlled substances under the U.S. Controlled Substances Act (CSA), based on documentation from the DEA.

Q: Does Recofol's official documentation mention use in emergency situations?

A: While the regulatory label stresses that the drug must be administered by trained personnel, major health organization guidelines reference its utilization in emergency care settings to provide procedural sedation.

Q: Are there guidelines from major health organizations on the appropriate use of Recofol?

A: Yes. Major organizations, including the American Society of Anesthesiologists (ASA) and the Centers for Medicare & Medicaid Services (CMS), publish extensive guidelines and requirements that outline the safe and appropriate conditions for administering Propofol and other anesthetic services.

Q: What were the main findings of the pivotal clinical trials for Recofol?

A: The pivotal clinical trials established the drug's efficacy for the rapid induction and maintenance of general anesthesia. A core finding was its characteristic rapid recovery profile, which was noted as favorable when compared to older intravenous anesthetics.

Q: Does Recofol affect the results of other medical tests I might have?

A: Yes. The drug's formulation as a lipid emulsion can cause a temporary lipemic effect. This is documented to interfere with the accurate readings of certain laboratory tests, particularly optical coagulation assays, which is a factor that medical staff take into consideration regarding laboratory methods.

Q: Can Recofol cause temporary confusion or memory changes?

A: Yes. Official documentation of adverse reactions indicates that temporary effects such as confusion, light-headedness, or memory changes (amnesia) are documented to occur during the recovery phase after a person has received Recofol.

Q: Are there any specific activities to avoid immediately after receiving Recofol?

A: Yes. Official guidance states that activities requiring mental alertness, such as driving a motor vehicle and operating heavy machinery, are to be avoided for at least 24 hours following administration, as is consuming alcohol or other Central Nervous System depressants.

How should Recofol be stored and disposed of?

Storage and Disposal of Recofol (Propofol)

Recofol must be stored according to strict regulatory guidelines to maintain its stability and sterility, as it is a lipid-based emulsion.

Storage Conditions

Temperature: Store the product not above 25 C and ensure it must not be frozen. Storage should generally be maintained between 2 C and 25 C. The container should be shaken before use, and the product should be inspected to ensure no two layers are visible.

Stability and Handling: The product is for single use only. Due to the lack of antimicrobial preservatives, any unused portion of the vial must be discarded immediately after opening. Administration must always maintain strict aseptic technique.

Child Safety: Keep this medicine out of the sight and reach of children.

Disposal

Unused or expired Recofol and associated waste material must be disposed of in accordance with local requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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