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Propofol Claris

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Propofol Claris

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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.

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Overview of Propofol Claris

Quick Facts Description
Active ingredient Propofol
Form Sterile oil-in-water emulsion for injection
Pharmacological class General Anesthetic / Sedative-Hypnotic
Route of administration Intravenous (IV)
Origin Synthetic, non-barbiturate compound

Identity and General Purpose

Propofol Claris is a generic pharmaceutical preparation whose active ingredient is propofol, chemically designated as 2,6-diisopropylphenol. This medication is classified as a potent, short-acting intravenous general anesthetic and sedative-hypnotic agent, acting primarily as a rapid-onset central nervous system (CNS) depressant. This compound is a synthetic, non-barbiturate derivative, distinguishing it from older anesthetic classes.

The medication is used to induce and maintain a state of controlled unconsciousness for surgical procedures (general anesthesia) or to provide deep sedation for patients requiring diagnostic tests or mechanical ventilation in specialized care settings. This high degree of control is the clinical benefit of its short-acting nature.

Form and Composition of Propofol Claris

The drug is formulated as a sterile, oil-in-water emulsion for injection, appearing as a distinctive white, milky fluid administered solely via the intravenous (IV) route. This preparation is necessary because the propofol molecule is highly lipophilic (fat-soluble) and practically insoluble in water. To facilitate safe delivery, the active ingredient is suspended within a lipid base or vehicle. This high-level composition typically includes refined soybean oil, glycerol, and purified egg phospholipid (lecithin) as the emulsifying agents, a formulation choice crucial for ensuring effective transport to the CNS and achieving its characteristic rapid anesthetic action.

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What side effects are possible with Propofol Claris?

Possible Side Effects and Safety Information

Propofol Claris is a short-acting agent with an established safety profile, but its administration requires continuous monitoring of vital functions due to its dose-dependent effects on the cardiorespiratory system. All adverse reactions are classified based on regulatory frequency frameworks.

Key Adverse Reactions

The most Very Common adverse reaction is local pain at the injection site. Common effects include hypotension (low blood pressure), bradycardia (slow heart rate), temporary apnea (pause in breathing) during induction, and involuntary movements. These cardiorespiratory effects are dose-dependent and necessitate immediate access to resuscitation facilities.

Serious and Significant Risks

Serious adverse reactions are reported across several system-organ classes:

  • Cardiorespiratory Depression: This is a dose-related risk, characterized by significant hypotension and respiratory depression, especially following rapid or bolus administration, and is compounded by co-administration with opioids.
  • Propofol Infusion Syndrome (PRIS): This rare but potentially fatal syndrome is associated with prolonged, high-dose infusions, primarily in the intensive care setting. Its components include metabolic acidosis, rhabdomyolysis, hyperkalemia, renal failure, and heart failure.
  • Hypersensitivity: Rare cases of severe allergic reactions (anaphylaxis) have been documented.

Safety Considerations and Restrictions

Propofol Claris is contraindicated in patients with known hypersensitivity to the drug, or to soy or egg products. The drug is not recommended for sedation in the Intensive Care Unit (ICU) for patients 16 years of age or younger. Caution is advised for elderly, hypovolemic, or severely ill patients, who typically require a reduced initial dose and slower titration to mitigate the risk of severe cardiorespiratory depression. Strict aseptic technique is mandatory due to the formulation's inability to support microbial growth once opened, a requirement vital for preventing contamination that has been linked to sepsis.

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Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Propofol is documented by regulatory bodies as an exaggeration of the drug’s primary pharmacological actions, arising from excessive administration or rapid infusion. The expected clinical presentation is dominated by severe cardiorespiratory depression.

Documented Manifestations and Severe Outcomes: The official labeling lists profound arterial hypotension, severe apnea leading to arterial oxygen desaturation, and potential progression to Cardiac Arrest or Respiratory Arrest. Additionally, the life-threatening complication known as Propofol Infusion Syndrome (PRIS) is associated with prolonged, high-dose exposure, marked by acute refractory bradycardia, severe metabolic acidosis, rhabdomyolysis, and renal failure. Special regulatory caution is noted for elderly or debilitated patients, who are highly susceptible to exaggerated cardiorespiratory depression.

Mandated Emergency Action: Regulatory authorities state that any suspected Propofol intoxication requires that patients seek immediate medical attention. As no specific antidote is known, treatment is strictly limited to immediate stabilization and supportive care. This mandated support includes continuous monitoring of vital signs, mechanical ventilation for respiratory failure, and the use of intravenous fluids or vasopressors to manage profound hypotension.

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Therapeutic Uses of Propofol Claris

Propofol Claris is applied across several therapeutic domains where controlling or suspending consciousness and managing acute distress are essential for patient care and medical intervention. The primary benefit is that it supports manageable sedation or anesthesia.

The drug is used to begin and maintain general anesthesia, provide sedation during medical procedures, and sedate adults in intensive care units receiving mechanical ventilation.

Control of Consciousness and Acute Symptoms

Propofol is predominantly used to address the need for complete, temporary loss of awareness and responsiveness during surgery and to alleviate the severe agitation and distress that interfere with life support in critical care. It is relevant in clinical settings that involve acute or unstable symptom patterns, including the suppression of severe, prolonged seizures or life-threatening bronchospasm in refractory cases. Its role in symptom management is important when short-term symptomatic assistance is needed. The controllable nature of this agent supports the ability of medical teams to rapidly adjust the level of necessary support.

Quick Fact: Relief for Acute Distress
Primary Symptom Domains Unwanted consciousness, severe agitation, post-treatment nausea
Core Therapeutic Benefit Provides support that helps ease the overall symptom burden during high-acuity interventions
Typical Contexts Surgery, ICU support, procedural sedation

Regulatory References

  1. Propofol Injection: MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Contraindications (Must Not Use)

Use of Propofol Claris is contraindicated in patients with a known hypersensitivity to the active ingredient, propofol, or to any excipient in the emulsion, including egg or soy products. The medication must also not be used for Intensive Care Unit (ICU) sedation in patients mathbf16 years of age or younger, as safety and effectiveness are not established for this group. Furthermore, use is not recommended for obstetric anesthesia, including Caesarean section deliveries.


Age- and Condition-Based Restrictions

Age-Related Eligibility

Adult patients are approved for all labeled indications. Minimum age requirements for general anesthesia vary by regulatory region, typically starting at mathbf1 month or mathbf3 years. Use is not recommended in newborn infants (mathbf< 1 month old).

Conditional Use

Special caution and reduced administration rates are required for elderly patients and those with high-risk conditions, including impaired cardiac function, hypovolemia, mitochondrial disorders, or hyperlipidemia. The drug is generally not recommended during pregnancy or breastfeeding; mothers are advised to discard milk for 24 hours after administration.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Propofol Claris details interactions primarily categorized by pharmacodynamic enhancement and pharmacokinetic modification.

Detail Official Regulatory Information
Medicinal product categories with documented interactions Opioids, Sedative-Hypnotics, Volatile Anesthetics, Valproate, Neuromuscular Blocking Agents.
Mechanistic basis of interactions Pharmacodynamic interaction (additive CNS/cardiorespiratory depression); Pharmacokinetic interaction (Valproate may increase Propofol plasma concentration).
Timing-based interaction rules The intravenous line must be rinsed before and after administering neuromuscular blocking agents (e.g., Atracurium) if the same line is used.
Population-specific interaction notes Use for ICU sedation is restricted to patients older than 16 years. Pediatric patients co-administered Fentanyl are noted for a risk of serious bradycardia.
Interaction-related restrictions Contraindicated in patients with known hypersensitivity to the soy or egg excipients in the formulation. Co-administration with alcohol increases CNS depressant effects.

Resulting Interaction Structure

Co-administration with other central nervous system depressants, such as opioids and benzodiazepines, is officially documented to cause an additive increase in sedative effects, leading to more pronounced decreases in blood pressure. The pharmacokinetic interaction with valproate may result in higher systemic exposure to propofol. These factors define a regulatory profile that mandates careful management due to increased effect and administration-based constraints.

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Mechanism of Action

Propofol (Propofol Claris) engages multiple inhibitory pathways in the central nervous system to modulate neuronal activity.


GABA-A Receptor Positive Allosteric Modulation

Propofol primarily acts within domains involving gamma-aminobutyric acid type A (GABA-A) receptors, which are the main inhibitory neurotransmitter receptors in the brain. It functions as a positive allosteric modulator, binding to specific sites on the receptor complex to potentiate the intrinsic effects of GABA . This action prolongs the duration of the chloride ion channel opening, thereby increasing the influx of chloride ions (Cl^-) and stabilizing the neuronal membrane at a hyperpolarized potential. This contributes to a net reduction in neuronal membrane depolarization via enhanced chloride ion conductance, which is a key mechanistic consequence.


Modulation of Excitatory Ion Channels

The drug also modulates pathways associated with excitatory neurotransmission. It engages mechanisms that affect neuronal processes by inhibiting N-methyl-D-aspartate (NMDA) receptors and by influencing voltage-gated sodium channels (Nav). These secondary effects result in reduced depolarization potential and decreased action potential initiation, influencing the overall systemic physiological response.

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Dosage and Administration Information

How to Use Propofol Claris: Administration Guidelines

Propofol Claris, a sterile oil-in-water emulsion (10 mg/mL), must be administered only by the intravenous (IV) route. Use is restricted to personnel trained in the delivery of general anesthesia or the management of critically ill, ventilated patients. Dosing is highly individualized and must be carefully titrated against the patient's clinical response.

Use Context Dosing Schedule Principle Dose Range (Adults)
Induction of Anesthesia Titrate over 20 to 30 seconds 1.5 to 2.5 mg/kg body weight
Maintenance of Anesthesia Continuous Variable Infusion 100 to 200 mu g/kg/min
ICU Sedation Titrate in 5 to 10 mu g/kg/min increments 5 to 50 mu g/kg/min (Rates > 4 mg/kg/h discouraged)

Special Procedural Requirements

  • Dose Adjustments: Lower doses are required for patients > 55 years of age, debilitated individuals, or those of ASA Grade III/IV. Rapid bolus injections must be avoided in these populations. Propofol is not recommended for ICU sedation in patients le 16 years old.
  • Duration: Continuous infusion for Intensive Care Unit (ICU) sedation should generally not exceed 7 days. Dosage is adjusted daily to ensure the minimum effective concentration is maintained.
  • Handling: Strict aseptic technique is mandatory. If the emulsion is diluted, it must only be with 5% Dextrose Injection, USP. All unused product, syringes, and infusion lines must be discarded within 12 hours of opening the vial.
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Recent Clinical Evidence

Research evidence / Overview of Studies for Propofol Claris

Propofol Claris is a generic medication whose research history is based on the extensive body of work for the active ingredient, propofol, which was evaluated extensively in studies reviewed by government regulators and academic institutions. The studies primarily consist of randomized controlled trials (RCTs) and comprehensive systematic reviews, which help show what has been observed so far.


Research Evidence for Controlled Unconsciousness (General Anesthesia)

Propofol was studied in research contexts involving the induction and maintenance of controlled unconsciousness for surgical procedures. Research examined endpoints such as the rate of achieving a controlled non-responsive state, the time it takes for a patient to lose consciousness, and the time required for patients to awaken after the procedure is complete.

Studies consistently reported measurements indicating the duration required to achieve a non-responsive state. Comparative studies reported specific objective differences between propofol and other anesthetic agents when measuring endpoints such as the quality of post-anesthesia recovery scores. Results apply only to the populations studied and the specific timeframes of the trials.


Research Evidence for Sedation in Intensive Care Settings

In the critical care setting, propofol was studied for its use in helping to manage and sedate critically ill adults requiring mechanical ventilation. The main outcomes monitored were the length of time patients required mechanical breathing support, the total length of stay in the ICU, and patient survival (all-cause mortality).

Findings describe patterns observed in the studies related to achieving and maintaining the measured depth of sedation in these populations. However, evidence derived from settings with varying symptom burdens has led to mixed findings regarding key long-term clinical outcomes, such as all-cause mortality, across the studies reviewed in meta-analyses. Data for certain groups remain insufficient, and the significant differences in patient severity and study protocols among trials contribute to the inconsistent findings.

Key Studies & References

  1. Propofol treatment of refractory status epilepticus: a study of 31 episodes
  2. PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Propofol 20 mg/ml MCT/LCT Fresenius, emulsion for - (EMA/MEB Generic Report)
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Frequently Asked Questions (FAQ)

Common questions about Propofol Claris (FAQ)

Q: Is Propofol Claris the same as other versions of Propofol?

A: Propofol Claris is defined in official documents as a generic pharmaceutical preparation whose active ingredient is propofol. Its generic status means it contains the same active medicinal compound as other propofol products approved by regulatory bodies.

Q: How quickly does Propofol Claris typically take effect?

A: When administered intravenously, the drug typically produces hypnosis, or loss of consciousness, rapidly. Official product information states that this usually occurs within 40 seconds from the start of the injection.

Q: How long do the effects of Propofol Claris usually last?

A: Following a single bolus dose, such as for the start of general anesthesia, the drug is noted to have a short duration of action, generally lasting 3 to 5 minutes. This short duration is a result of the drug quickly moving out of the central nervous system.

Q: What are the most common side effects patients report after Propofol Claris?

A: The most frequently reported effects observed during or immediately following administration include local pain at the injection site. Common effects can also include a decrease in blood pressure (hypotension) and a slow heart rate (bradycardia).

Q: Is it normal to feel dizzy or confused after waking up from Propofol Claris?

A: Dizziness, lightheadedness, or confusion upon waking up are described in official safety information as possible effects. The healthcare team typically manages and observes patients for these effects during the recovery phase.

Q: Can Propofol Claris be used if a patient has a known allergy to soy or eggs?

A: Use of Propofol Claris is contraindicated (must not be used) in patients with a known hypersensitivity to the active ingredient, propofol, or to any excipient in the emulsion. This includes allergies to egg or soy products, which are part of the formulation.

Q: Does alcohol use prior to a procedure affect how Propofol Claris works?

A: Regulatory information documents that co-administration with alcohol increases the drug's central nervous system (CNS) depressant effects. This heightened effect is a factor for the healthcare team to consider during patient assessment.

Q: Can pregnant women or those who are breastfeeding receive Propofol Claris?

A: The drug is generally not recommended for use during pregnancy or for mothers who are breastfeeding. Official guidelines indicate that mothers who receive the drug typically follow the recommendation to discard breast milk for 24 hours after administration.

Q: What is the risk of waking up during the procedure when using Propofol Claris?

A: Research and regulatory documents focus on the medical team's goal to achieve and maintain a controlled non-responsive state. Because the drug is short-acting, continuous monitoring is performed to help ensure the required depth of anesthesia is maintained throughout the entire procedure.

Q: What are the safety precautions used by the medical team during Propofol Claris administration?

A: Administration is restricted to personnel trained in general anesthesia or critical care settings. Official guidelines mandate the use of strict aseptic technique (sterile handling), and continuous monitoring of the patient’s vital functions is performed throughout the process.

Q: Does Propofol Claris cause a drop in blood pressure?

A: Hypotension (low blood pressure) is listed in official safety documents as a Common adverse reaction and is an expected dose-dependent effect of the drug that is monitored continuously during administration.

Q: Are there any serious or rare side effects associated with Propofol Claris?

A: Yes, serious adverse reactions have been reported, including the rare but potentially fatal Propofol Infusion Syndrome (PRIS), typically linked to prolonged high-dose infusions. Rare cases of severe allergic reactions (anaphylaxis) have also been documented.

Q: Do patients experience pain at the injection site with Propofol Claris?

A: Yes, regulatory documentation states that the most frequently reported adverse reaction is local pain or a burning sensation at the injection site where the medication is administered.

Q: Is there a list of drugs that should not be combined with Propofol Claris?

A: The official profile details categories of medicines with documented interactions, such as opioids, sedative-hypnotics, and volatile anesthetics. Combining these with propofol can cause an additive increase in sedative effects and more pronounced decreases in blood pressure.

Q: Why is it important to tell the doctor about all medicines before receiving Propofol Claris?

A: The regulatory profile shows that when propofol is co-administered with other depressants, it can result in an additive increase in sedative effects. This potential for combined effects, particularly on blood pressure and breathing, is a factor considered for safety and management.

Q: Can Propofol Claris be used in pediatric patients or children?

A: For general anesthesia, use is indicated in pediatric patients 3 years of age or older for induction, and 2 months of age or older for maintenance. However, it is not recommended for sedation in the Intensive Care Unit (ICU) for patients mathbf16 years old or younger.

Q: Is Propofol Claris appropriate for use in older adults (seniors)?

A: Official labeling requires lower doses and slower titration for patients mathbf55 years of age or older. This special caution is advised to help reduce the risk of severe effects on the cardiorespiratory system in elderly patients.

Q: Does having liver or kidney problems change how Propofol Claris is managed?

A: Propofol is primarily broken down by the liver and eliminated by the kidneys. While data suggests that moderate liver or kidney problems may not significantly alter how the drug is managed, official guidelines emphasize the need for caution and careful monitoring in these situations.

Q: Are there different brands of Propofol? How does Claris fit in?

A: Propofol Claris is a generic pharmaceutical preparation whose active ingredient is propofol. Official documents confirm that multiple brands containing the same active ingredient exist, which are approved by regulators after the original formulation.

Q: Is Propofol Claris a controlled substance?

A: Propofol is a prescription-only medication but is not controlled under the US Controlled Substances Act. Its legal status is defined by regional regulatory bodies around the world.

Q: How long does the drug stay in the body after a procedure?

A: The body primarily eliminates the drug through the liver and kidneys. Approximately 70% of the administered dose is excreted in the urine within 24 hours, with most of the remainder eliminated within five days of administration.

Q: What happens to Propofol Claris once it enters the body?

A: Once administered, the drug rapidly moves from the bloodstream to the tissues due to its high fat-solubility. It is primarily broken down (metabolized) in the liver into inactive components which are then excreted by the kidney.

Q: Are there any special monitoring requirements during or after the administration of Propofol Claris?

A: Yes, continuous monitoring is required according to official guidelines. This includes carefully checking the patient's level of consciousness, heart rate, blood pressure, oxygen saturation, and exhaled carbon dioxide during administration and throughout the recovery period.

Q: Does Propofol Claris affect memory after the procedure?

A: Studies and official information indicate the drug impairs the brain's ability to create and store new memories (amnesia) during the time of administration. This property is often utilized during procedures to prevent conscious recall of the event.

Q: Is Propofol Claris used in outpatient settings?

A: The drug is indicated for procedures requiring sedation, such as diagnostic tests. Research evidence shows it has been examined in contexts like gastrointestinal endoscopy, which are frequently conducted in outpatient or ambulatory settings.

Q: Why is continuous monitoring necessary when Propofol Claris is given?

A: Continuous monitoring is necessary due to the drug's dose-dependent effects on the cardiorespiratory system. This includes the risk of significant drops in blood pressure (hypotension) and slowed or stopped breathing (respiratory depression).

Q: Is Propofol Claris approved for all types of anesthesia?

A: The drug is specifically indicated as an intravenous agent for the induction and maintenance of general anesthesia and for sedation for mechanically ventilated adults or during certain diagnostic procedures, defining its approved roles.

Q: What is the difference between 'general anesthesia' and 'monitored anesthesia care' when Propofol Claris is used?

A: General anesthesia is a state of controlled unconsciousness and non-responsiveness. Monitored Anesthesia Care (MAC) sedation is a lighter level of sedation, but continuous monitoring is performed because the depth of sedation can rapidly and profoundly change into a state of general anesthesia.

Q: Is there a maximum amount of time Propofol Claris can be administered?

A: Official guidelines state that continuous infusion for ICU sedation should generally not exceed 7 days (one week). There is no explicitly stated maximum duration for its use during general anesthesia in the regulatory documentation.

Q: What is the significance of the Propofol Claris concentration in the solution?

A: Propofol Claris is formulated as an emulsion at a specific concentration of mathbf10 mg/mL. This concentration is critical because all dosing is carefully calculated based on a patient's weight and time, and the concentration ensures the correct dose is accurately delivered.

Q: Do studies mention the effect of Propofol Claris on breathing?

A: Official documentation notes that the drug causes dose-dependent respiratory depression (slowed or shallow breathing) and temporary cessation of breathing (apnea) during the induction phase. This potential effect is the reason for immediate monitoring and management by the healthcare team.

Q: Is Propofol Claris ever used to manage seizures?

A: While the drug is primarily an anesthetic, official regulatory summaries note it has been examined for use in treating severe, continuous seizures (status epilepticus) that are refractory to standard anticonvulsant therapies.

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How should Propofol Claris be stored and disposed of?

Storage and Disposal of Propofol Claris

Propofol Claris (Propofol Injectable Emulsion) must be stored and handled according to strict regulatory guidelines to maintain product integrity and prevent contamination.


Official Storage and Handling

Condition Requirement
Temperature Store unopened product at Controlled Room Temperature, typically 20 C to 25 C.
Protection Do not freeze the product. Keep the medicine out of the sight and reach of children.
Stability (In-Use) Administration must be completed within 12 hours after the vial is opened or spiked. Strict aseptic technique must be maintained at all times.

Disposal Requirements

Propofol is a single-use parenteral product. Any unused emulsion, administration tubing, and solutions containing the drug must be discarded at the end of the procedure or the 12-hour limit. Disposal of all residual product and waste materials must be performed in accordance with local requirements.

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

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