Cleviprex

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Cleviprex

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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 Cleviprex

Cleviprex is a specialized, fast-acting, prescription-only medication designed for the rapid and precise control of acutely elevated blood pressure in clinical settings. It is utilized when immediate intervention is necessary and the use of oral therapy is not appropriate or feasible.

Property Description
Active ingredient Clevidipine (as Clevidipine butyrate)
Form Injectable Emulsion
Pharmacological class Calcium Channel Blocker (CCB)
Common use Reduction of blood pressure in acute settings
Origin Synthetic, Dihydropyridine derivative

What is Cleviprex and Its Pharmacological Class?

The medication is the trade name for the active pharmaceutical ingredient Clevidipine (INN, International Nonproprietary Name), a synthetic compound chemically classified as a dihydropyridine derivative. Clevidipine belongs to the broader pharmacological class of Calcium Channel Blockers (CCBs), which regulate the flow of calcium ions into certain cells to achieve a therapeutic effect. Clevidipine is an intravenous dihydropyridine CCB, utilized for managing acute hypertension with precision and control.


Composition, Form, and Unique Action Profile

Cleviprex is supplied as a sterile, milky-white injectable emulsion for exclusive administration via the intravenous (IV) route. This single-ingredient product features the active substance, clevidipine butyrate (0.5 mg/mL concentration), suspended in a lipid emulsion base containing ingredients such as refined soybean oil and purified egg yolk phospholipids. This unique formulation contributes to Clevidipine's distinct character as an ultra-short acting and highly vasoselective agent. Its extremely rapid onset and offset of action—due to quick breakdown by enzymes in the blood—allows clinicians to achieve adjustable and tight control over blood pressure levels.


General Purpose: Why is Clevidipine Used?

The general purpose of using Clevidipine is to induce a controlled and immediate reduction of dangerously elevated blood pressure by quickly promoting the relaxation of the arteries. This potent, targeted effect on arterial resistance allows physicians to achieve rapid control. A typical use scenario involves stabilizing a patient whose blood pressure has spiked to severely high levels, requiring an intervention that can be precisely adjusted by the minute. Its ability to be quickly metabolized and cleared from the body provides a specific advantage for managing acute hypertensive events where a swift therapeutic intervention, followed by potential rapid cessation, is required.

Regulatory References

  1. Role of clevidipine butyrate in the treatment of acute hypertension (PMC Article)

What side effects are possible with Cleviprex?

Possible Side Effects and Safety Information

Cleviprex's official safety profile is primarily characterized by dose-dependent cardiovascular effects and specific contraindications related to its formulation.

Commonly Documented Adverse Reactions

Side effects documented in regulatory clinical trials are classified by frequency. Those classified as very common (occurring in 10% or more of patients) include Hypotension (low blood pressure), Sinus Tachycardia, Atrial Fibrillation, and Nausea. Common effects (occurring in 1% to 10%) include Headache, Vomiting, Acute Renal Failure, Flushing, and Edema. Effects are documented across system-organ classes including Vascular Disorders, Cardiac Disorders, Gastrointestinal Disorders, and Renal and Urinary Disorders.

Serious Adverse Reactions and Safety Patterns

The regulatory label documents the potential for Rebound Hypertension upon stopping prolonged infusions if subsequent therapy is not initiated. The drug can produce negative inotropic effects, which may exacerbate heart failure, and careful monitoring is required for such patients. Hypotension and Reflex Tachycardia are noted as potential consequences of rapid upward titration (dose increase).

Safety Restrictions (Contraindications)

Cleviprex is contraindicated (should not be used) in patients with known allergies to the emulsion's components, specifically soy products or egg products. Use is also prohibited in patients with severe aortic stenosis or conditions involving defective lipid metabolism, such as lipoid nephrosis or acute pancreatitis with hyperlipidemia. Safety and effectiveness have not been established for pediatric use.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Cleviprex

Overdose Profile

Official regulatory documents describe the expected major effects of Cleviprex overdosage as primarily cardiovascular in nature: hypotension (low blood pressure) and reflex tachycardia (an abnormally fast heart rate in response to the low blood pressure). These physiological effects stem directly from the drug's mechanism as a potent, short-acting blood pressure-lowering agent.

Emergency Actions and Risk Factors

In the event of suspected overdosage, the official required action is the immediate discontinuation of the Cleviprex infusion. The patient's blood pressure must then be supported by the healthcare team. A rapid reduction in the drug’s antihypertensive effect is expected, with a return toward baseline occurring within 5 to 15 minutes after the infusion is stopped.

One exposure-related factor noted in official labeling is the recommended maximum limit on the infusion volume. Due to the lipid-based formulation, no more than 1000 mL or an average of 21 mg/hour is recommended over a 24-hour period. While this restriction is related to overall lipid load, exceeding it could contribute to overdose risk or complications.

When to Seek Immediate Medical Help

As Cleviprex is only administered in a hospital setting by medical professionals, any suspected overdosage or signs of severe low blood pressure or rapid heart rate require immediate intervention by the administering healthcare providers, as detailed in the regulatory texts.

Therapeutic Uses of Cleviprex

What Cleviprex Treats: Main Uses and Benefits

Cleviprex is typically applied in acute, critical care settings to support the management of acute symptoms for patients experiencing severe elevations in blood pressure. The medication is considered relevant for use in conditions where oral therapy is not feasible or desirable.


Managing Acute Hypertension

This medication is commonly applied in conditions characterized by periods of heightened symptoms—specifically, a hypertensive crisis—which are associated with significant functional stress on vital organs. It is relevant for easing heightened systolic and diastolic pressures, and may be part of symptomatic management that helps address the significant physiological strain associated with the crisis. It supports the patient during difficult episodes by easing distress associated with these severe manifestations.

Hemodynamic Support in Critical and Perioperative Care

Cleviprex is relevant in clinical settings that involve acute or unstable symptom patterns, particularly in clinical environments where specialized support is needed. It is relevant for managing fluctuating or intense blood pressure manifestations that may arise during the surgical period. It is commonly used when short-term symptomatic assistance is needed in settings where physiological imbalance is marked.

“This approach is relevant when blood pressure is acutely elevated and supportive symptom management is appropriate.”


Quick Fact: Relief for Noticeable Physiological Strain Cleviprex assists with maintaining a sense of stability when symptoms are more noticeable, contributing to easing the overall symptom load associated with heightened blood pressure.

Eligibility and Restrictions for Use

Cleviprex is strictly for use in the adult population and has specific exclusions based on pre-existing conditions and allergies tied to its formulation as a lipid emulsion.

Absolute Non-Eligibility (Contraindications)

Cleviprex is contraindicated in patients with the following conditions or allergies, as stated in official labeling:

  • Known Allergy to soybeans, soy products, eggs, or egg products.
  • Defective lipid metabolism, including pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if accompanied by hyperlipidemia.
  • Severe aortic stenosis.

Use in Specific Populations

Population Group Regulatory Eligibility Status
Pediatric Patients (<18) Safety and effectiveness have not been established.
Geriatric Patients (ge 65) Use is established, though careful dosage selection is recommended.
Heart Failure Conditional Use; patients must be monitored carefully.
Renal or Hepatic Impairment Use is permitted; no dose adjustment is considered necessary.
Pregnancy Conditional Use (Category C); use only if the potential benefit justifies the potential risk.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documents define the interaction profile of Cleviprex (clevidipine) based primarily on its formulation, pharmacological class, and route of administration, rather than complex metabolic interactions. The potential for drug-drug interactions mediated by metabolism is low; Clevidipine and its metabolites do not inhibit or induce any major CYP450 enzymes at clinically relevant concentrations.

Contraindications and Restrictions

Formal restrictions exist based on the drug's composition. Cleviprex is contraindicated for co-administration in patients with known allergies to soy products or egg products, as the injectable emulsion contains refined soybean oil and purified egg yolk phospholipids. Furthermore, because Cleviprex is a lipid emulsion, patients with underlying disorders of lipid metabolism may require adjustments or restrictions on concurrent lipid intake to account for the infused lipid load.

Pharmacodynamic and Administration Constraints

As a calcium channel blocker, Cleviprex may cause an additive hypotensive effect when co-administered with other blood pressure lowering agents. Separately, administration requires strict procedural separation: Cleviprex must not be administered in the same intravenous line as any other medication. The use of beta-blockers specifically to manage reflex tachycardia induced by Cleviprex is also not recommended based on current regulatory information.

Mechanism of Action

The mechanism of Clevidipine (Cleviprex) is rooted in its selective interaction with calcium channels, resulting in a direct modulation of blood vessel tone. .

Selective Blockade of Arterial Calcium Channels

Clevidipine acts as an inhibitor by targeting the L-type voltage-gated calcium channels (CaV1.2) found on the resistance arteries. This blockade restricts the influx of extracellular calcium ions (Ca^2+) into the smooth muscle cells, thereby interrupting the primary signal required for muscle contraction.

Modulation of Systemic Vascular Resistance

The interruption of the calcium signaling pathway triggers widespread arteriolar smooth muscle relaxation, resulting in a rapid and predictable decrease in Systemic Vascular Resistance (SVR). This reduction in the heart's afterload is the core physiological consequence of the reduced SVR. The mechanism demonstrates high vasoselectivity, resulting in preferential modulation of arteriolar smooth muscle tone over myocardial contractility or venous capacitance.

Kinetics Ensure Rapid Pharmacological Reversal

The Clevidipine molecule is specifically designed for ultra-rapid degradation by esterases present in the blood and tissues, which ensures an extremely short half-life. This swift enzymatic clearance couples the drug's presence directly to its action, resulting in a rapid onset and offset of the pharmacological effect.

Dosage and Administration Information

Cleviprex (clevidipine) is a sterile injectable emulsion administered exclusively by intravenous (IV) infusion in a controlled medical environment. It is provided as a ready-to-use, single-use product at a concentration of 0.5 mg/mL.

Administration and Dosing

Procedural Step Official Instruction
Preparation Invert the vial gently several times to ensure uniformity; do not dilute. Strict aseptic technique is required.
Initial Dose Infusion is initiated at 1–2 mg/hour.
Dose Titration The dose may be doubled at short (90 second) intervals initially. As blood pressure approaches the goal, dose increases should be smaller, and the time between adjustments should be lengthened to every 5–10 minutes.
Maintenance Dose Most patients achieve the desired response at 4–6 mg/hour.
Maximum Dose Limit The maximum recommended infusion rate is 32 mg/hour, but due to lipid load restrictions (Cleviprex is a lipid emulsion), the total infusion volume should not exceed 1000 mL (or an average of 21 mg/hour) over a 24-hour period.
Transition Patients receiving prolonged infusions who are not transitioned to oral therapy should be monitored for rebound hypertension for at least 8 hours after the infusion is stopped.

Population and Handling Rules

No dose adjustment is necessary for patients with renal or hepatic impairment. For geriatric patients (ge 65 years), no overall dosage adjustment is required, but titration should begin at the low end of the range. Once the vial stopper is punctured, the contents must be used within 12 hours and any unused portion must be discarded.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Cleviprex

This section provides an objective overview of the types of clinical studies that have been conducted to evaluate Cleviprex, focusing only on the structure of the evidence for its main uses. Research does not determine whether an individual will respond similarly, but rather describes group patterns observed in the studies.


Evidence for Use in Acute Severe Hypertension

Research exploring the use of Cleviprex for acute severe hypertension, such as a hypertensive crisis, was studied in multicenter, randomized, and non-comparative trials. These studies focused on adult patients who presented with severe, high blood pressure. Researchers primarily examined outcomes related to episodic or acute changes, specifically monitoring the time required for patients to reach a pre-defined blood pressure target range, typically within 30 minutes of starting the medication. Trials also tracked how consistently that blood pressure goal was maintained over the infusion period and the ability to transition to oral medication after the IV drug was stopped.


Evidence for Use in Perioperative Blood Pressure Control

The research exploring Cleviprex for blood pressure control around the time of surgery (perioperative hypertension) has been evaluated in large, prospective, randomized trials. These studies primarily included adult patients undergoing cardiac surgery. The research examined high-level outcomes over defined time intervals, including the percentage of time a patient's SBP was within a pre-specified target range and the rates of major cardiac events (like heart attack or stroke) in the 30 days following study drug initiation. Findings describe patterns observed in these surgical settings where blood pressure control was monitored.


What is Still Uncertain About Cleviprex Research

Despite the availability of large, controlled trials for its primary indications, evidence quality varies across studies, and certain critical areas still have research gaps. The main uncertainty stems from the limited information for long-term outcomes and a lack of data on how blood pressure is managed well after the infusion stops. While initial descriptive studies exist for neurocritical care conditions, those sample sizes were modest, and certainty remains low for those specialized groups. Data for certain groups, such as pediatric populations, remain insufficient for patients under 18 years of age.

Frequently Asked Questions (FAQ)

Common questions about Cleviprex (FAQ)


Q: How long does the blood pressure effect of Cleviprex last after the infusion is stopped?

A: Cleviprex is characterized as an ultra-short-acting drug. Its effect has been characterized as wearing off very quickly, corresponding to an extremely short terminal half-life of approximately one minute. Official product information indicates that in most patients, a full recovery of blood pressure is observed approximately 5 to 15 minutes after the infusion is stopped.

Q: Does Cleviprex cause rebound hypertension if it's stopped suddenly?

A: Regulatory documents address the potential for rebound hypertension (a rapid, uncontrolled rise in blood pressure) after the drug is stopped. Regulatory warnings indicate that a transition to an oral antihypertensive agent should be considered for patients receiving prolonged Cleviprex infusions to mitigate the risk of rebound hypertension. Patients in this situation are often monitored for at least 8 hours after the infusion ends.

Q: Are there any common foods or supplements that interact with Cleviprex?

A: Cleviprex is contraindicated (should not be used) in patients with known allergies to soy products or egg products, as the formulation contains refined soybean oil and purified egg yolk phospholipids. Because the drug is formulated as a lipid emulsion, the total amount of lipids infused is restricted, and this must be accounted for when considering the patient’s concurrent intravenous lipid intake.

Q: Is it normal to feel a little dizzy or lightheaded while on Cleviprex?

A: Regulatory documents indicate that the most common side effect is hypotension (low blood pressure). Symptoms such as dizziness or lightheadedness may occur as a result of low blood pressure. Official warnings note that hypotension can be a consequence of rapid upward titration (dose adjustment).

Q: Is Cleviprex only for very high blood pressure or is it used for other heart issues?

A: Official information indicates that Cleviprex is used for the rapid reduction of blood pressure when oral therapy is not feasible or suitable. Its approved uses are specifically for acute severe hypertension and for controlling blood pressure around the time of surgery (perioperative hypertension).

Q: What happens if Cleviprex is given too quickly?

A: Regulatory information indicates that the dose is subject to titration (adjustment) by healthcare professionals. Official warnings state that hypotension (blood pressure dropping too low) and reflex tachycardia (increased heart rate) are potential consequences of rapid upward titration of the dose.

Q: Can Cleviprex be used in patients with a history of liver problems?

A: The drug's official information indicates this is generally acceptable. Cleviprex is broken down by enzymes in the blood and tissues, a process that does not rely on liver function. Consequently, no dose adjustment is necessary for patients with hepatic (liver) impairment.

Q: How long is a typical Cleviprex infusion for a hypertensive crisis?

A: The duration of Cleviprex treatment is determined by the patient's clinical needs and the timing of their transition to oral therapy. While clinical trials for severe hypertension lasted for approximately 21 hours on average, the total length of the infusion can vary significantly.

Q: Does Cleviprex interact with common pain medications like Tylenol or ibuprofen?

A: The potential for Cleviprex to cause complex drug-drug interactions is considered low because it is rapidly cleared by non-specific enzymes. However, co-administration with any other blood pressure lowering agent may lead to an additive hypotensive effect (blood pressure dropping too much), and monitoring is required.

Q: What should a patient tell their doctor before starting Cleviprex?

A: Official guidance highlights that the medical team should be informed of certain medical conditions and allergies prior to administration. Specifically, patients must report known allergies to soy or egg products, a history of defective lipid metabolism, or having severe aortic stenosis. These factors are critical for the medical team to consider.

Q: Are there any long-term effects associated with Cleviprex use?

A: Cleviprex is intended only for short-term control of acute blood pressure. Regulatory documents note that there is limited information available from clinical trials regarding long-term outcomes for patients.

Q: Is Cleviprex only used for emergency situations?

A: It is indicated for use in acute settings where immediate and precise control of blood pressure is needed. These settings include acute severe hypertension and for management around the time of surgery (perioperative hypertension), particularly when oral therapy is not feasible.

Q: What happens if the Cleviprex infusion site gets irritated?

A: Common side effects reported in official documents include flushing and edema (swelling). The drug is administered via intravenous infusion. If signs of irritation or pain at the IV site are observed, the healthcare provider managing the infusion should be notified.

Q: How does the body get rid of Cleviprex once it's done its job?

A: Cleviprex is unique because it is rapidly broken down by non-specific enzymes called esterases, which are found in the blood and in body tissues. This process quickly clears the active drug from the body, which helps ensure its ultra-short duration of action.

Q: Is Cleviprex part of the standard protocol for acute heart failure?

A: Official warnings state that Cleviprex may produce negative inotropic effects (meaning it can decrease the force of heart muscle contraction), which could potentially exacerbate heart failure. For this reason, patients with heart failure are monitored with extra care during the infusion.

Q: Can Cleviprex be used alongside oral blood pressure medications?

A: Official information mentions that Cleviprex is intended to be used temporarily, and patients are typically transitioned to an oral blood pressure medication. However, co-administration with other blood pressure lowering agents may cause an additive hypotensive effect (blood pressure dropping too much), and it must be done with caution and close monitoring.

Q: Why does the Cleviprex bottle need to be shaken before use?

A: Cleviprex is a milky-white emulsion, which is a mixture of liquids that need to be properly combined. To ensure the medication is evenly distributed and uniform, the vial must be inverted gently several times before it is prepared for the infusion.

Q: Can Cleviprex cause temporary vision changes?

A: While temporary vision changes are not listed as a primary side effect, severe hypotension (low blood pressure) is a very common side effect. Significant drops in blood pressure can sometimes cause secondary symptoms such as lightheadedness or blurry vision.

Q: Does Cleviprex have a sedative effect on patients?

A: The most common adverse reactions reported in regulatory trials, such as low blood pressure, headache, and nausea, do not include sedation. This suggests that the drug does not typically cause sleepiness.

Q: Is there a maximum time a patient can be on a Cleviprex infusion?

A: The total duration of the infusion is subject to restrictions based on the drug's formulation as a lipid emulsion. Due to lipid load restrictions (the total amount of fat infused), the maximum volume should not exceed 1000 mL over a 24-hour period. Official information notes that there is limited experience with infusion durations beyond 72 hours.

Q: What is Cleviprex's primary role in managing perioperative blood pressure?

A: Cleviprex is indicated for the rapid and precise control of high blood pressure around the time of surgery when immediate intervention is needed. This use has been studied, for example, in patients undergoing cardiac surgery to maintain their blood pressure within a specific target range.

How should Cleviprex be stored and disposed of?

How to Store and Dispose of Cleviprex

Cleviprex (clevidipine butyrate) injectable emulsion requires strict storage conditions defined by official labeling.

Storage Requirements

Cleviprex vials must be stored under refrigerated conditions between 2 C to 8 C (36 F to 46 F) and must not be frozen. The vials must remain in their original carton to protect the product from light. Cleviprex may be stored at controlled room temperature, 25 C (77 F), for a single period not exceeding 60 days (2 months); the product must not be returned to refrigeration after this transfer.

Storage Constraint Time Limit
Use after vial puncture 12 hours
Use after removal from refrigerator 60 days

Disposal and Handling

Due to the risk of microbial growth, strict aseptic technique is required during handling. Cleviprex is a single-use product, and any remaining portion must be discarded within 12 hours of puncture. All unused or expired product must be disposed of in accordance with local regulations for pharmaceutical waste. The medication must be stored out of the sight and reach of children.

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

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