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Vogalène

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Vogalène

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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.

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Overview of Vogalène

Quick Facts

Property Description
Active ingredient Metopimazine
Form Tablet, Solution, Suppository, Injection
Pharmacological class Antiemetic
Common use Relief of nausea and vomiting
Origin Synthetic (Phenothiazine derivative)

Vogalène: An Antiemetic Phenothiazine Derivative

Vogalène is the trade designation for the active ingredient metopimazine, a synthetic compound classified as an antiemetic agent used to manage symptoms of sickness. Chemically, metopimazine belongs to the phenothiazine derivative group, a class of organic molecules known to modify central nerve signaling. Its primary function is characterized by its action as a dopamine D2 receptor antagonist, meaning it specifically blocks certain signaling pathways involved in the emetic response. Vogalène is a single-ingredient product, focusing its therapeutic effect entirely on this anti-vomiting action.


Metopimazine Composition and Available Forms

The therapeutic effect of Vogalène derives exclusively from Metopimazine, its sole active ingredient. This medication is prepared across multiple pharmaceutical presentations to ensure effective delivery, particularly when the patient is actively vomiting. These forms include the standard solid tablet, an easily ingested oral solution (including orodispersible types), the suppository for rectal administration, and an injectable solution for parenteral routes. The availability of non-oral preparations is a key differentiating factor, an approach clinically recognized for ensuring consistent antiemetic therapy when swallowing is compromised.


The Core Purpose of Vogalène

The core purpose of Vogalène is to suppress the biological reflex known as emesis (vomiting) and mitigate the intense sensation of nausea. The drug achieves this by interfering with nerve signals originating from the chemoreceptor trigger zone (CTZ), the area of the brain responsible for detecting substances that cause sickness. This highly specific action defines its clinical role as an antiemetic, offering targeted control over the emetic reflex.

Regulatory References

  1. ANSM Product Characteristics for Vogalène (Metopimazine)
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What side effects are possible with Vogalène?

Possible Side Effects and Safety Information

The safety profile of Vogalène (metopimazine) is characterized by adverse reactions grouped according to physiological systems, reflecting its action as a phenothiazine derivative. The majority of documented side effects are typically described in official literature as few and mild in severity.


System-Organ Classes and Adverse Reactions

Official regulatory documents classify the medicine's effects across several physiological systems. Reactions are primarily associated with the Nervous System, commonly including somnolence (drowsiness) and dizziness. Effects on the Vascular System, such as orthostatic hypotension (a drop in blood pressure upon standing), are also noted. Anticholinergic effects like dry mouth and constipation are documented under Gastrointestinal Disorders.

Category Officially Documented Reactions (Examples)
Nervous System Somnolence, Dizziness, Extrapyramidal symptoms (Very Uncommon)
Vascular System Orthostatic hypotension, Asymptomatic decrease in standing blood pressure
Gastrointestinal Dry mouth, Constipation

Serious Reactions and Safety Constraints

As a derivative of the phenothiazine class, the potential for rare but serious reactions, such as Neuroleptic Malignant Syndrome (NMS), is recognized within the safety framework. Extrapyramidal symptoms, involving involuntary movements, are categorized as very uncommon in official regulatory classification.

Safety limitations include a restriction on use due to known hypersensitivity to the drug or any other compound belonging to the phenothiazine class. Additionally, official safety statements note that older adults may be more susceptible to certain movement disorders, and vascular effects are often linked to the use of higher doses.

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Overdose and Emergency Response

The official regulatory profile for Vogalène overdose, typically resulting from massive doses, details clinical manifestations focused on the Central Nervous System (CNS) and cardiovascular system. Documented signs of acute intoxication include significant CNS depression, presenting as somnolence (drowsiness) or even coma vigil, and hypotonia (muscle weakness). Cardiovascular effects noted are arterial hypotension, indicating low blood pressure.

Regulators explicitly state that any suspected overdose requires immediate consultation with a physician or pharmacist. The regulatory basis for management is symptomatic: treatment is administered for the observed disorders, and procedures such as gastric lavage may be performed if the patient is seen early in the course of the intoxication. There is no specific antidote for metopimazine overdose described in the official documentation, and the profile highlights that no fatalities have been reported.

Furthermore, a specific regulatory caution addresses the risk of potential overdose in the elderly and patients with renal or hepatic impairment. In these populations, increased somnolence or dizziness may be indicative of overdose and necessitate prompt medical assessment.

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Therapeutic Uses of Vogalène

What Vogalène Treats: Main Uses and Benefits

Vogalène (Metopimazine) plays a role as a therapeutic agent for the symptomatic management of sickness across distinct clinical situations. It is commonly used to provide short-term relief from pronounced symptoms, and its core benefit lies in its ability to support patient comfort and may contribute to easing the overall symptom load.


Therapeutic Applications and Patient Relief

The medication is commonly applied for conditions that present with disruptive symptom manifestations of sudden onset, such as severe nausea and vomiting associated with acute gastroenteritis or other systemic illnesses. It is also a relevant component in clinical settings marked by heightened patient distress due to necessary medical treatments.

The primary therapeutic benefit involves supporting the body's response to sickness, which can offer supportive relief to help patients cope with difficult episodes. Key situations where the medication is used include managing sickness related to Chemotherapy-Induced Nausea and Vomiting (CINV), addressing Postoperative Nausea and Vomiting (PONV), and is applied in addressing acute emesis.

The use is relevant when supportive symptom management is appropriate in acute episodes.

“The medication may assist with easing the impact of persistent sickness and supports general well-being during symptomatic phases.”

Quick Fact: Relief for Sickness
Primary Symptom Targeted Nausea and Vomiting (Emesis)
Core Therapeutic Role Symptomatic management of acute and treatment-induced sickness
Patient Benefit Focus Supports general well-being and helps ease symptom burden

Regulatory References

  1. French High Health Authority (HAS) assessment
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Vogalène — official regulatory information

Vogalène's official regulatory profile defines patient eligibility based on specific exclusions, age, and existing health conditions.

Eligibility Scope

Category Official Regulatory Statements
Populations for whom use is allowed (as stated in label) Adults; Use is established in children for certain indications, generally over six years of age for oral formulations.
Populations for whom use is contraindicated Individuals with known hypersensitivity to phenothiazines. Patients with severe central nervous system (CNS) depression. Patients with certain types of glaucoma.
Age-related eligibility rules Use is established in adults. Caution is advised when administering the drug to elderly patients.
Condition-specific eligibility rules Caution is advised in patients with pre-existing cardiovascular conditions, or with impaired hepatic or renal function.
Pregnancy and lactation eligibility status (if explicitly documented) Use with caution in both pregnant and breastfeeding women.

Eligibility Classifications (High-Level)

Classification Type Official Regulatory Statement
Eligibility severity classification Contraindicated (Absolute exclusion); Caution Advised (Conditional/Restricted use).
Eligibility-context constraints Restrictions are often linked to the drug's classification as a phenothiazine derivative.
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What should I know about interactions with other medicines?

The official regulatory profile for Vogalène (metopimazine) specifies interactions based on additive pharmacodynamic effects and a significant pharmacokinetic food interaction.

Pharmacodynamic and Substance Interactions

The co-administration of metopimazine with certain classes of agents can lead to additive functional effects formally documented in regulatory sources:

  • Central Nervous System (CNS) Depressants: Co-use with agents such as sedatives or anxiolytics, or consumption of Alcohol, may potentiate the sedative effects. This interaction is noted as a restriction for use due to augmented CNS depression.
  • Anticholinergic Drugs: Combining metopimazine with medications possessing anticholinergic activity may exacerbate side effects like dry mouth and constipation due to additive pharmacodynamic effects.
  • Other Antiemetics: When combined with other classes of antiemetics, such as 5 HT3 receptor antagonists (e.g., ondansetron), there is a documented potential for an asymptomatic decrease in standing blood pressure (orthostatic hypotension).

Pharmacokinetic Constraints

Metopimazine exhibits specific pharmacokinetic characteristics that limit its co-use with food:

  • Food Interaction: Oral administration of metopimazine concurrent with food reduces its systemic exposure. Official data confirms that postprandial administration reduces the area under the plasma concentration-time curve ( AUC) by approximately 30%.
  • Low Metabolic Risk: The overall risk for common metabolic drug-drug interactions is low, as regulatory studies indicate that metopimazine is primarily metabolized by a liver amidase, with negligible involvement from major Cytochrome P450 (CYP) enzymes.
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Mechanism of Action

How Vogalène Works

The physiological action of Metopimazine is defined by its selective antagonism of the dopamine D2 receptor, a mechanism that provides a dual-level effect on the body's emetic control system.


Blocking Signal Transmission at the Chemoreceptor Trigger Zone (CTZ)

Vogalène's primary mechanism is the selective blockade of D2 receptors located in the Chemoreceptor Trigger Zone (CTZ) . This area, situated outside the brain's main protective barrier, detects chemical stimuli circulating in the blood. By preventing these stimuli, particularly dopamine, from binding to and activating the D2 receptors, the drug inhibits the generation of the nerve signal that would otherwise trigger the Vomiting Center. This central intervention in the dopaminergic pathway interrupts the emetic cascade, limiting signal transmission to the Vomiting Center.


Modulation of Upper Gastrointestinal Motility

In addition to its central effect, Metopimazine also acts peripherally in the gastrointestinal tract, where it blocks D2 receptors on smooth muscle cells. Dopamine normally exerts an inhibitory effect on gut movement; by removing this inhibitory influence, the drug enhances the coordination and force of contractions, particularly in the stomach. This mechanism leads to the physiological consequence of accelerated gastric emptying, an alteration within the upper digestive system.

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Dosage and Administration Information

Vogalène (metopimazine) is prepared in multiple pharmaceutical presentations to ensure effective administration according to standards. The official routes of use include oral (capsule, solution, orodispersible tablet), rectal (suppository), and parenteral routes, specifically intramuscular (IM) and intravenous (IV) injection.

The total daily dosage for general adult use is typically a divided amount, ranging from 15 mg up to a maximum of 30 mg per day, administered two to four times daily. A minimum interval of 4 to 6 hours between administrations is required. Oral forms are recommended to be taken 15 minutes before meals to optimize absorption. For parenteral administration, the injectable solution must be administered via a slow injection with the patient in a decubitus (lying down) position.

The use of Vogalène is strictly defined as a short-term treatment. The duration must not exceed two days for self-medication, and treatment should be immediately discontinued upon the resolution of symptoms. If prescribed, the duration for some forms is typically limited to a maximum of five days. Specific high-level adjustments are required for certain populations: pediatric dosing for the oral solution is weight-based, calculated at 0.33 mg/kg up to three times per day for children under 15 kg. Furthermore, documentation specifies that dose reduction is necessary for older adults and in patients presenting with renal or hepatic impairment.

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Recent Clinical Evidence

Metopimazine, commonly known by the brand name Vogalène, is an antiemetic drug primarily studied for its effect on nausea and vomiting. The clinical evidence surrounding metopimazine is detailed through several lines of research focusing on its primary use and tolerability profile.


Overview of Primary Efficacy Studies

Clinical research has explored the use of metopimazine for various causes of nausea and vomiting, including acute gastroenteritis and chemotherapy-induced symptoms. Studies assessed the drug's effect in reducing the frequency and severity of emetic episodes. Study participants received the drug consistent with the protocol design.

One clinical trial examined whether the drug, often used as part of a treatment regimen, was associated with a change in the frequency of flare-ups of acute symptoms.


Comparative Research

Comparative research has been conducted to examine metopimazine versus other established antiemetic treatments, such as certain serotonin receptor antagonists. The research sought to examine any reported differences in symptom reports and tolerability profiles between groups. For instance, some evidence has evaluated its use in combination with other agents, particularly for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV).

One study specifically evaluated the timeframe within which participants reported feeling a change in symptoms. This study utilized data collected from participants over a defined duration.


Long-Term Safety and Symptom Trajectory

Long-term observational data, particularly from French patient registries, have investigated the effect of metopimazine on safety and symptom progression over extended periods. These studies monitored participants, focusing on adverse event reports and changes in symptom status over time. Findings suggest a low incidence of certain neurological side effects sometimes associated with other drugs in its class, which is attributed to its limited penetration of the blood-brain barrier. This analysis has explored its use and safety profile in large, real-world populations.

Key Studies & References

  1. Metopimazine in the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a randomized, double-blind, comparative study with ondansetron
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Frequently Asked Questions (FAQ)

Common questions about Vogalène (FAQ)

Q: Can Vogalène cause long-term side effects?

Official safety information indicates that Vogalène belongs to the phenothiazine derivative class. This class carries a recognized, though rare, risk of neurological effects, such as extrapyramidal symptoms, when used long-term or at high doses. Regulatory documents emphasize that the medicine is intended for short-term use only.

Q: Does Vogalène affect sleep?

Yes, official product information lists somnolence (drowsiness) as a commonly reported adverse effect. Because the medicine works by acting on the nervous system, this drowsiness can affect a patient's normal state of wakefulness.

Q: What are the signs of a severe allergic reaction to Vogalène?

Regulatory safety documents list hypersensitivity to phenothiazines as a contraindication. Signs of a severe allergic reaction often include a rash, itching, or swelling of the face, lips, or throat, or difficulty breathing. If any of these symptoms appear, official guidance recommends seeking medical assistance immediately.

Q: How long after taking Vogalène can I safely drive?

Official warnings caution that the medicine can cause somnolence (drowsiness) and dizziness. Due to this documented risk to the nervous system, regulatory documents advise against driving or operating heavy machinery until the effects are known to have passed.

Q: Is there a list of foods or herbal supplements that should be avoided when taking Vogalène?

Official data confirms that taking the oral form of the medicine with food reduces its absorption. While specific herbal supplements are not universally listed in regulatory documents, official documents advise referring to the package leaflet or consulting a healthcare professional for specific restrictions.

Q: Can Vogalène be taken with antidepressants?

Official product information advises caution when Vogalène is used alongside other drugs classified as CNS depressants or those that have anticholinergic effects. Many types of antidepressants fit into these classes, and combining them may lead to augmented sedation or intensified anticholinergic side effects.

Q: What is Vogalène used for, besides the most common reasons?

Official therapeutic indications state that the medicine is approved for specific types of nausea and vomiting beyond general sickness. Examples include managing symptoms associated with chemotherapy-induced nausea and vomiting (CINV) or sickness in a post-operative care setting.

Q: Is Vogalène available over-the-counter in some countries?

The regulatory status of the medicine varies by country. While the active ingredient, Metopimazine, requires a prescription in many places, it is available under some brand names as an over-the-counter (OTC) medicine in certain jurisdictions.

Q: Why is Vogalène sometimes mentioned for motion sickness?

The medicine works by blocking specific dopamine receptors in the Chemoreceptor Trigger Zone (CTZ). This central antiemetic mechanism effectively interrupts the nerve signals that cause the vomiting reflex, making it relevant for various types of sickness stimuli.

Q: Is Vogalène the same as the drug 'Prochlorperazine'?

No. Regulatory descriptions confirm that Vogalène is the brand name for the active ingredient Metopimazine. While both medicines are antiemetics and belong to the phenothiazine class of compounds, they are chemically distinct drugs.

Q: Is Vogalène used for stomach flu?

Research evidence and therapeutic uses indicate that Vogalène is studied and used to relieve the nausea and vomiting symptoms that are commonly associated with acute gastroenteritis, which is often referred to as stomach flu.

Q: Does Vogalène have a risk of causing confusion in older adults?

Official information notes that caution is advised in older adults, and the medicine is known to potentiate the effects of other CNS depressants. This potential for augmented sedation may lead to symptoms such as confusion in sensitive individuals, especially the elderly.

Q: Is it normal for Vogalène to cause blurry vision?

Official documentation lists anticholinergic effects like dry mouth and constipation. While not always directly listed, drugs with anticholinergic properties are occasionally associated with minor, transient visual disturbances.

Q: How long does Vogalène typically take to start working?

According to the official pharmacological data, the onset of action for the oral form is generally noted to occur within 30 to 60 minutes after administration. This timeframe indicates the period during which the medicine's effects are typically initiated.

Q: How long do the effects of Vogalène last?

Official data on the medicine's elimination indicates that the antiemetic effects of a single dose are commonly described as persisting for 1 to 2 hours. The duration of effect is related to the drug's elimination half-life.

Q: Can Vogalène tablets be cut in half?

Regulatory guidance advises against cutting or splitting tablets unless the form is explicitly scored (marked) or the package leaflet permits it. This is to help ensure the dose integrity.

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How should Vogalène be stored and disposed of?

The storage and disposal of Vogalène (metopimazine) must strictly follow the conditions defined in the official regulatory documentation.

Storage Conditions

Requirement Official Instruction
Temperature Store at a temperature not exceeding 25 C.
Protection Keep in the original outer packaging to protect from light and moisture.
Handling The injectable solution must not be frozen.
Child Safety Store out of the sight and reach of children.
Stability Oral solutions have post-opening storage limits (consult the package leaflet).

Disposal Instructions

Official regulations require proper disposal to protect the environment. Unused or expired Vogalène must be returned to a pharmacist for disposal via an authorized pharmaceutical waste collection program. The product must not be discarded in household trash or disposed of by pouring it into wastewater.

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

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