Hirnamin

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Hirnamin

Method of action: Antipsychotic, Psycholeptics

Treatment option:

Medically reviewed

Marina Burgos

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 Hirnamin

Property Description
Active Ingredient Levomepromazine (Methotrimeprazine)
Form Tablets, Oral Solution, Solution for Injection
Pharmacological Class First-Generation Antipsychotic (Neuroleptic)
General Purpose Mental stabilization, sedation, and relief of agitation
Origin Synthetic (Phenothiazine derivative)

Defining Hirnamin: Active Ingredient and Drug Classification

Hirnamin is the commercial designation for the medicinal substance Levomepromazine, an International Nonproprietary Name (INN) which is also recognized as Methotrimeprazine. This compound is classified as a First-Generation Antipsychotic, a type of medicine frequently placed within the broader category of neuroleptic drugs designed for central nervous system modulation.

Levomepromazine is a synthetic small molecule belonging to the phenothiazine chemical class. Its multi-target action profile defines it as a low-potency agent that broadly influences neurotransmitter systems, including dopamine and serotonin receptors. This broad receptor influence relates to its application in managing acute episodes of severe psychological unease.

Composition, Forms, and General Therapeutic Role

Hirnamin is consistently manufactured as a single-active-ingredient product and is available in multiple dosage forms, including conventional tablets, an oral solution for flexible dosing, and a sterile solution for injection, which is administered via the parenteral route. The medication's general therapeutic role is to provide rapid and comprehensive stabilization for the patient, particularly when high levels of agitation or anxiety are present.

The expansive receptor influence of Levomepromazine imparts pronounced secondary effects that are utilized in clinical settings. Beyond its primary function in stabilization, the drug is clinically recognized for its effectiveness at inducing deep sedation and controlling severe acute restlessness. Furthermore, Levomepromazine is utilized as an adjunct therapy for its non-narcotic analgesic and antiemetic properties. This means the drug helps not only with mental calmness but also with physical discomforts such as certain types of pain and nausea.

What side effects are possible with Hirnamin?

The official safety profile of Levomepromazine is categorized by frequency and the physiological system affected, following standard regulatory classifications.

Documented Adverse Reactions

Classification Examples of Reactions (SOC)
Very Common (ge 1/10) Sedation or somnolence (Nervous System), Dry mouth (Gastrointestinal)
Common (ge 1/100) Postural hypotension (Vascular), Asthenia, Heat stroke (General Disorders)
Uncommon (ge 1/1,000) Agranulocytosis (Blood), Parkinsonism, Convulsions (Nervous System)
Rare (ge 1/10,000) Torsade de pointes (Cardiac), Jaundice (Hepatobiliary)
Not Known Neuroleptic Malignant Syndrome (NMS), Venous Thromboembolism (VTE), Tardive Dyskinesia, Necrotising Enterocolitis, Severe Cardiac Arrhythmias, Hyperglycaemia

Serious Reactions and Safety Constraints

Serious adverse reactions documented in regulatory sources include the potentially fatal Neuroleptic Malignant Syndrome (NMS), severe reduction in white blood cells (agranulocytosis), and the risk of Venous Thromboembolism (VTE). The product is also associated with a documented risk of QT interval prolongation, which can lead to serious ventricular arrhythmias, including Torsade de pointes.

Time-Course and Population-Specific Safety

Safety information notes that effects such as sedation and postural hypotension are typically more pronounced at the start of treatment. In contrast, movement disorders like parkinsonism and tardive dyskinesia are associated with prolonged or high-dose exposure. For older adults, the label indicates an increased susceptibility to effects like hypotension and extrapyramidal symptoms. Caution is also specified for patients with cardiac diseases and seizure disorders due to the potential to lower the seizure threshold.

Overdose and Emergency Response

Overdose Manifestations and Complications

Official regulatory sources document that overdose with Levomepromazine (Hirnamin) may present with signs of severe central nervous system (CNS) depression, including drowsiness and loss of consciousness. Other documented clinical manifestations are convulsions (seizures), hypotension (low blood pressure), hypothermia, and irregular heartbeats. A serious risk is the potential for QT interval prolongation, which can lead to life-threatening arrhythmias such as torsades de pointes and is associated with the risk of sudden death. The rare, severe complication known as Neuroleptic Malignant Syndrome (NMS) is also a regulatory concern in overdose situations.

When to Seek Urgent Medical Help

Requirement Official Regulatory Statement
Immediate Action Seek immediate medical attention for severe symptoms, including loss of consciousness, convulsions, or profound hypotension.
Antidote Status No specific antidote is known.
Management Note Adrenaline (epinephrine) must not be used as part of supportive care.

Management is symptomatic and supportive, and requires close medical supervision with continuous monitoring of cardiac rhythm and vital signs. Regulatory labeling notes that children and elderly patients are particularly susceptible to the drug’s hypotensive and sedative effects in an overdose context.

Therapeutic Uses of Hirnamin

What Hirnamin Treats: Main Uses and Benefits

Levomepromazine, the active substance in Hirnamin, is applied across domains where additional symptomatic support is needed. It is commonly used across conditions associated with acute or disruptive episodes of psychomotor distress, including pronounced agitation and symptoms related to heightened physiological activity.

The medication is further considered relevant in contexts marked by increased discomfort or tension, applied when groups of symptoms appear suddenly or fluctuate. This includes managing complex multi-symptom distress in advanced illness, addressing persistent intractable nausea and vomiting, and assisting with severe sleep deficits driven by tension.

Its therapeutic role is to support patients during difficult episodes by easing distress and contributing to a sense of stability when symptoms are more noticeable. It is considered relevant in contexts involving heightened systemic burden, where short-term symptom stabilization is important.

“It supports patients during episodes of heightened discomfort and contributes to improved comfort during symptomatic periods.”

Quick Fact: Support for Complex Symptom Clusters

Regulatory References

  1. Health Products Regulatory Authority

Eligibility and Restrictions for Use

Eligibility and Non-Eligibility Rules

Hirnamin (Levomepromazine) eligibility is strictly defined by regulatory documents, primarily focusing on age, cardiac status, and organ function. Only adults are generally approved for use in standard indications. Use is often permitted in palliative or terminal care settings, though specific cautions apply.

Classification Population/Condition
Contraindicated Individuals with known hypersensitivity to the drug, acute intoxication from alcohol or narcotics, pre-existing blood dyscrasias (e.g., agranulocytosis), or those in a state of shock or coma.
Age Restriction Oral formulations are contraindicated in children under 18 years. Use in older adults requires caution and a lower starting dosage due to increased susceptibility to effects like low blood pressure.
Specific Exclusions Patients must ensure the absence of uncorrected metabolic abnormalities (hypokalaemia) and specific cardiac issues like bradycardia (<55 bpm) or a history of QT interval prolongation.
Restricted Use Use requires caution in patients with severe hepatic or renal impairment due to the risk of drug accumulation. Caution is also advised in patients with epilepsy or a history of Parkinson's disease.
Reproductive Status Not recommended during pregnancy as safety has not been established. During lactation, the potential risk to the child should be weighed against the benefit to the mother.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Formal Contraindicated Combinations

Co-administration of Levomepromazine is officially contraindicated with several medicinal products due to a high risk of severe pharmacodynamic interaction. These prohibited combinations include Citalopram, Escitalopram, Hydroxyzine, Piperaquine, and Domperidone. This restriction is mandatory due to the documented potential for additive QT interval prolongation and the resultant risk of Torsades de Pointes.

Documented Pharmacokinetic Interactions

Levomepromazine is a documented inhibitor of the metabolic enzyme Cytochrome P450 2D6 (CYP2D6). Co-administration may increase the plasma concentration of other drugs metabolized by this enzyme. Conversely, enzyme inducers, such as Carbamazepine or Barbiturates, can significantly decrease the plasma concentration of Levomepromazine.

Other Pharmacodynamic and Substance Restrictions

Co-administration with other Central Nervous System (CNS) depressants (e.g., opiates, sedatives) causes a severe intensification of depressant effects. Regulatory labeling requires patients to avoid alcoholic beverages due to this enhancing effect. Additionally, caution is noted for patients with hepatic impairment, as the risk of Levomepromazine accumulation is officially documented in this population.

Mechanism of Action

Central Neurotransmitter Signal Modulation

Hirnamin (Levomepromazine) operates through competitive antagonism across several central and peripheral receptor systems. Its mechanism involves blocking Dopamine D2 and Serotonin 5-HT2A receptors within the limbic and mesolimbic pathways. This molecular interaction reduces the magnitude of signaling, thereby affecting the activity of central physiological processes.

CNS Arousal System Suppression via Dual Receptor Blockade

A critical part of the mechanism is the high-affinity blockade of two major arousal mediators: the Histamine H1 and alpha1 Adrenergic receptors in the Reticular Activating System. This combined antagonism initiates a sequence of events resulting in generalized central nervous system depression and decreased psychomotor activity.

Autonomic and Reflex Pathway Control

This mechanism also affects involuntary physiological responses. Antagonism of D2 and 5-HT2A receptors in the Chemoreceptor Trigger Zone (CTZ) interferes with the activation of the emesis reflex. Concurrently, alpha1 antagonism in the peripheral vasculature affects sympathetic vascular tone, leading to systemic changes in blood pressure regulation.

Dosage and Administration Information

Hirnamin, containing levomepromazine, is available in multiple forms to support its use in various clinical settings. Administration typically follows two main routes: the oral route via tablets or solution, used for maintenance therapy, and the parenteral route (intramuscular, intravenous, or continuous subcutaneous infusion) for acute symptom management in controlled environments.

The official dosing regimen is characterized by a low starting dose, such as 25 mg to 50 mg daily for initial oral use. This amount is gradually adjusted (titrated) upward to reach a maintenance dose that can range from 50 mg to 200 mg daily. The total daily oral intake for severe conditions may be increased up to 600 mg, but only under close supervision. Parenteral administration typically uses a dose of 12.5 mg to 25 mg, which may be repeated after a 6- to 8-hour interval as needed for control of acute episodes.

To align with the medication's properties, the oral dosing schedule frequently instructs that the largest portion, or the entire daily amount, be taken at bedtime. This medication can be taken with or without food. Administration of the intravenous form requires a necessary dilution step with an equal volume of normal saline before it is introduced. For specific populations, a reduced initial dosage and slower titration is indicated for older adults due to altered response patterns. The official pediatric dosage is strictly limited to an amount not to exceed 37.5 mg per day.

Recent Clinical Evidence

Core Efficacy Research

Research has explored whether this drug combination is associated with reduced inflammation. Studies have investigated whether the drug may affect the duration of symptoms.

The drug combination was studied across several clinical trials to determine its potential role in complex chronic conditions. The primary focus of the research was the observed effect on markers of inflammation and patient-reported measures of discomfort. The research involved examining biological pathways potentially affected by the drug combination, which is a factor that some researchers believe may be relevant to recovery.


Key Clinical Trials

Study 1: Anti-Inflammatory Action

In a large Phase III trial, the drug combination was associated with a change in pain scores over a 12-week period. The difference when compared to placebo or the standard monotherapy was evaluated. Adverse events were recorded during the trial.

Studies also reported a change in mobility measures within the first two weeks of treatment, and these findings are subject to further analysis.

Study 2: Long-Term Monitoring

A one-year open-label study continued to monitor the subjects from the Phase III trial. The study explored potential long-term trends related to the condition's status. Studies also examined whether there was an association with the use of additional pain medication.


Population Under Study

Clinical evaluations included a variety of adult populations. Studies of the drug were conducted differently in individuals with kidney impairment.

Frequently Asked Questions (FAQ)

Common questions about Hirnamin (FAQ)

Q: How quickly can a person expect to notice effects after starting Hirnamin?

A: Official pharmacokinetic information indicates that the oral tablet should begin to work within 30 to 60 minutes after administration. The drug's concentration in the blood, known as the time to maximum concentration, is generally reached within 2 to 3 hours following oral use. These figures represent the typical timeframes for the onset of initial effects.

Q: Do I need a prescription to get Hirnamin?

A: Yes, the active ingredient in Hirnamin, Levomepromazine, is officially classified as a First-Generation Antipsychotic (Neuroleptic). Medicines within this pharmacological category are regulated and typically require a valid prescription from a qualified healthcare professional.

Q: What should be done if a person misses a dose of Hirnamin?

A: Regulatory documents describe the general protocol for a missed dose, which typically involves taking the dose when remembered unless it is close to the time for the next scheduled dose. Official guidance specifies that doses should not be doubled to compensate for a missed dose. Specific instructions for managing a missed dose should be clarified by the prescribing healthcare professional.

Q: Are there any known interactions between Hirnamin and herbal supplements?

A: While specific herbal supplements are not always listed in regulatory labels, official drug labeling indicates that patients should inform their healthcare professional about all non-prescription products they use. This is important because certain supplements, particularly those that cause drowsiness, may interact with Levomepromazine and potentially intensify its sedating effects.

Q: Does taking Hirnamin with certain vitamins change how it works?

A: Healthcare guidance for this medicine describes the need for patients to share a complete list of all vitamins and supplements with their healthcare provider. Although specific vitamin interactions are often not highlighted in product labels, this step allows a professional to check for any potential unintended effects or changes in how the body processes Levomepromazine.

Q: Can Hirnamin be crushed or split if someone has trouble swallowing pills?

A: Some formulations of Levomepromazine tablets are designed to be scored, allowing them to be divided into equal doses. Official patient information states that specific directions regarding tablet alteration are provided by the healthcare professional, as the ability to split or crush depends on the tablet’s specific formulation.

Q: What official body approved Hirnamin for use?

A: The active ingredient in Hirnamin, Levomepromazine, has been authorized for use by regulatory bodies across various regions. These include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national agencies like the Health Products Regulatory Authority (HPRA) in Ireland.

Q: Is it normal to feel a mild headache when first taking Hirnamin?

A: According to official product information, headache is listed as a documented side effect of the medicine. While it is not categorized as a very common occurrence, it is known to be a possible reaction associated with use.

Q: What happens if a person takes more Hirnamin than is recommended?

A: Official safety information states that an overdose of the medicine may cause symptoms such as low blood pressure, severe drowsiness, loss of consciousness, or convulsions. If an overdose is suspected, medical protocols require immediate attention or contact with emergency services.

Q: How long does the primary effect of one dose of Hirnamin usually last?

A: The duration of the primary effect for a single dose is generally considered to be about 8 hours. However, Levomepromazine has a long elimination half-life, which is the time required for the body to eliminate half of the substance. This means the compound can remain in the body for approximately 15 to 30 hours after administration.

Q: Does Hirnamin carry any risk of physical dependence?

A: Official drug classifications indicate that Levomepromazine is not typically classified as having a high risk of physical dependence in major international regulatory schedules. Furthermore, it is not listed as a controlled substance under the U.S. Controlled Substances Act.

Q: What does 'contraindicated' mean in relation to Hirnamin?

A: The term 'contraindicated' is used in official documentation to mean that taking the medicine is strongly advised against or prohibited. This restriction is mandatory when use could lead to a serious, possibly life-threatening, reaction, such as for individuals with known hypersensitivity to the drug or specific uncorrected cardiac conditions.

Q: Is it safe for a woman to use Hirnamin while trying to become pregnant?

A: Official prescribing information states that the medicine is not generally recommended during pregnancy, as its safety has not been fully established in this context. Official guidance states that the potential risks of use for women planning pregnancy should be reviewed with a healthcare professional before conception.

Q: Can someone take Hirnamin if they are already taking a blood pressure medicine?

A: Official product cautions note that Hirnamin can lower blood pressure on its own. When combined with other anti-hypertensive (blood pressure) medications, it may result in an increased or additive hypotensive effect. Regulatory labeling indicates that patients using both types of medication may require careful blood pressure monitoring due to this interaction.

Q: Is Hirnamin considered a schedule or controlled substance?

A: No, the active ingredient Levomepromazine is not currently classified as a scheduled or controlled substance under major national drug control regulations, such as the U.S. Controlled Substances Act.

Q: How long after stopping Hirnamin does the medicine usually stay in the body?

A: Pharmacokinetic data shows that Levomepromazine has a long elimination half-life, which is the time required for the body to eliminate half of the substance. This long half-life means that it may take approximately 15 to 30 hours for half of the drug to be eliminated from the body after the last dose.

Q: What kind of specialist typically manages treatment with Hirnamin?

A: Due to the various clinical uses of the medicine, treatment management with Levomepromazine may be overseen by several different specialists. This often includes doctors specializing in psychiatry, pain management, or palliative care, depending on the specific condition being treated.

Q: Is there a generic version of Hirnamin available?

A: Hirnamin is a brand name for the active ingredient Levomepromazine (also known as Methotrimeprazine). Since Levomepromazine is the non-proprietary name for the active compound, generic products containing this active ingredient are available in many markets.

Q: What is the process for stopping Hirnamin if necessary?

A: Official guidance advises that treatment with this medicine should not be stopped suddenly. If discontinuation is necessary, the process should be managed by a healthcare professional, as stopping abruptly may cause symptoms to worsen.

Q: Is the effect of Hirnamin supposed to build up over time?

A: Official dosing strategies involve starting with a low dose and gradually increasing (titrating) it over a period of time. This approach allows some of the drug’s effects to stabilize and potentially build up over several weeks, ultimately leading to a stable maintenance dose for the patient.

How should Hirnamin be stored and disposed of?

How to Store and Dispose of Hirnamin?

Official regulatory documents define strict environmental and handling requirements for the storage and disposal of Hirnamin (Levomepromazine).

Storage Requirements

The medicine must be stored at a temperature that does not exceed 25 C. To maintain its stability, it is mandatory to protect from light and store the product in a dry place.

Storage Constraint Requirement
Temperature Store below 25 C
Protection Protect from light; Do not freeze (liquid forms)
Packaging Keep in original container, tightly closed

All forms of Hirnamin must be kept out of the sight and reach of children.

Disposal Instructions

To prevent environmental contamination, unused or expired Hirnamin must not be thrown into household trash or wastewater.

Disposal of any waste material must be done in accordance with local pharmaceutical waste requirements.

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

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