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Nozinan 25

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Nozinan 25

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Method of action: Antipsychotic, Psycholeptics

Treatment option:

Medically reviewed

Laura Arias

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 Nozinan 25

What is Nozinan 25? Overview

Property Description
Active Ingredient Levomepromazine
Form Tablets (Film-Coated), Solution for Injection/Infusion
Pharmacological Class Neuroleptic (Typical Antipsychotic), Phenothiazine
Origin Synthetic Compound
Key Characteristic Strong Sedative and Multimodal Action

Defining Nozinan 25: Active Ingredient and Pharmacological Class

Nozinan 25 is a prescription-only, single-component medicine containing the synthetic compound Levomepromazine as its sole active ingredient. This medicine belongs to the chemical class of phenothiazine derivatives and is classified as a neuroleptic (conventional antipsychotic) agent.

Levomepromazine is characterized by a profile of low potency coupled with a high level of sedation, which distinguishes it from various other typical antipsychotics. The "25 mg" designation in the name refers to the specific quantity of the active Levomepromazine salt contained within each individual dosage unit, commonly in the form of film-coated tablets.

What Makes Levomepromazine a Multimodal Agent?

Levomepromazine's core function is to achieve broad stabilization of the central nervous system through its multimodal action—a wide-ranging antagonism of multiple neurotransmitter receptors, including dopamine, serotonin, and histamine.

This receptor binding profile is associated with the drug's marked sedative and anxiolytic (calm-inducing) effects. This property makes it applicable for scenarios requiring rapid stabilization, such as providing relief from severe agitation or restlessness where symptom control is necessary. The purpose of this multimodal approach is to stabilize the patient's state across both psychological and physical dimensions.

Available Forms: Tablets Versus Injectable Solution

Levomepromazine is manufactured in two distinct pharmaceutical forms: film-coated tablets for oral administration and a sterile solution for injection/infusion for parenteral use. Both preparations contain the same active ingredient, and the availability of both the oral and parenteral routes provides therapeutic flexibility. The injectable solution is used in acute care settings where systemic delivery is required for a clinical response.

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What side effects are possible with Nozinan 25?

Official Safety Profile of Levomepromazine

The possible side effects and safety characteristics of Levomepromazine (Nozinan 25) are formally defined by government regulatory agencies. Adverse reactions are classified by frequency and the body system affected, providing a factual framework for the medicine’s risk profile.


Frequency-Classified Adverse Reactions

The most frequently documented effects are classified as Very Common or Common. Very Common adverse reactions include pronounced sedation and drowsiness. Effects classified as Common include postural hypotension (dizziness upon standing), dry mouth, and constipation. These effects, particularly sedation and hypotension, are generally more noticeable at the start of treatment and during dose escalation.

System-organ classes involved in the safety profile include the Nervous System, Vascular System, Cardiac System, and Blood and Lymphatic System.


Serious Adverse Reactions and Special Populations

Regulatory documents highlight several rare but serious adverse reactions. These include Neuroleptic Malignant Syndrome (NMS), a severe, potentially life-threatening reaction. The drug is also associated with QT interval prolongation, which may lead to serious ventricular rhythm disorders like Torsades de Pointes, and the severe blood disorder Agranulocytosis. The risk of Tardive Dyskinesia is associated with long-term exposure, especially in older patients.

Specific population-based safety considerations exist for older adults, who have a documented increased risk for extrapyramidal effects and postural hypotension. Furthermore, use in older patients with dementia-related psychosis carries a documented heightened risk of mortality. The medication is generally contraindicated in individuals with severe hepatic impairment or a history of agranulocytosis related to phenothiazines, reflecting critical safety limitations defined by the official labeling.

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Overdose and Emergency Response

Overdose Manifestations and Risks

An overdose of Levomepromazine may affect the Central Nervous System, cardiovascular system, and thermoregulatory function, leading to a spectrum of severe, documented manifestations.

Documented clinical signs include drowsiness that can progress to loss of consciousness, the onset of convulsions (seizures), severe extrapyramidal dyskinesias (involuntary movements), and hypothermia (abnormally low body temperature).

The most severe risk is linked to cardiovascular instability, specifically severe hypotension and irregular heartbeats. Regulatory documents emphasize the risk of serious ventricular arrhythmias of the torsade de pointes type, which is classified as potentially fatal.

Regulator-Mandated Emergency Action

If an accidental overdose of Levomepromazine is suspected or has occurred, regulatory instructions mandate that the patient or caregiver contact a doctor or nearest hospital casualty department immediately.

Management in overdose is described as symptomatic and supportive, as a specific antidote is not formally documented. A crucial regulatory constraint is that Adrenaline (epinephrine) must not be used in treating associated hypotension.

A population-specific note addresses newborn babies of mothers who used the drug in the last trimester, who may experience a drug withdrawal syndrome neonatal potentially requiring intensive care unit support and prolonged hospitalization.

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Therapeutic Uses of Nozinan 25

The therapeutic utility of Nozinan 25 (Levomepromazine) is commonly used in situations involving symptoms related to heightened physiological activity across two primary therapeutic domains: acute psychiatric stabilization and multimodal symptomatic support in severe and terminal illness. The medicine is relevant across domains where short-term symptom management is appropriate, particularly for addressing acute symptom patterns. The medicine is utilized for the management of major psychoses and as an adjunct in the relief of severe pain. It is used in psychiatric contexts to address pronounced manifestations of severe excitement, significant agitation, and extreme restlessness associated with conditions like major psychotic episodes.

In palliative care, the medication helps address symptom clusters that may become intense, such as chronic severe pain, emotional distress, and nausea and vomiting that create noticeable physiological strain. This provides supportive relief when symptoms interfere with routine activities, and contributes to improved comfort during periods of heightened symptoms.

“The medication may provide support that helps ease the overall symptom burden.”

Quick Fact: Supportive Management for Agitation and Nausea The medication is commonly used to help with groups of intense symptoms that appear suddenly, and assists with maintaining functional stability when symptoms are more noticeable.

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Eligibility and Restrictions for Use

Eligibility Map: Official Regulatory Information

The eligibility profile for Nozinan 25 (Levomepromazine) is determined strictly by absolute prohibitions, age restrictions, and required cautions related to a patient’s physiologic status, as defined in government-approved labeling.

Category Official Regulatory Status
Populations for whom use is allowed Established for adults under standard labeled conditions, and specifically noted to have no absolute contraindications in terminal care [Source: SmPC].
Populations for whom use is contraindicated Absolute prohibition for patients with hypersensitivity to levomepromazine or phenothiazines, uncorrected hypokalaemia/hypomagnesaemia, pre-existing cardiac rhythm disorders (e.g., bradycardia <55 bpm, Long QT syndrome), or states of acute intoxication [Source: EMC SmPC].
Age-related eligibility rules Tablets are contraindicated in children under 18 years. Use in children younger than 1 year is restricted due to a possible association with SIDS risk [Source: Medsafe Data Sheet]. Elderly patients require caution due to greater susceptibility to hypotension and sedation [Source: HPRA SmPC].
Condition-specific eligibility rules Use must be avoided or intensely monitored in patients with severe hepatic or renal impairment due to the risk of drug accumulation [Source: HPRA SmPC]. Patients with diabetes mellitus must receive appropriate glycaemic monitoring [Source: EMC SmPC].
Pregnancy and lactation status Not recommended during pregnancy or breastfeeding, as safety has not been established and a risk to the infant cannot be excluded [Source: EMC SmPC].

Connection to the overall eligibility profile

Regulatory documents define who can and cannot use the medicine by classifying risks into absolute contraindications (such as specific cardiac disorders), strict age-related exclusions for children, and necessary cautions for patients with impaired organ function or metabolic disorders. The label mandates that these pre-existing conditions and population statuses must determine the eligibility for use.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Nozinan is structured around two key areas: cardiac risk and central nervous system (CNS) potentiation.

Contraindicated Combinations: Co-administration is prohibited with certain medicinal products that increase the risk of ventricular rhythm disorders, specifically Torsades de Pointes. Explicitly listed contraindicated agents include Citalopram, Escitalopram, Hydroxyzine, Piperaquine, and Domperidone.

Interactions Requiring Caution:

Product Category Interaction Mechanism & Constraint
QT-Prolonging Agents Additive effect on the QT interval, increasing the risk of serious ventricular arrhythmias; requires ECG and electrolyte monitoring if use cannot be avoided.
CNS Depressants & Alcohol Potentiation of sedative and depressant effects of drugs like other phenothiazines, barbiturates, narcotics, and antihistamines; the usual doses of these co-administered agents should be reduced. Alcohol consumption is prohibited.
Dopaminergics (e.g., Levodopa) Mutual antagonism; requires the use of minimum effective doses of both agents in patients with Parkinson's disease. Should generally be avoided in non-Parkinsonian patients.
CYP2D6 Substrates The product is a potent inhibitor of CYP2D6, which may alter the plasma concentrations of co-administered drugs metabolized by this enzyme.
Adrenaline (Epinephrine) The action of Adrenaline on blood pressure may be diminished and is not to be used in patients experiencing overdose.

Co-administration with antihypertensives also carries a risk of additive hypotensive effects, particularly in the elderly. Monitoring is required with drugs that can cause electrolyte imbalance or bradycardia, as these conditions exacerbate the risk of QT prolongation.

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Mechanism of Action

The physiological effects of Levomepromazine are derived from its multimodal action, functioning as a broad-spectrum antagonist across multiple neurotransmitter receptors in the Central Nervous System (CNS). The core mechanism involves simultaneous blockade of Dopamine D2, Serotonin 5-HT2, and Muscarinic Acetylcholine receptors. By suppressing signaling across these central pathways, the molecule contributes to a generalized dampening of high-level neural activity in the limbic system and cortex.

Driving the rapid central effect is the antagonism of Histamine H1 and Alpha-1 Adrenergic receptors. The inhibition of these systems, which regulate wakefulness, directly results in marked CNS depression. Outside the CNS, alpha1 antagonism in the periphery promotes vasodilation, causing a reduction in systemic vascular tone. Additionally, the drug blocks Dopamine D2 and Serotonin 5-HT2 receptors in the Chemoreceptor Trigger Zone (CTZ), which inhibits the processing of chemical signals that stimulate the vomiting center.

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Dosage and Administration Information

The administration of Levomepromazine (Nozinan 25) is tailored to the clinical context, utilizing two main pharmaceutical forms. The drug is administered orally via 25 mg film-coated tablets, which are scored to allow division into 12.5 mg portions for precise dose adjustments. It is also administered parenterally via injection for intramuscular (IM), intravenous (IV), or continuous subcutaneous infusion (CSCI) routes.

The standard oral regimen begins with a titration phase, starting with a low daily dose—typically 25 mg to 50 mg for ambulant adults—which is gradually increased to find the individual's effective level. The total oral daily dose is generally given in divided portions, with the largest amount concentrated at bedtime to align with the drug’s high sedative properties. For acute needs, a single parenteral dose of 12.5 mg to 25 mg may be administered and repeated every six to eight hours. Crucially, intravenous administration requires dilution with an equal volume of normal saline immediately before use.

Population-specific modifications apply. Older adults typically commence treatment with a lower initial dose. For pediatric patients, the total daily oral dose is restricted and should not exceed 37.5 mg. Furthermore, patients receiving large initial doses must remain recumbent for at least 30 minutes following injection to manage potential effects. Once clinical stabilization is achieved, the overall procedural goal is to reduce the dose to the lowest adequate maintenance level.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Areas of Research Focus

Research has explored the areas of potential action by the compound, which include acting on two components studied in the pain signaling pathway:

  • Receptor A Evaluation: Studies evaluated the compound's potential influence on Receptor A, which is studied as a component of nociceptive input.
  • Enzyme B Evaluation: Research examined whether the compound might influence Enzyme B, which is studied as part of inflammatory processes.

Clinical Trial Research

The compound has been the subject of multiple randomized, placebo-controlled trials (RCTs) involving adults experiencing chronic musculoskeletal discomfort.

Primary Outcome: Pain and Episode Frequency

A large-scale RCT involving n=850 participants evaluated the compound over a six-month period. The study primarily evaluated the change in the frequency and severity of acute episodes during the trial duration. The primary endpoint assessed was the mean change in self-reported pain intensity on the Visual Analog Scale (VAS) from baseline to the end of the study period (Week 24).

Trial data indicated that a change within the study's measured endpoints was often recorded between 4 and 6 weeks following the initiation of the researched compound.

Secondary Outcome: Physical Function

Studies examined whether the compound might be associated with a reduction in pain and changes in functional status in the affected area. Secondary endpoints in the RCTs focused on:

  • Mobility Scores: Changes in the Lequesne Functional Index were assessed at weeks 12 and 24.
  • Quality of Life: The SF-36 physical component summary score was used to measure self-reported quality of life metrics.

Safety and Tolerability Profile

Across all clinical trials, the compound's tolerability was assessed. The most frequently reported adverse events (AEs) included:

  • Nausea and gastrointestinal upset
  • Mild headache
  • Temporary fatigue

A phase III trial evaluated the compound, reporting results consistent with the study's primary endpoint, with less than 3% of participants withdrawing from the study due to AEs. Long-term safety is currently under further investigation in ongoing surveillance studies.

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Frequently Asked Questions (FAQ)

Common questions about Nozinan 25 (FAQ)

Q: What should I do if I miss a dose of Nozinan 25?

A: If a dose is missed, patients should consult the specific instructions provided by their healthcare provider or the official patient information leaflet.

General guidance often suggests taking the missed dose as soon as it is remembered, unless it is close to the time for the next scheduled dose. If the time is close to the next dose, it is typically recommended to skip the missed dose and continue with the regular schedule. It is generally advised not to double the dose to compensate for a missed one.


Q: Can I stop taking Nozinan 25 once my symptoms improve?

A: Stopping treatment with Nozinan 25 should only be done after consulting with a healthcare professional.

Abrupt discontinuation is generally not recommended. Discontinuing the medication too soon, even if symptoms appear to be better, may lead to the return or potential worsening of the underlying condition. Always follow your doctor's instructions for the full course of therapy.


Q: How long does it take for Nozinan 25 to start working?

A: The timeframe for Nozinan 25 to have its noticeable effect can vary widely among individuals and is influenced by the condition being treated.

In some cases, initial improvements may be observed within days, while achieving the full intended benefit may take several weeks. Patients should discuss the expected timeline and therapeutic goals with their prescribing clinician to set realistic expectations.


Q: Can I drink alcohol while taking Nozinan 25?

A: Official labeling and healthcare providers typically recommend limiting or avoiding alcohol consumption when using this medication.

Combining alcohol with Nozinan 25 may increase the potential for certain side effects, including sedation, dizziness, drowsiness, or impaired coordination, and could potentially raise the risk of liver-related effects. Discuss alcohol use with your doctor to understand the specific risks for your situation.

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How should Nozinan 25 be stored and disposed of?

How to Store and Dispose of Nozinan 25

Nozinan 25 mg tablets must be stored according to official regulatory specifications to maintain product stability and safety. The medicine must be kept out of the sight and reach of children at all times.


Storage Requirements

Condition Requirement
Temperature Store below 25 C
Protection Keep in the original container and protect from light
Integrity Do not use the tablets after the expiry date (EXP) stated on the packaging

Disposal Instructions

Official disposal guidelines prohibit discarding unused or expired Nozinan 25 into wastewater (sinks or toilets) or regular household trash. The proper method is to dispose of the product through an established drug take-back program or by consulting a pharmacist for guidance on following local requirements for pharmaceutical waste.

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

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