Overview of Nozinan 100

Quick Facts

Property	Description
Active Ingredient	Levomepromazine
Form	Film-coated tablets (100 mg strength), solution for injection
Pharmacological Class	First-Generation Antipsychotic (Neuroleptic)
Common Use	Stabilization of severe mental distress and agitation
Origin	Synthetic, Phenothiazine derivative

What Type of Medicine is Nozinan 100?

Nozinan 100 is a highly potent synthetic prescription medicine whose active ingredient is Levomepromazine, scientifically classified as a First-Generation Antipsychotic (FGA) or neuroleptic. This medication belongs to the established chemical family of phenothiazines, which are primarily used to modulate activity within the central nervous system. Levomepromazine is clinically recognized for its efficacy in rapidly managing intense psychological tension and promoting calmness.

Active Substance, Form, and Chemical Profile

The core component of Nozinan 100 is the single active ingredient, Levomepromazine, supplied as the maleate or hydrochloride salt. The 100 mg designation specifies the amount of active substance in this particular strength of the film-coated tablet formulation, which is intended for oral administration. Levomepromazine is recognized as a critical medication for public health globally. The active substance is also manufactured in a sterile solution for injection, providing a key differentiating feature in administration route flexibility.

How Levomepromazine Functions and General Purpose

Levomepromazine primarily functions by acting as a dopamine receptor antagonist, which helps regulate circuits in the brain associated with thought and emotion, thereby promoting stabilization. The compound also possesses a dominant histamine-blocking effect. This dual action means the drug provides both chemical regulation and a strong calming effect. The general purpose of Levomepromazine is to manage states characterized by acute instability or profound psychological tension, utilizing its unique sedative profile to reduce intense agitation associated with various severe mental conditions.

What side effects are possible with Nozinan 100?

Possible Side Effects and Safety Information

Regulatory documents classify the potential adverse effects of Levomepromazine (Nozinan 100) across various physiological systems. The official risk profile is structured by frequency, the organ system affected, and specific safety considerations.

Frequency-Classified Adverse Reactions

The most commonly documented adverse reactions, classified as Very Common, include somnolence (sleepiness) and dry mouth. Effects classified as Common include postural hypotension (a drop in blood pressure upon standing) and asthenia (physical weakness). These more frequent effects, particularly sedation and hypotension, are often noted as being more pronounced at the start of treatment.

Classification	Examples of Officially Documented Effects
Uncommon	Agranulocytosis, Parkinsonism-like reactions
Rare	Torsade de pointes (a serious heart rhythm disorder), Jaundice
Frequency Not Known	Neuroleptic Malignant Syndrome (NMS), Venous Thromboembolism (VTE), Tardive dyskinesia, Hyperglycemia

Systemic and Serious Adverse Reactions

Adverse effects are documented across several System-Organ Classes, including the Nervous System (e.g., extrapyramidal symptoms, convulsions), Vascular System, and Cardiac System. Regulatory sources highlight several Serious Adverse Reactions (SARs): the rare but life-threatening Neuroleptic Malignant Syndrome (NMS); Venous Thromboembolism (VTE); and potential cardiac events such as QT interval prolongation and sudden death of cardiac origin.

Special Population Safety and Constraints

The official label includes specific safety notes for certain populations. Older adults are noted to have increased susceptibility to orthostatic hypotension, extrapyramidal effects, and sedation. If the medication is used during the last trimester of pregnancy, neonates are at risk of a documented drug withdrawal syndrome. The label also specifies that caution is required in patients with Parkinson’s disease or a history of epilepsy (due to a lowered seizure threshold) and advises monitoring of blood glucose levels due to the risk of hyperglycemia.

Overdose and Emergency Response

Overdose and when to seek help

The official prescribing information for Nozinan 100 dictates that immediate medical attention is required upon swallowing too many tablets. If an overdose is suspected, you must contact a doctor or nearest hospital casualty department immediately.

Documented overdose presentations primarily affect the Central Nervous System (CNS) and the Cardiovascular System. Clinical manifestations include drowsiness or loss of consciousness, convulsions, and severe extrapyramidal dyskinesias (involuntary movements). Other physical signs documented include hypothermia (abnormally low body temperature) and cardiovascular instability.

The official profile emphasizes that this toxicity carries a risk of severe, life-threatening outcomes. The risk of dose-dependent QT interval prolongation may lead to serious ventricular arrhythmias, such as Torsades de pointes, cardiac arrest, and sudden death.

A specialized consideration is documented for newborn babies whose mothers received the medicine in the last trimester. Such neonates may exhibit symptoms of withdrawal, including shaking, muscle stiffness or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. The regulatory documents define the overdose profile by its potential for these severe consequences, which necessitates the strict mandate to seek urgent medical help immediately.

Therapeutic Uses of Nozinan 100

What Nozinan 100 Treats: Main Uses and Benefits

Nozinan 100 is commonly used to support symptomatic stabilization and provide assistance in clinical settings marked by heightened patient distress. The medication is generally applied across two main therapeutic domains.

Stabilization of Acute Psychotic Distress and Agitation

Nozinan 100 is commonly used across conditions characterized by periods of heightened symptoms, such as schizophrenia and manic-depressive syndromes. It helps address clusters of symptoms that include profound psychomotor agitation, pronounced restlessness, and high levels of psychological tension. This provides supportive relief when symptoms interfere with routine activities and helps maintain a sense of stability when symptoms are more noticeable. This application is relevant in settings where supportive symptom management is appropriate for conditions like major psychoses and mania.

“This therapeutic support helps patients achieve a state of calmness and assists with maintaining functional stability during challenging acute episodes.”

Comprehensive Symptom Relief in Palliative Care

This medication is applied in clinical settings marked by heightened patient distress, particularly in terminal illness and the management of severe chronic pain. It offers symptomatic relief that helps ease the overall symptom burden, supports the management of challenging nausea and vomiting, and contributes to enhanced pain relief as an adjunct to primary analgesics. This supports patients during episodes of heightened discomfort.

Quick Fact: Relief for Acute Distress
Primary Goal	Stabilization and calming in acute psychiatric states
Symptom Example	Profound psychomotor agitation
Secondary Benefit	Adjunctive pain and nausea relief (palliative settings)

Regulatory References

Summary of Product Characteristics

Eligibility and Restrictions for Use

Who Can and Cannot Use Nozinan 100?

Eligibility for Nozinan 100 (Levomepromazine) is strictly defined by regulatory health authorities, focusing on age, underlying conditions, and physiological status.

Populations Not Eligible (Contraindications)

Official labeling contraindicates the use of Nozinan 100 in patients with known hypersensitivity to levomepromazine or related compounds, and those in a state of coma or acute Central Nervous System (CNS) depression due to depressant substances. Patients with a history of blood dyscrasia must not use this medicine. The tablet formulation is generally contraindicated for children and adolescents under 18 years.

Conditional Use and Restrictions

Population/Condition	Regulatory Status
Severe Organ Impairment (Hepatic/Renal)	Use with caution or avoided (due to accumulation risk).
Pregnancy and Lactation	Not Recommended (safety not established; excreted in breast milk).
Older Adults (Geriatric)	Use with caution (increased risk of hypotension/sedation).
Parkinson's Disease	Should not be used (apart from exceptional situations).
Epilepsy/Seizure History	Use with caution (may lower epileptic threshold).

This medicine is designated for use in adults for its approved indications, with specific exceptions to contraindications sometimes noted for its use in terminal care.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section provides a summary of officially documented interactions for Levomepromazine (Nozinan 100) as noted in regulatory prescribing information.

Contraindicated Combinations

Co-administration is strictly prohibited for several medicines due to a documented cardiac risk. This includes Citalopram, Escitalopram, Hydroxyzine, Piperaquine, and Domperidone, which are contraindicated due to the increased risk of severe ventricular arrhythmias (Torsades de Pointes). Additionally, non-antiparkinsonian dopamine agonists are contraindicated due to the risk of mutual antagonism.

Pharmacokinetic and Pharmacodynamic Effects

Levomepromazine is officially reported to be a potent inhibitor of Cytochrome P450 2D6 (CYP2D6). This pharmacokinetic mechanism leads to the increased plasma concentrations of co-administered drugs metabolized by this enzyme, such as certain tricyclic antidepressants.

The regulatory profile also highlights multiple pharmacodynamic interactions. Concomitant use with other CNS depressants, including opioids, sedatives, or other neuroleptics, results in significant additive depressant effects. For this reason, alcohol consumption must be avoided during treatment. Levomepromazine also exhibits antagonism with Levodopa and increases the risk of additive effects with anticholinergic and other QT-prolonging agents.

Population-Specific Note

The official labeling notes that in elderly patients, the risk of interaction-related hypotension and the frequency of extrapyramidal effects are heightened.

Mechanism of Action

The active ingredient, Levomepromazine, exerts its action as a non-selective antagonist primarily within the central nervous system. It binds to and blocks multiple key neurotransmitter receptors, notably dopamine ( D2), serotonin ( 5-HT2 A), histamine ( H1), and alpha-1 (alpha 1) adrenergic receptors. This simultaneous engagement across diverse systems alters chemical communication dynamics in the mesolimbic and cortical pathways. Antagonism of H1 receptors in the Reticular Activating System initiates a cascade that reduces CNS arousal signals. alpha 1 receptor blockade reduces sympathetic activity and vascular tone, which results in a reduction in blood pressure (orthostatic hypotension). Additionally, D2 receptor antagonism in the Chemoreceptor Trigger Zone (CTZ) alters the signaling cascade that mediates the vomiting reflex. This multi-receptor blockade results in the physiological consequences of CNS depression and decreased wakefulness.

Dosage and Administration Information

Instruction Map: How to use Nozinan 100 — Administration Guidelines

This map details the administration protocol for Levomepromazine, defining the necessary steps for use.

Administration Scope

Feature	Guideline
Route of administration	Approved for Oral intake (tablets/solution), Intramuscular (IM) Injection, Intravenous (IV) Injection, and Continuous Subcutaneous Infusion (CSCI).
Dosing schedule	Oral (Ambulant, Initial): Max 25 mg to 50 mg daily, divided. Maximum Oral: Up to 1000 mg (1 g) daily. Parenteral (Acute): 12.5 mg to 25 mg, repeatable every 6 to 8 hours.
Timing in relation to meals (if applicable)	Can be taken with or without food.
Preparation requirements (if applicable)	IV/CSCI Solution: Requires immediate dilution with an equal volume of normal saline (IV) or calculated volume of normal saline (CSCI).
Age-group administration rules	Older Adults: Requires a lower initial dosage and gradual adjustment. Paediatric: Total daily oral dosage should generally not exceed 40 mg.
Missed-dose rules	Guidance on a specific procedural instruction for a missed dose is not consistently or universally detailed in clinical documentation.
Special procedural conditions	Patients receiving large initial doses (e.g., 100–200 mg/day) must be kept in bed for the first few days. Patients must remain lying down for at least one hour after an injection.

Instruction Classifications (High-Level)

Classification	Description
Administration method type	Oral and Parenteral (IM, IV, SC)
Frequency pattern	Divided daily, Once-daily (at bedtime), As-needed (PRN), Continuous (CSCI)
Standard basis	National health and medicine authorities
Use-context constraints	Bed-rest requirement for initiation of high doses; Dilution requirement for parenteral routes

Resulting Procedural Structure

Step sequence:

Initiate treatment at a low dose via the appropriate route (oral or parenteral) for the patient’s condition.
Titrate the dose by gradually increasing the daily intake until the minimum effective level is established, adhering to approved maximum limits.
Adhere to the required patient positioning (e.g., lying down) after injection or during the start of a high-dose oral regimen.
Reduce the dosage to the minimum effective maintenance level once clinical stability is established.

Connection to the overall use protocol: The instructions establish a structured protocol that begins with the selection of the correct administration route and dose range based on the clinical context. This is followed by a process of titration, where the dosage is gradually adjusted to optimize the required level. The documentation also defines the necessary technical steps for preparation (like dilution) and post-administration patient management (such as positioning), which are part of the protocol for administering the medicine.

Recent Clinical Evidence

Nozinan 100: Research Evidence Overview

Research has explored levomepromazine in studies that examined two primary clinical situations. For acute agitation and psychotic distress, the evidence base includes Randomized Controlled Trials (RCTs) and systematic reviews, which evaluated the medicine in adult populations presenting with conditions like schizophrenia. These studies monitored changes in global clinical status and measured outcomes describing episodic or acute changes, such as agitation. Findings describe patterns observed over short- to medium-term periods. However, a key limitation is that the available evidence base consists of a limited number of recent RCTs, and the original trials frequently reported small total sample sizes.

For symptom relief in palliative care, the research examines outcomes related to physical discomfort like nausea, vomiting, and general restlessness. This evidence is derived mainly from Systematic Reviews that synthesize findings from non-randomized studies and open-label case reports, meaning the evidence quality is variable. The key limitation here is the lack of published, placebo-controlled RCTs specifically designed for many palliative applications.

Studies for levomepromazine have focused primarily on acute or episodic management, meaning there is limited information for long-term outcomes and tracking durability of response. Research has explored the medicine in studies including older adults in some cohorts, but results apply only to the populations studied, and data for certain subgroups remain insufficient.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Nozinan 100 (FAQ)

Q: How quickly does Nozinan 100 usually start working?

A: The time it takes for the medicine to start working varies depending on how it is administered. For the oral tablet, the active substance typically reaches its highest concentration in the bloodstream after approximately 2 to 3 hours. If the medicine is administered by injection, this peak concentration is reached faster, usually within 30 to 90 minutes.

Q: How long do the effects of Nozinan 100 last after taking a dose?

A: The duration of the effect is generally correlated with the drug's elimination half-life. According to the official product information, the elimination half-life is between 15 to 30 hours, which helps determine the duration of the medication's clinical action.

Q: How long can a person stay on Nozinan 100?

A: Regulatory documents indicate that long-term treatment is possible but requires careful and regular monitoring by a healthcare professional. Official documentation indicates that the dosage is typically reduced to the minimum level necessary for maintenance once stability is achieved. Special caution is noted for older adults during prolonged use due to an increased risk of certain movement disorders.

Q: Can Nozinan 100 be used long-term?

A: Yes, official safety information indicates that if long-term treatment is required, careful monitoring should be employed. It is noted that continuous or prolonged use, especially in older adults, carries an increased risk of developing drug-induced Parkinsonism (a movement disorder).

Q: Can Nozinan 100 affect a person's mood in other ways?

A: The medicine is officially indicated for suppressing severe psychomotor restlessness and agitation and has a strong sedative effect. However, official reports also include adverse effects such as disorientation or confusion. Other psychological changes are described in the official adverse effect profile.

Q: What are the less common, but serious side effects of Nozinan 100?

A: Regulatory safety documents describe several serious, though less frequent, adverse reactions. These include Neuroleptic Malignant Syndrome (NMS), a severe life-threatening reaction; severe blood disorders like Agranulocytosis; and serious heart rhythm disturbances such as Torsade de Pointes. Venous Thromboembolism (VTE), which is the formation of blood clots, is also listed as a risk.

Q: Does Nozinan 100 interact with common pain relievers?

A: Official interaction warnings state that Phenothiazines may intensify the Central Nervous System (CNS) depressant actions of other agents. This includes opiates or other analgesics (pain relievers). Combining these medications may result in increased drowsiness and a heightened risk of respiratory depression.

Q: Can Nozinan 100 be crushed or split?

A: The 100 mg tablets are designed with a break-line, which means they can be divided into equal doses if required by a medical professional. However, regulatory information describes the use of the tablet as being swallowed whole, unless specific instruction for a partial dose has been provided.

Q: Can Nozinan 100 interact with supplements like melatonin?

A: While specific interactions with supplements like melatonin are not consistently detailed, the sedative actions of Levomepromazine are additively intensified by other sedating substances. Given the potential for additive sedative effects, caution is warranted when combining this medication with any sedative supplements, as this may increase drowsiness and impair alertness.

Q: Does Nozinan 100 have any long-term monitoring requirements?

A: Yes, official warnings advise that patients on long-term treatment require specific monitoring. This includes regular monitoring of the complete blood count due to the risk of a severe blood disorder, and monitoring of the QT interval using an ECG to check heart rhythm.

Q: Does Nozinan 100 cause weight gain?

A: Official reports indicate that weight gain is a potential adverse effect of this medication, classified under the endocrine and metabolic system side effects.

Q: Is it hard to stop taking Nozinan 100 once you start?

A: Official guidance advises that to help prevent relapse and potential acute withdrawal symptoms, the medication’s label indicates that gradual withdrawal is advisable and should occur under medical supervision. Sudden stopping of high doses has been very rarely reported to cause withdrawal symptoms.

Q: What happens if you miss a dose of Nozinan 100?

A: The official patient information leaflets do not provide a specific instruction for handling a missed dose. If there is uncertainty about how to proceed after missing a dose, consultation with a doctor or pharmacist is advised for guidance specific to the prescribed schedule.

Q: Can Nozinan 100 affect a person's liver function?

A: Yes, Levomepromazine is extensively broken down (metabolized) by the liver. Due to this, the medicine should be used with special caution in patients with hepatic impairment, and serious adverse effects like jaundice have been reported in safety documents.

Q: How is Nozinan 100 different from Chlorpromazine?

A: Both are in the same class of medicines, but Levomepromazine is clinically described as being more sedative than Chlorpromazine. It is often used as an alternative when the primary goal is to reduce psychomotor activity or when the specific anti-emetic (anti-nausea) effects of Levomepromazine are desired.

Q: Is Nozinan 100 used to treat nausea or vomiting?

A: Yes, one of the official indications for Nozinan 100 is the treatment of refractory nausea (nausea that does not respond to other drugs). It is typically used as a second or third line treatment for adults when other anti-nausea agents have failed.

Q: Can Nozinan 100 cause sensitivity to sunlight?

A: Yes, the official warnings specify a risk of photosensitization (increased sensitivity to sunlight). Due to this risk, official information suggests that minimizing exposure to direct sunlight may be advisable during treatment.

Q: Is Nozinan 100 a controlled substance?

A: In many countries, Levomepromazine is not classified as a DEA-scheduled controlled substance. However, due to its potency and safety profile, it is strictly managed as a Prescription Only Medicine (POM) in countries like the UK and Australia. In some regions, it is categorized as an 'other controlled substance'.

Q: Are there any known herbal supplement interactions with Nozinan 100?

A: Specific herbal interactions are not consistently listed in all core documents. However, because the drug is a strong Central Nervous System (CNS) depressant and is metabolized by the liver, combination with any other sedative substance may intensify the CNS depressant actions. Discussion of all supplements with a healthcare provider is generally recommended.

Q: Is there a risk of movement issues, like tremors, with Nozinan 100?

A: Yes, official safety information lists a risk of various movement issues, known as extrapyramidal reactions. These include Parkinsonian-like syndrome (which can involve tremors), dystonia (involuntary muscle contractions), and tardive dyskinesia (uncontrollable, repetitive movements).

How should Nozinan 100 be stored and disposed of?

How to Store and Dispose of Nozinan 100?

Nozinan 100 (levomepromazine maleate) tablets must be stored according to specific conditions to maintain their stability and effectiveness.

Storage Requirements

Temperature: Store the tablets below 25 C (or 77 F).
Protection: It is mandatory to keep Nozinan 100 in its original container and protected from light at all times.
Stability: When stored correctly, the tablets have a long shelf life, varying from 24 to 60 months depending on the specific packaging (e.g., blister or bottle). After the expiration date, the medication should not be used.

Disposal Instructions

Currently available drug labeling for Nozinan 100 does not provide specific instructions for environmental disposal, such as prohibitions against flushing or requirements for specialized controlled waste. Consult your pharmacist or local waste management authority for the appropriate and safe disposal method for unused or expired medication.

Nozinan 100