Prexolan

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Prexolan

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.

Overview of Prexolan

Prexolan is a brand-name, synthetic, prescription-only medication whose active ingredient is olanzapine (INN), a psychotropic agent classified as a second-generation antipsychotic (SGA), or atypical antipsychotic. Olanzapine is chemically identified as a thienobenzodiazepine derivative.


Quick Facts

Property Description
Active ingredient Olanzapine
Pharmacological class Second-Generation Antipsychotic (SGA)
Forms Tablet, ODT, Powder for injection
Route of administration Oral, Intramuscular
Origin Synthetic (Thienobenzodiazepine derivative)

What Type of Medicine is Prexolan?

The medication is categorized as an atypical antipsychotic, a modern pharmaceutical class characterized by its unique receptor binding profile. This class is clinically recognized for its high affinity for both dopamine (D2) and serotonin (5-HT2A) receptors, a key feature that distinguishes it from older agents. This broad action means the medication works to regulate a wider range of key chemical signals in the brain.

Composition and Available Forms of Olanzapine

Prexolan is a single-ingredient product utilizing olanzapine and is supplied for administration via two primary routes: oral forms, including film coated tablets and orally disintegrating tablets (ODTs), and parenterally, as a sterile powder for injection for intramuscular use. The variety of forms ensures that healthcare providers can administer the medicine appropriately, whether for stable daily management or acute stabilization.

What is the General Purpose of Taking Prexolan?

The general purpose of Prexolan is clinically recognized for its ability to promote stability in the brain's regulatory systems. It helps manage severe disruptions in thought, mood, and behavior. By modulating the activity of neurotransmitters like dopamine and serotonin, the medication works as a monoaminergic antagonist to stabilize mental processes, facilitating clearer thinking and more grounded emotional responses.

Regulatory References

  1. Olanzapine: Mechanism of Action and Receptor Binding Profile

What side effects are possible with Prexolan?

Possible Side Effects and Safety Information

The safety profile of Prexolan (olanzapine) is defined by officially documented adverse reactions classified by frequency and body system, as established in government regulatory materials.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their documented occurrence in clinical studies. Very Common reactions (occurring in 10% or more of users) include somnolence (drowsiness) and weight gain, alongside elevated levels of the hormone prolactin. Common reactions (occurring in 1% to 10% of users) involve changes such as dizziness, orthostatic hypotension (a drop in blood pressure when standing), peripheral edema, increased appetite, dry mouth, constipation, and elevated levels of hepatic aminotransferases or certain lipids (triglycerides and cholesterol).


System-Organ Classes and Serious Reactions

The most frequently affected system-organ classes are Metabolism and Nutrition Disorders and Nervous System Disorders. Serious adverse reactions, though generally rare, are documented in the official labeling. These include Neuroleptic Malignant Syndrome (NMS), seizures, and Venous Thromboembolism (VTE). Additionally, significant metabolic changes, such as severe hyperglycemia and diabetes mellitus, are also noted.


Safety Considerations and Constraints

Certain safety patterns are associated with the duration of use. Orthostatic hypotension and somnolence are officially noted to be more frequent during the initial phase of treatment. Conversely, weight gain and elevated lipid/glucose levels are effects associated with long-term exposure. A specific constraint is noted for older adults with dementia-related psychosis, who have a documented increased risk of cerebrovascular adverse events.

Overdose and Emergency Response

Overdose and When to Seek Help

The information in this section is derived strictly from official government regulatory documents regarding olanzapine (Prexolan) overdose.

Documented Overdose Manifestations

Olanzapine overdose is officially documented to primarily affect the central nervous system (CNS) and the cardiovascular system. Manifestations include severe drowsiness progressing to coma, agitation, slurred speech, and sudden, uncontrollable movements. Cardiovascular signs include a rapid heart rate (tachycardia) and low blood pressure (hypotension).

Severe complications documented in regulatory sources include the risk of convulsions (seizures), cardiac arrhythmias, respiratory depression, and the potential for Neuroleptic Malignant Syndrome (NMS). Fatal outcomes have been reported in acute cases.

Required Emergency Actions

If an overdose is suspected, immediate medical attention is required. The official documents mandate calling emergency services (e.g., 911) if the person has collapsed, had a seizure, has trouble breathing, or can't be awakened. It is also recommended to contact the Poison Control Helpline.

There is no specific antidote available for olanzapine overdose. Management must be entirely supportive, involving establishing and maintaining an airway and providing continuous support for cardiovascular and respiratory function.

Monitoring Requirements

Continuous hospital monitoring is required for any suspected overdose. Additionally, regulatory documents note that overdose in children may be associated with more significant adverse effects and often requires more active intervention than in adults.

Therapeutic Uses of Prexolan

What Prexolan Treats: Main Uses and Benefits

Prexolan (olanzapine) is generally relevant in clinical settings marked by heightened patient distress, offering symptomatic relief and stabilization across several major therapeutic domains where symptoms create noticeable interference with daily stability. The core therapeutic uses for olanzapine are applied across domains where additional symptomatic support is needed, including the management of symptom patterns associated with major conditions like schizophrenia and bipolar I disorder.

The medication is commonly used to help with groups of symptoms that may become intense or disruptive, such as those related to psychosis, acute mania, and agitation. It provides supportive relief when symptoms interfere with routine activities. For example, it is relevant for easing the symptom burden of hallucinations, delusions, disorganized thought, and severe hyperactivity. The medication plays a role in managing symptoms that create noticeable functional strain, assisting patients in coping more steadily with difficult episodes.

Quick Fact: Relief for Psychotic and Manic Episodes

Prexolan is commonly used to help manage symptoms during acute episodes of schizophrenia and bipolar I disorder, and supports the patient during episodes of heightened discomfort by easing distressing manifestations and promoting behavioral stability.

Eligibility and Restrictions for Use

Who Can and Cannot Use Prexolan?

The population eligibility for Prexolan (olanzapine) is strictly defined by official regulatory documentation, outlining who is approved for use and who is formally excluded. The medicine is officially approved for use in adults (18 years and older). Specific oral uses are also approved for adolescents aged 13 to 17 years for certain conditions, but use is not established for children younger than 13 for monotherapy.

Absolute Non-Eligibility

The medicine must not be used by individuals with a known hypersensitivity or allergy to olanzapine or any component of the formulation. Use is prohibited in elderly patients with dementia-related psychosis, a population exclusion supported by a regulatory warning due to an increased risk of death.

Conditional Use and Restrictions

Certain patient groups require conditional use or exclusion based on pre-existing conditions. Individuals with hepatic impairment (liver dysfunction) or a history of seizures must use the medicine cautiously. The Orally Disintegrating Tablet (ODT) form is contraindicated for patients with phenylketonuria (PKU).

During pregnancy, particularly the third trimester, use is restricted and is only permissible if the potential benefit outweighs the documented risk to the neonate. Breastfeeding is not recommended, as the substance is excreted into human milk.

What should I know about interactions with other medicines?

Prexolan (olanzapine) has documented interaction patterns that primarily involve pharmacokinetic changes altering its concentration in the body and pharmacodynamic effects modifying its physiological impact when combined with other substances.

A major restriction documented by regulatory authorities is the contraindication against co-administering the intramuscular form of olanzapine with intramuscular diazepam, due to a heightened risk of severe sedation and cardiorespiratory depression.

The clearance of olanzapine is significantly affected by co-administered medicines that influence the CYP1A2 enzyme pathway. Agents such as the antidepressant fluvoxamine and the antibiotic ciprofloxacin act as CYP1A2 inhibitors, which formally increases olanzapine exposure by reducing its clearance. Conversely, substances that induce CYP1A2 activity, such as the anticonvulsant carbamazepine and tobacco smoking, significantly decrease olanzapine plasma concentrations.

Pharmacodynamic interactions involve additive effects on the central nervous system. Co-administration with alcohol or other centrally acting agents may increase sedation or cognitive impairment. Similarly, combining olanzapine with antihypertensive medications can lead to enhanced hypotensive effects, resulting in a greater risk of low blood pressure upon standing. Consideration must be given to patients who exhibit factors that may slow drug metabolism, such as non-smoking status or older age, as these conditions are linked to higher olanzapine exposure.

Mechanism of Action

Prexolan, chemically olanzapine, functions as a multi-receptor antagonist throughout the central nervous system. Its primary biological targets are dopamine and serotonin receptors. The compound exhibits high-affinity binding and antagonistic activity at multiple dopamine receptor subtypes, notably the D2 receptor. This D2 antagonism occurs predominantly within the mesolimbic pathway, where it blocks the post-synaptic binding of the endogenous neurotransmitter, thereby modulating dopaminergic signaling.

Prexolan also serves as a potent antagonist at various serotonin receptors, particularly the 5-HT2A subtype. Antagonism of 5-HT2A receptors in the frontal cortex is hypothesized to disinhibit the release of dopamine in this specific region. This multi-site receptor blockade, including additional antagonistic action at histamine H1 and muscarinic M1- M5 receptors, alters numerous intracellular signaling cascades, ultimately leading to widespread system-level physiological modulation of neurotransmission and subsequent neuroendocrine function across several brain regions.

Dosage and Administration Information

How Prexolan (Olanzapine) is Used: Official Administration Patterns

Prexolan is administered through two official routes: oral for daily long-term management and intramuscular (IM) injection strictly for short-term acute stabilization. The usage protocol is standardized and varies based on the form and treatment phase.

Oral forms are taken once daily and may be administered with or without food. The medication is available in standard tablets and orally disintegrating tablets (ODTs), where ODTs must be allowed to dissolve on the tongue without water immediately after opening the blister. For conditions like schizophrenia, the starting oral dose is typically 5 mg or 10 mg, aiming for a maintenance range often between 10 mg/day to 20 mg/day. The maximum recommended oral daily dose is 20 mg.

Dose adjustments are mandated to be gradual, typically in 5 mg increments, and should occur at intervals of not less than one week. A lower starting dose of 5 mg/day should be considered for older adults (65 years and over) and patients with hepatic impairment.

The IM injection is reserved for acute, short-term use. The typical IM dose is 5 mg or 10 mg, which may be repeated after a minimum of 2 to 4 hours, not exceeding a total of 30 mg in a 24-hour period. The powder must be reconstituted before injection, and the formulation is not for intravenous or subcutaneous use. This structured approach ensures administration adheres to the precise conditions established for this therapeutic approach.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Prexolan


Evidence for Use in Schizophrenia

The research evidence is comprised of numerous short-term Randomized Controlled Trials (RCTs), where Prexolan (olanzapine) was studied for its use in the context of symptoms associated with schizophrenia. These studies were used in research exploring how symptoms change over time compared to a placebo or other active antipsychotic agents. The research also included longer-term observational studies tracking patients over extended periods. These trials examined outcomes related to episodic or acute changes, primarily focusing on the measurement of symptom intensity or variability. Studies reported how symptoms evolved in the observed populations, including adults and adolescents. However, long-term effects are not fully established because follow-up durations were limited in many controlled trials, and treatment discontinuation was common.


Evidence for Use in Bipolar I Disorder

The evidence base for Prexolan also was evaluated in conditions involving periods of heightened symptoms, specifically Bipolar I Disorder. Research explored the use of the medicine in trials designed to evaluate outcomes during acute manic or mixed episodes and maintenance treatment. These studies examined outcomes describing episodic or acute changes in mood, using scales to measure the severity of both manic symptoms and depressive symptoms. Findings describe patterns observed in the studies related to outcomes capturing phases of heightened symptom activity. The evidence for treating bipolar depression when Prexolan is used alone was observed in some studies to have mixed findings.


What is Still Uncertain About the Research Base

The research base for Prexolan, while substantial, still presents several areas where certainty remains low. Long-term effects are not fully established due to limitations in study duration. Research exploring outcomes reflecting daily functioning or activity level over extended periods is limited. Evidence highlights what is known—and what is still uncertain—and stresses that research is ongoing to address these evidence gaps.

Frequently Asked Questions (FAQ)

Common questions about Prexolan (FAQ)


Q: How quickly does Prexolan start to work?

A: Studies and official information indicate that clinical trials typically measure the initial change in symptoms within the first one to two weeks of starting treatment. Regulatory documents do not provide a specific time frame for the onset of the medicine's full effect, as the individual response time can vary widely among patients.

Q: If I miss a dose of Prexolan, what happens?

A: According to the official product information, if a dose is missed, it may be taken as soon as the patient remembers. However, official instructions state that if it is close to the time for the next scheduled dose, the patient is advised to skip the missed dose and resume the usual schedule. This information helps ensure proper administration as directed by a healthcare provider.

Q: Why is it important to keep taking Prexolan even if I feel better?

A: Official regulatory documents indicate that the medicine is approved for the maintenance of effect in long-term conditions. Discontinuation of treatment is associated with documented risks of symptoms recurring. For this reason, the continuation of treatment is determined and monitored by a healthcare professional.

Q: Is Prexolan safe to take with alcohol?

A: Regulatory documents describe that combining Prexolan with alcohol may lead to an increase in sedation (drowsiness) and a heightened risk of orthostatic hypotension (a drop in blood pressure when standing). These effects are associated with the combined use of central nervous system depressants.

Q: Is Prexolan habit-forming or addictive?

A: Official labeling does not classify olanzapine, the active ingredient, as a controlled substance. Regulatory documentation does not list the medicine as having a known risk for abuse or dependence.

Q: Are there any food restrictions while taking Prexolan?

A: According to the official product information, oral forms of the medicine are described as being able to be administered with or without food. There are no specific food restrictions cited in regulatory documents.

Q: Is Prexolan a controlled substance?

A: Olanzapine is not classified as a controlled substance under the regulatory schedules of major government agencies, such as the US Drug Enforcement Administration (DEA) or its international equivalents.

Q: What happens if I stop taking Prexolan suddenly?

A: Official warnings state that abrupt discontinuation should be avoided. Stopping suddenly may be associated with symptoms such as nausea, vomiting, sweating, tremor, or difficulty sleeping. Gradual dose reduction is described in the regulatory approach to ending treatment.

Q: What is the risk of withdrawal symptoms from Prexolan?

A: Regulatory documentation notes that symptoms like nausea, vomiting, or tremor may occur following abrupt cessation. Regulatory documents emphasize that dose reduction should be gradual and managed by a healthcare provider.

Q: Can Prexolan be used long-term?

A: Regulatory documents indicate that the medicine is officially approved for the maintenance treatment of certain conditions. This maintenance indication supports its use over extended periods of time.

Q: Does taking Prexolan affect my ability to drive?

A: Official regulatory documents advise caution when operating machinery or driving, especially when treatment is first starting. This is due to the potential risk of side effects like somnolence (drowsiness) and orthostatic hypotension (dizziness upon standing).

Q: What should I do if I think I'm having a bad reaction to Prexolan?

A: Official regulatory materials describe that for severe reactions, such as an allergic reaction or signs of serious side effects, immediate medical attention or contact with a healthcare provider is recommended. Patients should be familiar with the documented serious adverse reactions.

Q: Is there a generic version of Prexolan available?

A: Yes, the active ingredient, olanzapine, is available in a generic formulation. This availability is noted in regulatory drug approval status records following the expiration of patent protection for the original product.

Q: Does Prexolan interact with caffeine?

A: Regulatory documents state that substances which inhibit the CYP1A2 enzyme can increase the concentration of olanzapine in the body. Caffeine is known to affect this metabolic pathway, suggesting a potential for interaction.

Q: Can Prexolan cause headaches?

A: Headaches are listed among the documented adverse reactions observed in clinical trials, according to official regulatory adverse events tables.

Q: Will Prexolan change my personality?

A: The medicine is intended to promote stability and manage severe disruptions in thought and behavior associated with the approved conditions. Regulatory documents do not describe the medicine as altering a patient's fundamental personality.

Q: Is Prexolan effective for everyone who tries it?

A: Clinical trial results are described using statistical averages, which highlights that effectiveness can vary. Clinical trial data highlights that effectiveness can vary among patients.

Q: Is it normal to feel worse when first starting Prexolan?

A: Regulatory documents note that certain side effects, such as somnolence (drowsiness) and orthostatic hypotension (dizziness upon standing), are more frequent during the initial phase of treatment. These documented effects can influence how a patient feels when first starting the medicine.

Q: Can Prexolan affect my sex life?

A: Adverse reactions related to sexual function, including decreased libido, are documented in the official labeling under the list of frequency-classified side effects reported during clinical studies.

Q: Can Prexolan cause changes in mood besides the intended effect?

A: Yes, adverse reactions documenting changes in mood or behavior, such as agitation or nervousness, are listed among the reported side effects in official regulatory materials.

Q: Is Prexolan safe during pregnancy or breastfeeding?

A: The use of the medicine is restricted in pregnancy, particularly the third trimester, and is only permissible if the potential benefit is determined to outweigh the documented risks. Breastfeeding is not recommended, as the substance is excreted into human milk.

Q: What should I tell my doctor before starting Prexolan?

A: Official warnings and contraindications imply that a healthcare provider should be informed of specific pre-existing conditions. These include known hypersensitivity (allergies), a history of seizures, hepatic impairment (liver problems), and whether the patient is an older adult with dementia-related psychosis.

Q: Is Prexolan used to treat chronic pain?

A: The approved uses for the medicine are restricted to specific psychiatric conditions, such as schizophrenia and bipolar I disorder. Regulatory documents do not include the treatment of chronic pain as an official indication.

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

A: Regulatory documents state that substances which induce or inhibit the CYP1A2 enzyme can alter olanzapine concentrations. Many herbal supplements are known to affect these metabolic pathways, and patients should be mindful of this potential for interaction.

Q: Do I need to change my diet while on Prexolan?

A: Official warnings describe a risk of metabolic changes associated with the medicine, including weight gain and elevated lipid and glucose levels. These documented effects often require monitoring and potential lifestyle adjustments related to diet.

Q: Is Prexolan the same type of medicine as [similar drug name]?

A: The medicine is classified as a second-generation antipsychotic with a distinct pharmacological profile. Regulatory documents describe its mechanism as involving antagonism at both dopamine and serotonin receptors, which distinguishes it from many other drug classes.

Q: What is the difference between Prexolan and a standard antidepressant?

A: Regulatory materials classify the medicine as an atypical antipsychotic that works through the dual antagonism of dopamine and serotonin receptors. This mechanism is different from that of standard antidepressant classes, such as selective serotonin reuptake inhibitors (SSRIs).

Q: How long does Prexolan stay in your system?

A: Official regulatory documents contain pharmacokinetic information, which describes how the body handles the medicine. The half-life of olanzapine is documented as being approximately 30 hours, though this can range between 21 and 54 hours in adults.

Q: Why is Prexolan sometimes given with another medicine?

A: The medicine is specifically approved in the official indications for use in combination with certain other medicines. This approach is sanctioned for treating complex conditions such as bipolar I disorder or treatment-resistant depression.

How should Prexolan be stored and disposed of?

How to Store and Dispose of Prexolan? (Official Regulatory Information)

Storage & Disposal Scope Requirements Based on Regulatory Documents
Labeled Storage Temperature Store at room temperature (typically 20 C to 25 C), or below 30 C.
Light/Moisture Protection Must be protected from light, excess heat, and moisture. Do not store in the bathroom.
Handling & Packaging Rules Keep the medicine in the tightly closed, original container. Orally Disintegrating Tablets (ODT) must be used immediately after opening their sealed package. Do not freeze.
Child-Protection Storage Keep this medication out of the sight and reach of children and use safety caps where applicable.
Disposal Instructions Do not keep outdated or unused medicine. Consult your healthcare professional or follow local take-back programs for disposal. Avoid flushing or discarding in wastewater unless specifically instructed by official guidelines.

Official storage and disposal statements: Regulatory documents require storing the product in its original, tightly closed container and protecting it from environmental constraints like light, heat, moisture, and freezing. Disposal must follow official channels, ensuring unused product is properly discarded and kept inaccessible to children.

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

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