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Кетилепт

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Кетилепт

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Method of action: Antipsychotic

Treatment option: Bipolar Disorder, Schizophrenia

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Кетилепт

Property Description
Active ingredient Quetiapine fumarate
Form Film-coated tablets
Pharmacological class Atypical antipsychotic (Second-generation)
Common use Systemic stabilization of mood and thought patterns
Origin Synthetic
Status Prescription-only (Rx)

Кетилепт is a prescription-only medicine and a single-compound product manufactured primarily by Egis Pharmaceuticals PLC. This brand specifically provides Quetiapine (as Quetiapine fumarate) in the form of film-coated tablets for systemic use. The active substance is a synthetic compound structurally categorized as a dibenzothiazepine derivative, and it is one of the most clinically recognized atypical antipsychotics available for managing serious mental health conditions.

What is the Active Ingredient and Class of Кетилепт?

The core component of Кетилепт is Quetiapine, which places it within the Pharmacological class of second-generation antipsychotics (SGAs), also known as neuroleptics. Quetiapine is characterized by its therapeutic efficacy in treating mood and psychotic disorders. This establishes the drug's role as an agent for stabilizing complex neurochemical imbalances. Кетилепт distinguishes itself by being a highly distributed, orally administered psychotropic agent with a rapid absorption profile for its immediate-release tablet form.

What is the General Purpose of this Atypical Antipsychotic?

The general purpose of the psychotropic agent is to achieve systemic neurochemical stabilization in adults and adolescents by providing balanced control over key brain messengers. This stabilization involves the management of the full spectrum of bipolar disorder symptoms. This indicates that the medicine is used for both manic and depressive episodes. The therapeutic use of Кетилепт involves leveraging its multireceptor action—specifically the antagonism of dopamine D2 receptors and serotonin 5-HT2 receptors—to influence thought and mood stability, serving as a foundational treatment for conditions like schizophrenia and psychoses.

Regulatory References

  1. NIH Quetiapine Monograph
  2. EMA Product Information for Seroquel/Quetiapine
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What side effects are possible with Кетилепт?

Official Safety Profile and Adverse Reactions

The safety profile of Quetiapine fumarate (Кетилепт) is defined by regulatory documents, which classify potential adverse reactions based on their frequency of occurrence and the physiological system affected. The medicine's risk profile includes both common, expected effects and the potential for rare, serious adverse events.

Frequency-Classified Adverse Reactions

The following effects are organized by the standard frequency tiers used in official labeling:

Classification Examples of Documented Effects
Very Common (ge 1/10) Somnolence, Dizziness, Dry mouth, Weight gain, Elevated triglycerides, and Total cholesterol increase.
Common (ge 1/100 to < 1/10) Tachycardia, Orthostatic hypotension (dizziness upon standing), Constipation, Blurred vision, and Extrapyramidal symptoms (EPS).
Uncommon (ge 1/1,000 to < 1/100) Seizure, Tardive Dyskinesia, and Hypersensitivity reactions (e.g., Anaphylaxis).
Rare (ge 1/10,000 to < 1/1,000) Neuroleptic Malignant Syndrome (NMS), Priapism, and Venous Thromboembolism (VTE).

System-Organ and Serious Safety Concerns

Adverse reactions are documented across several physiological systems. These include Metabolism and nutrition disorders, such as the potential for hyperglycemia and significant weight gain, and Nervous system disorders, which include somnolence and the risk of developing Tardive Dyskinesia with prolonged use. Effects on the Blood and the lymphatic system (e.g., leukopenia) are also officially noted.

Serious Adverse Reactions highlighted in regulatory text include Neuroleptic Malignant Syndrome (NMS), Tardive Dyskinesia (a syndrome of involuntary movements), and the rare potential for Venous Thromboembolism (VTE).

Population-Specific Safety Notes

The official label contains specific safety statements for certain groups. The medicine is not approved for treating psychosis in older adults with dementia due to increased mortality risk. Additionally, pediatric and adolescent populations are documented as having a generally higher incidence of Extrapyramidal Symptoms (EPS), increased prolactin levels, and weight gain compared to adults. The effects of somnolence, dizziness, and orthostatic hypotension are officially noted as being more frequently observed at the start of treatment or during dose escalation.

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Overdose and Emergency Response

Overdose and When to Seek Help

Immediate medical attention is required if a Quetiapine overdose is suspected, as documented in official regulatory guidance. The official overdose profile is characterized by an exaggeration of known effects on the central nervous and cardiovascular systems.

Officially documented clinical manifestations include prominent somnolence (severe drowsiness), tachycardia (rapid heart rate), and hypotension (low blood pressure) [1.1, 2.5]. More severe outcomes officially reported include coma, respiratory depression requiring mechanical ventilation, seizures, and the risk of QTc interval prolongation [2.3, 4.2].

Required Emergency Actions

The established treatment in regulatory guidance is strictly symptomatic and supportive, as no specific pharmacological antidote is known [1.3, 4.2]. Management protocols mandate the maintenance of an adequate airway, provision of oxygenation and ventilation, and continuous cardiovascular monitoring (including ECG) to observe for cardiac events [2.3, 4.1].

In cases of severe hypotension, Norepinephrine is the required vasopressor; the use of Epinephrine or Dopamine should be avoided due to the potential for paradoxical worsening of the low blood pressure [2.3, 4.1]. Patients with severe symptoms or those who ingested modified-release formulations typically require a prolonged period of hospital observation [1.3].

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Therapeutic Uses of Кетилепт

Kетилепт (Quetiapine) is commonly used across therapeutic domains involving symptoms related to systemic imbalance that affect thought patterns and mood. The medication is applied in clinical settings that involve acute or unstable symptom patterns associated with major psychiatric conditions.

The medicine is used for managing conditions like Schizophrenia, where it helps address symptom clusters that may become intense or disruptive, such as hallucinations and delusions. It is also considered relevant in conditions characterized by periods of heightened symptoms, specifically Bipolar Disorder, where it is used to help with both the extreme energy of manic episodes and the persistent low mood of bipolar depressive episodes. Furthermore, it is commonly used in conditions associated with Major Depressive Disorder, where additional symptomatic support may be needed.

This provides support that helps ease the overall symptom burden, and may assist with supporting functional stability. The medication helps patients cope more steadily with difficult mood swings, supporting the patient during difficult episodes by easing distress.

“The medicine is used to offer symptomatic relief and helps manage challenging thought and mood fluctuations.”

Quick Fact: Support for Affective Symptoms
Kетилепт is applied in addressing both manic symptoms (e.g., racing thoughts, agitation) and depressive symptoms (e.g., persistent low mood, loss of interest) associated with Bipolar Disorder.
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Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Кетилепт (Quetiapine)

Official regulatory documents define specific populations who are eligible for treatment and others for whom use is contraindicated or restricted.

Classification Population Status Defined by Regulators
Absolute Contraindication Patients with known hypersensitivity to quetiapine or any formulation component. Must Not Use (Prohibited)
Elderly patients with dementia-related psychosis. Must Not Use (Not Approved/Prohibited)
Patients taking strong CYP3A4 inhibitors concurrently. Contraindicated (Drug-Interaction Linked)
Pediatric Eligibility Children under 10 years of age. Not Approved/Not Recommended
Adolescents (Ages ge 10 or ge 13 years). Allowed for specific indications (e.g., Schizophrenia, Bipolar Mania).
Conditional Use/Caution Patients with hepatic impairment (liver disease). Allowed, but Caution Required (Must be monitored)
Patients with known cardiovascular disease or a risk of hypotension. Allowed, but Caution Required
Elderly patients (Ages ge 65) for general use. Allowed, but Caution Required (Slower titration/monitoring)
Reproductive Status Pregnancy. Use Not Recommended unless clearly necessary (Restricted)
Breastfeeding women. Use Not Recommended (Discontinuation of drug or nursing advised)
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Quetiapine (the active ingredient in Ketilept) is primarily defined by its metabolism through the Cytochrome P450 3A4 (CYP3A4) enzyme and its potential for additive central nervous system (CNS) depression and QTc interval prolongation.

Pharmacokinetic Interactions (Enzyme-Related)

Concomitant use with strong inhibitors or inducers of the CYP3A4 enzyme significantly alters Quetiapine's concentration in the body, necessitating dose adjustments as directed by a healthcare professional.

Interaction Mechanism Interacting Agent Examples Regulatory Action
Strong CYP3A4 Inhibition Ketoconazole, Ritonavir, Erythromycin, Grapefruit juice Requires a substantial dose reduction of Quetiapine due to increased exposure.
Strong CYP3A4 Induction Phenytoin, Rifampin, Carbamazepine, St. John's wort Requires a significant dose increase of Quetiapine, or combination should be avoided, due to reduced efficacy risk.

Pharmacodynamic Interactions

Quetiapine should be used with caution when combined with other medicines or substances that share similar effects on the body's systems:

  • Other CNS Depressants: Coadministration with alcohol or other centrally acting agents (e.g., sedatives) may potentiate sedation and other CNS depressant effects. Avoid alcohol consumption.
  • QTc Prolonging Agents: Caution is required with medicines known to prolong the QTc interval or cause electrolyte imbalance due to the potential for an additive effect on the heart rhythm. Monitoring is recommended.
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Mechanism of Action

Quetiapine (Кетилепт) is an atypical antipsychotic agent that engages multiple neurotransmitter receptors and transporters to modulate key signaling pathways within the central nervous system. This pharmacodynamic action results in the downstream adjustment of physiological processes.

It functions primarily as an antagonist at the dopamine D2 and serotonin 5-HT2A receptors, which influences central nervous system pathways by suppressing specific signaling sequences. Its active metabolite, norquetiapine, also contributes by antagonizing histamine H1 and alpha1 and alpha2 adrenergic receptors. H1 antagonism influences central nervous system function, while alpha1 antagonism modulates peripheral vascular responses, resulting in altered sympathetic activity and vascular tone.

Norquetiapine additionally acts as a partial agonist at the serotonin 5-HT1A receptor and inhibits the norepinephrine transporter (NET). NET inhibition increases synaptic norepinephrine concentrations. These modifications influence the feedback regulation within pathways that affect mediator activity.

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Dosage and Administration Information

Кетилепт (Quetiapine fumarate) is an oral medication available as Immediate-Release (IR) and Extended-Release (XR) film-coated tablets. Proper administration is governed by formulation type and a gradual dose adjustment schedule.

Dosing and Administration Schedule

The medicine must always be initiated using a titration schedule, where the dose is gradually increased over several days (e.g., Days 1–4) until the recommended effective dose is reached. The schedule is specific to the condition being managed. For example, IR tablets are typically dosed twice or three times daily, whereas XR tablets are taken once daily, often in the evening.

Formulation Dosing Frequency Meal Instruction
Immediate-Release (IR) Divided doses (e.g., twice daily) May be taken with or without food.
Extended-Release (XR) Once daily (e.g., in the evening) Must be taken without food or with a light meal (approx. 300 calories).

Administration Rules and Precautions

For the Extended-Release tablets, the official instruction is that the tablets must be swallowed whole and must not be split, chewed, or crushed. This is required to maintain the controlled release mechanism of the medicine.

Population-Specific Use

Dosage is adjusted for certain populations to account for altered metabolism:

  • Older Adults (Geriatric): A lower starting dose (e.g., 50 mg per day) and a slower titration rate are required.
  • Hepatic Impairment: Patients with known liver impairment must begin with a lower starting dose (e.g., 25 mg to 50 mg per day) and require cautious dose increases.

Discontinuation and Missed Doses

If discontinuation is necessary, a gradual withdrawal over a period of at least one to two weeks is recommended, as abrupt cessation may lead to withdrawal symptoms. If a dose is missed, the patient should take the next dose at the regularly scheduled time and should not take a double dose to compensate.

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Recent Clinical Evidence

Quetiapine (Кетилепт): Overview of Clinical Evidence


Clinical research has extensively evaluated quetiapine, the active compound in Ketilept, across several psychiatric conditions. The majority of evidence focuses on its use in Schizophrenia and Bipolar Disorder, with recent studies also exploring its role as an adjunctive treatment for Major Depressive Disorder (MDD).

Core Efficacy Findings

Condition Studied Primary Research Focus Key Findings Reported
Schizophrenia Influence on positive and negative symptoms. Studies evaluated whether the compound influenced acute episodes and maintenance of stability.
Bipolar Disorder Management of acute manic and depressive episodes. Research explored the compound's effect on symptom severity during both phases.
Major Depressive Disorder Adjunctive use with standard antidepressants. Studies assessed whether co-administration influenced reported measures of depression.

Mechanism of Action and Safety Assessments

Research has explored the compound's activity against certain neurotransmitter receptors in the central nervous system. This activity is thought to be the basis for its influence on symptoms. The compound's safety profile has been assessed across numerous trials, noting the frequency of adverse events.

Commonly reported events include somnolence (drowsiness), dry mouth, and dizziness. Researchers also monitor for metabolic changes, including alterations in weight and lipid levels. Long-term studies continue to evaluate the potential need for regular metabolic monitoring in patient populations receiving quetiapine.

Key Studies & References

  1. Quetiapine monotherapy for major depressive disorder: a systematic review and meta-analysis of randomized controlled trials.
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Frequently Asked Questions (FAQ)

Common questions about Кетилепт (FAQ)

Q: Can Кетилепт cause weight changes, and is that common?

Regulatory documents state that weight gain is a very common adverse reaction, meaning it has been reported in 10% or more of patients in clinical studies. Official product information notes that atypical antipsychotic medicines, including Кетилепт, have been linked to changes in metabolism, which can include increases in body weight.

Q: Is it true that Кетилепт can affect how sleepy I feel?

Somnolence, which is the term for drowsiness or sleepiness, is listed in official documents as a very common side effect. It is noted that this effect may be more pronounced when a person first begins treatment or when the dosage is being adjusted.

Q: Does Кетилепт have any important interactions with common over-the-counter pain relievers?

Official information does not make a general statement about all over-the-counter pain relievers. However, official documents note that combining substances that cause CNS depression with this medicine may potentially increase effects like drowsiness or sedation.

Q: Why do some people say they take Кетилепт for sleep issues?

Кетилепт is officially approved and studied for treating conditions like schizophrenia and bipolar disorder. The reason it is sometimes discussed in the context of sleep is because somnolence (drowsiness) is a very common side effect. Regulatory documents define the designated uses for the medication.

Q: Can Кетилепт be used by older adults?

Use in older adults is permitted, but regulatory guidance requires caution. Official information indicates a need for a lower starting dose and a slower dose-adjustment schedule for this population. However, the medicine is specifically not approved for use in elderly patients who have psychosis related to dementia due to an increased risk of death.

Q: Does Кетилепт affect blood sugar levels?

Official drug labeling states that atypical antipsychotic medicines have been associated with metabolic changes, including a risk of hyperglycemia (high blood sugar). The product information also notes that metabolic monitoring, including blood glucose, is generally recommended for those using the medicine.

Q: Does Кетилепт affect a person's ability to drive or operate machinery?

Official warnings state that a person's judgment or motor skills may be impaired due to effects like somnolence and dizziness. For this reason, official product labeling advises caution regarding activities requiring mental alertness, such as driving or operating hazardous machinery.

Q: Is Кетилепт considered a controlled substance?

The official labeling in the United States states that Quetiapine is not classified as a controlled substance under the Controlled Substances Act.

Q: Can Кетилепт affect cholesterol or fat levels in the blood?

Yes, regulatory documentation reports that metabolic changes, known as dyslipidemia, can occur with atypical antipsychotic use. This can involve changes in blood fats, such as elevated triglycerides and an increase in total cholesterol levels. Because of this association, metabolic monitoring, including cholesterol and triglyceride levels, is generally noted in official recommendations.

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

A severe allergic reaction is considered an uncommon event, but official patient information describes certain warning signs. These may include swelling of the lips, tongue, or throat, and experiencing difficulty swallowing or breathing.

Q: How is Кетилепт typically described in official medical information?

Official medical information describes the active ingredient, Quetiapine fumarate, as an atypical antipsychotic. Its function is to modify the activity of natural chemical messengers in the brain, such as dopamine and serotonin, to help stabilize mood and thought patterns in approved conditions.

Q: Does Кетилепт interact with blood pressure medications?

Caution is advised when using Кетилепт alongside any medication, including those for blood pressure. Official documentation notes a risk of orthostatic hypotension (a drop in blood pressure upon standing) which may be enhanced by co-administration with other hypotensive agents.

Q: Does Кетилепт cause issues with vision?

The product labeling lists blurred vision as a common side effect of the medicine. Furthermore, regulatory documentation notes that lens changes (cataracts) have been observed during long-term use, and official information indicates that regular eye examinations may be recommended to check for these changes.

Q: Are there studies on the combination of Кетилепт with antidepressants?

Yes, clinical research has been conducted and supports the use of Кетилепт as adjunctive therapy, meaning it is used in addition to standard antidepressant medications. This research was focused on patients with Major Depressive Disorder (MDD) who had not fully responded to antidepressant treatment alone.

Q: How is the need for continued treatment with Кетилепт determined?

Conditions like schizophrenia and bipolar disorder often require ongoing management. The need for continued use is based on the findings from maintenance clinical trials which assess the drug’s ability to prevent the return of symptoms (relapse) over time.

Q: What are the general expectations for a person starting treatment with Кетилепт?

Treatment is usually started at a low dose and gradually increased until the appropriate effective dose is reached. During this initial phase of adjustment, common effects such as dizziness, somnolence, and orthostatic hypotension (dizziness upon standing) are noted to be more frequently observed.

Q: Is there a risk of becoming dependent on Кетилепт?

Regulatory labeling indicates that the abuse or dependence potential of the active ingredient has not been systematically studied. However, official guidelines warn that abrupt cessation can lead to symptoms such as nausea, vomiting, or insomnia.

Q: Can a person stop taking Кетилепт on their own if they feel better?

Regulatory guidance recommends a gradual withdrawal process over one to two weeks if discontinuation is necessary. Abrupt cessation may lead to withdrawal symptoms such as insomnia, nausea, or vomiting.

Q: Are headaches a common side effect of Кетилепт?

Headache is listed as a potential effect in official drug documentation, and it may be reported during discontinuation. However, it does not consistently appear in the official 'very common' or 'common' frequency categories in major regulatory labels.

Q: Does the time of day matter when taking Кетилепт?

The timing depends on the specific formulation being used. The Extended-Release (XR) tablets are typically taken once daily in the evening without food or with a light meal. The Immediate-Release (IR) tablets are usually taken in divided doses throughout the day, with or without food.

Q: What does the research say about the use of Кетилепт in adolescents?

Clinical trials support the use of Кетилепт for adolescents (ages 10 or 13 and up) for specific regulatory-approved indications. These indications typically include the acute treatment of Schizophrenia and Bipolar Mania in this age group.

Q: Is there an official patient information leaflet available for Кетилепт?

Yes, regulatory bodies like the FDA, EMA, and others legally require that all prescription medicines be accompanied by official patient information. This document, often called a Medication Guide or Patient Information Leaflet (PIL), summarizes the drug’s use and safety data in accessible language.

Q: Can Кетилепт affect body temperature regulation?

Official labeling notes that this medicine has the potential to interfere with the body's natural ability to lower its core temperature. Official documentation notes a potential risk of heat-related illness in situations that lead to dehydration or increased core body temperature.

Q: How long does it typically take to start feeling the effects of Кетилепт?

While the immediate-release tablet form is noted to be rapidly absorbed into the bloodstream, the full therapeutic benefit for certain conditions may take longer to be observed. Clinical trials often run for several weeks or months to assess the full effectiveness of the medication.

Q: How long does the effect of one dose of Кетилепт last?

The amount of time the active ingredient, Quetiapine, remains active in the body is related to its half-life, which is approximately 7 hours according to regulatory pharmacokinetic data.

Q: Can Кетилепт interact with herbal supplements?

Yes, official regulatory documents specifically identify the herbal supplement St. John's wort as a strong inducer of the CYP3A4 enzyme. Official product information notes that using St. John's wort alongside Кетилепт may reduce the medicine’s concentration in the body, potentially decreasing its expected effect.

Q: What kind of monitoring is typically recommended for patients using Кетилепт?

Official documentation advises that monitoring may be recommended to track potential changes. This often includes regular checks of fasting blood glucose and lipid (cholesterol and triglyceride) levels, as well as periodic eye examinations to check for lens changes.

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How should Кетилепт be stored and disposed of?

Storage Requirements

Kетилепт (Quetiapine fumarate) must be stored at room temperature, typically between 15°C and 30°C (59°F and 86°F), and protected from excess heat and moisture. The medicine must be kept in the original container it came in, sealed tightly closed to maintain its stability. It is mandatory to store Kетилепт out of the sight and reach of children and to always lock safety caps to prevent accidental ingestion.

Disposal Instructions

Unused or expired Kетилепт should be disposed of properly. The preferred method is to use a drug take-back program or mail-back service. If these options are unavailable, the medicine must be removed from its container, mixed with an undesirable substance (e.g., dirt or used coffee grounds), placed in a sealed bag, and then discarded in the household trash. The medication must not be flushed down the toilet or poured down a sink.

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

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