Quentiax tablets: instructions for use, price and reviews

Pharmacodynamics and pharmacokinetics

Quentiax tablets are classified as atypical antipsychotics similar to serotonin . The drug also shows affinity for histamine and alpha-1 receptors and slightly with alpha-2 receptors.

The use of these tablets in the prescribed dosage does not cause extrapyramidal symptoms and does not lead to a long-term increase in the concentration of prolactin in the blood plasma .

The positive therapeutic effect, observed from the very beginning of taking the tablets, is maintained for a long time. Their effect on serotonin and dopamine receptors lasts more than 12 hours.

This drug is characterized by high absorption, while its bioavailability does not depend on food intake. Plasma protein binding reaches about 83%. In the body, the drug undergoes active metabolism in the liver. As a result, pharmacologically inactive metabolites . The drug is excreted in several stages in metabolites and unchanged form through the kidneys and intestines.

Quentiax

Antipsychotic drug (neuroleptic). Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin 5HT2 receptors than for dopamine D1 and D2 receptors in the brain. Quetiapine has an affinity for histamine and α1-adrenergic receptors, and less affinity for α2-adrenergic receptors. No significant affinity of quetiapine for cholinergic muscarinic and benzodiazepine receptors was found.

In standard tests, quetiapine exhibits antipsychotic activity.

The results of a study of extrapyramidal symptoms in animals revealed that quetiapine causes mild catalepsy at a dose that effectively blocks dopamine D2 receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10-dopaminergic neurons, in comparison with A9-nigrostriatal neurons involved in motor functions.

There were no differences between the use of quetiapine (at a dose of 75-750 mg/day) and placebo in the incidence of extrapyramidal symptoms and in the concomitant use of anticholinergic drugs. Does not cause a long-term increase in the concentration of prolactin in the blood plasma.

Quetiapine maintains long-term clinical improvement in those patients who develop a positive effect at the very beginning of treatment.

The duration of action of quetiapine on serotonin 5HT2 receptors and dopamine and D2 receptors is less than 12 hours after taking the drug.

Pharmacokinetics

Suction and distribution

Absorption is high, food intake does not affect bioavailability. Plasma protein binding - 83%.

The pharmacokinetics of quetiapine is linear and does not differ between men and women.

Metabolism

Actively metabolized in the liver with the formation of pharmacologically inactive metabolites under the influence of the CYP3A4 isoenzyme. Quetiapine and some of its metabolites are weak inhibitors of human cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6 and 3A4, but only in concentrations at least 10-50 times higher than the drug concentration when used in the effective dose range from 300 to 450 mg/day. days

Based on in vitro results, coadministration of quetiapine with other drugs should not be expected to result in clinically significant inhibition of cytochrome P450-mediated metabolism of other drugs.

Removal

T1/2 is approximately 7 hours. Approximately 73% is excreted by the kidneys and 21% through the intestines. Less than 5% of quetiapine is not metabolized and is excreted unchanged.

Pharmacokinetics in special clinical situations

The average clearance of quetiapine in elderly patients is 30-50% less than in patients aged 18 to 65 years.

The average plasma clearance of quetiapine in patients with severe renal failure (creatinine clearance < 30 ml/min/1.73 m2) and in patients with liver damage (stable alcoholic cirrhosis) is reduced by approximately 25%.

Contraindications

Quentiax tablets are not prescribed for:

sensitivity to their components;
lactation;
patients under 18 years of age.

In addition, caution is necessary when treating patients suffering from cardiovascular and cerebrovascular disorders and other conditions accompanied by arterial hypotension , congenital increase in the QT interval on the ECG, elderly age, liver failure, epilepsy and pregnancy.

Kventiax®

Since Quentiax® has several indications for use, its safety profile is determined depending on the patient's diagnosis and dose of the drug.

Children and adolescents (ages 10 to 17 years)

Quentiax® is not indicated for use in children and adolescents under 18 years of age due to insufficient data on use in this age group.

According to the results of clinical studies, some adverse reactions (increased appetite, increased concentration of prolactin in the blood serum, vomiting, rhinitis and fainting) were observed in children and adolescents with a higher frequency than in adult patients, or had other clinical manifestations (EPS and irritability). An increase in blood pressure was also noted, which was not observed in adult patients.

Changes in thyroid function have also been observed in children and adolescents. The effects on growth, puberty, mental development and behavioral reactions with long-term use (more than 26 weeks) of quetiapine have not been studied. In placebo-controlled studies in children and adolescents with schizophrenia and mania in bipolar disorder, the incidence of EPS was higher with quetiapine compared with placebo.

Suicide/suicidal ideation or clinical worsening

Depression in bipolar disorder is associated with an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). This risk persists until significant remission occurs. Because it may take several weeks or more for the patient's condition to improve from the start of treatment, patients should be under close medical supervision until improvement occurs.

According to generally accepted clinical experience, the risk of suicide may increase in the early stages of remission.

Patients (especially those at increased risk for suicide) and their caregivers should be warned to monitor for clinical worsening, suicidal behavior or thoughts, unusual changes in behavior, and to seek immediate medical attention if these occur.

In short-term, placebo-controlled clinical trials in depressed patients with bipolar disorder, the risk of suicide-related events was 3.0% (7/233) for quetiapine and 0% (0/120) for placebo in patients aged 18 years. -24 years, 1.8% (19/1616) for quetiapine and 1.8% (11/622) for placebo in patients over 25 years of age.

A population-based retrospective study of quetiapine in patients with major depressive disorder found an increased risk of self-harm and suicide attempts in patients aged 25 to 64 years without a history of self-harm taking quetiapine with other antidepressants.

Other psychiatric disorders treated with quetiapine are also associated with an increased risk of suicide-related events. In addition, such conditions may be comorbid with a depressive episode. Thus, the precautions used when treating patients with a depressive episode should also be taken when treating patients with other mental disorders.

If quetiapine therapy is abruptly discontinued, the potential risk of suicide-related events should be taken into account.

Patients with a history of suicidal events, as well as patients who clearly express suicidal thoughts before starting therapy, are at increased risk of suicidal intent and suicide attempts and should be carefully monitored during treatment. An FDA meta-analysis of placebo-controlled studies of antidepressants, summing up data from approximately 4,400 children and adolescents and 7,700 adult patients with mental disorders, found an increased risk of suicidal behavior with antidepressants compared with placebo in children, adolescents and adult patients under 25 years of age. This meta-analysis does not include studies using quetiapine (see section "Pharmacodynamics").

In short-term placebo-controlled studies across all indications and all age groups, the incidence of suicide events was 0.8% for both quetiapine (76/9327) and placebo (37/4845).

In these studies in patients with schizophrenia, the risk of suicide-related events was 1.4% (3/212) for quetiapine and 1.6% (1/62) for placebo in patients aged 18–24 years. 8% (13/1663) for quetiapine and 1.1% (5/463) for placebo in patients over 25 years of age, 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients under the age of 18 years.

In patients with manic bipolar disorder, the risk of suicide-related events was 0% (0/60) for quetiapine and 0% (0/58) for placebo in patients aged 18–24 years, 1.2% (6 /496) for quetiapine and 1.2% (6/503) for placebo in patients over 25 years of age, 1.0% (2/193) for quetiapine and 0% (0/90) for placebo in patients under 18 years of age years.

Metabolic disorders

Given the risk of deterioration in the metabolic profile, including changes in body weight, plasma glucose and lipid concentrations, observed during clinical studies, patients' metabolic parameters should be assessed at the beginning of therapy and should be monitored regularly during therapy. If these indicators worsen, appropriate treatment should be undertaken.

Extrapyramidal symptoms

The use of quetiapine has been associated with the development of akathisia, which is characterized by subjectively unpleasant restlessness or anxiety, and is often accompanied by an inability to sit or stand still. Such phenomena are most often observed in the first few weeks of treatment. Increasing the dose in patients who develop such symptoms may have a negative effect.

Tardive dyskinesia

If symptoms of tardive dyskinesia develop, it is recommended to reduce the dose of the drug or gradually discontinue it. Symptoms of tardive dyskinesia may intensify or even occur after stopping the drug (see section "Side effects").

Drowsiness and dizziness

During quetiapine therapy, drowsiness and associated symptoms, such as sedation, may occur (see section "Side effects"). In clinical studies involving patients with depression in the structure of bipolar disorder and with a depressive episode, somnolence usually developed during the first days of therapy. The severity of this adverse reaction was generally minor or moderate. If severe drowsiness develops, patients with depression as part of bipolar disorder and patients with a depressive episode may require more frequent visits to the doctor within 2 weeks from the onset of drowsiness or until the severity of symptoms decreases. In some cases, discontinuation of quetiapine therapy may be necessary.

During quetiapine therapy, orthostatic hypotension and dizziness may occur (see section "Side effects"), usually during dose titration at the beginning of therapy. Patients, especially older patients, should be careful to avoid accidental injury (falls).

Patients with cardiovascular diseases

Caution should be exercised when using quetiapine in patients with cardiovascular, cerebrovascular disease and other conditions predisposing to arterial hypotension. In such patients, dose selection should be slower. Orthostatic hypotension may occur during quetiapine therapy, especially during dose titration at the beginning of therapy. If orthostatic hypotension occurs, a dose reduction or more gradual titration may be required.

Sleep apnea syndrome

Sleep apnea syndrome has been reported in patients taking quetiapine. In patients concomitantly taking CNS depressants or with a history of sleep apnea (eg, overweight/obese patients, male patients), quetiapine should be used with caution.

Seizures

There were no differences in the incidence of seizures in patients taking quetiapine or placebo. However, as with therapy with other antipsychotic drugs, caution is recommended when treating patients with a history of seizures (see section "Side effects").

Neuroleptic malignant syndrome

While taking antipsychotic drugs, including quetiapine, neuroleptic malignant syndrome may develop (see section “Side effects”). Clinical manifestations of the syndrome include hyperthermia, altered mental status, muscle rigidity, lability of the autonomic nervous system, and increased creatine phosphokinase activity. In such cases, it is necessary to stop taking quetiapine and carry out appropriate treatment.

Severe neutropenia and agranulocytosis

Leukopenia and/or neutropenia resolved after discontinuation of quetiapine therapy. Possible risk factors for the occurrence of neutropenia are a previous low white blood cell count and a history of drug-induced neutropenia. The development of agranulocytosis was also noted in patients without risk factors. The possibility of neutropenia should be considered in patients with infection, especially in the absence of obvious predisposing factors, or in patients with unexplained fever, and these cases should be managed in accordance with clinical guidelines.

In patients with a neutrophil count <1.0 x 109/L, quetiapine should be discontinued. The patient should be observed for possible symptoms of infection and the neutrophil count should be monitored (until the count rises to 1.5 x 109/L).

Patients should be informed and promptly report any signs/symptoms of agranulocytosis or infection (eg, fever, weakness, lethargy, sore throat) throughout therapy with Quentiax.

Anticholinergic (muscarinic) effects

Norquetiapine, the active metabolite of quetiapine, exhibits moderate to high affinity for several muscarinic receptor subtypes, which explains the development of ADRs due to anticholinergic effects when quetiapine is used at recommended doses, during concomitant use of other anticholinergic drugs, and in overdose.

Caution should be exercised when using quetiapine in patients taking cholinergic (muscarinic) receptor antagonists, as well as in patients with urinary retention, including a history of clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, with increased intraocular pressure or angle-closure glaucoma.

Interaction with other drugs

Also see the section “Interaction with other drugs”.

The simultaneous use of quetiapine with powerful inducers of microsomal liver enzymes, such as carbamazepine and phenytoin, helps to reduce the concentration of quetiapine in the blood plasma and may reduce the effectiveness of therapy with Quentiax®.

The use of Quentiax® in patients receiving inducers of microsomal liver enzymes is possible only if the expected benefit from drug therapy outweighs the risk associated with discontinuation of inducers of microsomal liver enzymes. Changing the dose of drugs that induce microsomal liver enzymes should be gradual. If necessary, they can be replaced with drugs that do not induce microsomal liver enzymes (for example, valproic acid drugs).

Body mass

An increase in body weight was observed while taking quetiapine. Clinical monitoring of patients is recommended in accordance with accepted standards of therapy (see section “Side Effects”).

Hyperglycemia

While taking quetiapine, it is possible to develop hyperglycemia and/or develop and exacerbate diabetes mellitus, sometimes accompanied by the development of ketoacidosis or coma, including death. In some cases, previous weight gain was noted, which may be a predisposing factor. Regular monitoring of body weight and symptoms of hyperglycemia, such as polydipsia, polyuria, polyphagia and weakness, is recommended in patients taking antipsychotics, including quetiapine.

Clinical monitoring of patients with diabetes mellitus and patients with risk factors for developing diabetes mellitus is recommended (see section “Side Effects”).

Lipid concentration

While taking quetiapine, it is possible to increase the concentration of triglycerides, total cholesterol and LDL cholesterol, as well as a decrease in the concentration of HDL in the blood plasma (see section “Side Effects”). These changes should be adjusted in accordance with current recommendations.

QT prolongation

Caution should be exercised when using quetiapine, as with other antipsychotic drugs, in patients with cardiovascular disease and a history of QT prolongation.

Caution must also be exercised when using quetiapine simultaneously with drugs that prolong the QTc interval, other antipsychotics, especially in the elderly, in patients with congenital long QT syndrome, chronic heart failure, myocardial hypertrophy, hypokalemia or hypomagnesemia (see section “Interaction with other medicines").

Cardiomyopathy and myocarditis

During clinical trials and post-registration use, cases of cardiomyopathy and myocarditis were observed, but a causal relationship with the drug has not been established. The appropriateness of quetiapine therapy should be assessed in patients with suspected cardiomyopathy or myocarditis.

Acute reactions associated with drug withdrawal

If quetiapine is abruptly discontinued, the following acute reactions (withdrawal syndrome) may occur: nausea, vomiting, insomnia, headache, dizziness and irritability. Therefore, it is recommended to discontinue Quentiax® gradually over at least one or two weeks.

Elderly patients with dementia

Quentiax® is not indicated for the treatment of psychosis associated with dementia. Some atypical antipsychotics in randomized placebo-controlled trials increased the risk of advanced cerebrovascular events in patients with dementia by approximately 3 times. The mechanism for this increased risk has not been studied.

A similar risk of increased incidence of cerebrovascular complications cannot be excluded for other antipsychotic drugs or other patient groups. Quentiax should be used with caution in patients at risk of stroke.

An analysis of the use of atypical antipsychotics for the treatment of psychosis associated with dementia in elderly patients revealed an increased mortality rate in the group of patients receiving drugs of this group compared with the placebo group. Two 10-week placebo-controlled studies of quetiapine in a similar group of patients (n=710, mean age: 83 years, age range: 56-99 years) showed that mortality in the group of patients taking quetiapine was 5.5%, and 3.2% in the placebo group. The causes of death observed in these patients were consistent with those expected for this population. No causal relationship has been identified between quetiapine treatment and the risk of increased mortality in elderly patients with dementia.

Elderly patients with Parkinson's disease/parkinsonism

A population-based retrospective study of quetiapine in patients with major depressive disorder found an increased risk of death in patients aged > 65 years. An increased risk was not detected when patients with Parkinson's disease were excluded from the analysis.

Caution should be exercised when prescribing quetiapine to elderly patients with Parkinson's disease.

Dysphagia

However, caution should be exercised when using Quentiax® in patients at risk of aspiration pneumonia.

Constipation and intestinal obstruction

Constipation is a risk factor for intestinal obstruction. During the use of quetiapine, the development of constipation and intestinal obstruction was noted (see section “Side Effects”), including cases with a fatal outcome in patients at high risk of intestinal obstruction, including those receiving multiple concomitant medications that reduce intestinal motility, even in the absence of complaints for constipation. Patients with intestinal obstruction/ileus require urgent measures and close monitoring.

Venous thromboembolism

Cases of venous thromboembolism have been reported while taking antipsychotics. Before and during therapy with antipsychotic drugs, including quetiapine, risk factors should be assessed and preventive measures taken.

Pancreatitis

Liver disorders

If jaundice develops, quetiapine should be discontinued.

Additional Information

Data on the concomitant use of quetiapine with divalproate or lithium during acute moderate or severe manic episodes are limited. This combination therapy was well tolerated and had an additive effect at 3 weeks of treatment.

Misuse and Abuse

Cases of misuse and abuse have been reported. Caution should be exercised when prescribing quetiapine to patients with a history of alcohol or drug abuse.

Special information on excipients

Quentiax® contains lactose, so it should not be used for the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Side effects

When treated with Quentiax, side effects may occur that affect the functioning of the nervous, respiratory, lymphatic and cardiovascular systems, hematopoietic organs, gastrointestinal tract, and so on.

Therefore, it is possible to develop unfavorable symptoms such as: leukopenia , eosinophilia, metabolic disorders leading to weight gain, dizziness, headache, drowsiness, syncope, tachycardia , arterial hypotension, rhinitis , pharyngitis, dry mouth, diarrhea, constipation, dyspepsia, allergic reactions, swelling, asthenia and so on.

Quetiapine (Ketilept, Quentiax, Seroquel, Quetiap)

The most common adverse reactions associated with taking the drug: drowsiness (17.5%), dizziness (10%), constipation (9%), dyspepsia (6%), orthostatic hypotension and tachycardia (7%), dry mouth (7% ), increased activity of “liver” enzymes in the blood serum (6%), increased concentrations of cholesterol and triglycerides in the blood plasma.

Taking quetiapine may be accompanied by the development of moderate asthenia, rhinitis and dyspepsia, and an increase in body weight (mainly in the first weeks of treatment). Quetiapine may cause orthostatic hypotension (accompanied by dizziness), tachycardia and, in some patients, syncope; these adverse reactions mainly occur during the initial period of dose selection (see section "Special Instructions"). Quetiapine therapy is associated with a small dose-dependent decrease in the concentration of thyroid hormones, in particular total T4 and free T4. The maximum decrease in total and free T4 was recorded in the 2nd and 4th weeks of quetiapine therapy, without a further decrease in hormone concentrations during long-term treatment. There were no further signs of clinically significant changes in thyroid-stimulating hormone concentrations.

With long-term use of quetiapine, there is a potential for the development of tardive dyskinesia. If symptoms of tardive dyskinesia occur, reduce the dose or discontinue further treatment with quetiapine. With abrupt withdrawal of high doses of antipsychotic drugs, the following acute reactions (withdrawal syndrome) may be observed: nausea, vomiting, and rarely, insomnia.

There may be cases of exacerbation of psychotic symptoms and the appearance of involuntary movement disorders (akathisia, dystonia, dyskinesia). Therefore, it is recommended to discontinue the drug gradually.

The following are the adverse reactions observed with the use of quetiapine and distributed among organs and systems:

From the nervous system: drowsiness, dizziness, headache, anxiety, asthenia, hostility, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesia, neuroleptic malignant syndrome (hyperthermia, muscle rigidity, changes in mental status, lability of the autonomic nervous system, increased activity of creatine phosphokinase), restless legs syndrome.

From the cardiovascular system: orthostatic hypotension, tachycardia, prolongation of the QT interval.

From the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, diarrhea or constipation, increased activity of liver transaminases, jaundice, hepatitis.

From the respiratory system: pharyngitis, rhinitis.

Allergic reactions: skin rash, eosinophilia, angioedema, Stevens-Johnson syndrome, anaphylactic reactions.

Laboratory indicators: leukopenia, neutropenia, hypercholesterolemia, hypertriglyceridemia, decreased T4 concentration (first 4 weeks), hyperglycemia.

Other: lower back pain, chest pain, low-grade fever, weight gain (mainly in the first weeks of treatment), myalgia, dry skin, blurred vision, incl. blurred visual perception, decompensation of existing diabetes mellitus, priapism, galactorrhea.

Quentiax, instructions for use (Method and dosage)

These tablets are intended for oral administration, 2 times a day. In this case, the dosage is selected depending on the type of disorder and is often prescribed for use according to a certain scheme.

For example, during the treatment of acute or chronic forms of psychosis, including schizophrenia , the daily dosage for the first 4 days is usually: on the 1st day - 50 mg, on the 2nd and 3rd days take Quentiax 200 mg tablets, and already on the 4th day the dose is increased to 300 mg. In the future, the drug is taken exactly in this daily dosage, although it is possible to decrease or increase it within the range of 150-750 mg.

During the treatment of manic episodes characteristic of bipolar disorders, this drug may be prescribed as mono- or adjuvant therapy to stabilize mood. The dosage is prescribed by the attending physician, suggesting a gradual increase, but not more than 800 mg per day.

Overdose

Cases of overdose with this drug occur quite rarely. This usually happens when it is significantly exceeded. As a rule, unwanted symptoms go away on their own after lowering the dosage.

However, in patients suffering from severe cardiovascular disorders, the risk of side effects from overdose increases.

In this case, the main symptoms of overdose are: tachycardia, severe sedation, drowsiness , low blood pressure .

In such situations, patients are prescribed symptomatic treatment and other measures to help maintain respiratory and cardiovascular functions.

Specific antidotes have not been developed.

Interaction

When taking quetiapine, there is no induction of liver enzyme systems involved in the metabolism of Phenazone and lithium.

Combination with drugs that can inhibit liver enzymes , such as carbamazepine or phenytoino , as well as rifampicin and barbiturates , may reduce plasma concentrations of quetiapine.

Concomitant use of quetiapine with CYP3A4 inhibitors (azole antifungals and macrolide antibiotics ) often increases plasma concentrations of the drug. This especially needs to be taken into account when treating weakened patients and the elderly.

Various medications that can depress the nervous system may increase the risk of adverse effects.

Quentiax 25 mg 60 pcs. film-coated tablets in Moscow

Caution should be exercised when using Quentiax® simultaneously with other drugs that affect the central nervous system, as well as with alcohol.

Caution should be exercised in patients taking other cholinergic (muscarinic) receptor antagonists.

The cytochrome P450 isoenzyme 3A4 is the main isoenzyme responsible for the metabolism of quetiapine, which occurs through the cytochrome P450 system. In healthy volunteers, simultaneous use of quetiapine (at a dose of 25 mg) with ketoconazole (an inhibitor of the CYP3A4 isoenzyme) led to an increase in the AUC of quetiapine by 5-8 times. Therefore, the simultaneous use of quetiapine and CYP3A4 isoenzyme inhibitors is contraindicated.

During quetiapine therapy, it is not recommended to drink grapefruit juice.

In a pharmacokinetic study, the use of quetiapine at various dosages before or simultaneously with carbamazepine led to a significant increase in quetiapine clearance and, accordingly, a decrease in AUC by an average of 13% compared to taking quetiapine without carbamazepine. In some patients, the decrease in AUC was even more pronounced. This interaction is accompanied by a decrease in quetiapine plasma concentrations and may reduce the effectiveness of quetiapine therapy. Concomitant use of quetiapine with phenytoin, another inducer of microsomal liver enzymes, was accompanied by an even more pronounced (approximately 450%) increase in quetiapine clearance. The use of quetiapine in patients receiving inducers of microsomal liver enzymes is possible only if the expected benefit from quetiapine therapy outweighs the risk associated with discontinuation of the drug that is an inducer of microsomal liver enzymes. Changing the dose of drugs that induce microsomal liver enzymes should be gradual. If necessary, they can be replaced with drugs that do not induce microsomal liver enzymes (for example, valproic acid drugs).

The pharmacokinetics of quetiapine did not change significantly with simultaneous use of the antidepressant imipramine (inhibitor of the CYP2D6 isoenzyme) or fluoxetine (inhibitor of the CYP3A4 and CYP2D6 isoenzymes).

The pharmacokinetics of quetiapine does not change significantly when used simultaneously with antipsychotic drugs - risperidone or haloperidol. However, concomitant use of quetiapine and thioridazine resulted in an approximately 70% increase in quetiapine clearance.

The pharmacokinetics of quetiapine does not change significantly with simultaneous use of cimetidine.

The pharmacokinetics of lithium preparations does not change with simultaneous use of quetiapine.

When quetiapine was used concomitantly with lithium in adult patients with an acute manic episode, there was a higher incidence of EPS-related adverse reactions (especially tremor), somnolence, and weight gain compared with patients taking quetiapine with placebo in a 6-week randomized trial. .

There were no clinically significant changes in the pharmacokinetics of valproic acid and quetiapine with simultaneous use of semisodium valproate and quetiapine.

A retrospective study of children and adolescents who received sodium valproate and quetiapine alone or both drugs simultaneously found a higher incidence of leukopenia and neutropenia in the combination therapy group compared with the monotherapy group.

Pharmacokinetic studies examining the interaction of Quentiax® with drugs used for cardiovascular diseases have not been conducted.

Caution should be exercised when quetiapine is used concomitantly with drugs that can cause electrolyte imbalance and prolongation of the QTc interval.

False-positive results of screening tests for methadone and tricyclic antidepressants using enzyme-linked immunosorbent assays have been reported in patients taking quetiapine. To confirm the screening results, a chromatographic study is recommended.

With a single dose of 2 mg of lorazepam while taking quetiapine at a dose of 250 mg 2 times a day, the clearance of lorazepam is reduced by approximately 20%.

Quetiapine did not induce liver microsomal enzymes involved in the metabolism of phenazone.

special instructions

The prescription of the drug, as well as its withdrawal, requires the use of a special scheme - increasing or decreasing, followed by withdrawal, gradually. Otherwise, the development of “withdrawal syndrome” is possible, accompanied by nausea, vomiting, insomnia, exacerbation of psychotic symptoms, and so on.

When used with drugs that prolong the QT interval, extreme caution should also be exercised, especially when treating the elderly, with hypokalemia, congestive heart failure, and hypomagnesemia.

No less attention is required when combining this drug with other drugs. As a rule, lowering the dosage can reduce or completely eliminate the manifestation of various undesirable effects.

It has been established that the drug may influence the concentration of attention and the speed of psychomotor reactions. Therefore, people whose work involves driving vehicles and other potentially dangerous activities need to be extremely careful.

Quentiax analogs

Level 4 ATX code matches:
Lakvel

Leponex

Zalasta

Closasten

Ketilept

Zyprexa

Clozapine

Quetiapine

Seroquel

Azaleptin

The main analogues of Quentiax: Ketilept, Quetiapine and Seroquel .

Reviews of Quentiax

Numerous reviews of Quentiax are found on medical forums, the topics of which are related to various mental disorders. This drug is especially often prescribed to patients suffering from panic attacks. According to users, the effectiveness of the treatment is evident in almost all cases. As a result, fears disappear completely, but many patients experience drowsiness throughout treatment, which can be very undesirable.

An important condition for effective treatment is that this drug should be prescribed only by specialists. The fact is that the therapeutic regimen, and especially its dosage, requires a certain approach, with a gradual increase and then decrease in dose. When a therapeutic effect is achieved, a maintenance dosage of Quentiax 100 mg may be prescribed. Usually this is enough to consolidate the therapeutic effect.

You can also find reports of the development of undesirable effects manifested by extrapyramidal disorders, increased appetite, weight gain and headaches. One way or another, compared to other analogues, the use of this medicine is accompanied by fewer side effects.

Experts note that taking this drug without a prescription is not recommended. Although, as reviews show, none of the patients started taking it on their own. Moreover, these tablets are often prescribed during inpatient treatment. In any case, doctors warn patients against taking this medication on their own, as well as deviating from the therapeutic regimen. This can lead to disruption of the body’s internal regulation, as well as to an even greater deterioration of the mental state.

QUENTIAX SR

special instructions

Children and adolescents (ages 10 to 17 years)
Quentiax® SR is not indicated for use in children and adolescents under the age of 18 years due to insufficient data on use in this age group. According to the results of clinical studies, some adverse reactions (increased appetite, increased concentrations of prolactin in the blood serum and EPS) were observed with a higher frequency in children and adolescents than in adult patients. An increase in blood pressure was also noted, which was not observed in adult patients. Changes in thyroid function have also been observed in children and adolescents.

The effects on growth, puberty, mental development and behavioral reactions with long-term use (more than 26 weeks) of quetiapine have not been studied.

In placebo-controlled studies in children and adolescents with schizophrenia and mania in bipolar disorder, the incidence of EPS was higher with quetiapine compared with placebo.

Suicide/suicidal ideation or clinical worsening

Depression is associated with an increased risk of suicidal ideation, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. Because it may take several weeks or more for the patient's condition to improve from the start of treatment, patients should be under close medical supervision until improvement occurs. According to generally accepted clinical experience, the risk of suicide may increase in the early stages of remission.

In patients with manic bipolar disorder, the risk of suicide-related events was 0% (0/60) for quetiapine and 0% (0/58) for placebo in patients aged 18–24 years, 1.2% (6 /496) for quetiapine and 1.2% (6/503) for placebo in patients aged ≥ 25 years, 1.0% (2/193) for quetiapine and 0% (0/90) for placebo in patients aged up to 18 years old.

In patients with schizophrenia, the risk of suicide-related events was 1.4% (3/212) for quetiapine and 1.6% (1/62) for placebo in patients aged 18–24 years, 0.8% ( 13/1663) for quetiapine and 1.1% (5/463) for placebo in patients aged ≥ 25 years, 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients under the age of 18 years.

In patients with a depressive episode, the risk of suicide-related events was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo in patients aged 18–24 years; 0.6% (11/1798) for quetiapine and 0.7% (7/1054) for placebo in patients aged ≥25 years. Patients under the age of 18 years did not participate in studies for this indication.

Overall, the rate of suicide events was 0.8% for both quetiapine (76/9327) and placebo (37/4845) in short-term placebo-controlled studies across all indications and all age groups.

An FDA meta-analysis of placebo-controlled studies of antidepressants, summing up data from approximately 4,400 children and adolescents and 7,700 adult patients with mental disorders, found an increased risk of suicidal behavior with antidepressants compared with placebo in children, adolescents and adult patients under 25 years of age. This meta-analysis does not include studies using quetiapine (see Pharmacodynamics section).

Extrapyramidal symptoms

There was an increase in the incidence of EPS when taking quetiapine in adult patients with a major depressive episode in the structure of bipolar disorder or major depressive disorder compared to placebo (see section "Side effects"). However, during quetiapine therapy in patients with schizophrenia and mania in the structure of bipolar disorder, there was no increase in the incidence of EPS compared to placebo.

Tardive dyskinesia

While taking antipsychotics, including quetiapine, tardive dyskinesia may occur, which is manifested by violent involuntary movements and may be irreversible. If symptoms of tardive dyskinesia develop, it is recommended to reduce the dose of the drug or gradually discontinue it. Symptoms of tardive dyskinesia may intensify or even occur after stopping the drug (see section "Side effects").

While taking quetiapine, akathisia may occur, which is characterized by an unpleasant feeling of motor restlessness and the need to move and is manifested by the patient's inability to sit or stand without moving. If such symptoms occur, the dose of quetiapine should not be increased.

Drowsiness and dizziness

During quetiapine therapy, drowsiness and associated symptoms, such as sedation, may occur (see section "Side effects"). In clinical studies involving patients with depression in the structure of bipolar disorder and with a depressive episode, somnolence usually developed during the first three days of therapy. The severity of this adverse reaction was generally minor or moderate. If severe drowsiness develops, patients with depression as part of bipolar disorder and patients with a depressive episode may require more frequent visits to the doctor within 2 weeks from the onset of drowsiness or until the severity of symptoms decreases. In some cases, discontinuation of quetiapine therapy may be necessary.

Patients with cardiovascular diseases

Caution should be exercised when using quetiapine in patients with cardiovascular, cerebrovascular diseases and other conditions predisposing to arterial hypotension. In such patients, dose selection should be slower. Orthostatic hypotension may occur during quetiapine therapy, especially during dose titration at the beginning of therapy. If orthostatic hypotension occurs, a dose reduction or more gradual titration may be required.

Seizures

Neuroleptic malignant syndrome

Severe neutropenia and agranulocytosis

In short-term, placebo-controlled clinical trials of quetiapine monotherapy, cases of severe neutropenia (neutrophil count <0.5 x 109/L) without infection were reported infrequently. The development of agranulocytosis (severe neutropenia associated with infections) has been reported in patients receiving quetiapine in clinical trials (rare), as well as during post-registration use (including death). Most of these cases of severe neutropenia occurred several months after initiation of quetiapine therapy. No dose-dependent effect was found. Leukopenia and/or neutropenia resolved after discontinuation of quetiapine therapy. Possible risk factors for the occurrence of neutropenia are a previous low white blood cell count and a history of drug-induced neutropenia. The development of agranulocytosis was also noted in patients without risk factors. The possibility of neutropenia should be considered in patients with infection, especially in the absence of obvious predisposing factors, or in patients with unexplained fever, and these cases should be managed in accordance with clinical guidelines.

Interaction with other drugs

Also see the section “Interaction with other drugs”. The simultaneous use of quetiapine with powerful inducers of microsomal liver enzymes, such as carbamazepine and phenytoin, helps to reduce the concentration of quetiapine in the blood plasma and may reduce the effectiveness of therapy with Quentiax® SR.

The use of Quentiax® SR in patients receiving microsomal liver enzyme inducers is possible only if the expected benefit from therapy with Quentiax® SR outweighs the risk associated with discontinuation of microsomal liver enzyme inducers. Changing the dose of drugs that induce microsomal liver enzymes should be gradual. If necessary, it is possible to replace them with drugs that do not induce microsomal liver enzymes (for example, valproic acid drugs).

Body mass

An increase in body weight was observed while taking quetiapine. Clinical monitoring of patients is recommended in accordance with accepted standards of therapy (see section “Side Effects”).

Hyperglycemia

While taking quetiapine, it is possible to develop hyperglycemia and/or the development and exacerbation of diabetes mellitus, sometimes accompanied by ketoacidosis or coma. Regular monitoring of body weight and symptoms of hyperglycemia, such as polydipsia, polyuria, polyphagia and weakness, is recommended in patients taking antipsychotics, including quetiapine. Clinical monitoring of patients with diabetes mellitus and patients with risk factors for developing diabetes mellitus is recommended (see section “Side Effects”).

Lipid concentration

Metabolic disorders

An increase in body weight, an increase in the concentration of glucose and lipids in the blood plasma in some patients can lead to a deterioration in the metabolic profile, which requires appropriate monitoring.

QT prolongation

There was no relationship between taking quetiapine and a persistent increase in the absolute value of the QT interval. However, prolongation of the QT interval has been observed with an overdose of quetiapine (see section "Overdose"). Caution should be exercised when using quetiapine, as with other antipsychotic drugs, in patients with cardiovascular disease and a history of QT prolongation. Caution must also be exercised when using quetiapine simultaneously with drugs that prolong the QTc interval, other antipsychotics, especially in the elderly, in patients with congenital long QT syndrome, chronic heart failure, myocardial hypertrophy, hypokalemia or hypomagnesemia (see section “Interaction with other medicines").

Acute reactions associated with drug withdrawal

Elderly patients with dementia

Quentiax® SR is not indicated for the treatment of psychoses associated with dementia. Some atypical antipsychotics in randomized placebo-controlled trials increased the risk of cerebrovascular events in patients with dementia by approximately 3-fold. The mechanism for this increased risk has not been studied. A similar risk of increased incidence of cerebrovascular complications cannot be excluded for other antipsychotic drugs or other patient groups. Quentiax® SR should be used with caution in patients at risk of stroke.

Liver disorders

If jaundice develops, quetiapine should be discontinued.

Dysphagia

Dysphagia (see section "Side effects") and aspiration were observed during therapy with quetiapine. The cause-and-effect relationship between the occurrence of aspiration pneumonia and the use of quetiapine has not been established. However, caution should be exercised when using Quentiax® SR in patients at risk of aspiration pneumonia.

Venous thromboembolism

Pancreatitis

During clinical trials and post-registration use, cases of pancreatitis were observed, but a causal relationship with the drug has not been established. Post-marketing reports indicate that many patients had risk factors for the development of pancreatitis, such as increased triglyceride concentrations (see section "Adverse Effects"), including cases with a fatal outcome in patients at high risk of intestinal obstruction, including those receiving multiple concomitant medications , which reduce intestinal motility, even in the absence of complaints of constipation.

Cardiomyopathy and myocarditis

Additional Information

The long-term safety and effectiveness of Quentiax® SR as an add-on therapy in the treatment of major depressive disorder have not been studied, but the safety and effectiveness profile has been studied in monotherapy.

Special information on excipients

Quentiax® SR contains lactose, so it should not be used in the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Quentiax price, where to buy

The price of Quentiax tablets varies between 1,700-4,200 rubles. You can buy Quentiax in almost any Russian pharmacy with a prescription.

Online pharmacies in RussiaRussia

ZdravCity

Quentiax SR tab.
prolong release p/o captivity. 0.2g 60pcs JSC KRKA, d.d., Novo mesto 1224 rub. order
Quentiax tablets p.p.o. 200 mg 60 pcs. Krka-Rus LLC
RUB 1,669 order
Quentiax tablets p.p.o. 300 mg 60 pcs. Krka-Rus LLC
RUR 3,130 order
Quentiax tablets p.p.o. 25 mg 60 pcs. Krka-Rus LLC
RUB 505 order
Quentiax SR tab. prolong release p/o captivity. 0.3g 60pcs JSC KRKA, d.d., Novo Mesto
RUB 1,826 order