Tab., cover film coating, 25 mg: 30 or 60 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab. , Coated film coating, 100 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab., Coated film coating, 150 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

Tab., cover film coating, 200 mg: 30 pcs.

reg. No: LSR-008008/10
from 12.08.10
– Indefinitely

1

2. Drowsiness usually occurs within the first 2 weeks after the start of therapy and, as a rule, resolves on the background of continued administration of Quetiapine ^® Prolong.

3. Possibly asymptomatic increase in the activity of AST, ALT and GGT in the blood serum, as a rule, reversible against the background of continued administration of Seroquel ^® Prolong.

4. Like other antipsychotics and α ₁ -adrenergic blockers, quetiapine ^® Prolong often causes orthostatic hypotension, which is accompanied by dizziness, tachycardia, in some cases – fainting, especially at the beginning of therapy (see.”Special instructions”).

5. Very rare cases of diabetes mellitus decompensation have been reported.

6. The frequency of this side effect was estimated on the basis of the results of post-marketing observation of the use of the drug Seroquel ^® Prolong.

7. Increase in fasting blood glucose concentration ≥126 mg / dL (≥7 mmol / L) or blood glucose after meals ≥200 mg / dL (≥11.1 mmol / L), at least with a single determination.

8. A higher frequency of dysphagia with quetiapine compared with placebo was observed only in patients with depression in the structure of bipolar disorder.

9. More than 7% excess of the original body weight. It mainly occurs at the beginning of therapy.

10. When studying withdrawal syndrome in short-term placebo-controlled clinical trials of Seroquel ^® Prolong in monotherapy, the following symptoms were noted: insomnia, nausea, headache, diarrhea, vomiting, dizziness and irritability. Withdrawal rates were significantly reduced 1 week after discontinuation of the drug.

11.An increase in triglyceride concentration ≥200 mg / dL (≥2,258 mmol / L) in patients ≥18 years old or ≥150 mg / dL (≥1,694 mmol / L) in patients <18 years old, at least with a single determination.

12. Increase in total cholesterol concentration ≥240 mg / dL (≥6.2064 mmol / L) in patients ≥18 years old or ≥200 mg / dL (≥5.172 mmol / L) in patients <18 years old, at least with a single dose definition.

13. See the instructions below.

14. Decrease in the number of platelets ≤100 · 10 ⁹ / l, at least with a single determination.

15. Without connection with neuroleptic malignant syndrome. According to clinical studies.

16. Increase in prolactin concentration in patients ≥18 years of age:> 20 μg / l (≥869.56 pmol / l) in men; > 30 μg / L (≥1304.34 pmol / L) in women.

17. May cause a fall.

18. Reduction of HDL cholesterol concentration <40 mg / dL in men and <50 mg / dL in women.

Prolongation of the QT interval, ventricular arrhythmias, sudden death, cardiac arrest and bidirectional ventricular tachycardia are considered side effects inherent in antipsychotics.

The frequency of EPS in short-term clinical trials in schizophrenia and mania in the structure of bipolar disorder was comparable in the quetiapine and placebo groups (patients with schizophrenia: 7.8% in the quetiapine group and 8% in the placebo group; mania in the structure of bipolar disorder: 11, 2% in the quetiapine group and 11.4% in the placebo group).

The frequency of EPS in short-term clinical studies with depression in the structure of bipolar disorder in the quetiapine group was 8.9%, in the placebo group – 3.8%.At the same time, the frequency of individual EPS symptoms (such as akathisia, extrapyramidal disorders, tremor, dyskinesia, dystonia, anxiety, involuntary muscle contractions, psychimotor agitation and muscle rigidity), as a rule, was low and did not exceed 4% in each of the therapeutic groups. In long-term clinical trials of quetiapine for schizophrenia and bipolar disorder, the frequency of EPS was comparable in the quetiapine and placebo groups.

During therapy with quetiapine, there may be a slight dose-dependent decrease in the concentration of thyroid hormones, in particular total thyroxine (T4) and free T4.The maximum decrease in total and free T4 was registered on the 2nd and 4th weeks of therapy with Quetiapel ^® Prolong, without further decrease in the concentration of hormones during long-term treatment. In almost all cases, the concentration of total and free T4 returned to the initial level after cessation of therapy with Quetiroquel ^® Prolong, regardless of the duration of treatment. A slight decrease in total triiodothyronine (T3) and reverse T3 was observed only with the use of high doses.The concentration of thyroxine-binding globulin (TSH) remained unchanged; there was no increase in TSH concentration.

Seroquel XR – instructions, use, analogues of the drug, composition, indications, contraindications, side effects in the reference book of medicines from UNIAN

Quetiquel XR Application

Seroquel XR – composition and release form of the drug

Seroquel XR: how to take the drug

Seroquel XR – contraindications, side effects

Seroquel XR analogs

Quetiapine is an atypical antipsychotic drug.Quetiapine and its active plasma metabolite, norkvetiapine, interact with many neurotransmitter receptors.

Application of quetiapine XR

quetiauel XR is indicated for the treatment of

Schizophrenia, including the prevention of relapse in patients with stable schizophrenia receiving maintenance therapy with quetiapine.

Bipolar disorder, in particular:

• for the treatment of moderate to severe manic episodes in bipolar disorder;
• for the treatment of severe depressive episodes of bipolar disorder;
• for the prevention of recurrence of the disease in patients with bipolar disorder, in patients with manic or depressive episodes, in which quetiapine treatment is effective.

As adjunctive therapy for severe depressive episodes in patients with severe depressive disorder (TDR) in whom a suboptimal response to antidepressant monotherapy has been reported. Before starting therapy, the physician should carefully review the safety profile of Quetiroquel XR.

Seroquel XR – composition and release form of the drug

The drug is available in the form of tablets.

Active ingredient : Quetiapine.

50 mg tablets: 1 tablet contains 57.56 mg of quetiapine fumarate, which corresponds to 50 mg of quetiapine;

Tablets of 200 mg: 1 tablet contains 230.26 mg of quetiapine fumarate, which corresponds to 200 mg of quetiapine;

Tablets of 300 mg: 1 tablet contains 345.38 mg of quetiapine fumarate, which corresponds to 300 mg of quetiapine;

Tablets of 400 mg: 1 tablet contains 460.50 mg of quetiapine fumarate, which corresponds to 400 mg of quetiapine;

Excipients:

lactose, monohydrate; microcrystalline cellulose, sodium citrate, hypromellose 2208, magnesium stearate, hypromellose 2910, polyethylene glycol 400, titanium dioxide (E171),

for tablets of 50, 200 and 300 mg – iron oxide yellow (E172),

for tablets of 50 mg – iron oxide red (E172).

Quetiawel XR: How to take the drug

There are different dosing regimens for each indication. Seroquel XR should be used once a day on an empty stomach. The tablets should be swallowed whole without breaking, chewing or crushing them.

For the treatment of moderate to severe schizophrenia and manic episodes in bipolar disorder

Seroquel XR should be used at least 1 hour before meals. The daily dose at the beginning of therapy is 300 mg on the first day and 600 mg on the second day.The recommended daily dose is 600 mg, but if clinically justified, the dose can be increased to 800 mg per day. The dose should be adjusted within the effective dose range from 400 mg to 800 mg per day, depending on the clinical response and tolerability.

For the treatment of depressive episodes in bipolar disorder

Seroquel XR should be used at bedtime. The total daily dose for the first four days of treatment is 50 mg (on day 1), 100 mg (on day 2), 200 mg (on day 3), and 300 mg (on day 4).The recommended daily dose is 300 mg. The 600 mg dose may be effective in selected patients. Doses above 300 mg should be prescribed by a physician experienced in treating bipolar disorder.

For the prevention of recurrence of the disease in bipolar disorder

the prescribed dose at bedtime.The dose of quetiapine XR can be adjusted within a dose range of 300 mg to 800 mg / day, depending on the clinical response and tolerability of each individual patient.

For the concomitant treatment of severe depressive episodes in TDR.

Quetioquel XR should be taken at bedtime. The daily dose at the beginning of therapy is 50 mg on the 1st and 2nd day, and 150 mg on the 3rd and 4th day. In short-term studies of concomitant therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine), the antidepressant effect was observed at doses of 150 and 300 mg / day and at a dose of 50 mg / day as monotherapy …When using higher doses of the drug, the risk of developing adverse reactions increases. Therefore, the physician should ensure that the lowest effective dose is used for treatment, starting at 50 mg / day. The need to increase the dose from 150 to 300 mg / day should be based on an assessment of the individual patient’s condition.

Like other antipsychotics and antidepressants, quetiapine XR should be used with caution in elderly patients, especially at the beginning of treatment and dose selection. Treatment of elderly patients should be started with a dose of 50 mg / day.

Therefore, quetiapine XR should be used with caution in patients with known liver dysfunction, especially during the initial dose selection period.

Seroquel XR – contraindications, side effects

Contraindication

Hypersensitivity to the active substance or to any component of the drug.

Concomitant use of cytochrome P450 3A4 inhibitors such as HIV protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone is contraindicated.

Adverse reactions

When taking quetiapine, the following adverse reactions were most often reported: drowsiness, dizziness, dry mouth, headache, withdrawal symptoms (discontinuation), increased serum triglyceride levels, increased total cholesterol (especially cholesterol) LDL), decreased HDL cholesterol, weight gain, decreased hemoglobin, and extrapyramidal symptoms.

• Decreased hemoglobin level
• Leukopenia, decreased neutrophil count, increased eosinophil level
• Thrombocytopenia, anemia,
• Agranulocytosis
• Neutropenia
• Hypersensitivity
• Hypersensitivity reactions

allergic reactions

• T ₄ decrease in free T ₄ decrease in total T ₃ , increase in TSH
• hypothyroidism
• Inadequate secretion of antidiuretic hormone
• Increase in serum triglycerides _, increase in total cholesterol, cholesterol lowering (especially cholesterol) _, increased body weight
• Increased appetite, increased blood glucose levels to hyperglycemic levels
• Hyponatremia, diabetes mellitus
• Metabolic syndrome
• Unusual dreams and nightmares, suicide Thinking and suicidal behavior
• Sleepwalking and related phenomena such as sleep talk and sleep eating disorders
• Dizziness _, Drowsiness, headache, extrapyramidal symptoms
• Dysarthria
• Seizures dyskinesia _, syncope
• Tachycardia, palpitation
• Prolongation of QT interval, bradycardia
• Blurred vision
• Orthostatic hypotension
• Venous thromboembolism

Urinary retention

• Venous thromboembolism

Urinary retention

• vomiting
• Dysphagia
• Pancreatitis, intestinal obstruction / ileus
• Increased serum alanine aminotransferase (ALT) levels, increased gamma-HT levels
• Increased serum aspartate transaminase (

, hepatic hepatitis

• 06
• Angioedema, Stevens-Johnson syndrome
• Toxic epidermal necrolysis, erythema multiforme
• Rhabdomyolysis
• Neonatal withdrawal syndrome, neonatal withdrawal symptoms
• Sexual dysfunction
• Menstrual cycle disorders
• Withdrawal (discontinuation of use)
• Mild asthenia, peripheral edema, irritability, pyrexia
• Malignant neuroleptic syndrome, hypothermia
• Increased level of creatinine phosphokinase in the blood

Seroquel’s analogs XR

Source: State Register of Medicines of Ukraine.The instructions are published with abbreviations for information only. Before use, consult your doctor and read the instructions carefully. Self-medication can be harmful to your health.

instructions for use, analogs, composition, indications

Since quetiapine has several indications for prescription, its safety profile is determined depending on the disease and the dose of the drug.

Children and adolescents

Quetiapine is not recommended for use in children and adolescents under 18 years of age due to the lack of data confirming the efficacy and safety of the drug in this age group.Clinical studies have shown that in the group of children and adolescents, some side effects while taking quetiapine (increased appetite, increased serum prolactin levels and extrapyramidal symptoms) were observed more often than in the group of adults; and there was one side effect not seen in adults (increased blood pressure). Thyroid dysfunction has also been observed in children and adolescents.

The safety of long-term (more than 26 weeks) administration of quetiapine and the lack of effect on the growth and maturation of children and adolescents have not been studied.Long-term effects on cognitive and behavioral development are not known.

In placebo-controlled clinical trials in the group of children and adolescents who received quetiapine for the treatment of schizophrenia and manic episodes in bipolar disorders, there was an increase in the incidence of extrapyramidal symptoms (EPS) compared with the placebo group.

Suicide / Suicidal thoughts or clinical deterioration

Depression in bipolar disorder is associated with an increased risk of suicidal ideation, self-harm, and suicide.This risk persists until the onset of pronounced remission. Due to the fact that it may take several weeks or more before the patient’s condition improves from the start of treatment, patients should be under close medical supervision until improvement occurs. According to clinical experience, the risk of suicide may increase in the early stages of remission.

Other psychiatric disorders for which quetiapine is prescribed are also associated with an increased risk of suicidal events.In addition, such conditions can be comorbid with a major depressive episode. Thus, the precautions used in the treatment of patients with major depressive episodes should also be used in the treatment of patients with other mental disorders. 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 attempts and should be carefully monitored during treatment.

Patients with a history of suicidal episodes, as well as those with high levels of suicidal thoughts prior to starting treatment, are at greater risk of suicidal ideation or attempted suicide and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials on the use of antidepressants in adults with mental disorders showed an increased risk of suicidal behavior with antidepressants compared with placebo in patients younger than 25 years.

Careful monitoring of patients (especially those from the high-risk group) during treatment is necessary, especially at the beginning of treatment and when the dose is changed. Patients (and caregivers) should be aware of the need for immediate medical attention in case of symptoms of clinical deterioration, suicidal behavior or suicidal thoughts, unusual changes in behavior.

In short-term placebo-controlled clinical trials, patients with major depressive episodes of bipolar disorder who received quetiapine showed an increased risk of suicidal events in young adult patients (younger than 25 years) compared with patients who received placebo (3.0% and 0, 0% respectively).

Extrapyramidal symptoms

In placebo-controlled clinical trials in adult patients with major depressive episodes of bipolar disorder who took quetiapine, there was an increase in the incidence of extrapyramidal symptoms (EPS) compared with the group of patients taking placebo.

The use of quetiapine may be associated with the development of akathisia, characterized by a feeling of internal motor restlessness and manifested in the patient’s inability to sit or stand for a long time.

Symptoms of akathisia are most likely to develop during the first weeks of treatment.

If symptoms of akathisia develop, increasing the dose is undesirable.

Tardive dyskinesia

Tardive dyskinesia is a potentially irreversible syndrome characterized by involuntary dyskinetic movements that can develop in patients treated with antipsychotics, including quetiapine. If symptoms of tardive dyskinesia appear, it is necessary to resolve the issue of dose reduction or withdrawal of quetiapine.The symptoms of tardive dyskinesia may worsen or even occur after treatment is stopped.

Drowsiness and dizziness

Taking quetiapine has been associated with drowsiness and sedation. In clinical studies in patients with depression with bipolar disorders, drowsiness occurred during the first 3 days of treatment and was predominantly mild to moderate. Patients with depression in bipolar disorder who develop severe drowsiness require more frequent medical supervision for at least 2 weeks from the onset of drowsiness until symptoms have subsided; discontinuation of treatment may be considered if necessary.

Orthostatic hypotension

Reception of quetiapine may be associated with the occurrence of orthostatic hypotension and dizziness, which usually develop at the beginning of dose titration. This can increase the incidence of accidental injuries (falls), especially in the elderly. Therefore, patients should be warned to exercise caution until they are familiar with the potential effects of the drug.

Quetiapine should be used with caution in patients with cardiovascular disease, cerebrovascular disease and other conditions that predispose to a decrease in blood pressure.

Taking quetiapine can cause the development of orthostatic hypotension, especially at the beginning of dose titration (more often in elderly patients). In these cases, a dose reduction or more gradual titration is recommended. In patients with cardiovascular disease, a slow dose titration regimen is recommended.

Epileptic seizures

In controlled clinical trials, there was no difference in the incidence of seizures between patients receiving quetiapine and placebo.There are no reports of cases of seizures in patients with a history of seizures. However, caution should be exercised when prescribing antipsychotics (including quetiapine) in the treatment of patients with a history of epileptic seizures.

Malignant neuroleptic syndrome (NMS)

When using antipsychotics (including quetiapine), neuroleptic malignant syndrome may develop. Clinical manifestations of NMS include fever, changes in mental status, muscle stiffness, disorders of the autonomic nervous system, and an increase in creatine phosphokinase.If NMS develops, quetiapine should be discontinued and appropriate treatment prescribed.

Severe neutropenia and agranulocytosis.

In these clinical studies, there are rare reports of the development of severe neutropenia (neutrophil count <0.5 x 109 / L) with the use of quetiapine. Most cases of severe neutropenia occurred within a few months of starting quetiapine and were not dose-dependent. According to post-marketing data, leukopenia and / or neutropenia disappeared after discontinuation of quetiapine.Risk factors for the development of neutropenia: a previous decrease in the number of blood leukocytes or a history of neutropenia caused by taking medications. Patients should stop taking quetiapine (neutrophil count <1.0 x 109 / L). Patients should be monitored for possible symptoms of infection and until neutrophil levels are <1.5 x 109 / L and above.

The development of neutropenia during the use of quetiapine should be considered in patients with infection or fever, especially in the absence of obvious predisposing factors.In this case, appropriate therapeutic measures should be taken. Patients taking quetiapine should be informed to immediately inform their doctor about signs / symptoms of agranulocytosis or infection (eg, fever, weakness, drowsiness, or sore throat). In this case, it is necessary to immediately determine the number of leukocytes and the absolute number of neutrophils in the patient’s blood, especially in the absence of predisposing factors.

Interactions

Cm.See also the section “Interaction with other medicinal products”.

When used simultaneously with strong inducers of hepatic enzymes, such as carbamazepine or phenytoin, the concentration of quetiapine in the blood plasma is significantly reduced, which may affect the effectiveness of quetiapine. In patients receiving hepatic enzyme inducers, treatment with quetiapine can be started only in cases where the doctor believes that the intended benefit of using quetiapine outweighs the risk of canceling the hepatic enzyme inducer.Any change in the dose of the inducer should be gradual, and if necessary, it should be replaced with a non-inducible drug (for example, sodium valproate).

Body weight

An increase in body weight was noted in patients who took quetiapine. Patients taking quetiapine should be monitored in accordance with the basic rules for the use of antipsychotics.

G Ip Erglycemia

With the use of quetiapine, there have been rare reports of the development of hyperglycemia and / or exacerbation of preexisting diabetes mellitus, sometimes associated with the development of ketoacidosis or coma, including death.An increase in body weight in some cases may be a predisposing factor. Clinical observation is necessary in accordance with the basic rules for the use of antipsychotics. Patients taking antipsychotics, including quetiapine, should be monitored for symptoms of hyperglycemia (polydipsia, polyuria, polyphagia, and weakness). Patients with diabetes mellitus or with risk factors for the development of diabetes mellitus should regularly monitor their blood glucose levels. It is necessary to regularly monitor body weight.

Lipids

In clinical studies of quetiapine, there were cases of an increase in triglycerides, LDL and total cholesterol levels and a decrease in HDL cholesterol. If lipid metabolism is disturbed, appropriate treatment should be undertaken.

Risk of metabolic disorders

Given the changes in body weight, glucose and lipids in the blood observed in clinical trials (including in patients with normal baseline values ​​of these indicators), there may be an increase in the risk of metabolic disorders (see.(See also the Side Effects section).

Span extension QT

In the course of clinical studies and use according to the instructions, treatment with quetiapine was not associated with a permanent prolongation of the QT interval.

In the post-marketing period, with the use of therapeutic doses, as well as with an overdose, there have been reports of prolongation of the QT interval (see section “Side Effects”). As with other antipsychotics, caution should be exercised when prescribing quetiapine to patients with cardiovascular disease or a family history of QT prolongation.Caution should be exercised when prescribing quetiapine to patients taking drugs that prolong the QT interval (including other antipsychotics), especially elderly patients, patients with congenital prolongation of the QT interval, heart failure, cardiac hypertrophy, hypokalemia or hypomagnesemia (see the section “Interaction with other medicines “).

Cardiomyopathy and myocarditis

Cardiomyopathy and myocarditis have been noted in clinical studies and during post-marketing experience, but a causal relationship with quetiapine has not been established.Treatment with quetiapine should be reviewed in patients with suspected cardiomyopathy or myocarditis.

Elderly patients with psychosis associated with dementia

Quetiapine is not approved for the treatment of patients with dementia-related psychosis.

In randomized placebo-controlled clinical trials on the use of some atypical antipsychotics in the treatment of elderly patients with dementia, a 3-fold increase in the risk of developing cerebrovascular side effects was found in the group of patients receiving antipsychotics compared with the placebo group.The mechanism of this increase is not known. The increased risk cannot be excluded for other antipsychotics or other patient groups. Quetiapine should be used with caution in patients with risk factors for stroke.

A meta-analysis of studies of atypical antipsychotics demonstrates that elderly patients with psychosis associated with dementia have an increased risk of death compared to the placebo group. However, in two 10-week placebo-controlled studies in the same patient population (n = 710, mean age: 83 years, range: 56-99 years), the mortality rate in the group of patients taking quetiapine was 5.5%, and in placebo group – 3.2%.In these studies, patients died from a variety of causes that are consistent with the assumptions for this population. These data do not allow establishing a causal relationship between the use of quetiapine and death in elderly patients with dementia.

Dysphagia

Cases of dysphagia have been reported during treatment with quetiapine. Caution should be exercised when prescribing quetiapine to patients at high risk of developing aspiration pneumonia.

Constipation and intestinal obstruction

Constipation is a risk factor for bowel obstruction. There have been reports when, against the background of the use of quetiapine, there were cases of constipation and intestinal obstruction, including fatal cases in patients at high risk of developing intestinal obstruction, including those receiving concomitant medications that reduce intestinal motility, even in the absence of complaints. It is necessary to carefully monitor the condition of patients with intestinal obstruction and, if necessary, provide emergency care.

Withdrawal syndrome

Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability have been described after abrupt discontinuation of quetiapine. It is recommended to gradually discontinue quetiapine by reducing the dose for at least 1-2 weeks.

Liver

If jaundice develops while taking quetiapine, the drug should be discontinued.

Accompanying illnesses

Cases of dysphagia (see also the Side Effects section) and aspiration have been reported with quetiapine. Although a causal relationship with aspiration pneumonia has not been established, quetiapine should be used with caution in patients at risk of developing aspiration pneumonia.

Venous thromboembolism (VTE)

Cases of venous thromboembolism (VTE) have been reported in patients taking antipsychotics.Since patients receiving antipsychotics often have acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with quetiapine and preventive measures taken.

Pancreatitis

In clinical studies and during the post-marketing period, cases of pancreatitis have been reported while taking quetiapine. Among the post-marketing messages, not all patients had risk factors for pancreatitis, but many patients had risk factors (increased triglyceride levels, gallstones, alcohol).

Lactose

Kutipin tablets contain lactose. Patients with rare hereditary forms of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

Additional Information

There are limited data on the use of quetiapine in combination with divalproex and lithium for the treatment of moderate to severe manic episodes, but the combination therapy is well tolerated (see.(See also sections “Side effects” and “Interaction with other drugs”). The data obtained show an additive effect at the 3rd week.

Pregnancy and lactation Pregnancy

First trimester

The moderate amount of published data on pregnant women taking quetiapine (300-1000 pregnancy outcomes), including isolated reports and observational studies, do not suggest an increased risk of fetal malformations due to quetiapine treatment.However, based on all the available data, it is impossible to draw an unambiguous conclusion, since animal studies have shown reproductive toxicity. Quetiapine should only be used during pregnancy when the doctor believes the intended benefit of taking quetiapine outweighs the potential risk to the fetus.

Third trimester

Newborns whose mothers took antipsychotics (including quetiapine) in the third trimester of pregnancy are at risk of developing adverse reactions, including extrapyramidal disorders and / or withdrawal symptoms, which can be of varying severity and duration.There have been reports of the following manifestations: agitation, hypertension, hypotension, tremors, drowsiness, respiratory distress, or eating disorders. Newborns whose mothers took antipsychotics (including quetiapine) in the third trimester of pregnancy should be closely monitored.

Breastfeeding

Based on very limited data from published reports of quetiapine excretion in human breast milk, drug excretion at therapeutic doses remains uncertain.The risk to the newborn cannot be ruled out. Therefore, the decision to continue / discontinue breastfeeding or continue / discontinue quetiapine therapy should be made taking into account the benefits of breastfeeding for the baby and the benefits of the drug for the mother.

Fertility

The effect of quetiapine on human fertility has not been evaluated.

Effects associated with increased prolactin levels have been observed in rats.But this information is not directly related to people.

Quetiapine: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects, and when you should contact your healthcare provider.

Trade names: USA

SEROquel; SEROquel XR

Trade names: Canada

ACH-Quetiapine Fumarate XR; ACT QUEtiapine; AG-Quetiapine; APO-QUEtiapine; APO-QUEtiapine XR; Auro-QUEtiapine; BIO-QUEtiapine; DOM-QUEtiapine; JAMP-QUEtiapine; Mar-QUEtiapine; MINT-QUEtiapine; NAT-QUEtiapine; NRA-Quetiapine; PMS-QUEtiapine; Priva-QUEtiapine; PRO-QUEtiapine; RAN-QUEtiapine; RIVA-QUEtiapine; SANDOZ QUEtiapine XRT; SANDOZ QUEtiapine [DSC]; SEROquel; SEROquel XR; TEVA-QUEtiapine XR; TEVA-QUEtiapine [DSC]; VAN-QUEtiapine [DSC]

Warning

• There is an increased risk of death in older people who take this drug for mental health problems associated with dementia.Most of the known deaths were due to heart disease or infection. This drug is not approved for the treatment of mental health problems associated with dementia.
• Drugs like this have increased the likelihood of suicidal thoughts or actions in children and young people. This risk may be higher in people who have attempted suicide or have had suicidal thoughts in the past. All people taking this drug must be closely monitored.Call your doctor right away if you have signs such as depressed mood (depression), nervousness, anxiety, grumpiness, or anxiety attacks, or if other mood or behavior changes occur or worsen. Call your doctor right away if you have suicidal thoughts or attempted suicides.
• This drug is not approved for use in children under 10 years of age. Consult your doctor.

What is this drug used for?

• The drug is used to treat schizophrenia.
• This medication is used to treat bipolar disorder.
• The drug is used to treat depression.
• This drug can be given to children for other indications. Consult your doctor.

What do I need to tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
• If your child has ever had an increase in the length of the ECG QT interval or other abnormalities in the heart rhythm.
• If your child has any of the following health problems: Low potassium or magnesium levels.
• If your child is taking any drugs that can cause some type of heart rhythm disorder (prolonged QT interval). There are many drugs that can have this effect.If in doubt, consult your doctor or pharmacist.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure that this drug is safe for your child’s illness and in combination with other drugs he or she is already taking.You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• Get your child’s blood tested frequently.Check with your child’s doctor.
• Have your child avoid tasks or activities that require attention until you see how this drug is working for your child. This includes cycling, playing sports, or using items such as scissors, lawn mowers, electric scooters, toy cars, or motorized vehicles.
• To reduce the risk of dizziness or fainting, have your child get up slowly from a sitting or lying position.Make sure your child is careful when going up and down the stairs.
• This drug may interfere with some lab tests. Tell all healthcare professionals and laboratory staff providing your child’s healthcare that your child is taking this drug.
• Do not suddenly stop using this drug by your child without talking to your doctor. Your child may be at increased risk of developing withdrawal symptoms.If necessary, this drug should be discontinued gradually, as directed by your healthcare practitioner.
• Alcohol may interact with this drug. Make sure your child does not drink alcohol.
• Consult with your child’s doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow down your child’s actions.
• In rare cases, cataract formation is possible.
• Get your child’s vision checked as directed by a healthcare practitioner.
• With the use of drugs similar to this drug, there was an increase in blood sugar or diabetes, an increased level of cholesterol and an increase in body weight. These changes can increase the likelihood of developing vascular disease of the heart and brain.
• Monitor your child’s blood sugar as directed by your doctor.
• Low leukocyte counts were observed while taking drugs of this kind.This can increase the likelihood of infection. In rare cases, infections have been fatal. If your child has ever had a low white blood cell count, tell the doctor. See your doctor right away if your child develops symptoms of an infection, such as high fever, chills, or sore throat.
• Dizziness, drowsiness, or unsteadiness may happen with this drug. This can lead to a fall, which carries the risk of bone fractures or other harm.
• Make sure your child is careful in hot weather or during vigorous activity. Make sure your child drinks plenty of fluids to stay hydrated.
• If the patient is a child, use this medication with caution. In children, the risk of some side effects may be higher.
• Children and adolescents have high blood pressure. Monitor your child’s blood pressure as directed by the child’s doctor.
• Constipation is common with this drug. Bowel obstruction is sometimes observed. In rare cases, bowel obstruction has been fatal in people taking this drug with other drugs that slow the movement of food through the gastrointestinal (GI) tract. If you have any questions, please consult your doctor.
• This drug may adversely affect a woman’s ability to get pregnant. This ability is restored after stopping treatment with this drug.If you have any questions, please consult your doctor.

If your daughter is pregnant or breastfeeding:

• Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.
• Use of this drug during the third trimester of pregnancy may result in uncontrolled muscle contractions and withdrawal in the newborn.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Symptoms of decreased thyroid hormone levels such as constipation, cold intolerance, memory impairment, mood swings, or unexplained burning, numbness, or tingling sensations.
• Signs of high blood sugar, such as confusion, drowsiness, increased thirst and hunger, increased urination, facial flushing, rapid breathing, and fruity breath.
• Severe dizziness or fainting.
• Chest pain, angina pectoris, tachycardia or irregular heartbeat.
• Uncontrolled body movements, convulsive movements, imbalance, difficulty swallowing or speaking.
• Wobbly gait, difficulty walking, or muscle stiffness.
• Drooling.
• Convulsions.
• Change in vision.
• Severe constipation or abdominal pain. These may be signs of a severe bowel disorder.
• Obstruction of the urinary tract.
• Flu-like symptoms.
• Breast enlargement, nipple discharge, inability to achieve and maintain an erection, changes in the menstrual cycle.
• Patients can develop a very serious and sometimes fatal complication called neuroleptic malignant syndrome. Call your child’s doctor right away if the child has a fever, muscle cramps or stiffness in the muscles, dizziness, very bad headache, confusion, changes in thinking, tachycardia, a feeling of irregular heartbeat, and profuse sweating.
• Some people may develop a serious muscle disorder called tardive dyskinesia.This effect may decrease or disappear after the drug is discontinued, but it may persist. People with diabetes and older people, especially older women, are at increased risk. The risk increases with long-term use or high doses, but can also occur with short-term low doses. Call your child’s doctor right away if your child has uncontrolled body movements or muscle problems in the tongue, face, mouth, or jaw, such as protruding tongue, swollen cheeks, lips compressed into a tube, or involuntary chewing movements.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Nervous tension and agitation.
• Constipation.
• Dry mouth.
• Increased appetite.
• Weight gain.
• Nausea or vomiting.
• Pain in the intestines.
• Back pain.
• stuffy nose.

This list of potential side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor.Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

Immediate-release tablets of active ingredient:

• Give this drug with or without food.

Extended release tablets:

• Have your child swallow whole. Tell your child not to chew, crush, or crush the tablet.
• Give on an empty stomach or with a light meal.

All forms of issue:

• Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.
• Try to get your child to drink lots of non-caffeinated liquids every day, unless the doctor has told you to drink less liquids.

What if my child misses a dose of a drug?

• Give the missed dose as soon as possible.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal dosage schedule.
• Do not give a double dose at the same time or additional doses.
• If you are unsure what to do if your child misses a dose, contact your doctor.

How do I store and / or discard this drug?

• Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs.Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medication with others or give anyone else’s medication to your child.
• Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

instructions for use, reviews of doctors and patients, analogs, price

This information is for reference only. Do not self-diagnose and self-medicate. See a doctor .

Quetixol is a drug belonging to the group of atypical antipsychotic drugs. Able to interact with serotonin, histamine and alpha2-adrenergic receptors localized in the brain.

The main active ingredient is quetiapine. Additional substances included in the preparation include carbohydrates and mineral components.

Available in tablet form of 25, 100, 200 mg of active ingredient, capsules are covered with a specific protective shell.

Pharmacological profile

When administered into the body, Quetixol has a weak cataleptic effect, which blocks dopamine receptors in the brain.

The drug has a pronounced sedative and antipsychotic effect due to inhibition of neuro-reflex transmission. Quetiapine affects the production of pituitary and hypothalamic hormones, increases blood pressure and relieves symptoms of mental illness.

It is taken orally, actively absorbed on the gastric mucosa and enters the bloodstream.Eighty percent of the active ingredient is able to bind to the protein structures of plasma blood cells. At the end of their circulation, the waste products are filtered in the kidney tissue.

Indications and contraindications for use

As an antipsychotic drug, Quetixol is used at:

A positive effect occurs after two doses throughout the day. Quetixol is absolutely safe to use.

The only contraindications are:

• allergic reaction to any of the components of the preparation;
• simultaneous use of antibacterial drugs.

Treatment and dosage regimen

An adult should use the drug 2 times a day. The dosage regimen differs depending on the type of mental illness.

For schizophrenia, the dosages are as follows:

• 1 day – 50 mg / day;
• 2 day – 100;
• 3 day – 200;
• 4 day – 300.

The dosage can be adjusted depending on the individual tolerance and effectiveness of the effect on a particular patient.

In the treatment of manic-depressive syndrome and bipolar disorder:

• 1 day – 100 mg / day;
• 2 day – 200;
• 3 days – 300;
• 4 days – 400.

Quetixol should be taken with caution in the elderly and suffering from hepatic and renal insufficiency due to the increased risk of overdose.The initial dose should be no more than 25 mg per day, then the dose is gradually increased until the maximum therapeutic effect is achieved.

To date, the mechanism of action of the drug on children under the age of 18 has not been studied, which is why Quetixol is not used in pediatric practice.

How the use of the medication will affect the body of a pregnant woman and the fetus is not fully understood. That is why, in such situations, the use of a medicinal substance is carried out only in extreme and advanced forms of mental disorder.

Overdose cases and adverse reactions

Symptoms of overdose are very rare, and no deaths have been reported to date.

Signs of overdose can be directly related to insufficient functioning of the conductive system of the heart and manifest itself in the form of tachycardia, a decrease in blood pressure and “angina pectoris”.

When a dose is used above the norm, a pronounced sedative effect on the central nervous system develops, which is characterized by drowsiness and even apathy.

No specific drug has been developed as an antidote, patients must be urgently taken to the intensive care unit, where resuscitation measures and control over the general condition of the patient will be provided.

A side effect from taking a drug can develop at the level of any anatomical system of the body.

From the nervous system:

From the side of the alimentary canal:

• feeling of dryness of the oral mucosa;
• flatulence;
• constipation;
• Difficulty swallowing food.

From the side of the visual organs:

• sharp decrease in visual acuity;
• increased intraocular pressure;
• a feeling of flickering before the eyes.

From the side of the cardiovascular system:

• violation of the rhythm of heart contractions;
• heart palpitations;
• decrease in blood pressure indicators.

Special instructions

It is necessary to use Quetixol with extreme caution in persons who suffer from chronic cardiovascular pathologies, as there is an increased risk of developing a hypotensive state up to vascular collapse.

Epileptics need to strictly control the regimen of administration and dosing of the drug due to the fact that the drug is capable of increasing the frequency of seizures.

Taking this drug can provoke the development or progression of neuroleptic malignant syndrome, in which case it is recommended to temporarily stop taking the neuroleptic or replace it with another drug.

Withdrawal syndrome is a pathological condition that develops against the background of a sharp withdrawal of Quetixol.It manifests itself in the form of nausea, vomiting, dizziness and the sudden progression of a mental disorder. To prevent the development of such a condition, the dose of the drug must be gradually reduced until it is completely canceled.

Drug interactions

Given the fact that Quetixol has a direct effect on the functioning of the central nervous system, it should be taken with caution with other drugs of a similar mechanism of action. It must be combined with caution with drugs that lower blood pressure.

The drug interacts absolutely favorably with antipsychotics, hypnotics, and sedatives.

Practical experience of application

Reviews of doctors and patients about Quetixol, which we found on the Internet and which seemed interesting to us.

Hello! My sister has been suffering from manic-depressive syndrome for six years, when the doctor prescribed Quetixol, we noticed that the attacks of hallucinations and aggression became much less frequent.During the intake, no side effects were observed.

Galina, 47 years old

I prescribe Quetixol as a treatment for exacerbated forms of schizophrenia, my patients have a positive dynamics of the disease, the period of remission has increased in time.

During my clinical practice, when taking the drug, there were no manifestations of side effects and symptoms of overdose.

Elena Aleksandrovna, doctor of psychiatrist, 25 years of experience

Purchase and analogues

The price of a pack of Quetixol is from 500 -800 rubles, depending on the dosage, similar medicines are also available for purchase:

Store in a cool and dark place at a temperature not exceeding 25 degrees.Pharmacy dispensing only with a prescription from a psychiatrist.

Kapoten in diabetes: contraindications, composition

Patients with diabetes mellitus are accompanied by various complications, and one of them is diabetic nephropathy. In the fight against this pathology, “Kapoten” acts – a medical preparation of a wide spectrum of action, which is distinguished by the speed of the onset of the therapeutic effect. The therapeutic effect of “Kapoten” extends to another disease that is often diagnosed in diabetes mellitus – arterial hypertension.High blood pressure values ​​in people with diabetes are especially dangerous and therefore require urgent action.

Composition and form of release

Kapoten is sold in the form of tablets, packaged in blister packs of 10 or 14 pieces and placed in cardboard boxes, each of which contains 2 or 4 blisters. The drug contains an active ingredient – captopril and the following excipients:

• corn starch;
• MCC;
• octadecanoic acid;
• milk sugar.

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Indications

Pharmaceutical preparation “Kapoten” lowers blood pressure to normal levels and minimizes the load on the heart, which makes it possible to use it for the treatment of hypertension and cardiac dysfunctions accompanied by insufficient blood supply to organs and tissues. Helps “Kapoten” to cure myocardial infarction and, together with other medicines, to overcome diabetic nephropathy that occurs in type I diabetes mellitus.

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Instructions for the use of “Kapoten” in diabetes

Medical consultation before taking the drug is required.

Before starting a therapeutic course with the medication “Kapoten”, it is necessary to consult with a specialized physician, since the dosages indicated in the annotation to the medicine are generalized. The doctor will individually prescribe safe and effective doses based on the diagnosis, age and general condition of the patient.

The medicine is taken orally on an empty stomach, preferably one hour before a meal.The tablets are not crushed in any way, but are swallowed whole, washed down with purified water, at least ½ glass. Treatment is started with minimum doses, gradually increasing them every 14 days by 2 times. The maximum permissible dosage of the medication “Kapoten” is 0.6 g per day, however, doctors recommend using no more than 300 mg, since it is believed that exceeding this value can provoke undesirable consequences. Usually for the treatment of diabetic nephropathy it is recommended to drink “Kapoten” 25 mg three times a day.If this dosage is ineffective, then after two weeks it is increased to 50 mg in the morning and in the evening.

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Contraindications

It is not recommended to use “Kapoten” to eliminate complications of diabetes mellitus for patients under 18 years of age, as well as for individuals with individual intolerance to the components of the medication, pregnant and lactating mothers. “Kapoten” is capable of doing harm if taken under existing pathological conditions that impede the outflow of blood, stenosis of the arteries in patients with the 1st kidney and in case of violations of the normal functioning of the liver and kidneys.Contraindication to the use of “Kapoten” is Quincke’s edema, hyperkalemia and bilateral stenosis of the renal arteries. Patients with cerebral ischemia, the elderly, and those on a diet to control sodium intake should be taken with extreme caution.

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Side effects

Using “Kapoten”, the following negative effects may occur:

When taking the drug, sometimes pulmonary edema occurs.

• dry cough;
• painful palpitations;
• narrowing of the bronchial lumen;
• edema of the lungs, mucous walls of the larynx, extremities, mouth and face;
• increase in the level of potassium, sodium in the blood;
• the presence of protein in the urine;
• violation of acid-base balance;
• anemia;
• decrease in the number of platelets, neutrophils;
• violation of taste and vision, dry mouth;
• soreness in the abdomen, frequent loose stools;
• drowsiness, dizziness and headaches;
• increase in body temperature;
• Skin rashes and itching.

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Substitutes

Pharmaceutical agent “Kapoten” can be replaced by synonyms, that is, drugs that have an identical active substance in the composition, and analogs with a similar effect. Therefore, when it is not possible to use Capoten, doctors replace it with one of the following medicines:

Captopril has a similar composition and the same properties.

• “Blockordil”;
• “Amprilan”;
• Captopril;
• “Hypernik”;
• Akcupro;
• “Gopten”;
• Corpril;
• “Hypernik”;
• Metapril;
• Lysiprex;
• Diroton;
• “Lizoril”;
• Vasolong;
• Parnavel;
• Renitek;
• Sinopril;
• Zokardis;
• “Ramigamma”;
• “Lisinopril”;
• Dilaprel;
• “Leiten”;
• Envas;
• Stoppress;
• “Pyristal”;
• Enafarm;
• “Prenessa”;
• Fosinap;
• Arentopres.

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Special instructions

Before starting treatment and in the process of taking “Kapoten”, you must regularly monitor the renal performance. It may be necessary to discontinue therapy with the described medication if, against the background of its use, the concentration of creatinine has increased.