Atypical neuroleptic. Synonyms for clozapine: azaleptin, leponex, alemoxan, clazaril, iprox. In our country it is sold in two forms: azaleptin and leponex.
Clozapine
- one of the most powerful antipsychotics available today. It is included in the list of potent psychotropic drugs and therefore its circulation is especially controlled by the state (illegal trafficking may result in criminal liability).
In hospitals it is subject to special control and recording. It is prescribed to patients on special forms of strict accounting on numbered prescriptions of a special form: 148-1/u-88. Of all the antipsychotics, only two drugs have such enhanced control over their distribution and use: clozapine and levomepromazine (tisercin).
It was synthesized back in the 60s of the 20th century, the first experience of its use was in 1971, but it became widely used only in 1990. He is considered the founder of the second generation of antipsychotic drugs - atypical antipsychotics.
Unlike first-generation drugs, clozapine is able to influence negative symptoms (apathy, passivity, decreased emotions, withdrawal) and is noticeably less likely to cause extrapyramidal disorders.
Later, new antipsychotic drugs appeared and continue to appear, some of them are falling out of use, but clozapine is still widely used throughout the world as one of the most powerful antipsychotic drugs.
The mechanism of action is complex: it blocks dopamine (especially D-4) receptors in the brain. In addition, it has a similar effect on acetylcholine, adrenaline, histamine, GABA and serotonin receptors. Due to this, a strong sedative effect is achieved, excitement, impulsivity, and fear are relieved, and productive symptoms of psychosis (delusions, hallucinations) are reduced.
One of the intermediate products of clozapine metabolism is benzodiazepine, the active ingredient of many tranquilizers, which determines the anti-anxiety and hypnotic effects. In some cases, an antidepressant effect may also be observed.
Pharmacological properties of the drug Clozapine
Tricyclic dibenzodiazepine derivative. Neuroleptic, has antipsychotic and sedative effects. Blocks dopamine receptors in the central nervous system, has peripheral and central anticholinergic, as well as adrenolytic, antihistamine and antiserotonin effects. A distinctive feature of clozapine is that it practically does not cause significant extrapyramidal disorders and does not have a pronounced inhibitory effect. Treatment with clozapine does not cause an increase in prolactin levels in the blood and, therefore, does not lead to the development of gynecomastia, amenorrhea, galactorrhea and impotence.
Use of the drug Clozapine
Adults are usually prescribed on the 1st day at a dose of 25–50 mg. If well tolerated, the dose is slowly increased over 1–2 weeks by 25–50 to 300 mg/day (individual fluctuations in the daily dose from 200 to 450 mg are possible). Frequency of administration - several times a day; Moreover, a larger dose of the drug can be prescribed before bedtime. The maximum recommended dose is 600 mg/day, but some patients may require a dose of up to 900 mg/day; This dose can be achieved only with a very gradual (no more than 100 mg in one stage) increase. After achieving the maximum therapeutic effect, it is recommended to transfer the patient to maintenance treatment with clozapine at lower doses. The maintenance dose should be selected individually, with a gradual (in several stages) reduction of the initial dose. The maintenance daily dose averages 150–300 mg, although for some patients it may be lower. At a dose not exceeding 200 mg/day, clozapine can be taken once in the evening. In case of planned discontinuation of treatment, a gradual dose reduction over 1–2 weeks is recommended. If prompt withdrawal is necessary, the patient's mental status must be monitored. When resuming interrupted treatment, recommendations for an initial gradual dose increase should be followed. In patients with a history of seizures, as well as in persons with cardiovascular diseases and kidney and/or liver diseases, the initial dose of the drug should be low, and the dose should be increased very slowly.
Withdrawal syndrome
The drug has the property of being addictive. For this reason, in patients it is withdrawn slowly, gradually reducing the dose over several weeks. If a drug addict cannot take another dose for a certain reason, this leads to a strong withdrawal syndrome. It is accompanied by the following symptoms:
- irritability and aggression
- hypermobility
- tremors and convulsions
- hallucinations (most often visual, but can also be auditory)
- delirium and clouding of consciousness
Side effects of the drug Clozapine
The risk of occurrence and/or intensification of side effects increases when clozapine is prescribed in a daily dose exceeding 450 mg. Hematological: granulocytopenia, agranulocytosis (usually develops during the first 18 weeks of treatment); the development of eosinophilia and/or leukocytosis of unknown etiology is possible (especially during the first weeks of treatment). From the side of the central nervous system: most often - drowsiness, increased fatigue; Possible dizziness, headache, relatively rarely - extrapyramidal symptoms, usually of mild severity. There are reports of the development of rigidity, tremor, akathisia, as well as very rare reports of the development of neuroleptic malignant syndrome. From the autonomic nervous system: a feeling of dry mouth, disturbances of accommodation, sweating and thermoregulation, hyperthermia, excessive salivation. From the cardiovascular system: possible tachycardia, orthostatic hypotension, less often - fainting (especially in the first weeks of treatment), relatively rarely - hypertension (arterial hypertension). In rare cases, collapse has been reported, accompanied by depression or respiratory arrest. There are isolated reports of changes in the ECG, the development of arrhythmia, and myocarditis. From the digestive tract and liver: nausea, vomiting, constipation are possible. An increase in the activity of liver enzymes has been reported, and in rare cases, the development of cholestasis. From the urinary system: there are reports of cases of urinary incontinence and urinary retention. Other: weight gain; There are isolated reports of the development of skin reactions. Cases of sudden death have been described, occurring with equal frequency both among people with mental disorders receiving antipsychotic drugs and among patients who do not receive these drugs.
Special instructions for the use of Clozapine
Given the high risk of developing agranulocytosis during treatment with clozapine, it should be prescribed only to those patients with schizophrenia who have no effect from treatment with classical antipsychotics or in case of their intolerance. A prerequisite is also that the patient initially has a normal quantitative and qualitative composition (leukocyte formula) of leukocytes in the blood. During treatment with clozapine, systematic monitoring of the number of leukocytes and leukocyte formula is necessary: weekly for the first 18 weeks and at least once a month thereafter throughout the course of treatment. Caution should be exercised when prescribing clozapine to patients with prostatic hypertrophy and angle-closure glaucoma; diseases of the liver, kidneys, heart. In these patients, systematic monitoring of the function of the liver, kidneys, and cardiovascular system is necessary. Due to the ability of clozapine to cause sedation and lower the seizure threshold, patients should avoid driving vehicles or operating potentially dangerous machinery, especially during the first weeks of treatment. The safety of clozapine during pregnancy has not been established. If clozapine is prescribed during breastfeeding, breastfeeding should be interrupted.
Clozapine
Potentially serious side effects of Clozapine are granulocytopenia and agranulocytosis, the incidence of which is 3% and 0.7%, respectively. Agranulocytosis can be life-threatening.
Since the widespread use of white blood cell and absolute neutrophil counts, the incidence of agranulocytosis and the mortality rate among patients who develop agranulocytosis have decreased markedly. For this reason, the precautions below are mandatory.
Clozapine should only be used in patients with schizophrenia or in patients with psychosis associated with Parkinson's disease who have shown no or insufficient response to treatment with other antipsychotic drugs or who experience severe extrapyramidal side effects with other antipsychotic drugs (especially , tardive dyskinesia).
Clozapine may also be used in patients with schizophrenia or schizoaffective disorder who, based on their history and current clinical presentation, are believed to be at long-term risk of recurrent suicidal behavior.
In patients of all of these categories, Clozapine is used under the following conditions:
- before treatment, both the number of leukocytes (≥ 3.5x109/l [3500/mm3]) and the number of other blood cells should be normal;
- Patients should be regularly monitored for white blood cell counts and, if possible, absolute neutrophil counts (ANC) during treatment (weekly for the first 18 weeks and then at least once a month) and for 1 month after permanent discontinuation of clozapine.
Clozapine is contraindicated in patients who have had hematological disorders in the past while taking medications.
Physicians using the drug must fully comply with safety requirements.
During each consultation, patients receiving clozapine should be reminded that if they exhibit any signs of an infectious disease, they should contact their physician immediately. Particular attention should be paid to complaints of flu-like symptoms or other signs of infectious diseases (particularly fever or sore throat), which may indicate neutropenia. In such cases, a complete blood count should be performed immediately.
Special precautions
Hematological parameters
Since Clozapine may cause agranulocytosis, the following precautions must be observed.
Along with the drug Clozapine, you should not use medications that can significantly inhibit hematopoiesis. You should also avoid simultaneous use of Clozapine with depot forms of antipsychotic drugs, since such drugs can inhibit hematopoiesis, and in an emergency situation (for example, with granulocytopenia), rapid removal of such dosage forms from the body is impossible.
In patients with a history of primary bone marrow diseases, clozapine should be used only if the expected benefit outweighs the possible risk. Such patients should be carefully examined by a hematologist before starting treatment.
Before using clozapine in patients with a low white blood cell count due to benign ethnic neutropenia, the consent of a hematologist should be obtained.
Monitoring white blood cell count and ANC
10 days before starting treatment with Clozapine, the white blood cell count and other blood cell counts should be determined to ensure that only patients with normal values (white blood cell count ≥ 3.5 x 109/L [3500/mm3]) and ANC ≥ will receive the drug. 2.0×109/l [2000/mm3]). During the first 18 weeks of treatment, the number of leukocytes and ANC should be determined every week, and during further treatment - at least once a month; These parameters should also be monitored for one month after discontinuation of the drug Clozapine. During each consultation, patients receiving clozapine should be reminded that at the first sign of fever, sore throat, other flu-like symptoms, and especially other symptoms of an infectious disease that may indicate neutropenia, they should immediately contact their healthcare provider. doctor. In such cases, the leukocyte formula should be immediately determined.
Interruption of therapy due to non-hematological reasons
For patients in whom clozapine therapy of more than 18 weeks was interrupted for more than 3 days (but less than 4 weeks), weekly monitoring of the white blood cell count for an additional 6 weeks is indicated. If no abnormalities are detected, you can proceed to monitoring blood counts at intervals of 4 weeks (but not less often). If clozapine therapy is interrupted for 4 weeks or more, blood counts should be monitored weekly for the subsequent 18 weeks of treatment.
Low white blood cell count and ANC
If in the first 18 weeks of treatment with Clozapine the number of leukocytes decreases to 3.0-3.5910 / l (3000-3500 / mm3) and / or ANC decreases to 1.5-2.0 × 109 / l (1500-2000 / mm3), a general blood test must be performed at least 2 times a week. The same requirement also applies if after 18 weeks of treatment the number of leukocytes decreases to 2.5-3.0x 109/l (2500-3000/mm3) and/or ANC decreases to 1.0-1.5x109 /l (1000-1500/mm3).
If the number of leukocytes decreases significantly relative to the initial value, it is necessary to re-determine the number of leukocytes and the leukocyte formula.
A “significant” decrease is defined as a single decrease in white blood cell count of 3.0 x 109/L (3000/mm3) or more, or a cumulative decrease of 3.0 x 109/L (3000/mm3) or more over a 3-week period.
Clozapine should be discontinued immediately
if in the first 18 weeks of treatment the leukocyte count decreases to < 3.0 x 109/l (3000/mm3) or the ANC decreases to < 1.5 x 109/l (1500/mm3), or if in the period after 18 weeks of treatment the leukocyte count decreases to < 2.5 109/l (2500/mm3) or ANC decreases to < l .0x109/l (1000/mm3).
Thereafter, white blood cell and other blood cell counts should be determined daily, and patients should be closely monitored for the development of influenza-like symptoms or other symptoms suggestive of an infectious disease. After stopping the drug Clozapine, blood counts should be monitored until they return to normal.
If, despite discontinuation of Clozapine, the white blood cell count has decreased below 2.0 x 109/L (2000/mm3) and/or the ANC has decreased below 1.0 x 109/L (1000/mm3), this condition should be treated under the guidance of an experienced hematologist. .
If possible, the patient should be referred to a specialized hematology department, where he can be placed in a separate box and given GM-CSF (granulocyte-macrophage colony-stimulating factor) or G-CSF (granulocyte colony-stimulating factor). It is recommended to discontinue the colony-stimulating factor after the ANC increases again to a level above 1.0x 109/L (1000/mm3).
If an infectious disease develops, antibiotic therapy should be started immediately due to the possibility of septic shock.
In patients who have had Clozapine discontinued due to a low white blood cell count (see above), re-use of Clozapine is not recommended. To confirm the values of hematological parameters, it is recommended to conduct a blood test two days in a row, however, the drug Clozapine should be discontinued after receiving the results of the first test.
If eosinophilia develops, it is recommended to discontinue Clozapine if the eosinophil count exceeds 3.0 x 109/L (3000/mm3), and treatment can be resumed only after the eosinophil count has decreased to a level below 1.0 x 109/L (1000/mm3).
In case of thrombocytopenia, it is recommended to discontinue Clozapine if the platelet count decreases to <50 × 109/L (50,000/mm3).
Other Precautions
Cardiotoxicity
In patients with heart disease, the drug should be used in a low initial dose (on the first day - 12.5 mg in one dose). The dose should be increased slowly and gradually. For dosing accuracy, clozapine 25 mg scored tablets from another manufacturer should be used. The drug is contraindicated in patients with severe cardiovascular diseases. Patients with a history of heart disease or whose physical examination reveals cardiac abnormalities should be referred to a specialist for further evaluation, which should include an ECG. In such patients, Clozapine should only be used if the expected benefit outweighs the possible risk. The treating physician should consider performing an ECG before starting treatment.
Orthostatic hypotension with or without fainting may occur with the use of Clozapine. In rare cases (approximately one in 3000 patients), collapse can be severe and may cause circulatory and/or respiratory arrest, possibly leading to death. The likelihood of such phenomena increases at the stage of initial dose selection (especially in the case of rapid dose increases); very rarely they occurred even after the first use of the drug. Such complications appear to occur more frequently when the drug is used concomitantly with benzodiazepines or other psychotropic drugs. In this regard, at the beginning of treatment with Clozapine, it is necessary to ensure careful medical supervision of the patient.
In the first two months of treatment, in rare cases, resting tachycardia may occur, accompanied by arrhythmia, shortness of breath or symptoms of heart failure; in very rare cases, these phenomena may occur at later stages of treatment. If such symptoms occur (especially during dose selection), diagnostic measures should be carried out as early as possible in order to exclude myocarditis. Symptoms of clozapine-induced myocarditis may also resemble those of a myocardial infarction or the flu. There have also been cases of fatal myocardial infarction. However, due to the patients' severe pre-existing heart disease prior to treatment, it was difficult to assess a causal relationship with clozapine use.
If myocarditis or cardiomyopathy is suspected, clozapine should be discontinued immediately and the patient should be promptly referred to a cardiologist.
The same signs and symptoms may occur later in treatment and in very rare cases may be associated with cardiomyopathy. In such cases, further examination is indicated. If the diagnosis of cardiomyopathy is confirmed, Clozapine should be discontinued.
In patients who have experienced myocarditis or cardiomyopathy caused by clozapine, repeated use is not recommended.
In some cases, eosinophilia was observed simultaneously with myocarditis (in approximately 14% of cases) and pericarditis/pericardial effusion; however, whether eosinophilia is a reliable predictor of carditis is unknown. Mitral valve insufficiency may develop in patients diagnosed with cardiomyopathy during treatment with the drug. Case reports have been received of the development of mitral valve insufficiency in patients with cardiomyopathy associated with clozapine therapy. In these cases, two-dimensional echocardiography revealed mild or moderate regurgitation.
In patients with Parkinson's disease, blood pressure should be monitored while standing and lying down during the first weeks of treatment.
Prolongation of the
QT
As with other antipsychotic drugs, clozapine is recommended to be used with caution in patients with a family history of cardiovascular disease or QT interval disease. As with other antipsychotic drugs, clozapine is recommended to be used with caution concomitantly with drugs that may prolong the QTc interval.
Cerebrovascular events
The use of some atypical antipsychotics in patients with dementia increased the risk of adverse cerebrovascular events by approximately 3 times. The reason why the risk of such events increases has not been established. An increased risk of similar effects cannot be excluded for other antipsychotic drugs or for other categories of patients. In this regard, Clozapine should be used with caution in patients who have risk factors for stroke.
Epilepsy
The drug Clozapine may lower the seizure threshold. Since epileptic seizures have been reported during the use of Clozapine, the frequency and severity of which depended on the dose of the drug, patients with a history of epilepsy should be closely monitored during treatment with Clozapine. In such cases, the dose of the drug should be reduced and, if necessary, anticonvulsant therapy should be started.
In patients with a history of seizures, the dose of the drug on the first day should be 12.5 mg 1 time per day; further increases in the dose should be done slowly and gradually. For dosing accuracy, clozapine 25 mg scored tablets from another manufacturer should be used.
Fever
While taking Clozapine, patients' body temperature may temporarily increase to 38 °C or higher (most likely in the first 3 weeks of treatment). As a rule, such fever is benign. In some cases, it may be accompanied by an increase or decrease in the number of leukocytes.
Patients with fever should be carefully evaluated to exclude infectious disease or agranulocytosis. In case of high fever, the possibility of NMS should be taken into account. If NMS is diagnosed, clozapine should be discontinued immediately and the necessary therapeutic measures should be initiated.
Clozapine may have a sedative effect and cause weight gain, thereby increasing the risk of thromboembolism; for this reason, immobilization should be avoided.
Anticholinergic effects
The drug Clozapine has anticholinergic activity, which can cause side effects from various organs and systems of the body, therefore, in patients with prostate enlargement and angle-closure glaucoma, clozapine should be used under close supervision. Possibly due to its anticholinergic effects, clozapine may cause disturbances in intestinal motility, the severity of which varies from constipation to fecal impaction, intestinal obstruction and intestinal paresis. In rare cases, such phenomena have led to death.
The drug should be used with extreme caution in patients with diseases of the colon or a history of surgical interventions on the organs of the lower abdominal cavity, who are simultaneously receiving drugs that can cause constipation (especially drugs with anticholinergic activity, for example, various antipsychotic drugs, antidepressants and antiparkinsonian drugs ), since the latter can aggravate the situation. Constipation is extremely important to recognize and actively treat.
Particular caution is required when considering the use of Clozapine concomitantly with benzodiazepines (or other centrally acting drugs).
Metabolic disorders
During the use of atypical antipsychotic drugs, including the drug Clozapine, metabolic disturbances were observed, which may increase the risk of developing cardiovascular complications and cerebrovascular accidents. These metabolic abnormalities may include hyperglycemia, dyslipoproteinemia, and weight gain. Although some metabolic abnormalities may occur with all atypical antipsychotic drugs, each drug in this class has its own spectrum of side effects.
Hyperglycemia
Cases of diabetes mellitus and severe hyperglycemia (sometimes leading to ketoacidosis or hyperosmolar coma) have been reported even during the use of clozapine in patients without a history of hyperglycemia. A cause-and-effect relationship between these events and the use of clozapine has not been established, although after discontinuation of the drug in most patients, blood glucose concentrations returned to normal. In a small number of cases, there was a positive association with repeated use of the drug. The effect of clozapine on glucose metabolism in patients with pre-existing diabetes mellitus has not been studied. In patients with diabetes mellitus who are starting to use atypical antipsychotic drugs, serum glucose concentrations should be measured regularly. In patients with risk factors for diabetes mellitus (particularly overweight and a family history of diabetes mellitus) who are starting to use atypical antipsychotic drugs, fasting blood glucose concentrations should be measured before starting treatment and periodically during treatment. If hyperglycemia with symptoms such as polydipsia, polyuria, polyphagia, or weakness occurs in patients using clozapine, the possibility of impaired glucose tolerance should be considered. In patients who develop symptoms of hyperglycemia while using atypical antipsychotics, fasting glucose concentrations should be determined. In some cases, after discontinuation of atypical antipsychotic drugs, glucose concentrations returned to normal; in other cases, hyperglycemia required further treatment despite drug discontinuation. In patients with severe hyperglycemia that has developed while taking the drug, discontinuation of the drug Clozapine should be considered.
Dyslipoproteinemia
Abnormalities in lipid metabolism have been observed in patients using atypical antipsychotic drugs, including clozapine. It is recommended to monitor lipid metabolism in such patients (at the beginning and regularly during treatment).
Weight gain
Weight gain has been reported in patients taking atypical antipsychotics, including clozapine. Body weight should be regularly monitored in such patients.
Special categories of patients
Liver dysfunction
Use of atypical antipsychotic drugs, incl. Clozapine in patients with liver disease is possible with regular monitoring of liver function. If symptoms that may indicate liver dysfunction (such as nausea, vomiting, or loss of appetite) develop during treatment with clozapine, liver function tests should be performed immediately. If there is a clinically significant increase in these values or symptoms of jaundice appear, treatment with Clozapine should be discontinued. Treatment can be resumed only if liver function tests are normalized. In such cases, patients should be closely monitored.
Renal dysfunction
In patients with mild to moderate renal impairment, the drug should be used at a low initial dose (on the first day - 12.5 mg in one dose). For dosing accuracy, clozapine 25 mg scored tablets from another manufacturer should be used.
Patients aged > 60 years
In patients of this age group, it is recommended to start treatment with a lower dose.
Orthostatic hypotension may occur during the use of Clozapine. There have also been rare cases of tachycardia, which may not disappear for a long time. This category of patients, especially patients with impaired cardiovascular function, may be susceptible to these effects to a greater extent than younger patients. In addition, some patients aged >60 years may be particularly susceptible to the anticholinergic effects of clozapine (eg, urinary retention and constipation).
Psychosis/behavioral disorders in elderly patients
>
60 years with dementia
Clozapine is not indicated for the treatment of psychosis/psychotic disorders in patients over 60 years of age with dementia, as the effectiveness and safety of clozapine in this category of patients has not been proven.
The risk of death was increased with the use of atypical antipsychotics in patients aged > 60 years with psychosis/or behavioral disorders due to dementia. Data analysis showed that in patients in this category, the risk of death when using these drugs was 1.6-1.7 times higher than when using placebo. Factors that increase the risk of death with antipsychotic drugs include sedation, cardiovascular disease (eg, arrhythmia, sudden cardiac death), or pulmonary disease (eg, pneumonia with or without aspiration).
Rebound/withdrawal symptoms
If abrupt discontinuation of clozapine is necessary (eg, due to leukopenia), the patient should be carefully monitored for return of psychotic symptoms and rebound cholinergic symptoms, particularly sweating, headache, nausea, vomiting, and diarrhea.
Drug interactions Clozapine
Clozapine can potentiate the central effects of ethanol, MAO inhibitors and CNS depressants (narcotic analgesics, antihistamines, benzodiazepine derivatives). With the simultaneous administration of clozapine and benzodiazepines, as well as in the case of recent treatment with benzodiazepines, the risk of developing hypotensive reactions, collapse, as well as respiratory depression and arrest is increased. Mutual enhancement of effects is possible with the simultaneous administration of clozapine and drugs that have anticholinergic, hypotensive properties, as well as drugs that depress respiration. With the simultaneous administration of clozapine and drugs that have a high degree of binding to plasma proteins (for example, warfarin), it is possible to increase the content of the free fraction of any of the active substances in the blood, which can lead to side effects.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Clozasten, you should consult your doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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Clozapine drug overdose, symptoms and treatment
Drowsiness, coma, areflexia, confusion, agitation, delirium, increased reflexes, convulsions, increased salivation, mydriasis, impaired visual acuity, changes in body temperature, tachycardia, arterial hypotension, collapse, arrhythmia, myocardial conduction disorders, respiratory depression. Treatment: gastric lavage; if necessary, prescribe activated carbon. Symptomatic treatment while monitoring the function of the cardiovascular and respiratory systems; control of water-electrolyte balance and COR. In case of arterial hypotension, the use of adrenaline and its derivatives should be avoided. Medical supervision is required for at least 4 days due to the possibility of late reactions. Peritoneal dialysis and hemodialysis are ineffective.
List of pharmacies where you can buy Clozapine:
- Moscow
- Saint Petersburg
