Zalasta, pills 10mg, 28pcs

Composition

for 1 tablet 2.5 mg / 5 mg/7.5 mg / 10 mg/15 mg/20 mg:

Active ingredient:

Olanzapine 2.50 mg/5.00 mg/7.50 mg/10.00 mg/15.00 mg/20.00 mg

Auxiliary substances: Cellactose 1 [alpha-lactose monohydrate, cellulose], pregelatinized starch, corn starch, colloidal silicon dioxide, magnesium stearate

Cellactose 1 is a spray-dried compound consisting of alpha-lactose monohydrate and cellulose powder, a dry substance.

Pharmacological action

antipsychotic agent (neuroleptic)

Clinical Pharmacology

Pharmacodynamics

Olanzapine is an antipsychotic, anti-manic, and mood-stabilizing drug with a broad pharmacological spectrum of effects on a number of receptor systems. In preclinical studies established affinity (K_i < 100 nmol/l) to different receptors: 5-HT_{2 A/2}-,5-HT₃-,5-HT₆-serotonin, D₁-, D₂-, D₃– D₄– D₅-Dofaminum, M_1-5-muskarinovymi the cholinergic receptors, α₁-adrenergic – and H₁-histamine receptors. In animal studies evaluating the effect of olanzapine on behavior, olanzapine showed antagonism to serotonin, dopamine, and m-cholinergic receptors, which is consistent with the receptor binding profile.

In vitro and in vivo, olanzapine has a more pronounced affinity and activity for 5-HT2-serotonin than for D2_-dopaminereceptors. According to electrophysiological studies, olanzapine selectively reduces the activity of mesolimbic (A10) dopaminergic neurons, and at the same time has a minor effect on the striatal nerve pathways (A9) involved in the regulation of motor (motor) functions. Olanzapine reduces the conditioned defense reflex (in the antipsychotic activity test) at doses lower than those that cause catalepsy (an effect indicative of motor [motor] adverse reactions). Unlike some other antipsychotic drugs, olanzapine increases the response in the “anxiolytic” test.

In a study in healthy volunteers with a single dose (10 mg) followed by positron emission tomography, olanzapine binds more to 5-HT2A-serotonin than D2_–dopamine receptors. In addition, the results of a study in patients with schizophrenia using single-photon emission computed tomography showed that patients who responded to olanzapine showed a lower association with striar_D2receptors compared to patients who responded to other antipsychotic drugs and risperidone, while being comparable to patients who responded to clozapine.

Clinical effects

In two of the two placebo-controlled clinical trials and in two of the three comparative clinical trials involving more than 2,900 patients with schizophrenia who had both productive and negative symptoms, olanzapine use resulted in a statistically significant reduction in the severity of both types of disorders.

In an international double-blind comparative study with the participation of 1481 patients with schizophrenia, schizoaffective and related disorders associated with these conditions depressive symptoms (average score on a scale Montgomery-asberg for the assessment of depression is 16.6) in a prospective secondary analysis of changes in score in the assessment of mood in the end of the study compared to baseline values was statistically significant (p=0.001) improvement in the patients in patients receiving olanzapine (-6,0) compared with haloperidol (-3,1).

The use of olanzapine for 3 weeks in patients with a manic or mixed episode of bipolar disorder was more effective in reducing the severity of manic manifestations compared to placebo and a complex of sodium valproate and valproic acid in a ratio of 1: 1. olanzapine also showed comparable effectiveness with haloperidol in the proportion of patients who achieved symptomatic remission in relation to mania and depression at 6 and 12 weeks of use. The use of olanzapine at a dose of 10 mg as part of a combination therapy in combination with lithium or valproic acid for at least 2 weeks resulted in a greater reduction in the severity of mania manifestations than monotherapy with lithium or valproic acid after 6 weeks of use of the latter.

A 12-month clinical trial on relapse prevention in patients with a manic episode who achieved remission while taking olanzapine and were subsequently randomized to olanzapine or placebo groups showed a statistically significant superiority of olanzapine over placebo in terms of achieving the primary endpoint – relapse of bipolar disorder. Olanzapine has also been shown to have an advantage over placebo in preventing relapses of both manic and depressive episodes.

In another 12-month clinical trial on relapse prevention in patients with a manic episode who achieved remission while taking olanzapine in combination with lithium drugs, and subsequently randomized to olanzapine or lithium monotherapy groups, olanzapine was statistically as effective as lithium in achieving the primary endpoint of bipolar disorder relapse (olanzapine group – 30%, lithium group – 38.23%; p=0.055).

In the 18-month clinical trial of combination therapy olanzapine in combination with normotimics agent (drug lithium or valproic acid) in patients with a manic or mixed episode was not shown statistically significant long-term superiority of combination therapy over monotherapy with the drug lithium or valproic acid in relation to the time of the occurrence of relapse of bipolar disorder, determined in accordance with diagnostic (syndrome) criteria.

Pharmacokinetics

Suction

After oral use, olanzapine is well absorbed, its maximum concentration (cmax) in blood plasma is reached in 5-8 hours. Food intake does not affect absorption. Absolute oral bioavailability compared to intravenous use was not determined.

Distribution

The binding of olanzapine to plasma proteins is 93% (in the concentration range of 7-1000 ng / ml). Olanzapine mainly binds to albumin and_α1-acid glycoprotein.

Metabolism

Olanzapine is metabolized in the liver by conjugation and oxidation. The main circulating metabolite is 10-N-glucuronide, which does not cross the blood-brain barrier. The CYP1A2 and CYP2D6 isoenzymes are involved in the formation of N-desmethyl and 2-hydroxymethyl metabolites; in animal studies, both metabolites had significantly less pronounced pharmacological activity in vivothan olanzapine. The main pharmacological activity of the drug is due to the initial compound-olanzapine.

Deduction

After oral use, the average terminal half-life (T_1/2) of olanzapine in healthy volunteers depends on age and gender.

Pharmacokinetics in selected groups of patients

Elderly patients

In healthy elderly volunteers (65 years and older), the average T_{1/2 increased} (51.8 hours vs. 33.8 hours) and clearance decreased (17.5 l/h vs. 18.2 l/h) compared to younger subjects. Pharmacokinetic variability in elderly volunteers corresponded to the range of younger subjects. In 44 patients with schizophrenia older than 65 years, olanzapine use at doses of 5-20 mg / day did not lead to differences in the profile of adverse events.

Gender

The average T_1/2 in women compared to men is slightly increased (36.7 hours vs. 32.3 hours), and clearance is reduced (18.9 l/h vs. 27.3 l/h). However, the safety profile of olanzapine (at doses of 5-20 mg / day) in female patients (n=467) is comparable to that in male patients (n=869).

Kidney failure

No significant differences in mean T_1/2 (37.7 hours vs. 32.4 hours) or clearance (21.2 l/h vs. 25.0 l/h) were observed in patients with renal insufficiency (creatinine clearance < 10 ml/min) compared to healthy volunteers. A material balance study found that approximately 57% of radioisotope-labeled olanzapine is found in the urine, mainly as metabolites.

Liver failure

A small study of the effect of disturbances of liver function while taking olanzapine orally (by 2.5-7.5 mg dose) in 6 patients with clinically significant cirrhosis of the class A (n=5) and class B (n=1) according to the classification of child-Pugh showed a minor effect on the pharmacokinetics in patients with light and moderate hepatic impairment showed a slight increase in systemic clearance and shortening T_1/2 compared to patients without liver dysfunction (n=3). Among those with cirrhosis of the liver, there were more smokers (4/6; 67%) than among those without liver dysfunction (0/3; 0%).

Smoking

In smokers with mild hepatic insufficiency (Child-Pugh class A), the average T_{1/2 increased} (39.3 hours) and clearance decreased (18 l/h) similarly to non-smokers in healthy individuals (48.8 hours and 14.1 l/h, respectively).

In non-smoking patients, the mean T_1/2 lengthened (38.6 hours vs. 30.4 hours) and clearance decreased (18.6 l/h vs. 27.7 l/h) compared to smoking patients (men and women).

Plasma clearance of olanzapine is lower in the elderly compared to younger people, in men compared to women, and in non-smokers compared to smokers. However, the dependence of olanzapine clearance and T_1/2 on age, gender, and smoking is small compared to the overall inter-individual variability.

Racial background

No differences in the pharmacokinetics of olanzapine were found in a study involving individuals of European, Japanese, and Chinese descent.

Indications

Adults

·  Olanzapine is indicated for the treatment of schizophrenia.

·  Olanzapine is effective in maintenance and long-term therapy in patients with schizophrenia who have experienced an initial treatment effect.

·  Olanzapine is indicated for the treatment of moderate to severe manic episodes.

·  Olanzapine is indicated for preventing relapses in patients with bipolar disorder, in whom it has been shown to be effective in treating a manic episode.

Use during pregnancy and lactation

Pregnancy

Adequate and strictly controlled studies have not been conducted in pregnant women. Patients should be warned about the need to notify the attending physician about the onset of pregnancy or pregnancy planning during treatment with olanzapine. However, due to limited human experience, olanzapine should be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

Newborns whose mothers took olanzapine during the third trimester of pregnancy are at risk of developing adverse reactions, including extrapyramidal disorders and / or withdrawal symptoms, which may vary in severity and duration after delivery. Agitation, hypertonia, hypotonia, tremor, drowsiness, respiratory distress syndrome, and eating disorders have been reported. In this regard, newborns should be closely monitored.

Breast-feeding period

In a study in nursing healthy women, it was found that olanzapine penetrates into breast milk. The average dose received by the child (mg/kg) at steady state was 1.8% of the maternal dose of olanzapine (mg/kg). Patients using olanzapine are advised to stop breastfeeding.

Fertility

There is no data on the effect on fertility.

Contraindications

* Hypersensitivity to any of the components of the drug.

* Patients at risk of developing angle-closure glaucoma.

* Children under 18 years of age.

* Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Interaction

Drug interactions were studied exclusively in adult patients.

Potential interactions affecting the pharmacokinetics of olanzapine

Since olanzapine is metabolized by the CYP1A2 isoenzyme, substances capable of selectively inducing or inhibiting this isoenzyme can alter the pharmacokinetics of olanzapine.

Induction of the CYP1A2 isoenzyme

Smoking and carbamazepine can induce olanzapine metabolism, which can lead to a decrease in the serum concentration of olanzapine. There was an increase in the clearance of olanzapine from mild to moderate. Clinical results are limited, it is recommended to carry out clinical monitoring with an increase in the dose if necessary (see the section “Dosage and use”).

Inhibition of the CYP1A2 isoenzyme

Fluvoxamine, a specific inhibitor of the CYP1A2 isoenzyme, has been shown to significantly inhibit olanzapine metabolism. The average increase in plasma cmax of olanzapine after fluvoxamine use is 54% in non-smoking women and 77% in smoking men. The average increase in the area under the concentration-time curve (AUC) was 52% and 108%, respectively. Patients taking fluvoxamine or other CYP1A2 inhibitors, such as ciprofloxacin, should be given a lower dose of olanzapine. Patients receiving therapy with a CYP1A2 inhibitor should consider reducing the dose of olanzapine.

Reduced bioavailability

Activated charcoal reduces the bioavailability of oral olanzapine by 50-60%, so it should be used 2 hours before or after taking olanzapine.

Fluoxetine (an inhibitor of the CYP2D6 isoenzyme), single doses of antacids (aluminum -, magnesium-containing) and cimetidine do not significantly affect the pharmacokinetics of olanzapine.

The ability of olanzapine to influence the pharmacokinetics of other drugs

Olanzapine can block the effects of direct and indirect dopamine receptor agonists.

Olanzapine does not inhibit major cytochrome P 450 isoenzymes in vitro (e. g.,1A2,2D6,2C9,2C19,3A4). The results of in vivo studies confirm the absence of inhibition of the metabolism of the following drugs: tricyclic antidepressants (mainly metabolized with the participation of the CYP2D6 isoenzyme), warfarin (CYP2C19), theophylline (CYP1A2) and diazepam (CYP3A4 and CYP2C19).

Olanzapine does not interact with lithium and biperiden.

Plasma valproic acid concentrations showed that the concomitant use of olanzapine does not require dose adjustment of valproic acid.

General activity of the central nervous system (CNS)

Caution should be exercised in patients who consume alcohol or take medications that depress the central nervous system.

Concomitant use of olanzapine with Antiparkinsonian medications in patients with Parkinson’s disease and dementia is not recommended (see section “Special instructions”).

QTc Interval

Caution should be exercised when olanzapine is co-administered with medicinal products that prolong the QTc interval (see section “Special Instructions”).

How to take, course of use and dosage

Adult

Schizophrenia: The recommended starting dose of olanzapine is 10 mg once a day.

Manic episode: The initial dose is 15 mg once a day for monotherapy or 10 mg per day for combination therapy (with lithium or valproate).

Prevention of recurrent bipolar disorder: The recommended starting dose of olanzapine is 10 mg once a day. Patients who have received olanzapine for the treatment of a manic episode should continue therapy at the same dose to prevent relapse. If a new manic, mixed, or depressive episode develops, olanzapine therapy should be continued (with dose adjustments if necessary), with additional therapy to treat the symptoms of mood disorders as clinically indicated.

In the treatment of schizophrenia, manic episodes and prevention of relapses of bipolar disorder, the daily dose can be adjusted in the range from 5 mg to 20 mg per day. An increase in the initial dose should be made only after a proper clinical examination. Dose increases should be made at intervals of at least 24 hours. Olanzapine can be prescribed regardless of food intake, since food intake does not affect the absorption of the drug.

When stopping treatment with olanzapine, the dose of the drug should be reduced gradually.

Special patient groups

Elderly patients

The minimum starting dose (5 mg per day) is usually not prescribed, but its use should be considered in patients over 65 years of age, if the clinical condition of the particular patient requires it.

Patients with renal and / or hepatic insufficiency

Patients with renal and / or hepatic insufficiency should start treatment with a minimum dose (5 mg per day). In patients with moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the initial dose should be 5 mg, and the dose should be increased with caution if necessary.

Smoking

The initial dose and dose range generally need not be changed depending on whether the patient smokes or not. Olanzapine metabolism can be accelerated by smoking. It is recommended to conduct clinical monitoring, if necessary, the dose of olanzapine can be increased.

In the presence of more than one of the factors that can lead to a slowdown in metabolism (female patients, the elderly, non-smokers), a reduction in the initial dose may be recommended. Increasing the dose in such patients, if indicated, should be carried out conservatively.

Overdose

Symptoms: Very common symptoms (≥ 10%) of olanzapine overdose are tachycardia, agitation / aggressiveness, dysarthria, various extrapyramidal symptoms, and decreased consciousness of varying severity (from sedation to coma).

Other clinically significant effects of olanzapine overdose included delirium, seizures, neuroleptic malignant syndrome (NMS), respiratory depression, aspiration, hypertension or hypotension, and arrhythmias ( The minimum dose for an acute overdose with a fatal outcome was 450 mg, the maximum dose for an overdose with a favorable outcome (survival) was 2 g of olanzapine.

Treatment: There is no specific antidote for olanzapine. It is not recommended to provoke vomiting. Standard procedures for overdose are shown, for example, gastric lavage, taking activated charcoal. The use of activated charcoal with simultaneous oral use of olanzapine showed a decrease in the bioavailability of olanzapine up to 50-60%.

Symptomatic treatment is indicated in accordance with the clinical condition and control of vital body functions, including correction of arterial hypotension, circulatory disorders and maintenance of respiratory function. Do not use epinephrine, dopamine, or other adrenomimetics that are beta-adrenergic agonists, as stimulation of these receptors may worsen hypotension. In order to detect possible arrhythmias, cardiovascular activity should be monitored. Close medical monitoring should continue until the patient is fully recovered.

Description

2.5 mg tablets:

Round slightly biconvex tablets of light yellow color. Intersperses of a darker shade are allowed.

5 mg tablets:

Round slightly biconvex tablets of light yellow color with an engraving 5. Intersperses of a darker shade are allowed.

7.5 mg tablets:

Round slightly biconvex tablets of light yellow color with an engraving of 7.5. Intersperses of a darker shade are allowed.

10 mg tablets:

Round slightly biconvex tablets of light yellow color with the inscription 10. Intersperses of a darker shade are allowed.

15 mg tablets:

Round slightly biconvex tablets of light yellow color with the inscription 15. Intersperses of a darker shade are allowed.

20 mg tablets:

Round slightly biconvex tablets of light yellow color with the inscription 20. Intersperses of a darker shade are allowed.

Special instructions

Contraindicated in persons under 18 years of age.

Elderly patients

The minimum starting dose (5 mg per day) is usually not prescribed, but its use should be considered in patients over 65 years of age, if the clinical condition of the particular patient requires it.

Patients with renal and / or hepatic insufficiency

Patients with renal and / or hepatic insufficiency should start treatment with a minimum dose (5 mg per day). In patients with moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the initial dose should be 5 mg, and the dose should be increased with caution if necessary.

Improvement of the patient’s clinical condition with antipsychotic therapy can take from several days to several weeks, this period requires careful monitoring of the patient.

Suicide risk

Patients with schizophrenia and bipolar disorder type 1 have a tendency to commit suicide, and therefore, against the background of pharmacotherapy, careful monitoring of patients with a high risk of suicide is required. In order to reduce the risk of overdose, a minimum amount of the drug should be prescribed, sufficient to ensure the proper therapeutic effect.

Psychosis and / or dementia-related behavioral disorders

Olanzapine is not recommended for use in patients with psychosis and / or dementia-related behavioral disorders due to increased mortality and the risk of cerebrovascular complications. In placebo-controlled studies (lasting 6-12 weeks) in elderly patients (mean age 78 years) with psychosis and / or behavioral impairment due to dementia, there was a twofold increase in the frequency of deaths in patients treated with olanzapine compared to patients in the placebo group (3.5% vs. 1.5%, respectively). The increased mortality rate was independent of the olanzapine dose (mean daily dose 4.4 mg) and the duration of treatment. Risk factors that may predispose to increased mortality in this patient population are age over 65 years, dysphagia, sedation, malnutrition and dehydration, lung diseases (for example, pneumonia with or without aspiration), or concomitant use of benzodiazepines. However, the rate of death in olanzapine-treated patients compared to placebo-treated patients was higher regardless of these risk factors.

The results of the same clinical trials indicate cerebrovascular adverse events (CVNI) (for example, stroke, transient ischemic attack), including fatal outcomes. There was a threefold increase in the incidence of CVNI in olanzapine-treated patients compared to placebo-treated patients (1.3% vs. 0.4%, respectively). All patients treated with olanzapine and placebo who experienced cerebrovascular events had risk factors. Risk factors for developing CVNI associated with olanzapine treatment include age over 75 years and vascular / mixed dementia. Olanzapine has not been shown to be effective in these studies.

Parkinson’s disease

The use of olanzapine for the treatment of psychoses caused by the use of dopamine receptor agonists in Parkinson’s disease is not recommended. In clinical trials, worsening of Parkinsonian symptoms and hallucinations were very common (and with a higher frequency than in the placebo group) (see section “Side effects”), the effectiveness of olanzapine for the relief of psychotic symptoms did not exceed placebo. The criteria for inclusion in these studies were: stable lowest effective dose of antiparkinsonian drugs (dopamine receptor agonist) and the use of the same Antiparkinsonian drugs and doses throughout the study. Olanzapine was started at 2.5 mg / day with an increase in the dose at the discretion of the researcher to 15 mg / day. Neuroleptic

malignant syndrome (NMS)

NMS is a potentially fatal symptom complex caused by antipsychotic drugs. Rare cases of NMS have also been reported with olanzapine. Clinical manifestations of NMS include hyperthermia, muscle rigidity, changes in mental status, and vegetative disorders (unstable pulse or blood pressure, tachycardia, increased sweating, and arrhythmias). Additional signs may include: increased serum CPK activity, myoglobinuria (rhabdomyolysis), and acute renal failure. If a patient develops signs and symptoms of NMS or has an unexplained high fever without additional NMS symptoms, all antipsychotic medications, including olanzapine, should be discontinued.

Hyperglycemia and diabetes mellitus

Infrequently, hyperglycemia and / or the development or decompensation of diabetes mellitus, sometimes accompanied by ketoacidosis or diabetic coma, have been reported, including several fatal cases (see section “Side effects”). In some cases, previous weight gain has been reported, which may be a predisposing factor. Careful clinical monitoring is recommended in accordance with the current guidelines for antipsychotic therapy, for example, measuring the initial blood glucose concentration,12 weeks after the start of olanzapine therapy, and then annually. Patients receiving any antipsychotic medication, including olanzapine, should be monitored for signs and symptoms of hyperglycemia (such as polydipsia, polyuria, polyphagia, and weakness). Patients with diabetes mellitus or risk factors for its development should regularly monitor their blood glucose concentration. You should regularly check your body weight, for example, before starting,4,8 and 12 weeks after starting olanzapine, and then quarterly.

Lipid metabolism disorders

In placebo-controlled studies, undesirable changes in the lipid profile were observed in patients treated with olanzapine (see section “Side effects”). Lipid metabolism disorders should be corrected, especially in patients with dyslipidemia and patients with risk factors for developing lipid metabolism disorders. In patients receiving any antipsychotic medication, including olanzapine, the lipid profile should be regularly monitored in accordance with current antipsychotic therapy guidelines (for example, before starting treatment,12 weeks after starting therapy, and every 5 years thereafter).

Anticholinergic activity

Although olanzapine has shown anticholinergic activity in vitro, olanzapine therapy has rarely been associated with anticholinergic side effects in clinical trials. However, clinical experience with olanzapine in patients with concomitant diseases is limited, so caution is recommended when prescribing the drug to patients with prostatic hypertrophy, paralytic intestinal obstruction and similar conditions.

Liver function disorders

Olanzapine use was often accompanied, especially in the early stages of therapy, by a transient, asymptomatic increase in the activity of “hepatic” aminotransferases (ACT and ALT) in blood plasma. Caution and follow-up should be exercised in patients with elevated ALT and / or ACT plasma activity, symptoms of hepatic insufficiency, conditions that cause a decrease in the functional reserve of the liver, or in patients using potentially hepatotoxic drugs. In patients with hepatitis (including hepatic cell, cholestatic, and mixed liver disease), olanzapine treatment should be discontinued.

Neutropenia

Olanzapine should be used with caution in patients with low white blood cell and/or neutrophil counts, regardless of the cause, a history of drug-induced bone marrow suppression / toxicity, bone marrow depression due to concomitant disease, radiation or chemotherapy, as well as in patients with hypereosinophilic conditions or myeloproliferative disease. Neutropenia has often been reported with the concomitant use of olanzapine and valproic acid (see section “Side effects”).

Discontinuation of therapy

With abrupt withdrawal of olanzapine, rarely (≥ 0.01% and

QT Interval

In clinical studies, patients treated with olanzapine infrequently (0.1-1%) showed clinically significant prolongation of the QT interval (the Friederici-corrected QT interval [QTcF] ≥ 500 ms at the initial value equal to QTcF However, similar to other antipsychotics, caution should be exercised when prescribing olanzapine concomitantly with drugs that can prolong the QTc interval, especially in elderly patients, patients with congenital QT prolongation, chronic heart failure, myocardial hypertrophy, hypokalemia or hypomagnesemia.

Thromboembolism

During olanzapine therapy, infrequently (≥ 0.1% and A causal relationship between olanzapine use and VTE has not been established. However, given that patients with schizophrenia often have acquired risk factors for venous thromboembolism, it is necessary to identify all possible risk factors for VTE (for example, patient immobilization), and take the necessary preventive measures.

General activity of the central nervous system (CNS)

Given the main effect of olanzapine on the central nervous system, caution should be exercised when using olanzapine simultaneously with other centrally acting drugs and ethanol. Since olanzapine exhibits dopamine receptor antagonism in vitro, it can block the effects of direct and indirect dopamine receptor agonists.

Convulsions

Olanzapine should be used with caution in patients with a history of seizures or who are exposed to factors that reduce the threshold of seizure readiness. Seizures have been reported infrequently during olanzapine treatment. In most cases, a history of seizures or risk factors for seizures were reported.

Tardive dyskinesia

In comparative studies lasting one year or less, treatment with olanzapine was statistically significantly less likely to be accompanied by the development of iatrogenic dyskinesia. However, the risk of tardive dyskinesia increases with long-term olanzapine therapy. Therefore, if a patient using olanzapine shows signs or symptoms of tardive dyskinesia, you should consider reducing the dose or discontinuing olanzapine. After discontinuation of therapy, these symptoms may temporarily worsen or even reappear.

Postural hypotension

In clinical studies of olanzapine, postural hypotension was infrequently observed in elderly patients. Similar to other antipsychotic medications, periodic blood pressure monitoring is recommended for patients over 65 years of age.

Sudden death from cardiovascular failure

According to the post-marketing experience of olanzapine use, cases of sudden death from cardiovascular insufficiency have been reported. In a retrospective observational cohort study, the risk of suspected sudden death from cardiovascular failure in patients treated with olanzapine was approximately twice as high as in patients who did not receive antipsychotics. The risk of using olanzapine in the study was comparable to the risk of atypical antipsychotics included in the pooled analysis.

Olanzapine use in children

Olanzapine is not recommended for use in children and adolescents. Various adverse reactions, including weight gain, lipid metabolism disorders, and hyperprolactinemia, have been reported in adolescents aged 13-17 years.

Special information on excipients

Zalasta ® contains lactose, so it is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Studies of the effect on the ability to drive vehicles and other mechanisms have not been conducted. Since olanzapine can cause drowsiness and dizziness, patients should be warned about the dangers when working with machinery, including vehicles.

Form of production

Tablets,2.5 mg,5 mg,7.5 mg,10 mg,15 mg,20 mg.

7 tablets each in a blister of combined OPA/Al/PVC material and aluminum foil.

4 or 8 blisters together with the instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging.

Keep out of reach of children

Shelf

life is 5 years.

Do not use the drug after the expiration date.

Active ingredient

Olanzapine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Schizophrenia, Manic-depressive psychosis