Olanzapine-SZ - instructions for use, doses, side effects, contraindications

composition of the shell: Opaprai II (polyvinyl alcohol, partially hydrolyzed 0.8 mg, talc 0.296 mg: titanium dioxide E 171 0.4374 mg, macrogol (polyethylene glycol 3350) 0.404 mg, aluminum varnish based on yellow quinoline 0.0602 mg, aluminum varnish based on yellow sunset sunset 0.0014 mg, iron oxide dye (II) yellow 0.0006 mg, aluminum lignol based on indigocarmine 0.0004 mg).

dosage of 10 mg

active substance: olanzapine (olanzapine form 1) 10 mg;

Excipients: lactose monohydrate (lactopress) (sugar milk) 148.4 mg; calcium stearate 1.6 mg;

shell composition: opedrai II (polyvinyl alcohol, partially hydrolyzed 1.6 mg, talc 0.592 mg, titanium dioxide E 171 0.8748 mg, macrogol (polyethylene glycol 3350) 0.808 mg, aluminum varnish based on yellow quinoline 0.1204 mg, aluminum varnish based on yellow sunset sunset 0.0028 mg, iron oxide dye (II) yellow 0.0012 mg, aluminum lignum based on indigo carmine 0.0008 mg).

Description:Tablets are round, biconvex, covered with a film coating of yellow color. Tablets at a broken light yellow color.

Pharmacotherapeutic group:Antipsychotic agent (antipsychotic)

ATX: & nbsp

N.05.A.H.03 Olanzapine

Pharmacodynamics:

Olanzapine is an antipsychotic agent (neuroleptic).

In preclinical studies, affinity for 5-HT_{2A / 2C}-, 5-HT₃-, 5-HT₆- serotonin receptors; D₁-, D₂-, D₃-, D₄-, D₅dopamine receptors; m-cholinoblocking effects due to blockade m_1-5-choline receptors; also has an affinity for α₁adreno and H₁-histamine receptors. In animal experiments, antagonism was revealed with respect to serotonin, dopamine and m-cholinergic receptors. In vivo and in vitro olanzapine has a more pronounced affinity and activity with respect to 5-HT₂serotonin receptors in comparison with D₂dopamine receptors. According to electrophysiological studies olanzapine selectively reduces the excitability of mesolimbic dopaminergic neurons, and at the same time has an insignificant effect on the striatial neural pathways involved in the regulation of motor functions.

Pharmacokinetics:

After oral administration olanzapine well absorbed and its maximum concentration in the plasma is achieved after 5-8 hours. Absorption of olanzapine is not dependent on food intake.In studies with different doses ranging from 1 mg to 20 mg, it is shown that the plasma concentrations of olanzapine vary linearly and in proportion to the dose. Olanzapine metabolized in the liver as a result of conjugation and oxidation. The main circulating metabolite is 10-N-glucuronide, which theoretically does not penetrate the blood-brain barrier.

Isozymes CYP1A2 and CYP2D6 cytochrome P450 are involved in education N-desmethyl and 2-hydroxymethylmetabolites of olanzapine. Both metabolites in animal studies had significantly less pharmacological activity in vivo, than olanzapine. The main pharmacological activity of the drug is due to the parent substance olanzapine.

In healthy volunteers, after oral administration, the mean half-life of the half-life (T_1/2) was 33 hours (21-54 hours for 5-95%), and the average clearance of olanzapine in plasma was 26 l / h (12-47 l / h for 5-95%).

Pharmacokinetic parameters vary depending on smoking, sex and age (see table):

Characteristics patients	Half-life (hours)	Clearance in plasma (l / h)
Non-smokers	38,6	18,6
Smokers	30,4	27,7
Women	36,7	18,9
Men's	32,3	27,3
Elderly (65 years and over)	51,8	17,5
Younger than 65 years	33,8	18,2

However, the degree of changes in the half-life and clearance parameters under the influence of each of these factors is significantly inferior to the degree of difference between these indicators among individuals.

No significant differences between the mean half-life and clearance of olanzapine in plasma in patients with severe renal impairment as compared to individuals with normal renal function is not installed. About 57% labeled radioisotopes of olanzapine is excreted in the urine, mainly in the form of metabolites.

In smokers with minor violations of liver function, the clearance of olanzapine is lower than that of non-smokers without impaired liver function.

At a plasma concentration of 7 to 1000 ng / ml, about 93 are associated with plasma proteins% olanzapine. Olanzapine mainly binds to albumin and to acid α₁glycoprotein.

In a study involving individuals of European, Japanese and Chinese origin, there are no differences in the pharmacokinetics of olanzapine associated with race. Isoenzyme activity CYP2D6 cytochrome P450 does not affect the level of metabolism of olanzapine.

Indications:

Schizophrenia.

Bipolar affective disorder type I. Olanzapine in the form of monotherapy or in combination with lithium or valproic acid preparations is indicated for the treatment of acute manic or mixed episodes in bipolar affective disorder with or without psychotic manifestations and with / without rapid phase change. Olanzapine It is shown to prevent relapse in patients with bipolar disorder who have olanzapine was effective in treating the manic phase.

In combination with fluoxetine olanzapine is indicated for the treatment of a depressive episode in the structure of bipolar disorder.

Therapeutically resistant depression. In combination with fluoxetine olanzapine is indicated for the treatment of therapeutically-resistant depression in adult patients (major depressive episodes with a history of ineffective use of two antidepressant doses and the duration of therapy appropriate to the episode).

Contraindications:

Established hypersensitivity to any of the components of the drug.

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Use in children. The efficacy and safety of olanzapine in persons under the age of 18 years has not been proven.

Carefully:

Hepatic insufficiency, clinically significant hypertrophy of the prostate gland, angle-closure glaucoma, paralytic intestinal obstruction.

Olanzapine should be used with caution in patients with a reduced number of leukocytes and / or neutrophils in the peripheral blood, due to various causes; with signs of depression or toxic impairment of bone marrow function under the influence of medications (in the anamnesis); with oppression of bone marrow function due to concomitant disease, radio or chemotherapy (in history); with hypereosinophilia or myeloproliferative disease.

Olanzapine should be used with caution in patients with epileptic seizures in the history or in the presence of factors that reduce the threshold of convulsive readiness. In such patients, seizures were rare in the treatment with olanzapine.

Taking into account the main effect of olanzapine on the central nervous system, care should be taken when using the drug Olanzapine in combination with other central-action drugs and alcohol.

Pregnancy and lactation:

Olanzapine should be administered during pregnancy only if the potential benefit to the patient is significantly greater than the potential risk to the fetus. Patients should be warned that in case of approach or planning of pregnancy during the period of drug treatment Olanzapine, they need to inform their doctor about this.

Olanzapine is excreted in breast milk. The average dosage received by the child (mg / kg) when the mother's equilibrium concentration reached equilibrium was 1.8% of the mother's olanzapine dose (mg / kg). It is not recommended to breast-feed during drug therapy Olanzapine.

Dosing and Administration:

Olanzapine can be taken regardless of food intake, because eating does not affect the absorption of the drug.

Schizophrenia

The recommended initial dose of olanzapine is 10 mg once daily. Therapeutic doses of olanzapine range from 5 mg to 20 mg per day. The daily dose must be selected individually depending on the clinical condition of the patient.An increase in the dose above the standard daily dose (10 mg) is recommended only after an evaluation of the clinical picture.

Bipolar affective disorder type I

To treat a manic episode, the recommended initial dose of olanzapine is 15 mg once daily as monotherapy or 10 mg once daily in combination with lithium or valproic acid. Therapeutic doses of olanzapine range from 5 mg to 20 mg per day. The daily dose must be selected individually, depending on the clinical condition of the patient. An increase in the dose above the standard daily dose is recommended only after assessing the clinical state of the patient and with an interval of at least 24 hours.

Supportive therapy for bipolar disorder: patients receiving olanzapine for treatment of a manic episode, it is necessary to continue maintenance therapy in the same dose. In patients in remission, the recommended initial dose of olanzapine is 10 mg once daily. In the future, the daily dose should be selected individually, depending on the clinical state of the patient, ranging from 5 mg to 20 mg per day.

For the treatment of a depressive episode olanzapine should be administered in combination with fluoxetine 1 time per day, in the evening, regardless of food intake. Typically, the initial dose is 5 mg of olanzapine and 20 mg of fluoxetine. Antidepressant activity was confirmed with olanzapine 6-12 mg (mean daily dose 7.4 mg) and fluoxetine 25-30 mg (mean daily dose 39.3 mg). If necessary, you can change the dose of both olanzapine and fluoxetine.

Therapeutically resistant depression

Olanzapine should be prescribed in combination with fluoxetine 1 time per day, in the evening, regardless of food intake. Typically, the initial dose is 5 mg of olanzapine and 20 mg of fluoxetine. If necessary, you can change the dose of both olanzapine and fluoxetine. Antidepressant activity was confirmed with olanzapine in a dose of 6-12 mg and fluoxetine in a dose of 25-30 mg.

General rules for choosing a daily oral dose for specific groups of patients.

Reduction of the initial dose to 5 mg per day is recommended for elderly patients or patients with other clinical risk factors, including severe renal failure or moderate-level liver failure.A reduction in the initial dose may be recommended for patients with a combination of factors (female, elderly, non-smokers) who can slow the metabolism of olanzapine.

Side effects:

The table below summarizes the main side effects and their frequency recorded during clinical trials and / or post-marketing periods.

Often (≥10%)	Often (<10% and ≥1 %)	Infrequently (≥0,1 % and <1%)	Frequency unknown (the frequency can not be determined from the available data)
Violations of the blood and lymphatic systems
	Eosinophilia	Leukopenia Neutropenia	Thrombocytopenia
Immune system disorders
			Allergic reactions
Disorders from the metabolism and nutrition
Weight gain^¹	Increased cholesterol concentration^2,3 Increase in glucose concentration⁴ Increase in the concentration of triglycerides^2,5 Glucosuria Decreased appetite		Development or decompensation of diabetes mellitus, in some cases accompanied by ketoacidosis and diabetic coma, including fatal outcome Hypothermia
Disturbances from the nervous system
Drowsiness	Dizziness Akathisia⁶Parkinsonism⁶Dyskinesia⁶		Seizures in patients with a history of seizures or in the presence of risk factors for seizures Malignant neuroleptic syndrome Dystonia (including oculogic crisis) Late dyskinesia The "cancellation" syndrome⁷
Heart Disease
		Bradycardia Interval prolongation QTc	Ventricular tachycardia / ventricular fibrillation, sudden death
Vascular disorders
	Orthostatic hypotension		Pulmonary embolism Deep vein thrombosis
Disorders from the digestive system
	Short-term anticholinergic effects, including constipation and dry mouth		Pancreatitis
Disturbances from the liver and bile ducts
	The transient increase in the activity of "hepatic" transferases (ALT, ACT), especially in the early period of treatment		Hepatitis (including hepatic, hepatocellular, or mixed)
Disturbances from the skin and subcutaneous tissues
	Rash	The reaction of photosensitivity Alopecia
Musculoskeletal system disorders
			Rhabdomyolysis
Disorders from the kidneys and urinary tract
		Urinary incontinence	Delayed onset of urination
Violations of the genitals and mammary gland
			Priapism
General disorders
	Asthenia Fatigue Edema
Laboratory data
Increase in prolactin concentration in plasma⁸		Increase in activity of creatine phosphokinase, increase in the concentration of total bilirubin	Increased activity of alkaline phosphatase

¹ For all groups of patients, regardless of body mass index, a clinically significant increase in body weight was observed. An increase in body weight of 7% or more from the mean after a short course of treatment (mean duration 47 days) was very frequent (22.2%), an increase of 15% or more was frequent (4.2%) and an increase of 25% or more were infrequent (0.8%).

In patients receiving long-term treatment (at least 48 weeks), an increase of ≥7%, ≥15% and ≥25% were very frequent (64.4%, 31.7%, 12.3%% respectively).

²The average increase in fasting lipids (cholesterol, low-density lipoprotein (LDL), triglycerides) was more pronounced in patients without initial signs of lipid metabolism disorders.

³Often there was an increase in cholesterol concentration from normal fasting values (<5.17 mmol / L) to elevated (≥6.2 mmol / L). Cholesterol concentration change from fasting fasting (≥5.17 <6.2 mmol / l) to elevated (> 6.2 mmol / l) was very frequent.

⁴Often there was an increase in glucose concentration from normal fasting values (<5.56 mmol / l) to elevated (≥7 mmol / L). The change in glucose concentration from fasting margins (> 5.56 - <7 mmol / l) to elevated (≥7 mmol / l) was very frequent.

⁵Often there was an increase in the concentration of triglycerides from normal fasting values (<1.69 mmol / l) to elevated (≥2.26 mmol / l). The change in the concentration of triglycerides from the fasting borderline≥1.69 - <2.26 mmol / l) to elevated (≥2.26 mmol / l) was very frequent.

⁶In clinical trials, cases of parkinsonism and dystonia in patients taking olanzapine, were more frequent, but the difference with the placebo group was not statistically significant.

In patients who took olanzapine, cases of development of parkinsonism, akathisia, dystonia, were observed less often than in patients receiving titrated doses of haloperidol. In view of the lack of detailed information about the presence of acute and late dyskinesia in patients with an anamnesis, it is currently impossible to conclude that olanzapine to a lesser degree causes the development of late dyskinesias or other late extrapyramidal syndromes.

⁷With a sharp abolition of olanzapine, symptoms such as sweating, insomnia, tremors, anxiety, nausea, and vomiting were observed.

⁸In clinical studies of up to 12 weeks, the concentration of prolactin in the plasma exceeded the upper limit of the norm in approximately 30% of patients with normal baseline values of prolactin. In most of these patients, the increase in prolactin concentration was moderate, and less than 2 times the upper limit of the norm. In patients who took olanzapine, disorders of the genitals and mammary gland, possibly associated with taking olanzapine (amenorrhea, breast enlargement, galactorrhea in women, gynecomastia and breast enlargement in men) were infrequent. Sexual dysfunction, possibly associated with taking olanzapine (erectile dysfunction in men, decreased libido in men and women) were observed frequently.

Undesirable effects in specific patient groups

Very frequent (≥10%), the undesirable effect of olanzapine in clinical trials in patients with psychosis associated with dementia was a violation of gait and fall.

Frequent (<10% and ≥1%), unwanted effects with olanzapine in elderly patients with psychosis associated with dementia were incontinence and pneumonia.

In clinical studies in patients with psychosis induced by the drug (dopamine receptor agonist) in Parkinson's disease, an increase in Parkinsonian symptoms was noted very often (≥10%) and with a higher frequency than in the placebo group. Hallucinations were also noted very often (≥10%) and with a higher frequency than in the placebo group.

In patients with bipolar mania receiving olanzapine in combination with lithium or valproic acid, very frequent (> 10%) adverse effects were weight gain, dry mouth, increased appetite, tremor and frequent (<10% and ≥1%) speech disorder.

Overdose:

Symptoms. Very frequent (frequency ≥10%) symptoms - tachycardia, agitation / aggressiveness, articulation disorder, various extrapyramidal disorders and disorders of consciousness of varying severity (from sedation to coma). Other clinically relevant consequences of olanzapine overdose are delirium, seizures, malignant neuroleptic syndrome,respiratory depression, aspiration, increase or decrease in blood pressure (BP), cardiac arrhythmias (<2% of cases of overdose), cardiac arrest and respiratory depression. The minimum dose for acute overdose with a lethal outcome is 450 mg, the maximum dose for an overdose with a favorable outcome (survival) is 1500 mg.

Treatment. There is no specific antidote for olanzapine. It is not recommended to provoke vomiting. Standard procedures for overdose can be shown (gastric lavage, the appointment of activated charcoal). Co-administration of activated charcoal showed a decrease in bioavailability of olanzapine upon ingestion of up to 50-60%. Symptomatic treatment is shown in accordance with the clinical condition and control over the functions of vital organs, including treatment of arterial hypotension, circulatory disorders and maintenance of respiratory function. Do not use epinephrine, dopamine and other sympathomimetics, which are beta-adrenergic receptor agonists, since stimulation of these receptors can aggravate arterial hypotension.

Interaction:

The metabolism of olanzapine can change under the action of inhibitors or inducers of cytochrome P450 isoenzymes exhibiting specific isozyme activity CYP1A2.The clearance of olanzapine is increased in smokers and in patients taking carbamazepine (in connection with an increase in isoenzyme activity CYP1A2). Known potential isoenzyme inhibitors CYP1A2 can reduce the clearance of olanzapine. Olanzapine is not a potential inhibitor of isoenzyme activity CYP1A2, so when taking the drug Olanzapine pharmacokinetics of medicines, such as theophylline, mainly metabolized with the participation of isoenzyme CYP1A2, does not change. Single dose administration Olanzapine against the background of therapy with the following drugs was not accompanied by the suppression of the metabolism of these drugs: imipramine or its metabolite desipramine (isoenzyme CYP2D6, isoenzyme CYP3A, isoenzyme CYP1A2), warfarin (isoenzyme CYP2C19), theophylline (isoenzyme CYP1A2) or diazepam (isoenzyme CYP3A4, isoenzyme CYP2C19). There were no signs of drug interaction when using olanzapine in combination with lithium and biperidin.

Against the background of a stable concentration of olanzapine, there was no change in the pharmacokinetics of ethanol.However, the administration of ethanol in conjunction with olanzapine may be accompanied by an increase in the pharmacological effects of olanzapine (sedative action).

A single dose of aluminum-or magnesium-containing antacid or cimetidine did not interfere with the bioavailability of olanzapine when ingested. Co-administration of activated carbon reduced the bioavailability of olanzapine when administered orally to 50-60%.

Fluoxetine (60 mg once or 60 mg daily for 8 days) causes an increase in the maximum concentration (C_mOh) of olanzapine on average by 16% and a decrease in the clearance of olanzapine by an average of 16%, which is not clinically important (no correction of the olanzapine dose is required). Fluvoxamine, inhibitor of isoenzyme CYP1A2, reduces the clearance of olanzapine, increases C_mOh olanzapine in nonsmoking women by 54% and by 77% by men who smoke. Average increase AUC olanzapine 52% and 108% respectively. Small doses of olanzapine should be given to patients who are jointly receiving fluvoxamine.

In studies in vitro, using human liver microsomes, it is shown that olanzapine slightly suppresses the formation of valproate glucuronide (the main pathway of valproate metabolism). Valproate also slightly affects the metabolism of olanzapine in vitro. Therefore, clinically significant pharmacokinetic interaction between olanzapine and valproate is unlikely.

According to research in vitro, using human liver microsomes, olanzapine also demonstrated an extremely low potential in suppressing the activity of the following isoenzymes of cytochrome P450: isoenzyme CYP1A2, isoenzyme CYP2C9, isoenzyme CYP2C19, isoenzyme CYP2D6, isoenzyme CYP3A.

Special instructions:

Malignant neuroleptic syndrome. Malignant neuroleptic syndrome (CNS) can develop in the treatment of any neuroleptic, including Olanzapine. Clinical manifestations of CNS include a significant increase in body temperature, rigidity of the muscles, changes in mental status and vegetative disorders (unstable pulse or blood pressure, tachycardia, cardiac arrhythmias, increased sweating). Additional signs may include increased levels of creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Clinical manifestations of CNS or a significant increase in body temperature without other symptoms of NSA require the removal of all antipsychotics, including olanzapine.

Late dyskinesia. In comparative studies lasting more than 6 weeks, treatment with olanzapine was significantly less often accompanied by the development of dyskinesia requiring drug correction than haloperidol. However, the risk of tardive dyskinesia with prolonged therapy with neuroleptics should be considered. With the development of signs of tardive dyskinesia, a dose reduction or drug cancellation is recommended Olanzapine. Symptoms of tardive dyskinesia may increase or manifest after the drug is discontinued.

Application in elderly patients with psychosis in the background of dementia. Cerebrovascular adverse events (eg stroke, transient ischemic attack), including death, were noted in studies of olanzapine in elderly patients with psychosis on a background of dementia. In placebo-controlled studies, there was a higher incidence of cerebrovascular undesirable events in patients in the olanzapine group, compared with the placebo group (1.3% vs. 0.4%, respectively).

These patients had previous risk factors (cerebrovascular disorders (history), transient ischemic attack, hypertension, smoking),as well as concomitant diseases and / or medications, associated with time for cerebrovascular disorders.

The effectiveness of olanzapine in elderly patients with psychosis against dementia is not established. In this category of patients in placebo-controlled clinical trials, the incidence of lethal cases in the olanzapine group was higher than in the placebo group (3.5% versus 1.5%, respectively). The main risk factors for increased mortality for this group of patients in the treatment with olanzapine are the age ≥80 years, sedation, concomitant use with benzodiazepines or the presence of lung pathology (eg, pneumonia with or without aspiration). Elderly patients with psychosis in the background of dementia who are receiving atypical psychotic therapy are at increased risk of death compared with placebo. Olanzapine It is not recommended for the treatment of patients with psychosis on the background of dementia.

There is insufficient evidence to establish differences in the incidence of cerebrovascular disorders and / or mortality (compared to placebo), and in the risk factors for this group of patients when taking olanzapine inward and with intramuscular injection.

Dysfunction of the liver. In some cases, taking the drug Olanzapine, usually in the early stages of therapy, was accompanied by a transient, asymptomatic increase in the parameters of hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) in serum. There were rare cases of hepatitis. In very rare cases, hepatic cholestasis and other mixed liver damage were noted. Particular caution is needed when increasing aspartate aminotransferase and / or alanine aminotransferase levels in blood serum in patients with hepatic insufficiency, with limited functional liver reserve, or in patients receiving potentially hepatotoxic drugs. In the case of an increase in aspartate aminotransferase and / or alanine aminotransferase levels during treatment with olanzapine, careful monitoring of the patient and, if necessary, a reduction in dose are required.

Hyperglycemia and diabetes mellitus. There is a higher prevalence of diabetes mellitus in patients with schizophrenia. Very rarely there were cases of hyperglycemia, development of diabetes mellitus or exacerbation of pre-existing diabetes mellitus, ketoacidosis and diabetic coma.There is no established causal relationship between antipsychotic drugs and these conditions. Clinical monitoring of patients with diabetes mellitus or with risk factors for its development is recommended.

Hematologic changes. Application of the drug Olanzapine in patients with clozapine-dependent neutropenia or agranulocytosis (in the anamnesis) was not accompanied by relapses of these disorders.

Dopaminergic antagonism. Olanzapine exhibits antagonism against dopamine and, theoretically, can suppress the action of levodopa and dopamine agonists.

Parkinson's disease. It is not recommended to use olanzapine in the treatment of psychoses induced by dopamine receptor agonists in Parkinson's disease.

Change in lipid profile. In placebo-controlled trials, patients who received olanzapine, undesirable changes in the lipid spectrum were observed. Clinical observation is recommended (see "Side effect").

Development of risk of sudden death. Experience in the clinical use of any antipsychotic, including olanzapine, found a similar, dose-dependent, double increase in the risk of death due to acute heart failure, compared with deaths due to acute heart failure in patients who did not use antipsychotics.

Convulsions. Olanzapine should be used with caution in patients with a history of convulsions or exposed to factors that reduce the threshold of convulsive readiness. In such patients, seizures were rare in the treatment with olanzapine.

M-holinoblocking activity. In clinical trials, olanzapine therapy was rarely accompanied by m-cholinoblocking side effects. However, clinical experience with olanzapine in patients with concomitant diseases is limited, so caution should be exercised in prescribing olanzapine to clinically ill patientssignificant prostatic hyperplasia, paralytic intestinal obstruction, closed-angle glaucoma, and similar conditions.

Neutropenia. Caution should be applied olanzapine in patients with low leukocyte and / or neutrophil count in the blood; receiving drugs that can cause neutropenia; with oppression of bone marrow function due to radiation or chemotherapy disease; as well as in patients with eosinophilia and / or myeloproliferative diseases. The development of neutropenia has been reported, mainly, when olanzapine is combined with valproate.

Duration of the interval QT. In clinical studies, clinically significant lengthening of the interval QT (interval QT with the adjustment of Friederation [QTcF] ≥500 msec in patients with baseline QTcF <500 msec) in patients who received olanzapine, in the absence of significant differences with placebo in the frequency of occurrence of adverse events from the heart. However, as with other antipsychotics, caution should be exercised in prescribing olanzapine in combination with drugs that can lengthen the interval QT, especially in elderly patients, with congenital lengthening of the interval QT, congestive heart failure, myocardial hypertrophy, hypokalemia and hypomagnesemia.

Abolition of therapy. In the case of a sharp abolition of olanzapine, extremely rarely (<0.01%) was reported on the acute development of sweating, insomnia, tremor, anxiety, nausea and vomiting.

Thromboembolism. Very rarely (<0.01%) reported on the development of venous thromboembolism in the background of olanzapine therapy. The presence of a causal relationship between the administration of olanzapine and venous thromboembolism has not been established. However, given that patients with schizophrenia often have acquired risk factors for venous thromboembolism, it is required to conduct an overall assessment of all possible risk factors for the development of this complication, including immobilization of patients, and to take the necessary preventive measures.

Total activity against the central nervous system. Given the main effect of olanzapine on the central nervous system, caution should be exercised when using olanzapine in combination with other central-action drugs and alcohol.

Postural hypotension. Postural hypotension was rarely observed in clinical studies of olanzapine in the elderly. Just as with the use of other antipsychotics, in the case of olanzapine, patients older than 65 years are advised to periodically monitor blood pressure.

Children and teenagers under 18 years of age. Olanzapine is not recommended for use in children and adolescents under 18 years due to the lack of sufficient data on efficacy and safety. In short-term studies that were conducted in adolescents aged 13-17 years, there was a greater increase in body weight and a change in the concentration of lipids and prolactin than in similar studies in adults.

Effect on the ability to drive transp. cf. and fur:

Patients taking the drug Olanzapine, caution should be exercised when driving vehicles and engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions, since olanzapine may cause drowsiness.

Form release / dosage:

Tablets, film-coated, 5 mg and 10 mg.

Packaging:

For 10 or 14 tablets in a contour mesh package.

For 28, 30 or 90 tablets in a can of polymer or a bottle of polymer. Each can or bottle, or 3, 6, 9 contour cell packs of 10 tablets or 1, 2, 3, 4 contour packs of 14 tablets together with the instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002162

Date of registration:26.07.2013 / 20.09.2016

Expiration Date:26.07.2018

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Representation: & nbspNORTH STAR CJSC NORTH STAR CJSC Russia

Information update date: & nbsp04.06.2017

Illustrated instructions

Instructions

Olanzapine-SZ (Olanzapine)