Olanzapine-TL - instructions for use, dose, side effects, contraindications

core: active substance: olanzapine 2.5 mg / 5 mg / 7.5 mg / 10 mg; Excipients: lactose monohydrate 63.5 mg / 127.0 mg / 190.5 mg / 254.0 mg, microcrystalline cellulose 25.0 mg / 50.0 mg / 75.0 mg / 100.0 mg, Copovidone 4.0 mg / 8.0 mg / 12.0 mg / 16.0 mg, sodium carboxymethyl starch 4.0 mg / 8.0 mg / 12.0 mg / 16.0 mg, calcium stearate 1.0 mg / 2.0 mg / 3 , 0 mg / 4.0 mg;

composition of film shell: Opapray II (yellow) [polyvinyl alcohol 40%; titanium dioxide 23.7%; macrogol 20,2%; talc 14.8%; dye iron oxide yellow 1.3%] 3.0 mg / 6.0 mg / 9.0 mg / 12.0 mg.

Description:

The tablets are round biconvex, covered with a filmy coating of light yellow with a cream shade of color, two layers are visible on the cross section. The core of the tablet is from light yellow to yellow with a grayish hue.

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 are caused by blockade M_1-5-choline receptors; also has an affinity for α₁-adreno and H₁-histamine receptors.In animal experiments, antagonism was observed 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-HT₂-serotoninotm 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 is well absorbed from the gastrointestinal tract (GIT), the maximum concentration (TC_mOh) in plasma is achieved after 5-8 hours. The concentrations of olanzapine in plasma have a linear dose dependence (in the range of 1 up to 20 mg). Eating does not affect the absorption of olanzapine.

At a plasma concentration of 7 to 1000 ng / ml, binding to plasma proteins is about 93%.

Olanzapine is metabolized in the liver by conjugation and oxidation. The main circulating metabolite is l0-N-glucuronide, which does not theoretically penetrate the blood-brain barrier (BBB). Isozymes CYP1A2 and CYP2D6 participate in education N-desmethyl and 2-hydroxymethyl metabolites of olanzapine. AT experimental research on animals it is shown that these metabolites have much less pronounced pharmacological activity in vivothan olanzapine. The main pharmacological activity is due to unaltered olanzapine.

Isoenzyme activity CYP2D6 does not affect the level of metabolism of olanzapine.

Smoking, sex and age affect half-life (T_1/2) and plasma clearance. Non-smoking (clearance - 18.6 l / h, T_1/2- 38.6 hours), smoking (clearance - 27.7 l / h, T_1/2 - 30.4 h), women (ground clearance - 18.9 l / h, T_1/2 - 36.7 hours), men (ground clearance - 27.3 l / h, T_1/2 - 32.3 hours). Patients over 65 years of age T_1/2 is 51.8 h and a plasma clearance of -17.5 l / h; in patients younger than 65 years of age T_1/2 is 33.8 h and the plasma clearance is 18.2 l / h. Plasma clearance is lower in patients with hepatic insufficiency, women and non-smokers compared to the corresponding groups of patients. It is excreted mainly by kidneys (60%) in the form of metabolites.

Indications:

Schizophrenia.

Bipolar affective disorder of 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 or 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:

Hypersensitivity to any of the components of this drug. Hereditary intolerance to galactose, lactase deficiency, glucose-galactose malabsorption.

Contraindicated for persons under 18 years.

Carefully:

With extreme caution apply when increasing activity of aspartate aminotransferase (ACT) and alanine aminotransferase (ALT) in patients with insufficient liver function, limited functional liver reserve, or in patients receiving potentially hepatotoxic drugs.In case of increased activity ACT and / or ALT during treatment with olanzapine, careful monitoring of the patient is required, and, if necessary, dose reduction.

Use with caution in patients with epileptic seizures in the history or exposed to factors that reduce the threshold of convulsive readiness.

Use with caution in patients with a reduced number of leukocytes and / or neutrophils, due to various causes; with signs of oppression / toxic damage to bone marrow function under the influence of drugs in the anamnesis; with oppression of bone marrow function due to concomitant disease, radiotherapy or chemotherapy in history; with hypereosinophilia or myeloproliferative disease. In clinical studies, the use of olanzapine in patients with clozapine-dependent neutropenia or agranulocytosis in a history was not accompanied by relapses of these disorders.

Use with caution in patients with clinical manifestations of prostatic hyperplasia, paralytic intestinal obstruction, zakratougolnoy glaucoma and similar conditions.

When treated with antipsychotics, including olanzapine, possibly the development of malignant neuroleptic syndrome (CNS). Clinical manifestations of CNS or a significant increase in body temperature without other symptoms of this syndrome require the removal of all antipsychotics, including olanzapine.

With prolonged therapy with neuroleptics, there is a risk of developing tardive dyskinesia. With the development of signs of tardive dyskinesia, a dose reduction or elimination of olanzapine is recommended. Symptoms of tardive dyskinesia may appear or increase after the abolition of therapy. Given the nature of the action of olanzapine on the central nervous system (CNS), it should be used with caution in combination with other drugs of central action and ethanol.

The safety and efficacy of olanzapine in patients under the age of 18 years have not been studied.

Pregnancy and lactation:

Adequate and strictly controlled clinical studies of the safety of olanzapine during pregnancy have not been conducted. The use is possible only in cases when the expected benefit of therapy for the mother significantly exceeds the potential risk for the fetus.Women should be informed of the need to inform the doctor about the pregnancy or planned pregnancy with olanzapine therapy. There are isolated reports of tremors, muscle hypertension, lethargy and drowsiness in children born to mothers who took olanzapine in the third trimester of pregnancy. In studies, it was found that olanzapine penetrates into breast milk. The average dose (mg / kg) received by the child at equilibrium concentration in the mother was 1.8% of the mother's olanzapine dose (mg / ml). If you need to use olanzapine during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside, regardless of food intake, 1 time per day.

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. Dose increase above the standard daily dose (10 mg) is recommended only after evaluation of the clinical picture.When using the drug, it is necessary to regularly evaluate the need for continued therapy.

Bipolar disorder

For the treatment of the 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. Dose increase above the standard daily is recommended only after assessment of the clinical picture 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 must 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 at a dose of 6-12 mg (mean daily dose of 7.4 mg) and fluoxetine at a dose of 25-30 mg (mean daily dose - 39.3). If necessary, you can change the dose of both olanzapine and fluoxetine. When using the drug, it is necessary to regularly evaluate the need for continued therapy.

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. When using the drug, it is necessary to regularly evaluate the need for continued therapy.

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 patientsthere 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.

The use of olanzapine has not been studied in persons younger than 13 years.

Side effects:

Frequency of side effects: very often (more than 10%), often (more than 1% and less than 10%), not often (more than 0.1% and less than 1%), rarely (more than 0.01% and less than 0.1% ), very rarely (less than 0.01%).

From the nervous system: very often - drowsiness; often - dizziness, akathisia, parkinsonism, asthenia, dyskinesia; rarely - convulsions in patients with seizures in the history or in the presence of risk factors for seizures; very rarely - malignant neuroleptic syndrome (see section "Special instructions"), dystonia (including oculogic crisis) and tardive dyskinesia. With a sharp abolition of olanzapine, symptoms such as increased sweating, insomnia, tremor, anxiety, nausea, or vomiting are very rarely noted.

From the side of the cardiovascular system: often - arterial hypotension (including orthostatic); not often - a bradycardia with a collapse or without; very rarely - increasing the interval QTc on the ECG (see section "Special instructions"), ventricular tachycardia / fibrillation and sudden death (see section "Special instructions"); very rarely - thromboembolism (including pulmonary artery embolism and deep vein thrombosis).

From the digestive system: often - transient anticholinergic effects, including constipation and dryness of the oral mucosa; transient asymptomatic increase in the activity of "liver" transaminases (ALT, ACT, especially at the beginning of therapy (see section "Special instructions")); rarely - hepatitis (including hepatocellular, cholestatic or mixed liver damage); very rarely - pancreatitis.

From the side of metabolism: very often - weight gain; often - increased appetite, hypertriglyceridemia; very rarely - hyperglycemia and / or decompensation of diabetes mellitus, sometimes manifested by ketoacidosis or coma, including death; hypercholesterolemia, hypothermia.

On the part of the hematopoiesis system: often - eosinophilia; rarely - leukopenia; very rarely - thrombocytopenia, neutropenia.

From the side of the musculoskeletal system: very rarely - rhabdomyolysis.

From the genitourinary system: very rarely - urinary retention, priapism.

From the skin: rarely - skin rash; infrequently - photosensitization reactions; very rarely - alopecia.

From the endocrine system: increased prolactin levels (clinical manifestations of hyperprolactinaemia were rare, in most cases normalization of prolactin levels occurred without the abolition of olanzapine); in isolated cases - hyperglycemia, diabetic coma, diabetic ketoacidosis.

Allergic reactions: rarely - skin rash; very rarely - anaphylactoid reactions, angioedema, skin itching or urticaria.

On the part of the hematopoiesis system: often - eosinophilia; rarely - leukopenia; very rarely - thrombocytopenia.

Other: often - asthenia, peripheral edema; very rarely - withdrawal syndrome.

Laboratory indicators: very often hyperprolactinemia, but clinical manifestations (eg, gynecomastia, galactorrhea and breast enlargement) are rare. In most patients, the level of prolactin spontaneously normalized without the abolition of therapy. Rarely - transient, asymptomatic increase in ALT activity, ACT. Infrequently, an increase in the activity of creatine phosphokinase (CKF); very rarely - an increase in the activity of alkaline phosphatase (APF) and total bilirubin. In isolated cases, an increase in glucose in the blood plasma is more 200 mg / dL (suspected diabetes mellitus), 160-200 mg / dl (suspected hyperglycaemia) in patients with baseline glucose concentrations less than 140 mg / dl. There have been cases of elevation of triglycerides (by 20 mg / dl from the initial), cholesterol (by 0.4 mg / dl from the initial), asymptomatic eosinophilia (single cases).

In elderly patients with dementia, a large incidence of deaths and cerebrovascular disorders (stroke, transient ischemic attacks) is documented in studies. Very frequent in this category of patients were violations of gait and fall. Also often observed pneumonia, fever, lethargy, erythema, visual hallucinations and urinary incontinence.

Among patients with drug (against the background of dopamine agonists) psychoses on the background of Parkinson's disease often recorded worsening of parkinsonian symptoms and the development of hallucinations.

There are data on the development of neutropenia (4.1%) against a combination therapy with valproic acid in patients with bipolar mania.Simultaneous therapy with valproic acid or lithium helps to increase the frequency (more 10%) tremor, dryness of the oral mucosa, increased appetite or weight gain. Violations of speech (from 1 to 10%) were also recorded.

Overdose:

Symptoms: very frequent (more than 10%) with an overdose of olanzapine are - tachycardia, agitation / dysarthria, various extrapyramidal symptoms, a decrease in the level of consciousness from inhibition to coma; less than 2% of cases occur - delirium, convulsions. Coma, malignant neuroleptic syndrome, respiratory depression, aspiration, arterial hypertension or arterial hypotension, arrhythmias; in very rare cases - cardiopulmonary insufficiency. The minimum dose for acute overdose with a lethal outcome is 450 mg, the maximum dose was recorded for an overdose with a favorable outcome (survival) of -1500 mg.

Treatment: there is no specific antidote. It is not recommended to provoke vomiting. It is necessary to carry out: gastric lavage, reception of activated charcoal (reduces the bioavailability of olanzapine by 60%), symptomatic treatment under the control of vital functions, including treatment of arterial hypotension and collapse, maintenance of respiratory function.It is not recommended to use epinephrine, dopamine or other sympathomimetics with beta-adrenergic activity, the latter can aggravate arterial hypotension. To identify possible arrhythmias, cardiovascular control is necessary. The patient should be under continuous medical supervision until complete recovery.

Interaction:

Potential drug interactions affecting olanzapine metabolism: olanzapine is metabolized by isoenzyme CYP1A2, therefore inhibitors or inducers of cytochrome P450 isoenzymes exhibiting specific activity in relation to CYP1A2, may affect the pharmacokinetic parameters of olanzapine.

Inductors CYP1A2: The clearance of olanzapine can be increased in smokers or with the simultaneous administration of carbamazepine, which leads to a decrease in the concentration of olanzapine in the blood plasma. Clinical observation is recommended. some cases require an increase in the dose of the drug.

Inhibitors CYP1A2: fluvoxamine, a specific inhibitor CYP1A2 - significantly reduces the clearance of olanzapine. Average increase in TC_mOh olanzapine after the administration of fluvoxamine in non-smokers was 54%, and for men who smoke, 77%. The average increase in the area under the "concentration-time" curve (AUC) of olanzapine in these categories of patients was 52% and 108%, respectively. In patients receiving fluvoxamine or any other isoenzyme inhibitor CYP1A2 (e.g., ciprofloxacin), therapy with olanzapine is recommended to begin with smaller doses. A decrease in the dose of olanzapine may also be required if the isoenzyme inhibitors are added to therapy CYP1A2.

Drug interactions affecting / not affecting the bioavailability of olanzapine: Activated charcoal reduces absorption of olanzapine when ingested by 50-60%, so it should be taken at least 2 hours before or after taking olanzapine. Fluoxetine - inhibitor of isoenzyme CYP1A2 (60 mg once or 60 mg daily for 8 days) raises the vehicle_mOh olanzapine by 16% and reduces clearance by 16%, which has no clinical significance (no correction of olanzapine dose is required).

A single dose of magnesium - or aluminum containing antacids or cimetidine do not affect the pharmacokinetics of olanzapine.

Potential ability of olanzapine to influence other drugs

Olanzapine may reduce the effects of direct and indirect dopamine agonists. In conditions in vitro olanzapine does not suppress the main isoenzymes CYP450 (e.g., 1A2, 2D6, 2C9, 2C19, 3A4). In vivo There was no inhibition of the metabolism of the following active substances: tricyclic antidepressants (CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) and diazepam (CYP3A4 and 2C19).

No interaction was detected when used simultaneously with lithium or biperidene.

Olanzapine slightly suppresses the formation of valproic acid glucuronide (the main pathway of metabolism). Valproic acid slightly affects the metabolism of olanzapine. Clinically significant pharmacokinetic interaction between olanzapine and valproic acid is unlikely. Therapeutic monitoring of the content of valproic acid in the blood plasma showed that, when applied simultaneously with olanzapine, no changes in valproic acid doses are required (see the "Side effect" section).

Care should be taken when using other central-action drugs at the same time. Despite the fact that a single dose of alcohol (45 mg / 70 kg) does not have a pharmacokinetic effect, taking alcohol together with olanzapine may be accompanied by an increase in sedative effect on the central nervous system.

Special instructions:

Suicide

The risk of suicide attempts by patients with schizophrenia and bipolar disorder of the first type is due to the aforementioned diseases. In this regard, against the background of pharmacotherapy requires careful monitoring of those patients who have a risk of suicide is particularly high. When prescribing olanzapine, one should strive to minimize the number of tablets taken by the patient, so as to reduce the risk of overdose.

Hyperglycemia and diabetes mellitus

There is a higher prevalence of diabetes mellitus in patients with schizophrenia. As with some other antipsychotics, cases of hyperglycemia, decompensation of diabetes mellitus, in some cases accompanied by ketoacidosis and diabetic coma, including fatal cases, were rarely noted. A thorough clinical monitoring of patients with diabetes mellitus and patients with risk factors for the development of diabetes mellitus is recommended.

Change in lipid concentration

Changes in lipid concentrations in plasma with olanzapine should be monitored in patients with dyslipidemia and in patients with risk factors for lipid metabolism disorders.

M-holinoblocking activity

When conducting clinical trials, olanzapine therapy was rarely accompanied by undesirable reactions caused by blockade of M-cholinergic receptors. However, clinical experience with olanzapine in patients with concomitant diseases is limited, so caution should be exercised in prescribing olanzapine to patients with clinically significant prostatic hyperplasia, paralytic intestinal obstruction, occlusive glaucoma, and similar conditions.

The withdrawal syndrome

With a sharp discontinuation of olanzapine, very rarely (<0.01%) may develop the following symptoms: sweating, insomnia, tremor, anxiety, nausea, or vomiting.

Parkinson's disease

Olanzapine is not recommended for the therapy of psychoses induced by the intake of dopamine receptor agonists in Parkinson's disease. In clinical studies in patients with psychosis,induced drug intake (dopamine receptor agonist) in Parkinson's disease, increased symptoms of parkinsonism 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.

Experience in elderly patients with psychosis associated with dementia

The effectiveness of olanzapine in elderly patients with psychosis associated with 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% vs. 1.5%, respectively). Risk factors that may predispose this group of patients to a higher mortality with olanzapine include age> 80 years, sedation, concomitant use with benzodiazepines, or the presence of lung pathology (eg, pneumonia with or without aspiration). There is insufficient evidence to establish differences in the incidence of cerebrovascular and / or mortality (compared with placebo) and in the risk factors for this group of patients when taking anelanzapine.

Impaired liver function

In some cases, taking olanzapine.As a rule, in the early stages of therapy, accompanied by a transient, asymptomatic increase in the activity of "liver" transaminases (ALT and ACT) in the serum. There were rare cases of hepatitis. In addition, there were individual reports of cholestatic and mixed liver damage. Particular caution is needed when the activity of ACT and / or ALT in the blood serum is increased in patients with insufficient liver function, with limited functional liver reserve, limited functional liver reserve, or in patients receiving potentially hepatotoxic drugs. In the case of increased activity of ACT and / or ALT during treatment with olanzapine, careful monitoring of the patient and, if necessary, a reduction in dose are required. In case of serious violations of liver function caused by taking olanzapine, its use should be discontinued.

Neutropenia

Caution should be applied olanzapine in patients with a low content of leukocytes and (or) neutrophils in the blood; receiving drugs that can cause neutropenia; with oppression of bone marrow function due to concomitant disease, radiation or chemotherapy; 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.

Malignant neuroleptic syndrome (CNS)

ZNS is a potentially life-threatening condition associated with antipsychotic medication (neuroleptics), including olanzapine. Clinical manifestations of CNS include a significant increase in body temperature, rigidity of the musculature, change in status and vegetative disorders (unstable pulse or blood pressure, tachycardia, increased sweating, cardiac arrhythmias). Additional symptoms of ZNS: increased activity of creatine phosphokinase (CK), myoglobinuria (against rhabdomyolysis) and acute renal failure. Clinical manifestations of CNS or a significant increase in body temperature for no apparent reason require the removal of all antipsychotics, including olanzapine.

Convulsive Syndrome

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

Late dyskinesia

In comparative studies olanzapine treatment was significantly less often accompanied by the development of dyskinesias requiring medical correction than the use of typical and other atypical antipsychotics. However, the risk of tardive dyskinesia with prolonged therapy with neuroleptics should be considered. When developing signs of tardive dyskinesia, a dose adjustment of an antipsychotic is recommended. It should be borne in mind that when translated into olanzapine symptoms of tardive dyskinesia may develop due to the simultaneous withdrawal of previous therapy. Over time, the intensity of this symptomatology may increase, moreover, these symptoms may develop after discontinuation of therapy.

Total activity against the central nervous system

Care should be taken when using other means of central action and alcohol.

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.

Cerebrovascular adverse events, including stroke in elderly patients with dementia

Cerebrovascular adverse events (for example, stroke, transient ischemic attack), including death, were noted in studies of olanzapine in elderly patients with psychosis associated with dementia. In placebo-controlled studies, there was a higher incidence of cerebrovascular adverse events in patients in the olanzapine group than in the placebo group (1.3% vs. 0.4%, respectively). All patients with cerebrovascular disorders had preexisting risk factors for cerebrovascular adverse events (eg, mentioned earlier in case of cerebrovascular adverse event or a transient ischemic attack, hypertension, smoking), as well as comorbidities and (or) administration of drugs over time associated with cerebrovascular adverse phenomena. Olanzapine is not indicated for the treatment of patients with psychosis associated with dementia.

QT Interval

In clinical studies, infrequently observed clinically significant prolongation of the interval QT (QT interval corrected Fridericia [QTcF]> 500 ms in patients with baseline, QTcF <500 ms) in patients treated with 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 when using olanzapine in combination with drugs that can prolong the QT interval, especially in elderly patients, with congenital QT interval prolongation, chronic heart failure, myocardial hypertrophy, hypokalemia and hypomagnesemia .

Thromboembolism

With the use of olanzapine, very rarely (<0.01%) cases of venous thromboembolism have been reported. The causal relationship between olanzapine therapy and thrombosis has not been established. Since patients with schizophrenia often have acquired risk factors for venous thrombosis, all possible other factors (eg, immobilization) should be identified and preventive measures taken.

Blockade of dopamine receptors

In conditions in vitro olanzapine exhibits antagonism against dopamine receptors and, like other antipsychotics (antipsychotics), theoretically can suppress the action of levodopa and dopamine receptor agonists.

Postural hypotension

Postural hypotension was rarely observed in clinical studies of olanzapine in the elderly. As with other antipsychotics, in patients with olanzapine, it is recommended that patients who are older than 65 years have periodic monitoring of 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 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:

During the treatment period, care should be taken in the activities associated with the need to concentrate attention and high speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 2.5 mg, 5.0 mg, 7.5 mg and 10 mg.

Packaging:

For 7 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 28 or 56 tablets per can of polymer for medicines.

For 28 or 56 tablets in a bottle for medicines made of plastic.

Free space in the jar, bottle is filled with cotton wool hygroscopic. Each jar, bottle, 1, 2, 3, 4, 5, 6, 7 or 8 contour mesh packages together with the instruction for use are placed in a pack of cardboard box.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002098

Date of registration:13.06.2013

Expiration Date:13.06.2018

The owner of the registration certificate:TECHNOLOGY OF DRUGS, LTD. TECHNOLOGY OF DRUGS, LTD. Russia

Manufacturer: & nbsp

TECHNOLOGY OF DRUGS, LTD. Russia

Information update date: & nbsp04.06.2017

Illustrated instructions

Instructions

Olanzapine-TL (Olanzapine-TL)