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

Excipients: giprolose (hydroxypropylcellulose) low-substituted 2.5 mg, calcium hydrophosphate 40 mg, croscarmellose sodium 1 mg, mannitol 50.5 mg, magnesium stearate 1 mg;

composition of film shell: opadrai II yellow 3 mg, including: polyvinyl alcohol 1.2 mg, macrogol (polyethylene glycol) 0.606 mg, talc 0.444 mg, titanium dioxide 0.705 mg, iron oxide dye yellow 0.045 mg.

Dosage of 10 mg

active substance: olanzapine 10 mg;

Excipients: giprolose (hydroxypropylcellulose) low-substituted 3,5 mg, calcium hydrophosphate 58 mg, croscarmellose sodium 1.5 mg, mannitol 75.5 mg, magnesium stearate 1.5 mg;

composition of film shell: opadrai II yellow 5 mg, including: polyvinyl alcohol 2 mg, macrogol (polyethylene glycol) 1.01 mg, talc 0.74 mg, titanium dioxide 1.175 mg, iron oxide dye yellow 0.075 mg.

Description:

Round, biconvex tablets, covered with a film coating of yellow color. On a cross-section of yellow color.

Pharmacotherapeutic group:Antipsychotic agent (antipsychotic)

ATX: & nbsp

N.05.A.H.03 Olanzapine

Pharmacodynamics:

Olanzapine is an antipsychotic agent (neuroleptic) with a broad pharmacological spectrum of influence on a number of receptor systems.The affinity of olanzapine for serotonin 5-HT_{2A / C}, 5NT₃, 5NT₆; dopamine D₁, D₂, D₃, D₄, D₅; muscarinic M₁_-₅; adrenergic alpha1 and histamine H₁receptors. In animal experiments, the presence of antagonism of olanzapine with respect to 5HT, dopamine and cholinergic receptors was detected. In conditions in vitro and in vivo olanzapine has a more pronounced affinity and activity for serotonin 5HT₂ receptors, in comparison with dopamine D₂ receptors. Olanzapine reduces the conditioned protective reflex (a test characterizing antipsychotic activity) at doses lower than the doses that cause catalepsy (a disorder reflecting a secondary effect on motor function). Unlike other neuroleptics, olanzapine increases the anti-anxiety effect during the "anxiolytic" test.

Olanzapine provides statistically significant reduction as productive (delusions, hallucinations, etc.), and negative disorders.

Pharmacokinetics:

Absorption and bioavailability: after oral administration olanzapine well absorbed and its maximum concentration (C_mOh) in plasma is achieved after 5-8 hours. Absorption of olanzapine is not dependent on food intake. The concentration of olanzapine in the plasma varies linearly and in proportion to the dose.

Distribution: at a plasma concentration of 7 to 1000 ng / ml, about 93% of olanzapine binds to proteins, mainly with albumin and with alpha1acid glycoprotein. The main circulating metabolite is l0-N-glucuronide, which theoretically does not penetrate the blood-brain barrier.

Metabolism: olanzapine metabolized in the liver as a result of conjugation and oxidation. Isozymes CYP1A2 and CYP2D6 cytochrome P450 are involved in education N-desmethyl and 2-hydroxymethyl metabolites of olanzapine. Isoenzyme activity CYP2D6 cytochrome P450 does not affect the level of metabolism of olanzapine. Both metabolites in animal studies had significantly less pharmacological activity in vivothan olanzapine. The main pharmacological activity of the drug is caused by the initial substance - olanzapine, the activity of its metabolites is less pronounced.

Excretion: for oral administration, the mean half-life (T_1/2) is 33 hours. The clearance of olanzapine in plasma is 26 l / h.

The pharmacokinetic parameters of olanzapine vary depending on smoking, sex and age (see table below).

Characteristics of patients	T_1/2 (h)	Clearance in plasma (l / h)
Non-smokers	3,6	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 change in T_1/2and the clearance under the influence of each of these factors is significantly inferior to the degree of difference between these indicators between individuals.

Pharmacokinetics in different patient groups

Floor: plasma clearance in women is lower than that of men.

Age: pharmacokinetics in adolescents and adults are similar.

Ethnicity: there are no differences in the pharmacokinetics of olanzapine associated with race.

Renal insufficiency: significant differences between the mean values T_1/2 and the clearance of olanzapine in plasma in individuals with severe impairment of function of the night compared to those with normal renal function is not established. About 57% of radiolabelled olanzapine is excreted in the urine, mainly in the form of metabolites. Liver failure: in smokers with minor violations of liver function, the clearance of olanzapine is lower than that of non-smokers without disrupting liver function.

Indications:

Schizophrenia in adults

Olanzapine Canon is indicated for the treatment of exacerbations, supporting and prolonged anti-relapse therapy of patients with schizophrenia.

Bipolar affective disorder in adults

Olanzapine canon preparation in the form of monotherapy or in combination with preparations of lithium or valproic acid 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 canon is indicated to prevent relapse in patients with bipolar disorder who have olanzapine was effective in treating the manic phase.

In combination with fluoxetine, the Olanzanin Canon preparation is indicated for the treatment of depressive conditions associated with bipolar disorder.

Therapeutically resistant depression

In combination with fluoxetine, the Olanzapine Canon preparation 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 the drug;

- at a risk of glaucoma development;

- angle-closure glaucoma;

- age under 18 years (effectiveness and safety not proven);

- the period of breastfeeding.

Pregnancy and lactation:

Pregnancy: Because of insufficient experience with olanzapine during pregnancy, Olanzapine canon should be given during pregnancy only if the possible benefit to the mother is significantly greater than the potential risk to the fetus. Patients should be warned that in the event of the onset or planning of pregnancy during the treatment with Olanzapine Canon, you must inform your doctor. Very rare reports were received that newborns whose mothers were taking olanzapine in the third trimester of pregnancy, there was tremor, muscle hypertension, lethargy, drowsiness.

Breast-feeding: olanzapine is excreted in breast milk, therefore during the period of Olanzapine canon therapy breastfeeding should be discontinued. The average dosage received by the child (mg / kg) when the mother's equilibrium concentration is reached is 1,8% of the mother olanzapine dose (mg / kg).

Dosing and Administration:

Inside, regardless of food intake.

The recommended therapeutic dose of Olanzapine canon is 5 mg to 20 mg per day. The daily dose must be selected individually depending on the clinical condition of the patient.

Schizophrenia in adults

The recommended initial dose of Olanzapine Canon is 10 mg once daily.

Acute mania in bipolar disorder in adults

The recommended initial dose of Olanzapine canon is 15 mg once daily as monotherapy or 10 mg once a day in combination with preparations of lithium or valproic acid.

Supportive therapy for bipolar disorder in adults

The recommended initial dose of Olanzapine Canon is 10 mg once daily. Patients who received the Olanzapine Canon for the treatment of acute mania are encouraged to continue supporting therapy at the same dose.

Depression in bipolar disorder in adults

Olanzapine The canon in combination with fluoxetine should be administered once a day, in the evening. The initial dose is 5 mg of olanzapine and 20 mg of fluoxetine.

Antidepressant activity 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 dosage of both olanzapine and fluoxetine.

Therapeutic Resistant Depression

Preparation Olanzapine Canon should be prescribed in combination with fluoxetine 1 time per day, in the evening. The initial dose is 5 mg of olanzapine and 20 mg of fluoxetine. If necessary, you can change the dosage of both olanzapine and fluoxetine.

Special patient groups

In elderly patients a reduction in the initial dose (up to 5 mg per day) is usually not recommended, but it is possible in patients older than 65 years in the presence of risk factors (see section "Special instructions").

Patients with liver and / or kidney disease It is recommended to reduce the initial dose to 5 mg / day. With moderate hepatic insufficiency (cirrhosis of the liver, class A and B according to the Child-Pugh classification of hepatocellular insufficiency in patients with cirrhosis of the liver), the initial dose is 5 mg / day, possibly further dose increase with caution.

Women Do not need a change in dosage compared to men.

In non-smoking patients correction of the dose compared with smokers is not required. 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:

Classification of the incidence of adverse events (WHO): very often - ≥ 10 %; often - < 10 % and ≥ 1 %; infrequently - < 1% and ≥ 0,1 %; rarely - < 0,1 % and ≥ 0,01 %; very rarely - < 0,01 % including individual messages

Violations of the blood and lymphatic system: often - eosinophilia; infrequently - leukopenia, neutropenia; rarely: thrombocytopenia;

Immune system disorders: rarely - allergic reactions (anaphylactic shock, angioedema, skin itching, urticaria).

Metabolic disorders: rarely - development or decompensation of diabetes mellitus, in some cases accompanied by ketoacidosis and diabetic coma, including fatal cases; after the abolition of therapy, after 9-12 months of treatment, it is possible to reduce the concentration of glucose in the blood.

Disorders from the metabolism and nutrition: Often - increase in body weight; often - increased concentration of cholesterol, triglycerides, glucosuria, increased appetite. The change in glucose concentration from normal fasting values (<5.56 mmol / l) to elevated (≥7 mmol / l) is observed frequently. The change in glucose concentration from the boundary values (≥5.56 mmol / l - <7 mmol / l) to elevated (≥7 mmol / l) is very frequent; Very rarely: hypertriglyceridemia, hypercholesterolemia; frequency is not known - bloating.

Impaired nervous system: Often - drowsiness; often - dizziness, akathisia, parkinsonism, dyskinesia; infrequently: convulsions (more often against a background of a convulsive syndrome in the anamnesis); rarely - malignant neuroleptic syndrome, dystonia (including oculogic crisis), tardive dyskinesia, withdrawal syndrome (sweating, insomnia, tremor, anxiety, nausea, or vomiting).

Heart Disease: infrequently - bradycardia, lengthening of the interval QT; rarely - ventricular tachycardia / ventricular fibrillation, sudden death.

Vascular disorders: often - orthostatic hypotension; rarely - thromboembolism of the pulmonary artery, deep vein thrombosis.

Disorders from the gastrointestinal tract: often - transient anticholinergic effects, including dry mouth, constipation; rarely: pancreatitis;

Disturbances from the liver and bile ducts: often - transient increase in the activity of "hepatic" transferases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)), especially in the early period of the study; rarely: Hepatitis (including hepatocellular, hepatocellular or mixed).

Disorders from the rut and subcutaneous tissues: often - skin rash; infrequently - photosensitivity reaction; rarely - alopecia.

Disturbances from musculoskeletal and connective tissue: rarely - rhabdomyolysis; frequency not known: arthralgia.

Disorders from the kidneys and urinary tract: infrequently - urinary incontinence; rarely: delayed onset of urination; frequency is unknown: increased uric acid.

Violations of the genitals and mammary gland: rarely - priapism.

General disorders and disorders at the site of administration: often - asthenia, fatigue, swelling; rarely - hypothermia; frequency not known - fever.

Laboratory and instrumental data: Often - an increase in the concentration of prolactin in the plasma, according to clinical manifestations (eg, gynecomastia, galactorrhea and breast enlargement) are rare. Have most patients prolactin level spontaneously normalized without drug withdrawal; often - an increase in the activity of creatine phosphokinase (CK), total bilirubin; rarely - increased activity of alkaline phosphatase.

Undesirable effects in special therapeutic groups

A very frequent (≥10%) undesirable effect with olanzapine in patients with psychosis on the background of dementia is a violation of gait and fall.

Frequent (<10% and ≥1%) adverse effects with olanzapine in elderly patients with psychosis on the background of dementia are incontinence and pneumonia.

In patients with psychosis induced by taking the dopamine receptor agonist drug in Parkinson's disease, the symptoms of Parkinsonism are very often noted. Also, hallucinations are very common in this group of patients.In patients with bipolar mania receiving olanzapine in combination with preparations of lithium or valproic acid, very frequent undesirable effects are weight gain, dry mouth, increasedwAppetite, tremor, and frequent - speech disorder.

Data on the adverse effect of the drug on the results of clinical studies

In 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 such information about the presence of acute and late dyskinesias 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.

In clinical studies of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal in approximately 30% of patients with normal baselineindicators of prolactin. In most of these patients, the increase in prolactin concentration was moderate, and less than 2 times exceeded 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.

Overdose:

Frequent Symptoms: tachycardia, agitation / aggressiveness, articulation disorder, various extrapyramidal disorders and disorders of consciousness of varying severity (from sedation to coma).

Other clinically relevant consequences: delirium, convulsions, malignant neuroleptic syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (<2% of cases of overdose), cardiac arrest and respiration. The minimum dose for acute overdose with a lethal outcome is 450 mg, the maximum dose for overdose with a favorable outcome (survival) is 2000 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 carbon leads to a decrease in the bioavailability of olanzapine when administered orally 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 olanzapine, the pharmacokinetics of medicines, such as theophylline, mainly metabolized with the participation of isoenzyme CYP1A2, does not change.

In clinical studies, it has been shown that a single dose of olanzapine on the background of therapy with the following drugs is not accompanied by a suppression of the metabolism of the following drugs: imipramine or its metabolite desipramineCYP2D6, CYP3A, CYP1A2), warfarin (CYP2C19), theophylline (CYP1A2) or diazepam (CYP3A4, CYP2C19). There were no signs of drug interaction with olanzapine in combination with lithium or biperiden.

Against the background of a stable concentration of olanzapine, there is no change in the pharmacokinetics of ethanol. However, the administration of ethanol along with olanzapine may be accompanied by an increase in the pharmacological effects of olanzapine, for example, sedation. A single dose of aluminum or magnesium-containing antacids or cimetidine does not interfere with the bioavailability of olanzapine when ingested.Simultaneous use of activated carbon reduces 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 of olanzapine by an average of 16% and a decrease in the clearance of olanzapine by an average of 16%. The degree of influence of this factor is significantly inferior to the severity of individual differences in these indicators, so it is usually not recommended to change the dose of olanzapine when it is prescribed in combination with fluoxetine.

Fluvoxamine, inhibitor of isoenzyme CYP1A2, decreases the clearance of olanzapine. The result is an average increase in C_mOh olanzapine with the administration of fluvoxamine 54% in nonsmoking women and 77% in male smokers, the average increase in area under the pharmacokinetic curve (AUC) of olanzapine by 52% and 108%, respectively. Small doses of olanzapine should be given to patients who are jointly receiving fluvoxamine treatment.

In studies in vitro Using human liver microsomes, it has been shown that olanzapine slightly suppresses the process of formation of valproate glucuronide (the main pathway of valproic acid metabolism). Valproic acid also slightly affects the metabolism of olanzapine in vitro, therefore clinically significant pharmacokinetic interaction between olanzapine and valproic acid is unlikely.

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

As with other antipsychotics, caution should be exercised when using olanzapine when used concomitantly with medications that extend the interval QTc, as well as affecting the central nervous system.

Special instructions:

Clinical improvement can take several days and requires monitoring of the patient.

Malignant neuroleptic syndrome

Malignant neuroleptic syndrome (CNS) (potentially lethal symptom complex) can develop in the treatment of any neuroleptics, including Olanzapine Canon preparation, but to date there is no evidence to confirm a reliable association of olanzapine with the development of this condition. Clinical manifestations of malignant neuroleptic syndrome include a significant increase in body temperature, stiff musculature,change in mental status and autonomic 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 malignant neuroleptic syndrome or a significant increase in body temperature without other symptoms of malignant neuroleptic syndrome require the withdrawal of all antipsychotics, including Olanzapine Canon.

Late dyskinesia

Treatment with olanzapine is less often accompanied by the development of dyskinesia, which requires a drug correction, than with the use of 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 cancellation of Olanzapine canon is recommended. It should be borne in mind that when transferring to the preparation of Olanzapine Canon the symptoms of tardive dyskinesia may develop due to the simultaneous withdrawal of previous therapy. Symptoms of tardive dyskinesia may increase or manifest after the drug is discontinued.

Parkinson's disease

The efficacy of Parkinson's disease does not exceed the placebo (for the purpose of arresting iatrogenic psychoses). The use of Olanzapine Canon in the treatment of psychoses induced by dopamine receptor agonists in Parkinson's disease is not recommended, in these patients there is an increase in parkinsonian symptoms and hallucinations.

Experience in elderly patients with psychosis on the background of dementia

Cerebrovascular adverse events (for example, stroke, transient ischemic attack), including death, are noted in elderly patients with psychosis in the background of dementia. In placebo-controlled studies, a higher incidence of cerebrovascular adverse events was observed in patients in the olanzapine group, compared with the placebo group. These patients had previous risk factors (cerebrovascular disorders (history), transient ischemic attack, hypertension, smoking), as well as concomitant diseases and / or medications associated with cerebrovascular disorders.

The effectiveness of olanzapine in elderly patients with psychosis against a background of dementia is not established. The main risk factors for increased mortality for this group of patients in the treatment with olanzapine are 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 disorders and / or mortality (compared with placebo), and in the risk factors for this group of patients when taking olanzapine inward and with intramuscular injection. Olanzapine canon is not recommended for the treatment of patients with psychosis on the background of dementia.

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 not taking antipsychotics.

Duration of the interval QT

A clinically significant increase in the interval QT 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 when prescribing Olanzapine Canon in combination with drugs that can lengthen the interval QT, especially in elderly patients, with congenital lengthening of the interval QT, with congestive heart failure, myocardial hypertrophy, hypokalemia and hypomagnesemia.

Postural hypotension

Postural hypotension is rarely seen in elderly patients. As with other antipsychotics, in the case of Olanzapine canon administration, it is recommended that patients over 65 years of age be monitored for blood pressure.

Thromboembolism

Very rarely there is a development of venous thromboembolism on 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.

Dysfunction of the liver

In some cases, the reception of olanzapine, as a rule, at early stages of therapy is accompanied by a transient, asymptomatic increase in the indices of "liver" transaminases (ACT and ALT) in serum. Rare cases of hepatitis are noted. In very rare cases, hepatic cholestasis and other mixed liver damage were noted. A special precaution is necessary with increasing indicators ACT and / or ALT in the blood serum in patients with insufficient liver function, with limited functional reserve of the liver or in patients receiving potentially hepatotoxic drugs. In the case of increased indicators ACT and / or ALT during treatment with olanzapine requires careful monitoring of the patient and, if necessary, a reduction in the dose of Olanzapine Canon. When detecting hepatitis, including hepatocellular, cholestatic or mixed, the preparation of Olanzapine canon should be discontinued.

Hyperglycemia and diabetes mellitus

There is a higher prevalence of diabetes mellitus in patients with schizophrenia. As with some other antipsychotics, cases of hyperglycemia, diabetes mellitus, exacerbation of pre-existing diabetes mellitus, ketoacidosis and diabetic coma were very rare. There is no causal relationship between antipsychotic drugs and these conditions. A thorough clinical monitoring of patients with diabetes mellitus and patients with risk factors for the development of diabetes mellitus is recommended.

For all groups of patients, regardless of body mass index, a clinically significant increase in body weight was observed. An increase of 7% or more from the average after a short course of treatment (average duration 47 days) was very frequent (22.2%), an increase of 15% or more was frequent (4.2%) and an increase of 25% and more was infrequent (0,8%).

In patients receiving longer treatment (at least 48 weeks), an increase in ≥ 7%, ≥15% and ≥25% was very frequent (64.4%, 31.7%, 12.3%, respectively).

Changes in lipid profile

In patients who received olanzapine, undesirable changes in the lipid spectrum are observed. It is recommended to monitor the lipid profile and clinical observation.

Epileptic seizures

Olanzapine canon should be used with caution in patients with epileptic seizures in the history or exposed to factors that reduce the threshold of convulsive readiness. In such patients, seizures are rarely seen with olanzapine.

Hematologic changes

As with other antipsychotics, caution should be exercised when olanzapine is used in patients with reduced leukocyte counts and / or neutrophils in peripheral blood due to various causes; with signs of oppression or 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. On neutropenia was reported mainly in combined therapy with olanzapine and valproic acid.

Anticholinergic activity

Therapy with olanzapine is rarely accompanied by anticholinergic side effects. However, the clinical experience with olanzapine in patients with concomitant diseases is limited, so it is recommended that caution be given when administering the Olanzapine Canon preparation to patients with clinically significant prostatic hypertrophy, paralytic intestinal obstruction, and similar conditions.

Dopaminergic antagonism

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

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.

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, the Canon should strive to minimize the number of tablets taken by the patient, so as to reduce the risk of overdose.

Abolition of therapy

In the case of a sharp abolition of olanzapine, rarely (0.01-0.1%) develops sweating, insomnia, tremor, nausea and vomiting. With the withdrawal of the drug, a gradual dose reduction is recommended.

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, which 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 Olanzapine Canon preparation should be careful in managing motor vehicles and work requiring rapidity of psychomotor reactions, since olanzapine may cause drowsiness, dizziness.

Form release / dosage:

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

Packaging:

For 7 or 28 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 1, 2, 3, 4, 6, 8 contour cell packs of 7 tablets or 1, 2, 3, 4 contour cell packs of 28 tablets with instructions for use are placed in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002612

Date of registration:04.09.2014

Expiration Date:04.09.2019

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp05.06.2017

Illustrated instructions

Instructions

Olanzapine Canon (Olanzapine Canon)