An adagio – antipsychotic means.

for treatment of schizophrenia.

for maintenance of the reached clinical effect during long therapy at patients at whom the response to initial therapy was noted.

for treatment of maniacal episodes of moderate and heavy degree.

for prevention of repeated attacks at patients with bipolar disorders at which affirmative answer at treatment was received by mania olanzapine.

Structure

• active ingredient: olanzapine;
• 1 tablet contains olanzapine of 5 mg;
• other components: lactose, monohydrate; hydroxypropyl cellulose; krospovidon; microcrystalline cellulose; magnesium stearate;
• film cover: gipromelloza, Opadray White 13B28444 (gipromelloza, titan dioxide (E 171), macrogoal, polysorbate 80), wax of karnaubskiya: bee (60:40).

Contraindication

Hypersensitivity to active ingredient or any of medicine excipients. The risk of closed-angle glaucoma is known.

Side reactions

Most frequent side reactions (were observed at ≥ 1% of patients) connected with use of olanzapine during clinical trials were the following: drowsiness, increase in body weight, an eosinophilia, increase in level of prolactin, cholesterol, glucose and triglycerides in blood, a glucosuria, dizziness, an akathisia, parkinsonism, a leukopenia, a neutropenia, dyskinesia, orthostatic hypotension, anticholinergic effects, tranzitorny symptomless increase in hepatic transaminases, rash, an asthenia, fatigue, a hyperthermia, artralgiafosifaza.

Route of administration

Schizophrenia. The recommended initial dose of olanzapine makes 10 mg of 1 times a day.

Maniacal episodes. The initial dose makes 15 mg in the form of a single daily dose at monotherapy or 10 mg/days at combination therapy.

Prevention of a recurrence in bipolar disorders. The recommended initial dose makes 10 mg/days. The patients who are already receiving olanzapine for treatment of maniacal attacks are recommended to continue therapy in the same dose for prevention of a recurrence. At emergence of the new maniacal, mixed or depressive attacks the treatment by olanzapine should be continued (if necessary adjusting a dose) with purpose of additional treatment for correction of changes of mood according to clinical indications.

during treatment of schizophrenia, maniacal attacks and prevention of a recurrence of bipolar disorders can adjust a daily dose according to a clinical condition of the patient within 5–20 mg/days. Increase in a dose over the recommended initial dose is shown only after the corresponding repeated clinical assessment and should not happen in the range of less than 24 hours at all.

irrespective of meal as consumption of food does not influence medicament absorption. At cancellation of olanzapine it is necessary to apply gradual reduction of a dose.

Feature of use

At treatment from several days to several weeks. During this period the careful monitoring of a condition of patients is necessary.

Use during pregnancy or feeding by a breast

do not have adequate and well controlled researches of effect of olanzapine on pregnant women. Patients during treatment by olanzapine have to report to the doctor about pregnancy or intention to become pregnant. As experience of treatment of pregnant women olanzapine is limited, olanzapine during pregnancy needs to be applied only when the expected results justify possible risk for a fruit.

to Patients should advise not to nurse the child if they accept olanzapine.

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for treatment of children and teenagers as data on its safety and efficiency are not enough. In short-term researches at teenagers more significant increase in body weight and change of levels of lipids and prolactin, than in researches at adult patients was observed.

Ability to influence speed of response at control of motor transport or other mechanisms

Researches about influence of olanzapine on speed of response at control of motor transport or work with other mechanisms was not carried out. As olanzapine can result in drowsiness and dizziness, patients should be warned about the danger connected with operation of mechanisms, including vehicles.

Overdose

Symptoms. Very often overdose symptoms (frequency> 10%) included tachycardia, excitement/aggression, a dysarthtia, various extrapyramidal symptoms and decrease in degree of consciousness from a sedation to a coma.

Other clinically significant consequences of overdose included a delirium, convulsions, a lump, a malignant antipsychotic syndrome, respiratory depression, aspiration, arterial hypertension or hypotension, cardiac arrhythmia (in <2% of cases of overdose) and cardiopulmonary shock. It was reported about lethal outcomes after acute overdose of 450 mg, however messages about survivors after acute overdose about 2 g of olanzapine orally arrived.

Treatment. There is no specific antidote of olanzapine. It is not recommended to cause vomiting. Standard procedures of treatment of overdose are shown (including gastric lavage, use of activated carbon). Simultaneous use of activated carbon reduced bioavailability of oral olanzapine by 50-60%.

recommends symptomatic treatment and monitoring of functions of vitals according to clinical manifestations, including treatment of hypotension, vascular collapse and maintenance of respiratory function. It is not necessary to apply epinephrine, a dopamine or other sympathomimetic means of beta and agonistic action as beta stimulation can worsen a hypotension course.

Storage conditions

does not demand special storage conditions.

out of children's reach.