Malignant neuroleptic syndrome. When using any antipsychotics, including olanzapine, the development of ZNS, the clinical manifestations of which include a significant increase in body temperature, rigidity of the muscles, changes in mental status and vegetative disorders (tachycardia, unstable pulse or blood pressure, cardiac arrhythmia, increased sweating) may occur.
Additional signs may include an increase in serum CK, myoglobinuria (a symptom of rhabdomyolysis), and acute renal failure.
Clinical manifestations of malignant neuroleptic syndrome or a significant increase in temperature, the body without other symptoms of this syndrome require the removal of all antipsychotics, including olanzapine.
Parkinson's disease. The use of Olanzapine-Teva is not recommended for the treatment of psychosis in Parkinson's disease caused by the use of dopamine receptor agonists, due to the fact that the symptoms of parkinsonism and hallucinations can increase. The effectiveness of olanzapine in the treatment of psychotic symptoms in this case does not exceed the use of placebo.
Psychoses associated with dementia and / or behavioral disorders. Olanzapine-Teva is not recommended for use in elderly patients with psychosis associated with dementia and / or behavioral disorders due to the increased risk of developing cerebrovascular disorders (stroke, transient ischemic attacks) in this group of patients and death. It was found that high mortality was not associated with a dose of olanzapine or duration of treatment with olanzapine. Risk factors that could predispose to an increase in the mortality of patients in this population were age over 65 years, dysphagia, sedation, malnutrition, dehydration, lung disease (pneumonia with or without aspiration) or simultaneous use of benzodiazepines. Additionally, it was found that all patients who had cerebrovascular disorders, as well as in the group of patients receiving olanzapine, and in the placebo group, suffered from vascular dementia or mixed type dementia. The effectiveness of olanzapine in this group of patients has not been determined.
Hyperglycemia and / or development or exacerbation of diabetes mellitus. In some cases, with the use of olanzapine may develop hyperglycemia, diabetes mellitus, exacerbation of pre-existing diabetes, diabetic ketoacidosis and diabetic coma, including fatal. As reported, an increase in the patient's body weight may be a predisposing factor for the development of these side effects.
Care should be taken during the use of Olanzapine-Teva in patients with diabetes mellitus or with risk factors for developing diabetes mellitus, and monitor the manifestation of signs of hyperglycemia (polydipsia, polyuria, increased appetite, weakness), and regularly monitor the patient's body weight and glucose concentration in blood plasma.
Change in lipid concentration. Changes in plasma lipid concentrations when treated with Olanzapine-Teva should be monitored in patients with dyslipidemia and in patients with risk factors for lipid metabolism disorders.
M-anticholinergic effect. Therapy with olanzapine may be accompanied by adverse reactions associated with the manifestation of M-cholinoblocking effect.Clinical experience with olanzapine in patients with concomitant diseases is limited, so caution should be exercised when using olanzapine in patients with clinically significant benign prostatic hypertrophy, paralytic intestinal obstruction, occlusive glaucoma, and other similar conditions.
Liver function. Transient asymptomatic increase in the activity of "liver" transaminases (ALT and ACT) was most often noted at the beginning of treatment with olanzapine.
Caution should be exercised in patients with initially elevated ALT activity and / or ACT, in patients with hepatic insufficiency, limited functional reserve of the liver, or in patients receiving potentially hepatotoxic drugs. In the case of hepatitis (including hepatocellular, cholestatic or mixed etiology) Olanzapine-Teva should be discontinued.
Neutropenia. Caution should be exercised in patients with low leukocyte and / or neutrophil counts associated with any cause, including taking medications that cause neutropenia, oppression of bone marrow function,caused by concomitant diseases, radio or chemotherapy in history, as well as hypereosinophilia or myeloproliferative disease. Neutropenia, as a rule, occurs with the simultaneous use of olanzapine and valproic acid. The use of olanzapine in patients with clozapine-dependent neutropenia or agranulocytosis in a history was not accompanied by relapses-these disorders.
The withdrawal syndrome. With a sharp discontinuation of Olanzapine-Teva, in some cases, a condition may develop, accompanied by acute symptoms: increased sweating, insomnia, tremor, anxiety, nausea and vomiting.
Interval lengthening QT. In clinical trials in patients taking olanzapine, compared with patients in the placebo group, there was a clinically significant lengthening of the interval QTc (interval QT, corrected for Friederation; interval lengthening QTcF at least 500 ms in patients with baseline QTcF less than 500 ms), which was not associated with any effects from the cardiovascular system. However, as with other antipsychotics,when taking Olanzapine-Teva should be observed, caution with simultaneous use with medications that extend the interval QT, especially in the elderly, in patients with congenital syndrome of an elongated interval QT, with congestive heart failure, myocardial hypertrophy, hypokalemia, or hypomagnesemia. During treatment with olanzapine, periodic monitoring of the electrocardiogram should be performed.
Thromboembolism. Individual cases of VTE with olanzapine were reported. The causal relationship between VTE and olanzapine is not established. However, since patients with schizophrenia, along with the acquired risk factors for developing VTE, may have all other possible risk factors for developing VTE, for example, prolonged immobilization, it is necessary to identify these risk factors and carry out VTE preventive measures.
Convulsive Syndrome. Olanzapine-Teva should be used with caution in patients who have a history of a convulsive syndrome or risk factors that can help reduce the threshold of convulsive activity.
Late dyskinesia. In a comparative study of olanzapine less than 1 year was significantly less often accompanied by the development of dyskinesia, requiring medical treatment than treatment with haloperidol. However, the risk of developing tardive dyskinesia increases with prolonged use of olanzapine. If signs or symptoms of tardive dyskinesia should consider lowering the dose of the drug Olanzapine Teva, or its abolition. Symptoms of tardive dyskinesia may temporarily increase or appear even after the drug is discontinued.
Orthostatic hypotension. Due to the adrenoblocking effect olanzapine can cause orthostatic hypotension accompanied by dizziness, palpitations, fainting during primary selection dose. Most often orthostatic hypotension occurs in elderly patients and in the use of other neuroleptics. The development of these phenomena can be minimized by a more fractional dose titration and initiation of therapy with a minimal dose. When using Olanzapine-Teva, blood pressure should be monitored, especially in patients older than 65 years.If patients develop severe orthostatic hypotension, they should be prevented so that they do not stand up sharply and without outside help.
Sudden death. Experience in the clinical use of any antipsychotic, including olanzapine, revealed a similar, dose-dependent, double increase in the risk of sudden death, compared with sudden death in patients who did not use antipsychotics.
Influence on the central nervous system (CNS). Given the nature of the drug on the central nervous system, you should use caution olanzapine in combination with, other drugs of central action and ethanol.
In conditions in vitro olanzapine exhibits antagonism against dopamine receptors and, like other neuroleptics, can theoretically suppress the action of levodopa and dopamine receptor agonists.