Pilanz Special Precautions

Hyperglycemia and diabetes mellitus: Hyperglycemia, diabetes, exacerbation of preexisting diabetes, ketoacidosis and diabetic coma have been reported. Appropriate clinical monitoring is recommended in all patients, particularly in diabetic patients and in patients with risk factors for the development of diabetes.
Discontinuation of treatment: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (<0.01%) when Olanzapine is stopped abruptly. Gradual dose reduction should be considered when discontinuing Olanzapine.
Anticholinergic effect: Olanzapine demonstrated anticholinergic activity in vitro. Use with caution in patients with decreased GI motility, urinary retention, benign prostatic hyperplasia, xerostomia, or narrow angle glaucoma.
Parkinson's disease: Olanzapine should be started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement. The used of Olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinsonism is not recommended.
In elderly patient with dementia-related psychosis: Olanzapine is not recommended for elderly patient with dementia-related psychosis because it rises mortality rate and the risk of cerebrovascular accident.
Cerebrovascular adverse event including stroke in elderly patient with dementia: In trials of Olanzapine in elderly patient with dementia-related psychosis, cerebrovascular adverse events (CVAE e.g., transient ischemic stroke, stroke) including fatalities were reported.
Hepatic function indices: Caution should be exercised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patient with pre-existing conditions associated with limited hepatic functional reverse, and in patients who are being treated with potentially hepatotoxic medicines. In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, Olanzapine treatment was not established, Olanzapine treatment should be discontinued.
Neutropenia: Caution should be exercised in patients with low leukocyte and/or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hyper eosinophilic conditions or with myeloproliferative disease. Frequently monitor complete blood count (CBC) in the first period of the Olanzapine use. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil counts <1000/mm³.
Neuroleptic malignant syndrome (NMS): NMS is a potentially life-threatening condition associated with antipsychotic medication. Rare cases report as NMS have also been received in association with Olanzapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. If patient develop signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, Olanzapine must be discontinued.
Seizure: Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold. Seizures have been reported to occur rarely in patients when treated with Olanzapine.
Tardive dyskinesia: The risk of tardive dyskinesia increases with long term exposure, and therefore if signs and symptoms of tardive dyskinesia appear in a patient on Olanzapine, a dose reduction or discontinuation should be considered. These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
General CNS activity: Given the primary central nervous system effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol. As it exhibits in vitro dopamine antagonism, Olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Orthostatic hypotension: Orthostatic hypotension was infrequently observed in the elderly in Olanzapine trials. It is recommended that blood pressure is measured periodically in patients over 65 years.
Cardiac death: In post-marketing reports with Olanzapine, the event of sudden cardiac death has been reported very rarely(1/10000).
Lipid alteration: Using Olanzapine might alter serum lipid in adult and adolescent. Therefore, serum lipid should be monitored during Olanzapine use.
QT interval: Caution should be exercised when Olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Thromboembolism: Temporal association of Olanzapine treatment and venous thromboembolism has very rarely (0.01%) been reported. However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilization of patients should be identified and preventive measures undertaken.
Cardiovascular disease: Using Olanzapine in patients with cardiovascular disease should be closely monitored.