olanzapine injection spc


When suggestions are available use up and down arrows to review and ENTER to select. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials. It is available as tablets (round and white: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg; pink and oval: 20 mg) and as a powder to be made up into a solution for injection. ALT elevations ≥ 5 times ULN were observed in 4% (8/192) of olanzapine-treated patients, compared to 1% (1/109) of placebo-treated patients. Appropriate educational placement is essential and psychosocial intervention is often helpful. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. <> Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. In monkeys, single oral doses up to 100 mg/kg resulted in prostration and, at higher doses, semi-consciousness.In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.

Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.

Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.Neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery Olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (MRHD), based on mg/mThe estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations. Available for Android and iOS devices. Issue number: 1 . In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo.

In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hours) or clearance (21.2 versus 25.0 l/hr).

Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. The vial is for single use only.Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. Chronic antipsychotic treatment should generally be reserved for patients (1) who suffer from a chronic illness that is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.

This information is intended for use by health professionalsZYPADHERA 210 mg, 300 mg, and 405 mg, powder and solvent for prolonged release suspension for injection.Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. In another study, 4 270 acutely agitated inpatients with schizophrenia received 1 to 3 IM injections of olanzapine (2.5, 5, 7.5, or 10 mg), haloperidol (7.5 mg), or placebo. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics.
There is no general agreement about specific pharmacological treatment regimens for NMS.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. ZYPADHERA has not been studied in the paediatric population. Immediately prior to leaving the healthcare facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.

Close medical supervision and monitoring should continue until the patient recovers.Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.In preclinical studies, olanzapine exhibited a range of receptor affinities (KIn a Positron Emission Tomography (PET) study in patients treated with ZYPADHERA (300 mg/4 weeks), mean DThe effectiveness of ZYPADHERA in the treatment and maintenance treatment of schizophrenia is consistent with the established effectiveness of the oral formulation of olanzapine.A total of 1469 patients with schizophrenia were included in 2 pivotal trials:The first, an 8-week, placebo-controlled trial conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.