Olanzapine (6 brand names, 4 dosage forms, 2 routes)
Available dosage forms: POWDER, TABLET, TABLET, ORALLY DISINTEGRATING, CAPSULE.
Routes of administration: INTRAMUSCULAR, ORAL.
Brand Names
- LYBALVI
- OLANZAPINE
- OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
- SYMBYAX
- ZYPREXA
- ZYPREXA ZYDIS
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [See Warnings and Precautions (5.1), Use in Specific Populations (8.5) and Patient Counseling Information (17)]. When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
Contraindications
None with olanzapine monotherapy. When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products.
Warnings and Precautions
When using olanzapine and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
Adverse Reactions
When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
Drug Interactions
The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies.
Mechanism of Action
The mechanism of action of olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT 2) antagonism.