Olanzapine

What it is and how it works

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.

Indications

Olanzapine orally disintegrating tablets are atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder .

Dosage and administration (summary)

Schizophrenia in adults Oral: Start at 5 to 10 mg once daily; Target: 10 mg/day within several days Schizophrenia in adolescents Oral: Start at 2.5 to 5 mg once daily; Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) in adults Oral: Start at 10 or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) in adolescents Oral: Start at 2.5 to 5 mg once daily.

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. None with olanzapine monotherapy.

Warnings and precautions

When using olanzapine and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, during pregnancy.

Storage and supply

How Supplied Olanzapine orally disintegrating tablets, USP are yellow colored, round, flat face beveled edge, debossed tablets with characteristic flavour. The tablets are available as follows: TABLET STRENGTH Olanzapine orally disintegrating tablets, USP 5 mg 10 mg 15 mg 20 mg Debossed D5; CO D10; CO D15; CO D20.

Source: Olanzapine (Olanzapine) — US FDA prescribing information, 2025-03-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.