Olanzapine

ZYPREXA ® (olanzapine) is an 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 13-17): 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.

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.

Schizophrenia in adults. Oral: Start at 5 mg - 10 mg once daily, Target: 10 mg/day within several days Schizophrenia in adolescents. Oral: Start at 2.5 mg - 5 mg once daily, Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) in adults. Oral: Start at 10 mg or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) in adolescents. Oral: Start at 2.5 mg - 5 mg once daily, Target: 10 mg/day Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults. Oral: Start at 10 mg once daily Agitation associated with Schizophrenia and Bipolar I Mania in adults. Intramuscular: 10 mg (5 mg or 7.5 mg when clinically warranted) Assess for orthostatic hypotension prior to subsequent dosing (max. 3 doses 2-4 hours apart) Depressive Episodes associated with Bipolar I Disorder in adults.

None with ZYPREXA monotherapy. When using ZYPREXA 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. When using ZYPREXA in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products.

Boxed warning (increased mortality in elderly patients with dementia-related psychosis): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. When using ZYPREXA 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, when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax.

When using ZYPREXA and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia. Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth. Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor. Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity.

The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. Diazepam: May potentiate orthostatic hypotension. Alcohol: May potentiate orthostatic hypotension. Carbamazepine: Increased clearance of olanzapine. Fluvoxamine: May increase olanzapine levels. ZYPREXA and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax. CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol. Antihypertensive Agents: Enhanced antihypertensive effect. Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. Lorazepam (IM): Increased somnolence with Intramuscular olanzapine.

The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F), that results in a mean kinetic temperature calculated to be not more than 25°C, and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA IntraMuscular from light, do not freeze. Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F).