Olanzapine instructions for administration

List of precautions
Schizophrenia Maintanance of treatment in Schizophrenia patients Special Populations/lab test interactions Bipolar Mania Maintenance Treatment in Manic Patients Olanzapine in Combination with Lithium or Valproate

Schizophrenia
Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. The safety of doses above 20 mg/day has not been evaluated in clinical trials.Return to top

Maintanance of treatment in Schizophrenia patients
While there is no body of evidence available to answer the question of how long the patient treated with olanzapine should remain on it, the effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on ZYPREXA for approximately 8 weeks and were then followed for a period of up to 8 months has been demonstrated in a placebo-controlled trial. Patients should be periodically reassessed to determine the need for maintenance treatment with appropriate dose.Return to top

Special Populations
The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine (see CLINICAL PHARMACOLOGY; also see Use in Patients with Concomitant Illness and Drug Interactions under PRECAUTIONS). When indicated, dose escalation should be performed with caution in these patients.Return to top

Bipolar Mania
Olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.Return to top

Maintenance Treatment in Manic Patients
There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with olanzapine. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of olanzapine in such longer-term treatment.Return to top

Olanzapine in Combination with Lithium or Valproate
When administered in combination with lithium or valproate, olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.Return to top