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Zyprexa

[Olanzapine]

DOSAGE AND ADMINISTRATION

Schizophrenia Usual Dose - Olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/ day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/ decrements of 5 mg QD are recommended.

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. Dosing in 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.

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Maintenance Treatment -

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 (see CLINICAL PHARMACOLOGY). Patients should be periodically reassessed to determine the need for maintenance treatment with appropriate dose.

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