Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
IM for management of acute agitation in patients with schizophrenia for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.
Bipolar Disorder
Short-term management (alone or in combination with lithium or divalproex sodium [e.g., valproate sodium, valproic acid]) of acute mixed or manic episodes and maintenance of treatment response in patients with bipolar I disorder.
Management (in fixed-combination with fluoxetine) of acute depressive episodes in patients with bipolar depression (bipolar disorder, depressed).
IM for management of acute agitation in patients with bipolar I disorder for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.
Dosage and Administration
Administration
Administer orally or by deep IM injection. (See Possible Prescribing and Dispensing Errors under Cautions.)
Oral Administration
Administer orally as conventional tablets, orally disintegrating tablets, or capsules (in fixed combination with fluoxetine) once daily without regard to meals. Administer fixed-combination olanzapine and fluoxetine capsules in the evening.
Just prior to administration, gently remove orally disintegrating tablet from blister packet; do not push tablet through foil. With dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with or without liquid.
IM Administration
Administer by IM injection slowly and deeply into the muscle mass. Do not administer IV or sub-Q.
Reconstitution
Reconstitute by adding 2.1 mL of sterile water for injection to vial containing 10 mg of olanzapine to provide a solution containing approximately 5 mg/mL.
Following reconstitution, use immediately (within 1 hour). Discard any unused portion.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Adults
Schizophrenia
Oral
Initially, 5–10 mg, usually as a single daily dose. Within several days, may increase by 5 mg daily, to a target dosage of 10 mg daily.
Make subsequent dosage adjustments at intervals of not less than 7 days, usually in increments or decrements of 5 mg once daily.
Increasing dosage beyond 10 mg daily usually does not result in greater efficacy; such increases generally should occur only after assessment of the patient’s clinical status.
Optimum duration of therapy currently is not known, but maintenance therapy with antipsychotic agents is well established. In responsive patients, continue as long as clinically necessary and tolerated, but at lowest possible effective dosage; reassess need for continued therapy periodically.
Bipolar Disorder
Acute Mania: Monotherapy
Oral
Initially, 10–15 mg once daily. Make dosage adjustments in increments or decrements of 5 mg daily, at intervals of not less than 24 hours.
Effective dosage in clinical studies generally ranged from 5–20 mg daily.
If elect to use olanzapine for extended periods, periodically reevaluate the long-term usefulness for the individual patient.
Acute Mania: Combination Therapy
Oral
Initially, 10 mg once daily when administered with lithium or divalproex sodium.
Effective dosage of olanzapine in clinical studies generally ranged from 5–20 mg daily.
No dosage adjustment for lithium or divalproex sodium is required when used in combination with olanzapine.
Acute Depression: Combination Therapy
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Oral
Initially, 6 mg in fixed combination with 25 mg of fluoxetine (Symbyax® 6/25) once daily in the evening.
Increase dosage according to patient response and tolerance as indicated.
In clinical trials, antidepressive efficacy was demonstrated at olanzapine dosages ranging from 6–12 mg daily and fluoxetine dosages ranging from 25–50 mg daily.
If elect to use combined olanzapine and fluoxetine for extended periods, periodically reevaluate the long-term risks and benefits for the individual patient.
Acute Agitation in Schizophrenia and Bipolar Mania
IM
Initially, 10 mg. Consider lower doses (2.5, 5, or 7.5 mg) when clinically warranted.
In clinical trials, efficacy of IM olanzapine for controlling agitation in patients with schizophrenia or bipolar mania was demonstrated in a dosage range of 2.5–10 mg.
If agitation persists, may administer subsequent single doses of up to 10 mg. However, efficacy of repeated doses was not systematically evaluated in controlled trials.
Assess patients for orthostatic hypotension prior to administration of any subsequent IM doses. (See Cardiovascular Effects under Cautions.)
Oral therapy should replace IM therapy as soon as possible.
Prescribing Limits
Adults
Schizophrenia
Oral
Safety of dosages >20 mg daily not established.
Bipolar Disorder
Oral
Safety of dosages >20 mg daily not established.
Dosages >18 mg of olanzapine and 75 mg of fluoxetine in fixed-combination for acute depressive episodes not evaluated in clinical studies.
Acute Agitation in Schizophrenia and Bipolar Mania
IM
Safety of dosages >30 mg daily or of 10-mg IM doses given more frequently than 2 hours after the initial dose and 4 hours after the second dose not established.
Special Populations
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Initially, 5 mg orally daily or 2.5 mg IM in debilitated patients, in those predisposed to hypotension, in those who may be particularly sensitive to the effects of olanzapine, or in those who might metabolize olanzapine slowly (e.g., nonsmoking women ≥65 years of age); when indicated, adjust dosage with caution.
In fixed combination with fluoxetine for acute depressive episodes in bipolar disorder, an oral dosage of 6 mg of olanzapine and 25 mg of fluoxetine (Symbyax® 6/25) is recommended for initial and maintenance therapy in patients predisposed to hypotension, in those with hepatic impairment, or those who might metabolize the drugs(s) slowly (e.g., female gender, geriatric age, nonsmoking status); when indicated, adjust dosage with caution.
Geriatric Patients
Careful dosage titration of oral olanzapine recommended in patients >65 years of age; initiate therapy at low end of dosage range.
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