Olanzapine Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Bipolar Disorder

Oral (monotherapy):
Initial dose: 10 to 15 mg orally once a day.
Maintenance dose: 5 to 20 mg orally once a day.
Maximum dose: 20 mg orally once a day.

Oral (combination therapy with lithium or valproate):
Initial dose: 10 mg orally once a day.
Maintenance dose: 5 to 20 mg orally once a day.
Maximum dose: 20 mg orally once a day.

Injection:
Initial dose: 10 mg IM once.
Recommended dose: 10 mg IM once. A lower dose of 5 mg or 7.5 mg may be considered when clinical factors warrant. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of IM olanzapine in agitated patients has not been systematically evaluated in controlled clinical trials.

The safety of total daily dose greater than 30 mg (or 10 mg injections given more frequently than 2 hours after the initial dose and four hours after the second dose) has not been evaluated in clinical trials.

Dosage range: 2.5 mg to 10 mg IM once.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Usual Adult Dose for Schizophrenia

Oral:
Initial dose: 5 to 10 mg orally once a day.
Maintenance dose: 10 mg orally once a day.
Maximum dose: 20 mg orally once a day.

There are two olanzapine intramuscular formulations with different dosing schedules. Olanzapine intramuscular (10 mg/vial) is a short-acting formulation and should not be confused with olanzapine extended release injectable suspension (Brand Name: RELPREVV).

Short-acting Injection:
Initial dose: 10 mg IM once.
Recommended dose: 10 mg IM once. A lower dose of 5 mg or 7.5 mg may be considered when clinical factors warrant. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of IM olanzapine in agitated patients has not been systematically evaluated in controlled clinical trials.

The safety of total daily dose greater than 30 mg (or 10 mg injections given more frequently than 2 hours after the initial dose and four hours after the second dose) has not been evaluated in clinical trials.

Dosage range: 2.5 mg to 10 mg IM once.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Extended Release Injectable Suspension:

The extended release injectable suspension is intended for deep intramuscular gluteal injection only and should not be administered intravenously or subcutaneously.

Tolerability should be established with oral olanzapine prior to initiating treatment with the extended release injectable suspension.

The efficacy of olanzapine extended release injectable suspension has been demonstrated within the range of 150 mg to 300 mg administered every 2 weeks and with 405 mg administered every 4 weeks.

Recommended Dosing for Olanzapine Extended Release Injectable Suspension Based on Correspondence to Oral Olanzapine Doses:

1) If the target oral olanzapine dose is 10 mg/day, then the dosing during the first 8 weeks is 210 mg/2 weeks or 405 mg/4 weeks, and the maintenance dose after 8 weeks is 150 mg/2 weeks or 300 mg/4 weeks.

2) If the target oral olanzapine dose is 15 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks, and the maintenance dose after 8 weeks is 210 mg/2 weeks or 405 mg/4 weeks.

3) If the target oral olanzapine dose is 20 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks, and the maintenance dose after 8 weeks is 300 mg/2 weeks.

Olanzapine extended release injectable suspension doses greater than 405 mg every 4 weeks or 300 mg every 2 weeks have not been evaluated in clinical trials.

For 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 older), or who may be more pharmacodynamically sensitive to olanzapine:
Recommended starting dose: 150 mg/4 weeks
When indicated, dose escalation should be undertaken with caution in these patients.

Maintenance: Although no controlled studies have been conducted to determine how long patients should be treated with olanzapine extended release injectable suspension, efficacy has been demonstrated over a period of 24 weeks in patients with stabilized schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Usual Geriatric Dose for Bipolar Disorder

Oral:
Initial dose: 5 mg orally once a day if debilitated or predisposed to hypotension.
Maintenance dose: May increase cautiously.

Injection:
Initial Dose: 5 mg IM once. A lower dose of 2.5 mg per injection should be considered for patients who otherwise may be debilitated, predisposed to hypotensive reactions, or who are more pharmacodynamically sensitive to olanzapine.

Usual Geriatric Dose for Schizophrenia

Oral:
Initial dose: 5 mg orally once a day if debilitated or predisposed to hypotension.
Maintenance dose: May increase cautiously.

There are two olanzapine intramuscular formulations with different dosing schedules. Olanzapine intramuscular (10 mg/vial) is a short-acting formulation and should not be confused with olanzapine extended release injectable suspension (Brand Name: RELPREVV).

Short-acting Injection:
Initial Dose: 5 mg IM once. A lower dose of 2.5 mg per injection should be considered for patients who otherwise may be debilitated, predisposed to hypotensive reactions, or who are more pharmacodynamically sensitive to olanzapine.

Extended Release Injectable Suspension:

For 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 older), or who may be more pharmacodynamically sensitive to olanzapine:
Recommended starting dose: 150 mg/4 weeks
When indicated, dose escalation should be undertaken with caution.

Maintenance: Although no controlled studies have been conducted to determine how long patients should be treated with olanzapine extended release injectable suspension, efficacy has been demonstrated over a period of 24 weeks in patients with stabilized schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Usual Pediatric Dose for Schizophrenia

8 to 12 years (Limited data available):
Initial: 2.5 to 5 mg once daily; increase dose in 2.5 or 5 mg increments at weekly intervals to target dose of 10 mg once daily; maximum dose: 20 mg/day.

13 to 17 years old:
Initial dose: 2.5 to 5 mg orally once a day
Maintenance dose: 10 mg orally once a day
Efficacy in adolescents with schizophrenia has been demonstrated based on a flexible dose range of 2.5 mg to 20 mg/day in clinical trials. When dosage adjustments are necessary, dose increments/decrements of 2.5 mg or 5 mg are recommended.

The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.

Maintenance: The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated. However, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Usual Pediatric Dose for Bipolar Disorder

4 to 5 years: Limited data available: Initial: 1.25 mg orally once daily; increase at weekly intervals according to response and tolerability to target dose: 10 mg/day.
6 to 12 years: Limited data available: Initial: 2.5 mg orally once daily; increase dose in 2.5 or 5 mg increments at weekly intervals to target dose of 10 mg once daily; maximum dose: 20 mg/day.

13 to 17 years old:
Initial dose: 2.5 mg to 5 mg orally once a day
Maintenance dose: 10 mg orally once a day
Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials. When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.

Maintenance: The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated. However, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Usual Pediatric Dose for Anorexia Nervosa

9 years and older: (Limited data available): 1.25 to 2.5 mg orally once daily has been shown in one small trial and several case reports to improve BMI and other disease related symptoms (e.g., eating attitudes, anxiety); another case series used initial doses of 2.5 mg once daily and final doses of 5 mg to 10 mg once daily; reported range: 1.25 to 12.5 mg/day; however, it has been suggested that higher doses (greater than 2.5 mg once daily) may not be associated with greater efficacy. Further studies are needed.

Usual Pediatric Dose for Tourette's Syndrome

Tourette syndrome, tic disorder:
7 years and older: Limited data available:
Patient weight less than 40 kg: Initial: 2.5 mg orally every other day for 3 days, increase to 2.5 mg every day for remainder of week; increase to 5 mg/day by second week if needed; then increase in 5 mg increments at weekly intervals as tolerated; maximum dose: 20 mg/day
Patient weight greater than 40 kg: Initial: 2.5 mg every day for 3 days; increase to 5 mg every day for remainder of week if needed, then increase in 5 mg increments at weekly intervals as tolerated; maximum dose: 20 mg/day
An open-label study of 10 pediatric patients (7 to 13 years of age) reported significant reductions in tic severity [Yale Global Tic Severity Scale (YGTSS)] from baseline at a mean final dose of 14.5 mg/day after 8 weeks of treatment. An open-label trial of 12 children and adolescents (7 to 14 years of age) reported a significant reduction (30%) in total tic severity (YGTSS) at a final mean dose of 11.3 mg/day (range: 2.5 to 20 mg/day).

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Liver dysfunction is reported by the manufacturer to have little effect on the pharmacokinetic disposition of olanzapine, and does not typically require a dosage adjustment. However, since olanzapine may potentiate an increase in serum transaminase levels, caution is advised when treating patients exhibiting signs or symptoms of hepatic dysfunction, with preexisting conditions associated with limited liver functional reserve, or on concomitant therapy with potentially hepatotoxic medications.

Dose Adjustments

Schizophrenia: dosage adjustments may occur at intervals of not less than 1 week and a total daily dosage increment/decrement of no greater than 5 mg.

Mania in Bipolar Disorder: dosage adjustments may occur at intervals of not less than 24 hours and at a total daily dosage increment/decrement of no greater than 5 mg.

Additional caution in dosage titration and adjustments may be necessary in patients who are debilitated, have a predisposition to hypotensive reactions, exhibit a combination of factors that may result in slower metabolism of olanzapine, or are over 65 years old.

Immediate dose reductions should be made whenever patients cease smoking under treatment with CYP450 1A2 metabolized drugs with a narrow therapeutic ratio such as olanzapine.

Precautions

Olanzapine is not approved by the FDA for use in the treatment dementia related psychosis. Collective data from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including olanzapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Maximal dosing of IM olanzapine (e.g. 3 doses of 10 mg administered 2 to 4 hours apart) may be associated with a substantial occurrence of significant orthostatic hypotension. Therefore, it is recommended that patients requiring subsequent IM injections be assessed for orthostatic hypotension prior to the administration of any subsequent doses of IM olanzapine. Administration of an additional dose to a patient with a clinically significant postural change in systolic blood pressure is not recommended.

Olanzapine injection is intended for IM use. Do not administer olanzapine injection by the IV or subcutaneous routes. It should be injected slowly, deep into the muscle mass.

Serum transaminases should be measured in patients with liver dysfunction.

Safety and effectiveness have not been established in pediatric patients less than 13 years of age.

When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents.

Dialysis

No adjustment recommended

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for olanzapine intramuscular extended release (Zyprexa Relprev), it includes a communication plan, elements to assure safe use, and implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Due to a large interpatient variability in plasma levels at the same oral dosages, a therapeutic olanzapine plasma concentration has been identified and ranges between 20 ng/mL and 50 ng/mL, which will optimize response and minimize side effects. The therapeutic range is intended to complement the normal process of clinical evaluation and not replace it.

Development of hyperglycemia and/or diabetes mellitus is common in patients treated with atypical antipsychotics. Periodic monitoring of fasting plasma glucose is recommended in patients receiving olanzapine.

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