Olanzapine / Samidorphan Dosage

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Applies to the following strengths: 5 mg-10 mg; 10 mg-10 mg; 15 mg-10 mg; 20 mg-10 mg

Usual Adult Dose for:

Schizophrenia
Bipolar Disorder

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Schizophrenia

Initial dose: Olanzapine 5 mg-samidorphan 10 mg OR olanzapine 10 mg-samidorphan 10 mg orally once a day
Maintenance dose: Olanzapine 10 mg-samidorphan 10 mg to olanzapine 20 mg-samidorphan 10 mg orally once a day
Maximum dose: Olanzapine 20 mg-samidorphan 10 mg/day

Comment: Doses may be increased in weekly intervals of 5 mg (olanzapine component), based on response and tolerance.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Monotherapy:

Initial dose: Olanzapine 10 mg-samidorphan 10 mg OR olanzapine 15 mg-samidorphan 10 mg orally once a day
Maintenance dose: Olanzapine 5 mg-samidorphan 10 mg to olanzapine 20 mg-samidorphan 10 mg orally once a day
Maximum dose: Olanzapine 20 mg-samidorphan 10 mg/day

Adjunctive to lithium or valproate:

Initial dose: Olanzapine 10 mg-samidorphan 10 mg orally once a day
Maintenance dose: Olanzapine 10 mg-samidorphan 10 mg to olanzapine 20 mg-samidorphan 10 mg orally once a day
Maximum dose: Olanzapine 20 mg-samidorphan 10 mg/day

Comments:

Initial recommended dosages for monotherapy range from olanzapine 10 mg-samidorphan 10 mg to olanzapine 20 mg-samidorphan 10 mg/day.
Dosage increases of 5 mg (olanzapine component) may be performed in no less than 24-hour intervals in patients receiving monotherapy OR in no less than weekly intervals in those receiving valproate or lithium conjunctively, based on response and tolerance.

Uses:

Acute treatment of manic or mixed episodes as monotherapy and as and adjunct to lithium or valproate
Maintenance monotherapy treatment of bipolar disorder
Treatment of bipolar I disorder

Renal Dose Adjustments

Mild to severe renal dysfunction (estimated GFR 15 to 89 mL/min/1.73 m2): No adjustment recommended.
End-stage renal impairment (estimated GFR less than 15 mL/min/1.73 m2): Not recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Dose modifications are generally not necessary for age, gender, or smoking status; however, dose modification may be necessary in patients exhibiting a combination of these factors.

Patients using opioids:

Contraindicated in patients currently using opioids OR those undergoing acute withdrawal
Treatment should be delayed at least 7 days after the last short-acting opioid dose AND/OR 14 days after the last dose of long-acting opioids

An initial dose of olanzapine 5 mg-samidorphan 10 mg orally once a day should be considered in the following patients:

Those at higher risk of hypotensive reactions
Those at risk of slower olanzapine metabolism
Those who may be pharmacodynamically sensitive to olanzapine

Precautions

US BOXED WARNINGS:
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.

Recommendation:

This drug is not approved for the treatment of patients with dementia-related psychosis.

CONTRAINDICATIONS:

Patients who are undergoing acute opioid withdrawal
Patients who are using opioids

Safety and efficacy have not been established in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

This drug may be taken without regard to meals.
Tablets should not be divided, and different tablet strengths should not be combined.

Patient advice:

Inform patients that this drug may cause somnolence, and they should avoid driving or operating machinery if these side effects occur.
Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.