Drug Detail:Olanzapine and samidorphan (Olanzapine and samidorphan [ oh-lan-za-peen-and-sam-i-dor-fan ])
Drug Class: Psychotherapeutic combinations
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.
- 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.
