Olanzapine And Samidorphan｜Bipolar I Disorder

Olanzapine/Samidorphan Application Scope

Olanzapine/samidorphan (OLZ/SAM) is a fixed-dose combination therapy primarily used for:

• Schizophrenia in adults (acute and maintenance treatment).
• Bipolar I Disorder (manic/mixed episodes) as monotherapy or adjunctive therapy with lithium/valproate.
• Off-label use: Limited reports suggest potential exploration for metabolic side effect mitigation in other psychiatric conditions.

Olanzapine And Samidorphan Characteristics

• Ingredients:  – Olanzapine (atypical antipsychotic)- Samidorphan (opioid antagonist).
• Properties: – Olanzapine: Dopamine (D2) and serotonin (5-HT2A) antagonist.- Samidorphan: μ-opioid antagonist, partial κ/δ-opioid agonist; mitigates olanzapine-induced weight gain.
• Specification: Bilayer oral tablets: 5/10 mg, 10/10 mg, 15/10 mg, 20/10 mg (olanzapine/samidorphan)
• Packaging Specification: Bottles or blister packs (varies by market)
• Storage: Store at 20–25°C; protect from moisture
• Expiry Date: Typically 24 months (check packaging)
• Executive Standard: FDA, EMA-approved
• Approval Number: FDA: NDA 216342 (2021)
• Date of Revision: Latest label updates per FDA/EMA (e.g., 2023 safety warnings)
• Manufacturer: Alkermes Plc (originator); licensed partners

Guidelines For The Use Of Olanzapine And Samidorphan

Dosage and Administration

• Standard Dose: 5–20 mg olanzapine/10 mg samidorphan once daily (oral, with/without food).
  • Schizophrenia: Start at 10/10 mg, adjust based on response (range: 5–20 mg olanzapine).
  • Bipolar I Disorder: 10–20 mg olanzapine/10 mg samidorphan.
• Missed Dose: Skip if >12 hours late; resume next scheduled dose.

Adverse Reactions

• Common (≥10%): Weight gain, somnolence, dry mouth, headache, dizziness.
• Serious:
  • Opioid withdrawal (due to samidorphan).
  • Neuroleptic malignant syndrome (NMS), hyperglycemia, tardive dyskinesia.
  • Neurological disorders (e.g., sedation, dysarthria).

Contraindications

• Opioid use or acute withdrawal (risk of severe withdrawal).
• Hypersensitivity to olanzapine or samidorphan.
• Dementia-related psychosis (increased mortality risk).

Precautions

• Metabolic Monitoring: Weight, blood glucose, lipids at baseline and periodically.
• Hepatic/Renal Impairment: Reduce dose in moderate hepatic or severe renal impairment.
• Pregnancy/Lactation: Avoid (teratogenic risk; olanzapine excreted in milk).

Olanzapine and Samidorphan Interactions

Drug Interactions

• Opioids: Contraindicated (withdrawal or overdose risk).
• CYP3A4 Inducers (e.g., rifampin): May ↓ olanzapine/samidorphan efficacy.
• Anticholinergics/Benzodiazepines: ↑ Sedation risk.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.