HALD SR 300 MG
HALD SR 300 mg is a long-acting intramuscular (IM) depot injection of haloperidol decanoate, designed for maintenance therapy in chronic psychotic disorders (e.g., schizophrenia) in patients with compliance issues.
Composition
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Active Ingredient: Haloperidol Decanoate 300 mg/mL (in sesame oil base).
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Vehicle: Sesame oil, benzyl alcohol (preservative).
Mechanism of Action
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Potent dopamine (D₂) receptor antagonist (primary action in the mesolimbic pathway).
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Also blocks serotonin (5-HT₂), alpha-1 adrenergic, and histamine (H₁) receptors.
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Slow-release formulation: Provides sustained antipsychotic effects for 3–4 weeks per dose.
Dosage & Administration
Initial Dose (for Stabilized Patients)
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10–15x the equivalent daily oral dose (e.g., if oral dose = 10 mg/day → 100–150 mg IM).
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Max initial dose: 300 mg IM (adjust based on response).
Maintenance Dose
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50–300 mg IM every 4 weeks (titrate based on symptoms and tolerability).
Administration
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Deep IM injection (gluteal muscle preferred).
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Never give IV or subcutaneously (risk of oil embolism).
Switching from Oral to Depot
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Overlap oral haloperidol for 4–8 weeks to ensure stability.
Indications
✅ Maintenance treatment of schizophrenia (non-adherent patients).
✅ Chronic psychotic disorders (e.g., paranoid schizophrenia).
✅ Refractory Tourette’s syndrome (if oral therapy fails).
Storage & Stability
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Store at 15–30°C, protect from light.
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Do not freeze (oil base may solidify).
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Stable for 3 months after first use if stored properly.
Key Recommendations
✔ Monitor for EPS (extrapyramidal symptoms: dystonia, akathisia, tardive dyskinesia).
✔ Check ECG (risk of QT prolongation and torsades de pointes).
✔ Avoid in elderly dementia patients (↑ mortality risk – Black Box Warning).
✔ Use the lowest effective dose (higher doses increase EPS risk).
Important Safety Notes
⚠ Black Box Warnings:
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Increased mortality in elderly dementia patients (not approved for dementia-related psychosis).
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QT prolongation & arrhythmia risk (contraindicated in congenital long QT syndrome).
⚠ Contraindications:
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Parkinson’s disease/Lewy body dementia (worsens motor symptoms).
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Severe CNS depression/coma.
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Hypersensitivity to haloperidol or sesame oil.
⚠ Pregnancy (Category C): Risk of neonatal EPS; use only if benefits outweigh risks.
Adverse Effects
| Common (≥10%) | Serious (<1%) |
|---|---|
| – Extrapyramidal symptoms (EPS) | – Neuroleptic malignant syndrome (NMS) |
| – Sedation | – Torsades de pointes |
| – Dry mouth | – Tardive dyskinesia (irreversible) |
| – Weight gain | – Seizures |
Drug Interactions
| Interacting Drug | Effect | Management |
|---|---|---|
| CYP3A4 inhibitors (ketoconazole) | ↑ Haloperidol levels | Monitor for toxicity |
| CYP2D6 inhibitors (fluoxetine) | ↑ Haloperidol levels | Reduce dose |
| QT-prolonging drugs (amiodarone) | ↑ Arrhythmia risk | Avoid combo |
| CNS depressants (benzodiazepines) | ↑ Sedation | Use with caution |
Comparison with Other Depot Antipsychotics
| Feature | HALD SR 300 mg | Risperidone Consta | Fluphenazine Decanoate |
|---|---|---|---|
| Dosing Interval | Every 4 weeks | Every 2 weeks | Every 2–4 weeks |
| EPS Risk | High | Moderate | High |
| QT Prolongation Risk | High | Low | Moderate |
| Cost | Low | High | Moderate |
Conclusion
HALD SR 300 mg is a cost-effective long-acting antipsychotic for chronic schizophrenia, but requires careful monitoring for EPS and cardiac risks.
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