HALD SR 400 mg is a high-dose, long-acting intramuscular (IM) depot injection of haloperidol decanoate, designed for maintenance therapy in severe, chronic psychotic disorders (e.g., treatment-resistant schizophrenia) in patients with significant compliance issues.
Composition
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Active Ingredient: Haloperidol Decanoate 400 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 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 4 weeks per dose.
Dosage & Administration
Initial Dose (for Stabilized Patients)
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Only for patients already stabilized on lower doses (e.g., 200–300 mg monthly).
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Max initial dose: 300 mg IM (400 mg is not for first-time depot users).
Maintenance Dose
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200–400 mg IM every 4 weeks (reserved for severe cases with proven tolerance).
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 before using 400 mg dose.
Indications
✅ Severe, treatment-resistant schizophrenia (non-adherent patients).
✅ Chronic psychotic disorders with high relapse risk.
❌ Not for acute psychosis or first-episode patients.
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
✔ Strictly monitor for EPS (high risk of dystonia, akathisia, tardive dyskinesia).
✔ Mandatory ECG monitoring (↑↑ QT prolongation risk at this dose).
✔ Avoid in elderly/dementia patients (↑ mortality – Black Box Warning).
✔ Titrate slowly (400 mg is only for patients tolerating 300 mg well).
Important Safety Notes
⚠ Black Box Warnings:
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↑ Mortality in elderly dementia patients (not approved for dementia-related psychosis).
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High risk of QT prolongation & torsades de pointes.
⚠ Contraindications:
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Parkinson’s disease/Lewy body dementia (worsens motor symptoms).
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Congenital long QT syndrome.
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Severe hepatic impairment.
⚠ Pregnancy (Category C): Risk of neonatal EPS; avoid unless critical.
Adverse Effects
Common | Serious |
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– Severe EPS (dystonia, tremors) | – Neuroleptic malignant syndrome (NMS) |
– Sedation | – Torsades de pointes |
– Weight gain | – Irreversible tardive dyskinesia |
– Hyperprolactinemia | – Seizures |
Drug Interactions
Interacting Drug | Effect | Management |
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CYP3A4 inhibitors (ketoconazole) | ↑↑ Haloperidol levels | Contraindicated |
QT-prolonging drugs (amiodarone) | ↑↑ Arrhythmia risk | Absolute avoid |
CNS depressants (benzodiazepines) | ↑↑ Sedation | Extreme caution |
Comparison with Other High-Potency Depot Antipsychotics
Feature | HALD SR 400 mg | Fluphenazine Decanoate | Zuclopenthixol Decanoate |
---|---|---|---|
Dosing Interval | Every 4 weeks | Every 2–4 weeks | Every 2–4 weeks |
EPS Risk | Very High | High | Moderate-High |
QT Risk | Extreme | High | Moderate |
Cost | Low | Low | Moderate |
Conclusion
HALD SR 400 mg is a high-risk, high-potency depot antipsychotic reserved for the most severe, treatment-resistant cases. Close monitoring for cardiac and neurological effects is mandatory.
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