Haloperidol decanoate LAI
HALDOL DECANOATE
What it isA monthly depot D2 and D3 antagonist with additional serotonin and alpha-1 blockade; schizophrenia maintenance.
Why this oneThe classic economical LAI: ~10-15x the oral daily dose monthly, sesame-oil vehicle, Z-track deep IM.
What limits itAkathisia, parkinsonism, tardive dyskinesia, and prolactin elevation commonly limit use; QT prolongation and NMS can be life-threatening.
FDA-approved for
- schizophrenia (maintenance) (1986)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Schizophrenia (maintenance, patients stabilized on oral haloperidol) | Adults | 10-15× previous daily oral haloperidol dose (max initial 100 mg); if >100 mg, give 100 mg day 1 and remainder 3-7 days later | 10-15× previous daily oral dose every 4 weeks (typical 50-200 mg q4wk) | Limited experience above 450 mg every 4 weeks |
Titration Increase by increments of 50 mg or less every 4 weeks
Renal Undefined
Hepatic Consider starting at low end of dosing range in hepatic impairment
Long-acting depot; steady state reached in 2-4 months
Instructions
- Administer by deep intramuscular injection every 4 weeks by a healthcare provider; do not administer intravenously
- Use a 21-gauge needle; maximum 3 mL per injection site
- If symptoms worsen during dose modification, may add immediate-release oral haloperidol
Contraindications
- Severe toxic central nervous system depression or comatose states from any cause
- Parkinson's disease
- Dementia with Lewy bodies
Cautions
- Sudden death, torsades de pointes, and QTc prolongation
- Tachycardia and hypotension
- Cerebrovascular reactions in elderly with dementia-related psychosis
- Tardive dyskinesia
- Neuroleptic malignant syndrome
- Seizures
- Encephalopathic syndrome with concomitant lithium
- Leukopenia/neutropenia/agranulocytosis
- Hyperprolactinemia
- Severe neurotoxicity in thyrotoxicosis
Adverse reactions
- Parkinsonism
- Oculogyric crisis
- Akathisia
- Tremor
- Dystonia
- Sedation/somnolence
- Tachycardia
- Dry mouth
- Constipation
Pregnancy No established drug-associated risk of major birth defects; third-trimester exposure risks neonatal extrapyramidal/withdrawal symptoms
Lactation Detected in human milk (relative infant dose 2-12%); monitor infant for sedation, poor feeding, extrapyramidal symptoms
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Classes and tags
Clinical profile
Mechanism of action: Haloperidol decanoate LAI ballicule
