Fluphenazine decanoate LAI

PROLIXIN DECANOATE

Open Fluphenazine decanoate LAI in the interactive console ↗

What it isLong-acting injectable D2 antagonist for schizophrenia maintenance (PROLIXIN DECANOATE, ~1972).

Why this oneIts q2-3-week sesame-oil depot is an economical first-generation alternative to haloperidol decanoate; single-dose apparent half-life ~7-10 days.

What limits itParkinsonism, akathisia and tardive dyskinesia dominate; neuroleptic malignant syndrome and prolactin elevation also occur.

FDA-approved for

schizophrenia (maintenance) (~1972)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs; fluphenazine decanoate is not approved for dementia-related psychosis.

FDA dosing	Population	Start	Target	Max
Prolonged parenteral antipsychotic therapy (e.g., chronic schizophrenia)	Adults (not for use in children under 12 years)	12.5–25 mg (0.5–1 mL) IM or SC to initiate	Adjust interval/dose to response; a single injection may control symptoms up to 4 weeks or longer	100 mg

Renal Undefined

Hepatic Undefined

If doses greater than 50 mg are needed, increase in 12.5 mg increments; dosage should not exceed 100 mg.

Instructions

Give IM or SC using a dry syringe and needle of at least 21 gauge
Consider initiating with shorter-acting fluphenazine to establish response before using the decanoate
Monitor hepatic/renal function and blood counts on long-term therapy

Contraindications

Suspected or established subcortical brain damage
Patients receiving large doses of hypnotics
Comatose or severely depressed states
Presence of blood dyscrasia or liver damage
Children under 12 years of age

Cautions

Tardive dyskinesia (potentially irreversible)
Neuroleptic malignant syndrome (NMS)
Falls (somnolence, postural hypotension, motor/sensory instability)
Leukopenia, neutropenia, and agranulocytosis
Lowered seizure threshold; use caution in convulsive disorders
Hepatic damage; hypotension
Elevated prolactin; anticholinergic potentiation; caution with heat exposure

Adverse reactions

Extrapyramidal symptoms (pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises)
Tardive dyskinesia
Drowsiness/lethargy
Hypotension, autonomic effects (dry mouth, constipation, blurred vision)
Blood dyscrasias; cholestatic jaundice

Pregnancy Use during pregnancy only if potential benefit justifies potential risk; third-trimester exposure risks neonatal extrapyramidal and/or withdrawal symptoms.

Lactation Undefined

⚠ BOXED WARNING